National Maternity and Perinatal Audit (NMPA)

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

Datasets: + HES-ID to MPS-ID HES Admitted Patient Care

Objective for processing

[1 paragraph unchanged] The aim of this Data Sharing Agreement (DSA) the National Maternity and Perinatal Audit (NMPA) is to collect Data which will provide a framework for the continuous [7 words unchanged] Trust and Health Board maternity services using a comprehensive set of measures. [6 paragraphs unchanged] • To produce a range of measures that will be published on the NMPA website through accessible and interactive tables and charts. • To produce a 'snapshot audit' as a core deliverable which will link the data of the NMPA with the National Neonatal Audit Programme (NNAP), the audit will provide important data for stakeholders on the neonatal outcomes of maternity care which have previously gone unreported. This is with a view to providing this data in the annual clinical report outputs of both NMPA & NNAP audits. [1 paragraph unchanged] • Maternity Services Data Set (MSDS) – necessary as the main source of maternity data for reporting on births in English maternity units from 2017/18 onwards onwards. [12 paragraphs unchanged] For women giving birth and babies being born in English maternity units [13 words unchanged] these individuals alongside clinical information from a range of sources. The data disseminated received under this Agreement however however, only contains minimal direct identifiers as described above. There will be no requirement and no attempt to re-identify individuals when using the Data disseminated under this Agreement. [13 paragraphs unchanged] Royal College of Paediatrics & Child Health (RCPCH) are the host organisations of the National Neonatal Audit Programme (NNAP) and also processers for the purposes of accessing NMPA data to produce findings across a range of clinical measures to monitor and improve maternity and neonatal care through clinical reporting, benchmarking, and development of quality improvement tools. [2 paragraphs unchanged]

Processing activities

[2 paragraphs unchanged] RCOG also holds the identifying details of women giving birth and babies [22 words unchanged] Intensive Care National Audit & Research Centre, the National Neonatal Research Database, Royal College of Paediatrics & Child Health (RCPCH) (NNAP), and variables manipulated from HES APC Data previously provided by NHS England. Original HES APC Data provided for these cohorts has been destroyed). [2 paragraphs unchanged] The Data will not be transferred to any other location. A subset of pseudonymised data will be onwardly transferred to Royal College of Paediatrics & Child Health (RCPCH) for the purposes of clinical reporting, benchmarking, and development of quality improvement tools. Data will be stored and backed up on the RCPCH Azure tenant, provisioned by Microsoft Ltd. [11 paragraphs unchanged] Access is restricted to substantive employees of RCOG or LSHTM who (who are named NMPA staff and have permission from the NMPA lead. lead). Separately, substantive employees Royal College of Paediatrics & Child Health (RCPCH) are permitted to access a subset of the NMPA data. [2 paragraphs unchanged] Statisticians/methodologists from the NMPA at the RCOG RCOG, LSHTM and LSHTM separately Royal College of Paediatrics & Child Health (RCPCH) will process and analyse the Data for the purposes described in ‘Objective [11 words unchanged] used to compare maternity services at site, trust, regional and national level.

Expected output

[17 paragraphs unchanged] The expected outputs of the processing relating to the linkage of the NNAP data will be: A snapshot audit will be conducted by RCOG to assess the process and reportable outcomes from the initial data linkage exercise. It is anticipated that ongoing linkage of neonatal and maternity identifiers will enable continued use of the combined dataset to generate meaningful insights. Royal College of Paediatrics and Child Health (RCPCH) will use the linked NMPA data to support their annual clinical report and to update the neonatal data dashboard. This dashboard includes publicly accessible aggregated reports, as well as a secure area where neonatal units can access their own data. The outputs will include new findings across a range of clinical measures, such as: • Assessing clinical activity, care processes, and outcomes for preterm babies who are not admitted to neonatal units. • Evaluating the proportion of babies receiving therapeutic cooling among those meeting a case definition for neonatal encephalopathy. • Timely measurement of admissions to neonatal care for late and moderate preterm babies, with a focus on alignment with NMPA denominators. • Monitoring the proportion of term babies admitted to neonatal units at any point during the first week of life.

Expected measurable benefits

[10 paragraphs unchanged] The audit’s reports produced by the NMPA and NNAP include recommendations to enable NHS Trusts and Health Boards to drive effective [7 words unchanged] aimed at the full spectrum of stakeholders (e.g., individual clinicians, maternity units, neonatal units, commissioners, or higher levels, depending on the issues). These recommendations also feed into quality improvement programmes in maternity care organised by the Royal College of Obstetrics and Gynaecology (RCOG), Royal College of Midwives (RCM) and Royal College of Paediatrics and Child Health (RCPCH). Each College runs regular regional meetings and the audit results feed into their processes with the aim of standardising the delivery of care and improving the culture of safety for service users. There is close discussion These recommendations also feed into quality improvement programmes in maternity and collaboration neonatal care organised by the Royal College of Obstetrics and Gynaecology (RCOG), Royal College of Midwives (RCM), Royal College of Paediatrics and Child Health (RCPCH) and British Association of Perinatal Medicine (BAPM). Each runs regular regional meetings and the audit results feed into their processes with other perinatal audits, e.g., NNAP (National Neonatal Audit Programme) the aim of standardising the delivery of care and MBRRACE (Mothers and Babies: Reducing Risk through Audits and Confidential Enquiries), with cross-linking to each other’s websites. improving the culture of safety for service users. This would bring a clear benefit for users of maternity and neonatal services and staff by making information more easily accessible and less difficult [22 words unchanged] championing tools and recommendations to improve standards of maternity and perinatal care. The NMPA ensures and NNAP ensure the voices of service users are heard throughout this work by incorporating women and families in the advisory groups of all the outputs. The NMPA and NNAP thread these voices though the reports in the form of qualitative quotations, quotations and photographs/art work, helping to add a contextual narrative to the findings from those who [16 words unchanged] hear from a range of people who have accessed maternity care and neonatal care, and how they interpret and understand the NMPA findings.

Benefits reported

[1 paragraph unchanged] This includes: This includes multiple continuous Clinical Report cycles (using data on births for 2015-2023), with reports published in November 2017, September 2019, October 2021, June 2022 and September 2025. • Four continuous Clinical Report cycles (using data on births for 2015/16-2018/19), with reports published in November 2017, September 2019, October 2021, and June 2022. • In 2021, the NMPA launched a ‘Rapid Reporting’ feature which produced data for trusts each 3 months using HES Data. This provided stakeholders with valuable information to improve their services, being able to see changes over time much more frequently. This has now been discontinued due to a request from NMPA funders. [9 paragraphs unchanged] Findings from the latest NMPA Organisational Survey show that NMPA data has been used in the following ways: • To make improvements in clinical practice or organisation of care within the Trust/Board (59% of respondents). • To make improvements in clinical practice or organisation of care in collaboration with other Trusts/Boards, the Local Maternity System or network (32% of respondents). • To inform women using the service (15% of respondents). • To guide local audit (50% of respondents). • To make improvements to data (44% of respondents). [2 paragraphs unchanged] The NMPA has worked closely with the Care Quality Commission (CQC) and HQIP to manage a successful outlier process for the first two NMPA Annual Clinical reports and remain in close contact regarding potential future [22 words unchanged] ensure a clear understanding of the technical specification of the measures provided. [1 paragraph unchanged]

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

Datasets: + Civil Registrations of Death; + MSDS (Maternity Services Data Set) v1.5; + Mental Health Minimum Data Set (MHMDS); + Mental Health Services Data Set (MHSDS) · − HES:Civil Registration (Deaths) bridge; − MRIS - Personal Demographics Service

Objective for processing

Purpose and Background of the Audit: The Healthcare Quality Improvement Partnership (HQIP) and NHS England (NHSE) require access to NHS England Data for the purpose of the National Maternity and Perinatal Audit (NMPA). The NMPA is a HQIP National Clinical Audit and Patient Outcomes Programme (NCAPOP) audit. The NMPA reports on care processes and outcomes related to delivery events and births among NHS Trust and Health Board maternity units across England, Wales and Scotland. While the majority of women giving birth in the UK receive a safe and effective service and the stillbirth rate for England and Wales has decreased by nearly a fifth over the last decade, it is still at the higher end of the spectrum across European countries (European Perinatal Heath Report, 2015). The aim of this Data Sharing Agreement (DSA) is to collect Data which will provide a framework for the continuous monitoring of processes and outcomes of NHS Trust and Health Board maternity services using a comprehensive set of measures. There is also evidence of substantial variation in the maternity care received by women during pregnancy and delivery across hospitals, as well as the outcomes. These patterns of variation are also not the same for women from different socio-economic and ethnic backgrounds. (Maternity Indicators Report, RCOG). The following is a summary of the aims of the audit: To address these issues, high quality information on the processes and outcomes of care is required so that clinicians, NHS managers and policy makers can examine the extent to which current practice meets the array of guidelines and standards, and to compare services and maternal and neonatal outcomes among maternity units. Pregnant women and their families also require this information to enable them to make a more informed choice between the services available to them. • To create and maintain a nationwide database containing all delivery events and births to enable the development of robust and clinically meaningful quality indicators for maternity care. These indicators facilitate the comparison of antenatal, intrapartum, and postnatal care patterns and identify determinants of variation in maternity services at the national, regional and provider levels. Maternity care is becoming increasingly high profile and is a subject of great public interest. The introduction of the Safer Maternity Care Action Plan in October 2016, and more recent updates to this in November 2017, which includes the National Maternity and Perinatal Audit (NMPA), highlight that maternity care is a priority area for the Secretary of State for Health. • To enable NHS maternity care providers to benchmark themselves against their peers using a set of quality indicators that the NMPA has developed. The NMPA is a Healthcare Quality Improvement Partnership (HQIP) National Clinical Audit and Patient Outcomes Programme (NCAPOP) audit, established in July 2016. it was established to deliver a clinically meaningful and methodologically robust audit of all NHS maternity services in England, Scotland, and Wales, to inform decision making by Clinical Commissioning Groups, policy makers and clinicians, and support maternity services to improve the quality of care and outcomes for mothers and babies. The NMPA is commissioned by HQIP on behalf of the English and Welsh Governments and the Health Department of the Scottish Government. It is being carried out by the Royal College of Obstetricians and Gynaecologists (RCOG), in partnership with the Royal College of Midwives (RCM), Royal College of Paediatrics and Child Health (RCPCH) and the London School of Hygiene and Tropical Medicine (LSHTM), all of which are registered charities. • To enable clinicians, NHS managers, and policy makers to examine the extent to which current practice meets the array of guidelines and standards, and to compare services and maternal and perinatal outcomes among maternity units. The audit has developed a set of performance indicators to allow maternity units to benchmark themselves against their peers. The indicators facilitate the comparison of antenatal, intrapartum, and postnatal care patterns and identify determinants of variation both regionally and nationally. • To enable pregnant women and their families to make a more informed choice between the services available to them. One of the key objectives of the audit is to create and maintain a nationwide database containing all deliveries to enable the development of robust and clinically meaningful quality indicators for maternity care. The team working day-to-day on the NMPA database who have access to the NMPA data are based at the RCOG and the LSHTM, hence including both organisations as data processors. • To provide a balanced set of quality indicators that are meaningful, valid, fair, have sufficient statistical power and precise technical specification. This enables NHS maternity care providers to understand how to compare the care they deliver and identify what constitutes as best practice. Very few auditable standards exist in maternity care that can be measured via a national audit, and for many outcomes there are no clear acceptable ranges. Without such standards it can be challenging for those providing NHS maternity care to understand how to compare the care they deliver and what constitutes best practice. The NMPA aims to address these issues by providing a balanced set of clinical measures that are meaningful, valid, fair, and have sufficient statistical power and precise technical specification. The following NHS England Data will be accessed: Data Controllership: • Maternity Services Data Set (MSDS) – necessary as the main source of maternity data for reporting on births in English maternity units from 2017/18 onwards This agreement has Joint Data Controllership - consisting of the Healthcare Quality Improvement Partnership (HQIP) and NHS England. • Hospital Episode Statistics Admitted Patient Care (HES APC) – necessary to provide additional information on mothers and babies (e.g. socio-demographic characteristics), the care received (e.g. procedures that took place during delivery) and pregnancy risk factors or outcomes (e.g. diagnoses recorded) that complement the information provided in maternity datasets. These additional information shed light on the characteristics (“case-mix”) of the population accessing each provider, which is essential in performing risk-adjustment of the audit results (and enable a fair comparison between providers). HES APC also provides historical/future care records for mothers and babies, which is essential to identify risk factors and co-morbidities (e.g. outcomes of previous deliveries) and measure outcomes that are not observed immediately during or shortly after delivery (e.g. complications that require readmission to hospital). 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. • Office for National Statistics (ONS) register of live births and stillbirths, and the Personal Demographics Service (PDS) birth notification dataset which together form the “Birth Notification Data” - necessary for linkage of mother and baby records, case ascertainment and validation of key variables in maternity datasets. 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. • Civil registration of deaths - necessary to identify maternal and neonatal mortality cases in the cohort. Legal Basis Justification: • Mental Health Data Sets (MHMDS, MHSDS) – necessary for the purposes of a snapshot audit on perinatal mental health services. 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. Collectively, the Births Notification Data, MSDS and HES APC Data are used to identify all delivery and birth episodes in English NHS maternity units for cohorts relating to each financial year from 2017/18 onwards. HQIP rely on Article 9 (2)(i) as the legal basis for processing special category data 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. Only data items which are necessary for the Audit are requested, with one or more of the following purposes: NHS England rely on Article 9(2)(h) of the 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". NHS England are responsible for provision of health and social care, and management of systems and compliance. • to determine which provider or maternity unit administered the care Format of the audit: • to determine the quality of care for the service user The NMPA collects data on all registrable births (including live births before 24 weeks of gestation and stillbirths after 24 weeks of gestation) delivered under NHS care (including NHS home births) in England and Wales. Data are reported at hospital, trust/board, and national level. • to determine the nature of the episode and diagnosis The selection of measures for the NMPA was guided by a panel of clinical and academic experts, including obstetricians, midwives, statisticians, and health service researchers, as well as the NMPA Women and Families Involvement Group and organisations representing maternity and neonatal service users. A range of measures is available and reported via accessible and interactive tables/charts on the NMPA website and in the clinical reports. Three of these measures (third- and fourth-degree tears, obstetric haemorrhage, and Apgar score at five minutes of age) are used for potential outlier reporting. • to determine the case-mix of service users with a particular provider or maternity unit The NMPA does not rely upon bespoke data collection methods and does not limit the set of performance indicators produced by the continuous prospective audit to those indicators that have ‘auditable standards.’ • to determine the health outcomes for the service user There are three main reasons for this: The level of the Data will be identifiable, due to the inclusion of one identifiable variable: Baby date and time of birth. This information is necessary to derive audit measures such as readmission within 6 weeks of delivery (which requires comparing hospital episode dates with the date of delivery); to validate other data fields that have date/time of procedures or stages of labour and delivery; to derive other time dependent measures such as duration of labour, time between decision to delivery; and to assist with determining whether there has been a multiple birth, or whether records are duplicates. • Maternity care is complex and focusing on a small number of care processes would inappropriately ignore some strong associations between the processes and outcomes of maternity care; For women giving birth and babies being born in English maternity units between April 2015 and March 2017, the RCOG holds the identifying details of these individuals alongside clinical information from a range of sources. The data disseminated under this Agreement however only contains minimal direct identifiers as described above. There will be no requirement and no attempt to re-identify individuals when using the Data disseminated under this Agreement. • A wider set of indicators will allow maternity units to compare their antenatal, intrapartum and postnatal care patterns, which will prompt units to reflect on less common patterns, even in the absence of evidence-based guidelines; The Data will be minimised as follows: • Additional analyses aiming to identify determinants of variation in maternity services (‘epidemiology of the quality of maternity care’) will be possible, which will provide explicit guidance for quality improvement initiatives. • Limited to cohorts identified by NHS England as 1) women who gave birth and babies whose birth was registered in English maternity units from 2017/18 onwards, and 2) women who gave birth in English maternity units from 2004/05 – 2017/18. The latter cohort enables the obstetric history of women in the former cohort to be determined. The NMPA delivers clinically meaningful and methodologically robust outputs that guide quality improvement initiatives at local and national level. This is accomplished by providing: • The RCOG holds cohort data for women who gave birth and babies whose birth was registered in English maternity units from 2015/16 – 2016/17, as collected directly from maternity units. Limited analysis variables are retained for this cohort. • A continuous clinical audit that produces information for maternity units to monitor patterns of care and maternal and perinatal outcomes. Data for the continuous clinical audit include maternity data (such as Maternity Services Data Set (MSDS) for England and MIds for Wales) and routinely collected data on hospital episodes (such as Hospital Episode Statistics for England and PEDW for Wales) HQIP has commissioned the Royal College of Obstetricians and Gynaecologists (RCOG) to undertake the work. NHSE are the funders of the work for the English aspect of the audit. HQIP and NHSE are the controllers as the organisations responsible for ensuring that the Data will only be processed for the purpose described above. • A quarterly updated frequent online dashboard of data, “Rapid Quarterly Reporting” which shows English trusts their most recently available HES data to provide up-to-date information to facilitate quality improvement. The lawful basis for processing personal data under the UK GDPR for HQIP and NHSE is: • A series of in-depth topic-specific, time-limited audits “sprint audits” predominantly focusing on specific types of maternal and neonatal outcomes. Data for the sprint audits are collected following permission and approvals for access to datasets relevant to selected topics. Sprint audits on bloodstream infections and induction of labour currently in development. Sprint audits on Inequalities, Multiple Births and BMI have already been published. 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 NMPA first used the MSDS as the main source of maternity data for reporting on English births in 2017/18 and 2018/19. Prior to this, the NMPA used data extracted from NHS hospitals’ electronic maternity record systems/maternity information systems (MIS) for reporting in England for 2015/16 and 2016/17 reports. These databases include information along the complete care pathway, from antenatal booking through to postnatal care. The lawful basis for processing special category data under the UK GDPR for HQIP is: For England, NMPA also uses routinely collected data from HES which contains administrative information about each hospital admission, including deliveries. This data is necessary for several reasons. Firstly, knowledge of hospital admissions and diagnoses during and after delivery allows an understanding of maternal and neonatal outcomes and gives a greater level of detail on treatments that took place during delivery. Secondly, knowledge of diagnoses before delivery sheds light on case-mix, which is essential in performing risk-adjustment of the audit results (which enables a fair comparison between providers). Finally, the completeness of routine hospital episode datasets is very high, and thus it is used to validate data extracts from MSDS. 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. In the previous data request (v5), the NMPA reduced the complexity of the data request compared to the previous DARS agreements with the aim of ensuring data can be produced for those using NMPA data as quickly as possible. The current (v7) data request is aligned with v5, further simplified with respect to cohort definitions, with the addition of more recent data for MSDS. The key components in NMPA request for English data are: The lawful basis for processing special category data under the UK GDPR for NHSE is: • As with v5, the NMPA will not provide a cohort for linkage to current or previous data extracts. The data cohort will be restricted to babies/mothers as identified in respective datasets (HES APC, MSDS v2.0 and PDS Birth Notification dataset). Article 9(2)(h) - 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. • To improve the timeliness and relevance of outputs for maternity services providers and users, the NMPA will produce indicators using the most recent available data, with plans for incorporating MSDS in the quarterly data production and dissemination. Therefore, available data is requested on a quarterly basis (as in v5). The processing is in the public interest because the audits aim to drive improvements in the quality and safety of care and to improve outcomes for all deliveries and births occurring in maternity units. • The PDS Birth Notification dataset will be the “spine” to which all other NHS datasets will link to and furthermore will allow mothers’ and babies’ records to be linked since it contains the NHS number for the mother as well as for the baby. Royal College of Obstetricians and Gynaecologists (RCOG) and London School of Hygiene and Tropical Medicine (LSHTM) are processors acting under the instructions of HQIP and NHSE. The role of both RCOG and LSHTM is limited to maintaining and analysing the database of deliveries and births in English NHS Trusts, to enable the development of robust and clinically meaningful quality indicators for maternity care and generate outputs aligned with the aims of the NMPA. • Historical data (for HES APC M13 cohort, regular, annually) is requested for current and previous year only, to allow for identification of co-morbidities and other APC activity during pregnancy (for the mother) and for measurement of adverse outcomes after birth (e.g. readmissions for any reason for the mother and the baby). Both institutions will be processing the Data via the RCOG’s secure server, hosted by Microsoft Azure. Microsoft Limited will store the Data as contracted by the RCOG. • Data on all deliveries (for pre-2018, one-off) is requested to allow for identification of obstetric history for current and all future cohorts. The NMPA is carried out by RCOG in partnership with LSHTM, Royal College of Midwives (RCM), and Royal College of Paediatrics and Child Health (RCPCH). The RCOG is the host organisation of the audit, with the LSHTM, RCM and RCPCH being represented on the project board to provide clinical and methodological direction for the audit. • The NHS numbers will be pseudonymised and encrypted before being returned to the NMPA team, using the same encryption methods, allowing for both across-dataset and longitudinal linkages. The selection of measures for the NMPA was guided by a panel of clinical and academic experts from RCOG, RCM, RCPCH and LSHTM, including obstetricians, midwives, neonatologists, statisticians, methodologists and health service researchers, as well as the NMPA Women and Families Involvement Group (WFIG), and organisations and charities representing maternity and neonatal service users. The WFIG in particular provide regular input on all outputs of the audit, including deciding on the measures of the audit, choosing recommendations and ensuring clearly accessible language is used throughout the NMPA’s work. A range of measures is available and reported via accessible and interactive tables/charts on the NMPA website and in the clinical reports. Data requests (source, cohort, frequency) are summarised as below: Primary data request, for the NMPA’s Annual Clinical Report & Rapid Quarterly Reporting: (REGULAR data request) MSDS: • Cohort: all women who gave birth and all babies born in England, as available in the MSDS extracts • First dataset to be provided from 1 April 2019 to most recent quarter • Quarterly refreshes thereafter HES APC: • Cohort: all women who gave birth and all babies born in England, as per the HES data specification/filters provided by the NMPA (ICD10/OPCS4 codes for both deliveries and births) • NMPA holds data from 1 January 2018 to most recent quarter • Quarterly refreshes continued as per existing data flows (set in v5) • In Quarters 1-3, cohort as defined above, no historical data • In Quarter 4, M13 data to be provided for the cohort defined as above + historical data for current and previous year for the M13 cohort (e.g. 22/23 Quarter 4 to include all “clinical history”, including maternity and other HES APC records for 21/22 and 22/23). Civil Registration Mortality data: • Cohort: all women who gave birth and all babies born in England, as identified in HES (+MSDS, +PDS depending on whether data drop includes these datasets) • Quarterly refreshes continued as per existing data flows (set in v5) Quarterly refreshes of MSDS/HES/Civil Registration to be aligned (e.g. if the first MSDS extract is up to the most recent quarter of HES/Civil Registration; further quarterly refreshes would be covering exactly the same period) PDS Births Notifications data: • Cohort: all women who gave birth and all babies born in England, as identified in PDS Births Notifications data • Refreshes as available (minimum annually) • Addition to current PDS Birth Notification data specification: NMPA would also like to include “baby sex” variable which was omitted in v5 request. This is requested to improve data linkage across data sources. Secondary data request, for “obstetric history”, pre-2018: (ONE-OFF data request) • Delivery episodes as identified by HES data specification/filters provided by the NMPA (ICD10/OPCS4 codes for deliveries only) are requested, no historical data • For the period 2004/05 to 2017/18. Reason for requiring these data: Use of routinely collected data will minimise - if not eliminate - the burden on clinical staff of data collection for the sole purpose of the audit. It is required that extracts from each dataset contain all records from the specified cohorts, both linked and unlinked. Linkage of the data sources at the patient level and access to historical data has several advantages for the Audit. Data linkage and historical data will enable: 1) information to be provided on longitudinal patterns of care, for example, hospital readmission following delivery. 2) information to be collected on the clinical history of the women before pregnancy, their comorbidities and their health service use during pregnancy which is important for case-mix adjustment. All “clinical history” for the cohort is requested for the perinatal period only (during pregnancy and immediate post-natal). “Obstetric history” will cover at least 15 years. 3) validation of data from each source. Linkage of mothers and babies will enable: 1) all data items to be collated from babies and mother’s records for each delivery. 2) higher data quality for data items common to both babies and mother’s records (i.e. by cross-validation and/or completion of missing records) 3) measurement of the extent to which maternal characteristics and maternity care has an impact on baby outcomes. The unlinked records from these datasets are also being requested as this will enable the audit to assess their case ascertainment and whether maternity units are submitting all of their cases accordingly. The only identifier that is requested across the extracts is babies’ date/time of birth (i.e. date/time of delivery) - for which s251 support is in place. The date/time of birth field is essential to the audit for the following reasons: • To derive audit measures such as readmission within 6 weeks of delivery (which requires comparing hospital episode dates with the date of delivery) • To validate other data fields that has date/time of procedures or stages of labour and delivery, and to derive other time dependent measures such as duration of labour, time between decision to delivery • To assist with determining whether there has been a multiple birth, or whether records are duplicates. The audit will provide all NHS providers, commissioners and clinical networks with individualised feedback on the quality of care provided and maternal and neonatal outcomes. Patients and the wider public will have access to lay summaries of all audit outputs. A national report will also be created, written by clinicians, to provide key insights into the data with key messages and recommendations provided. The NMPA was commissioned on the basis that the above datasets would be linked for the purposes of the audit, and this is reflected in the audit contract with HQIP.

Processing activities

Purpose: No data will flow to NHS England for the purposes of this Data Sharing Agreement (DSA). The datasets requested by the NMPA will provide a framework for continuous monitoring of processes and outcomes of maternity services using a comprehensive set of measures, for example: NHS England will provide the relevant records from the HES Admitted Patient Care, Civil Registrations of Death, Maternity Services Data Set, Mental Health Datasets, and Birth Notification and Registration datasets to RCOG. The Data will contain directly identifying data items, comprising baby’s date and time of birth only for the reasons outlined in ‘Objective for Processing’. Each dataset will contain the same unique person ID to allow records from different datasets to be attributed to the same individual. - Rates of obstetric haemorrhage of 1500ml or more; RCOG also holds the identifying details of women giving birth and babies being born in English maternity units between April 2015 and March 2017 alongside clinical information from a range of sources (including the Intensive Care National Audit & Research Centre, the National Neonatal Research Database, and variables manipulated from HES APC Data previously provided by NHS England. Original HES APC Data provided for these cohorts has been destroyed). - Rates of third- and fourth degree tears among vaginal births; There will be no requirement and no attempt to re-identify individuals when using the Data. - Rates of singleton babies born at term with a five-minute Apgar score below 7. The Data will be stored and backed up on the RCOG’s Azure tenant, provisioned by Microsoft Ltd. These measures will be used to compare maternity services at national, regional and provider level. The development of these indicators has been guided by criteria related to validity, statistical power, fairness, and the appropriateness of the technical coding. The Data will not be transferred to any other location. Longitudinal/historical data allows for the detection of trends in patterns of care and in data quality over time, which is important in order to understand the audit’s results and to put them into context. The Data will be accessed by authorised personnel via remote access. Cohorts: The Controller(s) must confirm and provide evidence upon audit by NHS England that access via any remote device complies with the data security obligations within this DSA and the Data Sharing Framework Contract. The eligible cohort of individuals whose data is to be collected by the National Maternity and Perinatal Audit during the period of this version of the proposed Data Sharing Agreement with NHS England (v7) is all women who gave birth from 1 April 2019, and babies whose birth was registered in this period. Since this is a national audit, data from all NHS Trusts are required. For remote access: NHS England will be creating the eligible cohort based on data specification/filters provided by the NMPA: these data specifications and frequency of cohort derivation differ by data source as well as data availability at NHS England and existing data flows to NMPA. • Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA; Primary data request • Access controls granting users the minimum level of access required are in place; • MSDS (regular updates): All babies born and all women who gave birth between 1 April 2019 to latest quarter, updated quarterly • Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data; • HES APC (regular updates): All babies born and all women who have birth, extracted of HES delivery and birth records filtered via ICD10/OPCS codes, updated quarterly, with the last quarter’s cohort in the year derived from M13 data. NMPA currently holds HES APC extracts, updated quarterly, using this cohort definition from 2018Q1 to 2022Q2. • Multifactor authentication (MFA) is required for remote access; • PDS Birth Notifications data (regular updates): All babies born and all women who have birth, updates as available (minimum annually) • Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access; Secondary data request • All remote access is undertaken within the scope of the organisation’s DSPT (or other security arrangements as per this DSA) and complies with the organisation’s remote access policy. • HES APC (one-off data): All delivery records filtered via ICD10/OPCS codes between 1 April 2004 to 1 January 2018 (mothers’ records only). The above applies in addition to any condition set out elsewhere within the DSA (e.g. who may carry out processing, and for what purpose). For HES APC M13 cohort (primary data request, regular updates), current year and previous year’s historical HES APC data records is required. Historical data enables information on longitudinal patterns of care and on the clinical history of the women before pregnancy, their comorbidities and their health service use during pregnancy which is important for case-mix adjustment. Remote processing will be from secure locations within the UK. The Data will not leave the UK at any time. Data specification and minimisation: Access is restricted to employees of RCOG or LSHTM who are named NMPA staff and have permission from the NMPA lead. The cohort will be restricted to all as identified in PDS Birth Notification, MSDS v2.0 and HES APC respective data specifications as provided by the NMPA. There are approximately 650,000 births in England per annum, therefore the cohort will include 1.3 million individuals (mothers and babies) per year, and 325,000 individuals for each quarterly update. All personnel accessing the Data have been appropriately trained in data protection and confidentiality. All available data (linked or unlinked) from the PDS birth notification data set, HES APC, MSDS (including babies’ and mothers’ data), Civil Registration Mortality dataset will be returned to the NMPA, linked with the pseudonymised NHS number by NHS England. The only identifier that will be disseminated across the extracts is babies’ dates of birth - for which s251 support is in place. All other patient identifiers will be removed. The aggregated information derived from the Data may be combined with aggregated data from other sources. Only data items which are necessary for the Audit are requested, with one or more of the following purposes: Statisticians/methodologists from the NMPA at the RCOG and LSHTM will process and analyse the Data for the purposes described in ‘Objective for Processing’. The audit will produce performance indicators that will be used to compare maternity services at site, trust, regional and national level. • to determine which provider or maternity unit administered the care (for which potentially identifiable patient data is necessary); • to determine the quality of care for the service user; • to determine the nature of the episode and diagnosis; • to determine the case-mix of service users with a particular provider or maternity unit (for which potentially identifiable patient data is necessary); • to determine the health outcomes for the service user. All of MSDS’s non-sensitive variables have been requested as it is imperative for the audit to capture the maternity care pathway and pregnancy outcomes for all births in England. The only identifiable information requested is baby's time and date of birth which is essential to the audit as described earlier. Data drops (also see supplementary file on further information for the production team): 1: Initial data drop (covering period from 1 April 2019 to most recent quarter) - NHS England to supply MSDS v2.0 from 1 April 2019 to latest quarter available. - Continue to supply quarterly refreshed HES APC data extracts to latest quarter available. - Supply refreshed PDS Birth notifications data to latest date available - Continue to supply quarterly refreshed Civil Registration Mortality data extracts to latest quarter available If at the time of the initial data drop, the most recent quarter is M13: - Supply M13 HES APC data extract. - Supply previous year’s and all future available historical HES APC records for the M13 cohort. The MSDS v2.0 is requested for the latest quarter available (rather than latest date available) to align the schedule with HES APC regular data drops. 2: Regular data drops: - Continue to supply quarterly refreshed HES APC data extracts. In the fourth quarter drop in the year, replace the drop with M13; also provide previous year’s and all future available historical HES APC records for the M13 cohort (e.g. for 22/23 fourth quarter, supply all HES APC from 21/22 to most recent available date for the M13 cohort, including all mothers and babies, and all records - not limited to maternity records). - Supply quarterly refreshed MSDS v2.0 data extracts - Supply quarterly refreshed Civil Registration Mortality data extracts - Supply refreshed PDS Birth notifications data (as available, minimum annually) 3: One-off data request - Supply HES APC data extract for 2004/5 to 2017/8, defined by “HES delivery filters” - Only HES APC episodes identified using the filters are requested, no “cohort” generation or historical data needed. Data environment: The NMPA stores data on a secure server within the secure NHS N3 network/Health and Social Care Network (HSCN). The secure server is leased from RedCentric by the RCOG and is based at the RedCentric site in Reading, with backups located at the RedCentric Harrogate site. Files can only be transferred onto/off the server by four individuals on the NMPA team with ‘Data manager permissions’. These individuals are the NMPA data manager, NMPA analysts (x2) and the NMPA senior methodologist. When data are received from NHS England via the SEFT system, the nominated individual (NMPA Senior Methodologist) will immediately securely transfer (via SFTP) the data to the secure NMPA server. The NMPA have access to data erasure software (Blancco) for the destruction of any data when necessary. All analysis of the data takes place on the secure server hosted by RedCentric. Terms & conditions: 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). Additional information on other s251 approved data processing activities in the NMPA: Please note that in previous NMPA data requests (up to v4), the NMPA team provided a cohort to NHS England for linkage to current or previous data extracts. s251 support remains valid and in place for the NMPA to continue to hold and process the data that was facilitated via this linkage of a specified cohort under previous iterations of this agreement. The audit's section 251 support also lists several further linkages that are permitted. These include linkage to ICNARC, PHE's Surveillance Systems and BadgerNet Neonatal Data. The intensive care and neonatal care data is linked to the maternity data NMPA currently holds for April 2014 to March 2017, using identifiers they have collected along with the maternity data from NHS trusts. This allows for additional data to be obtained on maternal admissions to intensive care units and admissions to neonatal units for babies born. The PHE data is expected to be linked in the future but is not currently linked. This will allow for additional data on blood stream infections to be provided. Linkage with PHE data will require a further amendment since NMPA do not hold identifiers (apart from babies’ dates of birth) for births after April 2017.

Expected output

From the start of the audit, a reporting framework has been developed that produces frequent, individualised, and timely outputs using online feedback to NHS providers, commissioners, and networks. All the outputs are written in a language that is accessible to the public. There are a number of different approaches to report the results: The expected outputs of the processing will be: 1. Annual Clinical Reports are used by NHS trusts to monitor the quality of maternity care they provide, maternal and perinatal outcomes and trends over time. Variation in outcomes is reported, carefully adjusted for differences in case-mix. The first annual report was published on 9th November 2017, with the second report published in July 2019. The 2021 annual report was based on the 2017/18 Maternity Services Data Set (MSDS v1.5) which was received under v4 of this agreement and published in October 2021. The 2022 annual report is based on the 2018/19 Maternity Services Data Set (MSDS v1.5) which was received under v5 of this agreement and will be published in Spring/Summer 2022. The reports are available on the audit website and do not contain any identifiable data. All data displayed in the report is aggregated with small number suppression in line with the HES analysis guide. • Annual Clinical Reports. These are used by NHS Trusts and Health Boards to monitor the quality of maternity care they provide, maternal and perinatal outcomes, and trends over time and include the following: 2. Rapid Quarterly Reporting feature, launched in March 2022 provides timely and more frequent data for providers. This is provided on the audit website and provides timely information on maternity care practices and the outcomes of women and families using NHS maternity services in England. It reports results for each English Trust as well as nationally. The data is more timely but less detailed than the data used for the Clinical Audit results for England. - A full report, written by clinicians and statisticians to provide key insights into the data with key messages and recommendations provided, aimed at clinicians and decision makers. The above online reports have been set up to allow individual providers, commissioners, and relevant clinical networks to benchmark their process and outcomes indicators against care provided nationally and regionally. These reports are designed to facilitate the use of national data for local audit activities. Moreover, the audit supports English maternity units to contribute to the Quality Accounts. The reports do not contain any patient identifiable information. - Online interactive tables and graphs of the report’s results. 3. Reports of periodic time-limited, topic-specific audits are produced at least annually, allowing a more detailed and in-depth insight into specific aspects of the care provided by maternity services. Several of these reports have been published, including a report on maternity care for women with a BMI>30 and a report on Inequalities by ethnicity and socio-economic deprivation. The aim of each “sprint” audit is to investigate the extent to which further insight into the quality of maternity care can be gained by using additional datasets. If the datasets used in the sprint audits are found to add significant value, they will be incorporated into the continuous clinical audit in future years. • Reports of periodic time-limited, topic-specific audits (“snapshot audits”). These will be predominantly focusing on specific types of maternal and neonatal outcomes. 4. The audit team have produced and continue to produce manuscripts to submit for peer-reviewed publications, especially related to the additional analyses aiming to identify determinants of variation in maternity services and methodological development work (e.g., risk adjustment, handling of missing data, continuous monitoring, combining multiple linked indicators to assess maternity unit performance, design of outputs that are most effective in local quality improvement). The types of journals the audit has been published in include clinical journals such as The Lancet, Plos Med, American Journal of Obstetrics and Gynecology, British Journal of Obstetrics and Gynaecology, as well as methodological journals such as the Journal of Clinical Epidemiology and the BMC Health Services Research. • An online resource (the Family Gateway) which will provide printable content aimed at women and birthing people • Lay summaries of all audit outputs (annual reports, snapshot audit) including professionally designed infographics, aimed at service users, their families and the wider public. • Submissions to peer reviewed journals. These aim to identify determinants of variation in maternity services and methodological development work. The outputs 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 target dates for production and dissemination of the outputs are 6-12 months following receipt of the data, and then each year in Spring for subsequent annual reports. The outputs will be communicated to relevant recipients through the following dissemination channels: • Main audit website (www.maternityaudit.org.uk) and on HQIP’s website (https://www.hqip.org.uk/a-z-of-nca/maternity-perinatal-audit/). • HQIP’s National Clinical Audit Benchmarking (NCAB) online portal – https://ncab.hqip.org.uk/reports/card/audits/NMPA/. • Social media via the NMPA X (formerly Twitter) account and partner organisations such as the RCOG, RCM and RCPCH. • Briefing documents and launch communications provided to stakeholder organisations represented on the NMPA Clinical Reference Group such as The Twins Trust, Maternity Voices Partnerships and Sands. • Conferences and events where NMPA has a presence such as RCOG Congress and the BAPM Conference. • Journals (e.g., The Lancet, British Medical Journal, PLOS Med, American Journal of Obstetrics and Gynaecology, British Journal of Obstetrics and Gynaecology, Journal of Clinical Epidemiology, and BMC Health Services Research).

Expected measurable benefits

The NMPA has implemented an active engagement strategy, communicating in a way that is accessible to all stakeholders. The audit team is committed not just to the reporting of the results of the audit in annual reports but to ensuring that the results lever local change and quality improvement. The evidence-based clinical indicators derived in the audit are used by maternity units to assess their performance and compare it with others. Information is made publicly available, including key results at individual maternity unit level where available. This informs decisions made by local managers on policies and procedures within maternity units, and also enables women and families using services to engage in informed conversations with health service providers regarding their care. The audit ensures that appropriate comparisons can be made to allow an assessment of whether local maternity units are meeting relevant standards of care. The findings of this audit are therefore expected to inform best practice to improve the care, treatment, and experience of women who give birth and babies who are born in NHS Trust or Health Board maternity units. The audit provides robust and rigorous evidence to NHS maternity service providers and to inform decisions on prioritising services for commissioning through its website (www.maternityaudit.org.uk) and various other communications channels. The use of the Data could: In the future, it is hoped that results from the audit will relate patterns of care to maternal and neonatal outcomes, guiding policies on, for example, the situations in which induction of labour lead to better or worse clinical outcomes. This will have a direct impact on clinical practice. • help the system to better understand the health and care needs of populations. The evidence-based clinical indicators derived in the audit are used by maternity units to assess their performance and compare it with others. Information is made publicly available, including key results at individual maternity unit level where available via the NMPA ‘results’ area of the website, data are made available to registered users from Trusts and Sites two weeks before the data is publicly available in this area of the website. This informs decisions made by local managers on policies and procedures within maternity units, and also enables women and families using services to engage in informed conversations with health service providers regarding their care. The audit ensures that appropriate comparisons can be made to allow an assessment of whether local maternity units are meeting relevant standards of care. • lead to the identification or improvement of treatments or interventions, or health and care system design to improve health and care outcomes or experience. The audit’s reports include recommendations to enable NHS Trusts and Health Boards to drive effective local quality improvement initiatives. The recommendations are aimed at the full spectrum of stakeholders (e.g., individual clinicians, maternity units, commissioners, or higher levels, depending on the issues). These recommendations also feed into quality improvement programmes in maternity care organised by the RCOG, RCM and RCPCH. Each College runs regular regional meetings and the audit results feed into their processes with the aim of standardising the delivery of care and improving the culture of safety for service users. Giving birth is the most common reason for admission to hospital in the UK, with approximately 700,000 births per year throughout England, Scotland, and Wales. Thus, each benefit described above has the potential to positively affect the experience of maternity care for a very large number of women and their families. The NMPA ensures the voices of service users are heard throughout this work, not least by incorporating women and families in the advisory groups of all the outputs. The NMPA thread these voices though the reports in the form of qualitative quotations, helping to add a narrative to the findings from those who use services. This also supports quality improvement by enabling service providers and wider stakeholder groups to hear from a range of people who have accessed maternity care and how they interpret and understand the NMPA findings. • advance understanding of regional and national trends in health and social care needs. • inform planning of 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). Giving birth is the most common reason for admission to hospital in the UK, with approximately 700,000 births per year throughout England, Scotland, and Wales. Thus, each benefit described above has the potential to positively affect the experience of maternity care for a very large number of women and their families. The audit’s reports include recommendations to enable NHS Trusts and Health Boards to drive effective local quality improvement initiatives. The recommendations are aimed at the full spectrum of stakeholders (e.g., individual clinicians, maternity units, commissioners, or higher levels, depending on the issues). These recommendations also feed into quality improvement programmes in maternity care organised by the Royal College of Obstetrics and Gynaecology (RCOG), Royal College of Midwives (RCM) and Royal College of Paediatrics and Child Health (RCPCH). Each College runs regular regional meetings and the audit results feed into their processes with the aim of standardising the delivery of care and improving the culture of safety for service users. There is close discussion and collaboration with other perinatal audits, e.g., NNAP (National Neonatal Audit Programme) and MBRRACE (Mothers and Babies: Reducing Risk through Audits and Confidential Enquiries), with cross-linking to each other’s websites. This would bring a clear benefit for users of maternity services and staff by making information more easily accessible and less difficult to find. Combination of each organisation’s knowledge and expertise, and collaboration between these audits is expected to provide a stronger voice in championing tools and recommendations to improve standards of maternity and perinatal care. The NMPA ensures the voices of service users are heard throughout this work by incorporating women and families in the advisory groups of all the outputs. The NMPA thread these voices though the reports in the form of qualitative quotations, helping to add a contextual narrative to the findings from those who use services. This also supports quality improvement by enabling service providers and wider stakeholder groups to hear from a range of people who have accessed maternity care and how they interpret and understand the NMPA findings.

Benefits reported

The NMPA delivers a clinically meaningful and methodologically robust continuous clinical audit that guides quality improvement initiatives at local and national level. The results and reports generated by the NMPA can be used by clinicians, policymakers, commissioners and women to reflect on maternity and perinatal care in Britain. This has been welcomed across the three countries and three professions of obstetrics, midwifery and neonatology. A number of key reports have been created which have led to the identification of good practice and areas of improvement in the care of mothers and babies, and the understanding of the determinants of variations across providers The reports also identified gaps in data quality which have been reported back to the maternity units as well as data providers. A number of key reports have been created: This includes: • Four continuous Clinical Report cycles completed using the most recent (using data available to the NMPA (births in 2015/16, 2016/17, 2017/18 and 2018/19), on births for 2015/16-2018/19), with reports published in November 2017, September 2019, October 2021 2021, and May 2022 (expected). June 2022. • Two Organisational Survey Reports (2017 and 2019) completed and published. Both organisational reports received a 100% response rate, demonstrating the ongoing commitment of the maternity and neonatal services to work with the NMPA for the purpose of improving care provision. • In 2021, the NMPA launched a ‘Rapid Reporting’ feature which produced data for trusts each 3 months using HES Data. This provided stakeholders with valuable information to improve their services, being able to see changes over time much more frequently. This has now been discontinued due to a request from NMPA funders. • Rapid Quarterly Reporting was launched in March 2022, with the first set of results covering September 2020 to September 2021. The quarterly update, covering births up to January 2022 is expected to be online in June 2022. The NMPA has also developed several snapshot audits which have provided valuable information and timely recommendations on specific topics. These reports share findings and generate recommendations for various audiences including Trusts and Health Boards, data providers and policy makers. The NMPA has also developed several sprint audits which have provided valuable information and timely recommendations on specific topics. These reports share findings and generate recommendations for various audiences including Trusts, data providers and policy makers: This includes: • Ethnic and Socio-economic Inequalities in NHS Maternity and Perinatal Care for [8 words unchanged] from births between 1 April 2015 and 31 March 2018 across England, Scotland Scotland, and Wales (published in 2021) 2021). This led to a webinar held by the RCOG attended by a wide range of speakers, including Five X More, Bell Ribeiro-Addy MP, and Jacqueline Dunkley-Bent on the importance of the findings and recommendations, particularly with calls for joint actions between organisations to improve care. • NHS Maternity Care for Women with a Body Mass Index of 30 kg/m2 or Above, births between 1 April 2015 and 31 March 2017 in England, Wales Wales, and Scotland (published in 2020) 2020). The group ‘BigBirthas’ was involved in the creation of this report, providing lay input, and mentioned in a blog how this report allowed to them to understand limitations in the data and support recommendations in the report to improve data collection. • Technical report: Feasibility of evaluating perinatal mental health services, based on births between 1 April 2014 and 31 March 2017 in Scotland (published 2021) • Technical Report: Linking the National Maternity and Perinatal Audit Data Set to the National Neonatal Research Database for 2015/16, which then allowed reporting of neonatal unit data in 16/17 clinical report (published in 2019). The findings from this report were presented to national and international obstetric and neonatal colleagues at scientific meetings organised by British Association of Perinatal Medicine (BAPM), the neonatal Managed Clinical Network (MSN) for Scotland, and RCOG Congress. • Maternity Admissions to Intensive Care in England, Wales and Scotland in 2015/16 (published 2019) • NHS Maternity Care for Women with Multiple Births and Their Babies (published in 2020). The results from this report have been cited in reports by the Maternity and Newborn Safety Investigations (MNSI (formerly Healthcare Safety Investigation Branch (HSIB)) and Each Baby Counts (EBC), as well as the Royal College of Nursing (RCN) Multiple Births Midwife Standard document. The report has been supported and publicised by Twins Trust and Association for Improvements in Maternity Services (AiMS) charities. • Technical Report: Linking the National Maternity and Perinatal Audit Data Set to the National Neonatal Research Database for 2015/16, which then allowed reporting of neonatal unit data in 16/17 clinical report (published 2019) The outputs from the “Ethnic and Socio-economic Inequalities in NHS Maternity and Perinatal Care for Women and their Babies” have been cited in a recent report from the House of Commons Women and Equalities Committee on Black maternal health and the Muslim Women’s Network report on Maternity Experiences of Muslim Women from Racialised Minority Communities. The report contributed to bringing attention to the issue of maternal health ethnic and socio-economic disparities that affect maternal mortality. • NHS Maternity Care for Women with Multiple Births and Their Babies (published August 2020) The results of the audit on “NHS Maternity Care for Women with a Body Mass Index of 30 kg/m2 or Above” have been used by a lay member with interest on the topic on their webpage, bringing the benefit of increased information and awareness for this group of women. Lay members that were involved in the sprint audit also felt that their voices had been heard. • Sprint audits on the topics of blood stream infections and induction of labour are currently in development. In addition to the above reports, lay/accessible summaries including professionally designed infographics are now produced for all NMPA outputs. These summaries are coproduced with experts by experience and have been particularly well supported and received by the NMPA Women and Families Involvement Group. In addition to the above reports, the NMPA has developed a wealth of other resources for the wide range of audiences who use NMPA data, all with the goal of facilitating quality improvement in maternity care: • The NMPA’s Family Gateway is a new coproduced online resource, aiming to provide printable content, aimed at women and birthing people, with the purpose of improving access to NMPA information and facilitating conversations between service users and healthcare professionals • Lay/accessible summaries including professionally designed infographics are now produced for all NMPA outputs, most recently for the sprint audits on perinatal mental health, inequalities and BMI. These summaries are coproduced with experts by experience and have been particularly well supported and received by the NMPA Women and Families Involvement Group • An interactive table which displays a large range of NMPA data, allowing users to filter for certain measures and trusts. This also allows users to download ‘readymade’ Excel tables that include all measures. The tables can be used to find maternity services which are similar in terms of size, neonatal unit designation or available birth settings, offering a large amount of practical and relevant information for quality improvement purposes. • Information for each site and trust/board are available on the NMPA website, providing accessible and valuable data for easy comparison both against the national mean, but also in the context of other relevant measures at the same site or trust/board. [6 paragraphs unchanged] Furthermore, vignettes Vignettes from NHS organisations were used throughout the NMPA clinical report published in [85 words unchanged] Trust have noted a reduction in the incidence of severe perineal tears. Luton and Dunstable University Hospital NHS Foundation Trust identified increased rates in a number of areas including, including: the proportion of small-for-gestational-age babies not born by their estimated due date, third third- and fourth degree tears fourth-degree tears, and a high Caesarean birth rate. The Trust have implemented a range of solutions comprising GROW [customised growth charts as recommended by the GAP protocol33], charts] - with midwives being trained in scanning to increase capacity and a dedicated [36 words unchanged] at full dilatation are reviewed by an obstetric consultant and midwifery manager. The NMPA has worked closely with the Care Quality Commission (CQC) and [12 words unchanged] Annual Clinical reports and remain in close contact regarding potential future collaboration. The CQC has used a number of NMPA measures within their own service inspections, and NMPA have provided methodological expertise to ensure a clear understanding of the technical specification of the measures provided. The CQC has used a number of NMPA measures within their own service inspections, and NMPA have provided methodological expertise to ensure a clear understanding of the technical specification of the measures provided. The NMPA has supported the Avoiding Brain injury in Childbirth (ABC) collaboration (funded by the Department of Health and Social Care), a new maternity safety project led by the RCOG, the Royal College of Midwives and The Healthcare Improvement Studies (THIS) Institute which aims to support maternity services to improve clinical practice of two significant contributors to avoidable brain injury in childbirth. Several of the NMPA measures (including low Apgar and perineal tears) have been used within the Maternity Transformation Programme. These data are now available in the National Maternity Dashboard - https://digital.nhs.uk/data-and-information/data-collections-and-data-sets/data-sets/maternity-services-data-set/maternity-services-dashboard NMPA data is provided for the National Clinical Audit Benchmarking (NCAB) online portal – https://ncab.hqip.org.uk There is close discussion and collaboration with other perinatal audits, e.g. NNAP and MBRRACE, with cross-linking to each other’s websites. A shared portal where these audit data may be published is under discussion, allowing the viewer to see the full suite of measures and outcomes from individual providers. NMPA data has been used by Tommy’s Charity as part of the development of their tool. The NMPA has also assisted the Insights Group which has developed the CREATED SMART recommendation framework and online registry of recommendations. The NMPA has supported the Avoiding Brain injury in Childbirth (ABC) collaboration (funded by the Department of Health), a new maternity safety project led by the RCOG, the Royal College of Midwives and The Healthcare Improvement Studies Institute

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

Datasets: + MSDS (Maternity Services Data Set) v2.0 · − Hospital Episode Statistics Accident and Emergency (HES A and E); − Hospital Episode Statistics Critical Care (HES Critical Care); − Hospital Episode Statistics Outpatients (HES OP); − MSDS (Maternity Services Data Set) v1.5; − Mental Health Minimum Data Set (MHMDS); − Mental Health Services Data Set (MHSDS)

Objective for processing

Purpose and Background of the Audit Audit: [4 paragraphs unchanged] The NMPA is a Healthcare Quality Improvement Partnership (HQIP) National Clinical Audit [17 words unchanged] meaningful and methodologically robust audit of all NHS maternity services in England, Scotland Scotland, and Wales, to inform decision making by Clinical Commissioning Groups, policy makers [75 words unchanged] of Hygiene and Tropical Medicine (LSHTM), all of which are registered charities. The audit has developed a set of performance indicators to allow maternity units to benchmark themselves against their peers. The indicators facilitate the comparison of antenatal, intrapartum intrapartum, and postnatal care patterns and identify determinants of variation both regionally and nationally. [10 paragraphs unchanged] Format of the audit audit: The NMPA collects data on all registrable births (including live births before [8 words unchanged] weeks of gestation) delivered under NHS care (including NHS home births) in England, Scotland England and Wales. Data are reported at hospital, trust/board, regional and national level. The NMPA is also working to include Northern Ireland as part of the audit. The selection of measures for the NMPA was guided by a panel of clinical and academic experts, including obstetricians, midwives, statisticians, and health service researchers, as well as the NMPA Women and Families Involvement Group and organisations representing maternity and neonatal service users. A range of measures is available and reported via accessible and interactive tables/charts on the NMPA website and in the clinical reports. Three of these measures (third- and fourth-degree tears, obstetric haemorrhage, and Apgar score at five minutes of age) are used for potential outlier reporting. The selection of measures for the NMPA was guided by a panel of clinical and academic experts, including obstetricians, midwives, statisticians and health service researchers, as well as the NMPA Women and Families Involvement Group and organisations representing maternity and neonatal service users. A range of measures is available and reported via accessible and interactive tables/charts on the NMPA website and in the clinical reports. Three of these measures (third and fourth degree tears, obstetric haemorrhage and Apgar score at five minutes of age) are used for potential outlier reporting. [6 paragraphs unchanged] • An "organisational audit” that collects provider-level information on service availability, delivery and the organisation of maternity care, which contribute to a better understanding of the care provided to pregnant women. Data for the organisational audit are collected via an NHS maternity service survey in England, Scotland and Wales. To date, two organisational audit reports have been published (2017 and 2019). [1 paragraph unchanged] • A series of in-depth topic-specific, time-limited audits “sprint audits” predominantly focusing on specific types of maternal and neonatal outcomes. Data for the sprint audits are collected following permission and approvals for access to datasets relevant to selected topics. Sprint audits on perinatal mental health, bloodstream infections and maternity care for women with Body Mass Index (BMI) over 30 are currently in development. Sprint audits on multiple births, maternal admissions to intensive care and neonatal data linkage have already been published. • A quarterly updated frequent online dashboard of data, “Rapid Quarterly Reporting” which shows English trusts their most recently available HES data to provide up-to-date information to facilitate quality improvement. The NMPA first used the MSDS as the main source of maternity data for reporting on English births in 2017/18, with the data currently undergoing analysis at the time of submission of this agreement (V5) to the Data Access Request Service (DARS). Prior to this, the NMPA used data extracted from NHS hospitals’ electronic maternity record systems/maternity information systems (MIS) for reporting in England for 2015/16 and 2016/17 reports. These databases include information along the complete care pathway, from antenatal booking through to postnatal care. • A series of in-depth topic-specific, time-limited audits “sprint audits” predominantly focusing on specific types of maternal and neonatal outcomes. Data for the sprint audits are collected following permission and approvals for access to datasets relevant to selected topics. Sprint audits on bloodstream infections and induction of labour currently in development. Sprint audits on Inequalities, Multiple Births and BMI have already been published. The NMPA first used the MSDS as the main source of maternity data for reporting on English births in 2017/18 and 2018/19. Prior to this, the NMPA used data extracted from NHS hospitals’ electronic maternity record systems/maternity information systems (MIS) for reporting in England for 2015/16 and 2016/17 reports. These databases include information along the complete care pathway, from antenatal booking through to postnatal care. [1 paragraph unchanged] Current data request (v5 - 2020) In the previous data request (v5), the NMPA reduced the complexity of the data request compared to the previous DARS agreements with the aim of ensuring data can be produced for those using NMPA data as quickly as possible. The current (v7) data request is aligned with v5, further simplified with respect to cohort definitions, with the addition of more recent data for MSDS. The key components in NMPA request for English data are: A number of single site studies in the UK have highlighted the adverse impact of the COVID19 pandemic on maternal health services and outcomes, including an increase in stillbirths rate (Khalil et al, Lancet). Other processes and outcomes reported include preterm births, mode of birth and low birthweight babies. In light of the emerging evidence, the NMPA has prioritised the COVID19 work theme. The NMPA aims to report on variations and trends in care in the pre- and post-pandemic periods for relevant indicators, and to provide timely updates at the national, regional and provider levels as appropriate. Therefore - The NMPA plan to reduce the complexity of the data request compared to the previous iterations of this agreement with the aim of ensuring data can be produced for those using NMPA data as quickly as possible. The key changes the NMPA propose for English data are: • As with v5, the NMPA will not provide a cohort for linkage to current or previous data extracts. The data cohort will be restricted to babies/mothers as identified in respective datasets (HES APC, MSDS v2.0 and PDS Birth Notification dataset). The NMPA plan to reduce the complexity of the data request compared to the previous DARS agreements with the aim of ensuring data can be produced for those using NMPA data as quickly as possible (ie quicker updates - less linkage time). This is especially important due to the COVID-19 pandemic. The key changes the NMPA propose for English data are: • To improve the timeliness and relevance of outputs for maternity services providers and users, the NMPA will produce indicators using the most recent available data, with plans for incorporating MSDS in the quarterly data production and dissemination. Therefore, available data is requested on a quarterly basis (as in v5). - The NMPA will not provide a cohort for linkage to current or previous data extracts. The data cohort will be restricted to babies/mothers identified in the PDS Birth Notification dataset for the requested time period as available from NHS Digital. • The PDS Birth Notification dataset will be the “spine” to which all other NHS datasets will link to and furthermore will allow mothers' mothers’ and babies' babies’ records to be linked since it contains the NHS number for the mother as well as for the baby. For this data dissemination - the NHS number will be pseudonymised and encrypted before being returned to the NMPA team. - This initial cohort will also be created from deriving a HES created cohort of maternity related ICD10/OPCS4 codes. • Historical data (for HES APC M13 cohort, regular, annually) is requested for current and previous year only, to allow for identification of co-morbidities and other APC activity during pregnancy (for the mother) and for measurement of adverse outcomes after birth (e.g. readmissions for any reason for the mother and the baby). - Quarterly updates of HES data will be provided by NHS Digital based on a HES created cohort of maternity related ICD10/OPCS4 codes. • Data on all deliveries (for pre-2018, one-off) is requested to allow for identification of obstetric history for current and all future cohorts. - To improve the timeliness and relevance of outputs for maternity services providers and users, the NMPA will produce indicators using the most recent available data, with plans for quarterly data production and dissemination in the future. Therefore, the current data request includes PDS Birth Notifications linked with HES APC and Civil Registration Data Set from 1st January 2018 to latest available data • The NHS numbers will be pseudonymised and encrypted before being returned to the NMPA team, using the same encryption methods, allowing for both across-dataset and longitudinal linkages. - The NMPA will process the data in two stages. For the first stage, the requested datasets for the cohort are restricted to HES APC and Civil Registration Mortality Data Secondary Care Cut linked via the PDS Birth Notification dataset. In the second stage, mental health datasets and linkage to neonatal data (if available) will be added to the request. . As MSDS v2.0 is not currently available at present, MSDS will be restricted to a one-off request covering all births from 1 April 2018 to 31 March 2019 for now. Data requests (source, cohort, frequency) are summarised as below: - The NMPA requests that pseudo NHS numbers for mothers and babies, generated from PDS Birth Notification Data are added to each dataset provided to the NMPA Primary data request, for the NMPA’s Annual Clinical Report & Rapid Quarterly Reporting: It is requested that NHS Digital provides the following files as an initial data request and quarterly updates to the NMPA team via secure transfer: (REGULAR data request) Initial data request (1A) MSDS: - PDS Birth notification data set covering all babies born in England between 1st January 2018 to latest available data. • Cohort: all women who gave birth and all babies born in England, as available in the MSDS extracts - HES APC data covering all women who gave birth, and all babies born, in England between 1st January 2018 to the latest available date - this cohort is to be based on both PDS Birth Notification data and a HES data specification provided by the NMPA (ICD10/OPCS4 Codes relating to Maternity episodes) • First dataset to be provided from 1 April 2019 to most recent quarter - Civil Registration Data Set (covering all women who gave birth, and all babies born, in England between 1st January 2018 to latest available data. • Quarterly refreshes thereafter Initial Data Request (1B) HES APC: - Maternity Services Data Set (MSDS) covering all women who gave birth, and all babies born, between 1 April 2018 and 31 March 2019. • Cohort: all women who gave birth and all babies born in England, as per the HES data specification/filters provided by the NMPA (ICD10/OPCS4 codes for both deliveries and births) - Mental Health Minimum Data Set (MHMDS), and Mental Health Services Data Set (MHSDS) covering all women who gave birth between 1 April 2018 and 31 March 2019. • NMPA holds data from 1 January 2018 to most recent quarter - The historical (from 1 April 2000 or earliest available date) and future (up to most recent available date) records in PDS Birth Notification data, HES APC, Civil Registration data, Mental Health datasets for all individuals (mothers and babies as relevant) in the cohort. • Quarterly refreshes continued as per existing data flows (set in v5) PDS birth notification dataset will form the spine to which all other women’s and babies’ records are linked. It is required that extracts from each dataset contain all records from the specified cohorts, both linked and unlinked. The unlinked data will enable the audit to assess their case ascertainment and whether maternity units are submitting all of their cases accordingly. In particular, the date and time of delivery field is required. This is the only identifiable field requested. • In Quarters 1-3, cohort as defined above, no historical data Quarterly updates • In Quarter 4, M13 data to be provided for the cohort defined as above + historical data for current and previous year for the M13 cohort (e.g. 22/23 Quarter 4 to include all “clinical history”, including maternity and other HES APC records for 21/22 and 22/23). - Quarterly refreshed extracts of HES APC covering all women who gave birth and all babies born in England; cohort to be based on the HES data specification provided by the NMPA. This includes ICD10 codes and OPCS4 codes relating to maternity Civil Registration Mortality data: - Civil Registration Mortality data covering all women who gave birth, and all babies born, in England between 1st January 2018 to the latest available data • Cohort: all women who gave birth and all babies born in England, as identified in HES (+MSDS, +PDS depending on whether data drop includes these datasets) - The historical (from 1 April 2000 or earliest available date) and future (up to most recent available date) records in HES APC and Civil Registration data for all individuals (mothers and babies as relevant) in the cohort. • Quarterly refreshes continued as per existing data flows (set in v5) Annual refreshes of data to be provided at the relevant time points within the year. Quarterly refreshes of MSDS/HES/Civil Registration to be aligned (e.g. if the first MSDS extract is up to the most recent quarter of HES/Civil Registration; further quarterly refreshes would be covering exactly the same period) Reason for requiring these data PDS Births Notifications data: Linkage of the maternity data with NHS Digital data at a patient level has several advantages for the Audit. It will: • Cohort: all women who gave birth and all babies born in England, as identified in PDS Births Notifications data 1) minimise - if not eliminate - the burden on clinical staff of data collection for the sole purpose of the audit; • Refreshes as available (minimum annually) 2) enable information to be provided on longitudinal patterns of care, for example, hospital readmission following delivery, • Addition to current PDS Birth Notification data specification: NMPA would also like to include “baby sex” variable which was omitted in v5 request. This is requested to improve data linkage across data sources. (3) enable validation of data from each source, and Secondary data request, for “obstetric history”, pre-2018: (4) enable information to be collected on the clinical history of the women before pregnancy, their comorbidities and their health service use during pregnancy which is important for case-mix adjustment. (ONE-OFF data request) The date and time of delivery field is essential to the audit for the following reasons: • Delivery episodes as identified by HES data specification/filters provided by the NMPA (ICD10/OPCS4 codes for deliveries only) are requested, no historical data - Without date and time of delivery it is impossible for the NMPA to derive audit measures such as readmission within 6 weeks of delivery (which requires comparing hospital episode dates with the date of delivery) • For the period 2004/05 to 2017/18. - In order to validate other data fields such as OxytocinAdministeredDateTime; Reason for requiring these data: - To assist with determining whether there has been a multiple birth, or whether records are duplicates. Use of routinely collected data will minimise - if not eliminate - the burden on clinical staff of data collection for the sole purpose of the audit. It is required that extracts from each dataset contain all records from the specified cohorts, both linked and unlinked. Linkage of the data sources at the patient level and access to historical data has several advantages for the Audit. Data linkage and historical data will enable: 1) information to be provided on longitudinal patterns of care, for example, hospital readmission following delivery. 2) information to be collected on the clinical history of the women before pregnancy, their comorbidities and their health service use during pregnancy which is important for case-mix adjustment. All “clinical history” for the cohort is requested for the perinatal period only (during pregnancy and immediate post-natal). “Obstetric history” will cover at least 15 years. 3) validation of data from each source. Linkage of mothers and babies will enable: 1) all data items to be collated from babies and mother’s records for each delivery. 2) higher data quality for data items common to both babies and mother’s records (i.e. by cross-validation and/or completion of missing records) 3) measurement of the extent to which maternal characteristics and maternity care has an impact on baby outcomes. The unlinked records from these datasets are also being requested as this will enable the audit to assess their case ascertainment and whether maternity units are submitting all of their cases accordingly. The only identifier that is requested across the extracts is babies’ date/time of birth (i.e. date/time of delivery) - for which s251 support is in place. The date/time of birth field is essential to the audit for the following reasons: • To derive audit measures such as readmission within 6 weeks of delivery (which requires comparing hospital episode dates with the date of delivery) • To validate other data fields that has date/time of procedures or stages of labour and delivery, and to derive other time dependent measures such as duration of labour, time between decision to delivery • To assist with determining whether there has been a multiple birth, or whether records are duplicates. [1 paragraph unchanged] The NMPA was commissioned on the basis that the above datasets would be linked for the purposes of the audit audit, and this is reflected in the audit contract with HQIP. Requesting these data also minimises the data burden on NHS staff by ensuring the audit team use routinely collected data.

Processing activities

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). Purpose: In previous iterations of this agreement - the following was permitted (up to and including v4): The datasets requested by the NMPA will provide a framework for continuous monitoring of processes and outcomes of maternity services using a comprehensive set of measures, for example: For women who delivered, and babies born up until 31 March 2017, English maternity units supplied the NMPA team with an annual extract of patient-level data relating to the deliveries that occurred at their unit in the previous financial year period (12 months) from their maternity information systems. - Rates of obstetric haemorrhage of 1500ml or more; NHS Trusts provided data from their maternity information systems by transferring it to the NMPA’s secure server within the N3 network using a Secure File Transfer Protocol. All data processing took place on this server. The secure server is leased from RedCentric by the RCOG and is based at the RedCentric site in Reading, with backups located at the RedCentric Harrogate site. - Rates of third- and fourth degree tears among vaginal births; Data was pseudonymised by the audit’s data managers, who separated the patient identifiers contained within the data extracts from maternity record and treatment MIS (Maternity Information Sytems) data. The data managers were based at the RCOG and held full contracts of employment there. No other individuals have access to patient identifiers. The records belonging to the same individual could only be identified by the project team with an NMPA-derived study ID. - Rates of singleton babies born at term with a five-minute Apgar score below 7. The audit’s data managers securely transferred the patient identifiers of a cohort of patients in the audit to NHS Digital. The following identifiers were sent in; this covered the earlier part of the audit cohort (women giving birth and babies born between 1 April 2014 and 31 March 2017): These measures will be used to compare maternity services at national, regional and provider level. The development of these indicators has been guided by criteria related to validity, statistical power, fairness, and the appropriateness of the technical coding. - Mother’s NHS Number Longitudinal/historical data allows for the detection of trends in patterns of care and in data quality over time, which is important in order to understand the audit’s results and to put them into context. - Baby’s NHS Number Cohorts: - Postcode The eligible cohort of individuals whose data is to be collected by the National Maternity and Perinatal Audit during the period of this version of the proposed Data Sharing Agreement with NHS England (v7) is all women who gave birth from 1 April 2019, and babies whose birth was registered in this period. Since this is a national audit, data from all NHS Trusts are required. - Mother’s Date of Birth NHS England will be creating the eligible cohort based on data specification/filters provided by the NMPA: these data specifications and frequency of cohort derivation differ by data source as well as data availability at NHS England and existing data flows to NMPA. - Baby’s Date of Birth Primary data request - Baby’s Gender • MSDS (regular updates): All babies born and all women who gave birth between 1 April 2019 to latest quarter, updated quarterly All available data from the civil registration of live births, stillbirths, neonatal deaths and mortalities, PDS birth notification data set, HES, MSDS, MHSDS, MHLDDS and MHMDS for this cohort was returned to the RCOG. • HES APC (regular updates): All babies born and all women who have birth, extracted of HES delivery and birth records filtered via ICD10/OPCS codes, updated quarterly, with the last quarter’s cohort in the year derived from M13 data. NMPA currently holds HES APC extracts, updated quarterly, using this cohort definition from 2018Q1 to 2022Q2. A derived civil registration cohort of births and deliveries between 1 April 2000 and 31 March 2018 was created by NHS Digital and returned to the RCOG. This cohort contained records from the civil registration of live births and stillbirths. This cohort was linked to the requested civil registration data of neonatal deaths and mortalities, PDS birth notification data set, HES, MSDS, MHSDS, MHLDDS, MHMDS and MIS identifiers. • PDS Birth Notifications data (regular updates): All babies born and all women who have birth, updates as available (minimum annually) Both the linked and unlinked records from these datasets were requested. The resulting database was be returned to the NMPA’s data managers at the RCOG who linked it to MIS data using the NMPA study ID, resulting in a linked dataset. Secondary data request In addition, the NMPA also required civil registration birth registration data and PDS birth notification data for babies born in Wales and their mothers. This was obtained using the following process. • HES APC (one-off data): All delivery records filtered via ICD10/OPCS codes between 1 April 2004 to 1 January 2018 (mothers’ records only). The NHS Wales Informatics Service (NWIS) securely transferred patient identifiers for women who gave birth, and babies born between 1 April 2000 and 31 March 2018, to NHS Digital, along with a pseudonymised study ID for these individuals. The following identifiers were sent in: For HES APC M13 cohort (primary data request, regular updates), current year and previous year’s historical HES APC data records is required. Historical data enables information on longitudinal patterns of care and on the clinical history of the women before pregnancy, their comorbidities and their health service use during pregnancy which is important for case-mix adjustment. - Mother’s NHS Number Data specification and minimisation: - Baby’s NHS Number The cohort will be restricted to all as identified in PDS Birth Notification, MSDS v2.0 and HES APC respective data specifications as provided by the NMPA. There are approximately 650,000 births in England per annum, therefore the cohort will include 1.3 million individuals (mothers and babies) per year, and 325,000 individuals for each quarterly update. - Postcode All available data (linked or unlinked) from the PDS birth notification data set, HES APC, MSDS (including babies’ and mothers’ data), Civil Registration Mortality dataset will be returned to the NMPA, linked with the pseudonymised NHS number by NHS England. The only identifier that will be disseminated across the extracts is babies’ dates of birth - for which s251 support is in place. All other patient identifiers will be removed. - Mother’s Date of Birth - Baby’s Date of Birth - Baby’s Gender All available data from the civil registration of live births, stillbirths, neonatal deaths and mortalities and PDS birth notification data set for this cohort was returned to the RCOG, linked with the pseudonymised study IDs by NHS Digital. The NMPA team received a linked NCCHDS-MIds-PEDW dataset from NWIS, for women who gave birth, and babies born between 1 April 2000 and 31 March 2018,, using the same pseudonymised study IDs as sent to NHS Digital. Both the linked and unlinked records from these datasets were requsted. The NMPA data managers used the pseudonymised study IDs to combine the civil registration-PDS data sent by NHS Digital and the NCCHDS-MIds-PEDW dataset set by NWIS and created a linked dataset. The NMPA collected the data of all women who give/gave birth in England between 1 April 2014 and 31 March 2019, and all babies born in this time period. Longitudinal data allows for the detection of trends in patterns of care and in data quality over time, which is important in order to understand the audit’s results and to put them into context. Update - December 2020: Due to increased pressures of COVID-19, the NMPA are choosing to simplify the data request for v5 of this agreement. The eligible cohort of individuals whose data is to be collected by the National Maternity and Perinatal Audit during the period of this version of the proposed Data Sharing Agreement with NHS Digital (v5) is all women who gave birth from 1st January 2018, and babies whose birth was registered in this period. Therefore, the data requested covers the currently available records in this cohort. Unlike the previous NMPA data request, the NMPA team will not provide a cohort for linkage to current or previous data extracts, this will simplify the process of the linkage and the data request. s251 support still remains valid and in place for the NMPA to continue to hold and process the data that was facilitated via this linkage of a specified cohort under previous iterations of this agreement - however it has been decided by the NMPA that future data dissemination (starting with what is approved under this version of the agreement (v5)) can facilitate the purpose of the audit without this specific cohort being provided by NMPA to NHS Digital. Instead - NHS Digital will create the cohort based on criteria of women who gave birth from 1st January 2018. [1 paragraph unchanged] - • to determine which provider or maternity unit administered the care (for which potentially identifiable patient data is necessary); - • to determine the quality of care for the service user; - • to determine the nature of the episode and diagnosis; - • to determine the case-mix of service users with a particular provider or maternity unit (for which potentially identifiable patient data is necessary); - • to determine the health outcomes for the service user. Since this is a national audit, data from all NHS trusts is required. All of MSDS’s non-sensitive variables have been requested as it is imperative for the audit to capture the maternity care pathway and pregnancy outcomes for all births in England. The only identifiable information requested is baby's time and date of birth which is essential to the audit as described earlier. For England, a derived cohort of all babies born between 1st January 2018 to the latest available month and their mothers will be created by NHS Digital using the PDS birth notification dataset, combined with an extract of HES data filered via ICD10/OPCS Codes Data drops (also see supplementary file on further information for the production team): All available data from the PDS birth notification data set, HES APC, MSDS, MHSDS,and MHMDS for this cohort (including babies’ and mothers’ data) will be returned to the RCOG. 1: Initial data drop (covering period from 1 April 2019 to most recent quarter) All historical and future data (up to most recent available date) from these same individuals is required. There are two main reasons for requiring the historical data: - NHS England to supply MSDS v2.0 from 1 April 2019 to latest quarter available. 1) it enables information to be provided on longitudinal patterns of care, for example, maternal or neonatal hospital readmission following delivery, - Continue to supply quarterly refreshed HES APC data extracts to latest quarter available. (2) it enables information to be collected on the clinical history of the women before pregnancy, their comorbidities and their health service use during pregnancy which is important for case-mix adjustment. - Supply refreshed PDS Birth notifications data to latest date available Both the linked and unlinked records from these datasets have been requested. - Continue to supply quarterly refreshed Civil Registration Mortality data extracts to latest quarter available All available data from PDS birth notification data set for this cohort will be returned to the RCOG, linked with the pseudonymised nhs number by NHS Digital. If at the time of the initial data drop, the most recent quarter is M13: NHS Digital will only provide the data extracts to the RCOG with a pseudonymised NHS number for mother and baby. The only identifier that will be disseminated across the extracts is babies’ dates of birth - for which s251 support is in place. - Supply M13 HES APC data extract. All other patient identifiers will be removed. - Supply previous year’s and all future available historical HES APC records for the M13 cohort. No further patient identifiers will be sent from NHS Digital to the RCOG. The MSDS v2.0 is requested for the latest quarter available (rather than latest date available) to align the schedule with HES APC regular data drops. The NMPA data managers will keep patient identifiers separate from the pseudonymised clinical data sent by NHS Digital. There will be no attempts to re-link the data to the identifiers for re-identification. 2: Regular data drops: The linked datasets described above will provide a framework for continuous monitoring of processes and outcomes of maternity services using a comprehensive set of measures, for example: - Continue to supply quarterly refreshed HES APC data extracts. In the fourth quarter drop in the year, replace the drop with M13; also provide previous year’s and all future available historical HES APC records for the M13 cohort (e.g. for 22/23 fourth quarter, supply all HES APC from 21/22 to most recent available date for the M13 cohort, including all mothers and babies, and all records - not limited to maternity records). - Rates of spontaneous vaginal, instrumental and caesarean section births; - Supply quarterly refreshed MSDS v2.0 data extracts - Rates of third- and fourth degree tears among vaginal births; - Supply quarterly refreshed Civil Registration Mortality data extracts - Rates of singleton babies born at term with a five minute Apgar score below 7. - Supply refreshed PDS Birth notifications data (as available, minimum annually) These measures will be used to compare maternity services at national, regional and unit level. The development of these indicators has been guided by criteria related to validity, statistical power, fairness and the appropriateness of the technical coding. 3: One-off data request Longitudinal data allows for the detection of trends in patterns of care and in data quality over time, which is important in order to understand the audit’s results and to put them into context. - Supply HES APC data extract for 2004/5 to 2017/8, defined by “HES delivery filters” The audit's section 251 support lists several linkages that are permitted. These include linkage to ICNARC, PHE's Surveillance Systems and BadgerNet Neonatal Data. - Only HES APC episodes identified using the filters are requested, no “cohort” generation or historical data needed. The intensive care and neonatal care data is linked to the maternity data RCoG hold, using identifiers they have collected along with the maternity data from NHS trusts. This allows for additional data to be obtained on maternal admissions to intensive care units and admissions to neonatal units for babies born. Since the maternity data will also be linked to HES, ONS and PDS data, these data-sets will therefore also be linked to the intensive care and neonatal care data. Data environment: The PHE data will be linked in the future, but is not currently linked. This will allow for additional data on blood stream infections to be provided. Linkage with PHE data will require a further amendment since RCoG do not hold identifiers (apart from babies’ dates of birth) for births after March 2018. The NMPA stores data on a secure server within the secure NHS N3 network/Health and Social Care Network (HSCN). The secure server is leased from RedCentric by the RCOG and is based at the RedCentric site in Reading, with backups located at the RedCentric Harrogate site. Files can only be transferred onto/off the server by four individuals on the NMPA team with ‘Data manager permissions’. These individuals are the NMPA data manager, NMPA analysts (x2) and the NMPA senior methodologist. In previous iterations of this agreement - HES Critical Care, HES Outpatients and HES Accident and Emergency data sets were requested. The NMPA team have determined these are not required for continuation of the audit -and will not be requested again. The NMPA team will continue to hold previously disseminated extracts of these datasets - but they will not be requesting a renewal of these datasets under v5 of this agreement. When data are received from NHS England via the SEFT system, the nominated individual (NMPA Senior Methodologist) will immediately securely transfer (via SFTP) the data to the secure NMPA server. The NMPA have access to data erasure software (Blancco) for the destruction of any data when necessary. All analysis of the data takes place on the secure server hosted by RedCentric. Data Minimisation Terms & conditions: HES filters/data minimisation: 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). The cohort will be restricted to all as identified in a) PDS Birth Notification data and b) HES specification as provided by the NMPA, for births between 1st January 2018 to latest available and updated quarterly. There are approximately 650,000 births in England and Wales per annum, therefore the cohort will include 1.3 million individuals (mothers and babies) per year - e.g. approximately 3 million individuals from 1st January 2018 to 31 July 2020, and 325,000 individuals for each quarterly update. Additional information on other s251 approved data processing activities in the NMPA: MSDS filters/data minimisation: Please note that in previous NMPA data requests (up to v4), the NMPA team provided a cohort to NHS England for linkage to current or previous data extracts. s251 support remains valid and in place for the NMPA to continue to hold and process the data that was facilitated via this linkage of a specified cohort under previous iterations of this agreement. All non-sensitive / high risk variables have been requested as it is imperative for the audit to capture the maternity care pathway and pregnancy outcomes for all births in England. The audit's section 251 support also lists several further linkages that are permitted. These include linkage to ICNARC, PHE's Surveillance Systems and BadgerNet Neonatal Data. The intensive care and neonatal care data is linked to the maternity data NMPA currently holds for April 2014 to March 2017, using identifiers they have collected along with the maternity data from NHS trusts. This allows for additional data to be obtained on maternal admissions to intensive care units and admissions to neonatal units for babies born. The PHE data is expected to be linked in the future but is not currently linked. This will allow for additional data on blood stream infections to be provided. Linkage with PHE data will require a further amendment since NMPA do not hold identifiers (apart from babies’ dates of birth) for births after April 2017. The only identifiable information requested is baby's date of birth: The date and time of delivery field is essential to the audit for the following reasons: - Without date and time of delivery it is impossible for the NMPA to derive audit measures such as readmission within 6 weeks of delivery (which requires comparing hospital episode dates with the date of delivery) - In order to validate other data fields such as OxytocinAdministeredDateTime; - To assist with determining whether there has been a multiple birth, or whether records are duplicates. All historical and future HES APC data (from 2000/2001 up to most recent available date) from these same individuals is required. There are two main reasons for requiring the historical data: 1) it enables information to be provided on longitudinal patterns of care, for example, maternal or neonatal hospital readmission following delivery, (2) it enables information to be collected on the clinical history of the women before pregnancy, their comorbidities and their health service use during pregnancy which is important for case-mix adjustment. Only variables required for the audit will be requested. Mental health data filters/data minimisation The cohort will be restricted to all mothers who have given birth between 1 April 2018 to 31 March 2019 as identified by the PDS Birth Notification data for the same period and all historical / future records for this cohort. Approximately 650,000 individuals. 3 packages selected: Package 1d) Mental Health Services: Community Activity - Admin Data, Clinical Data, Demographics in one package. Package 2d) Mental Health Services Inpatient Activity, Uses of the Mental Health Act, Forensic Pathways, Individual incidents of assault, restrictive intervention and self harm. Package 4) Mental Health Services: Currencies - Detailed information about MH Currency Assessments and assignments. Summary: Data will be delivered as follows by NHS Digital For births/deliveries in England: Data drop 1 split into 1a and 1b. 1a. - NHS Digital to create the requested cohort using data from the birth notifications data set, using births from 01/01/2018 to latest available. NHS Digital will exclude any invalid dates of birth. - NHS Digital will supply HES APC data using both the birth notifications cohort created above, and a HES created cohort made from maternity related ICD10/OPCS4 codes in HES for the same period.. Historical data will be provided from 2000 onwards for this cohort - Supply mortality data linked to the combined cohort - Supply the bridge file of mother nhs number to baby nhs number (pseudonymised) - Quarterly HES extracts will continue for the duration of the DSA based on the HES created cohort only (created from ICD/OPCS codes). Historical HES APC data will be provided from 2000 onwards. 1b. - Supply 18/19 Maternity Services Data Set linked to the birth notifications cohort - Supply Mental Health data (MHSDS/MHMDS) linked to the birth notifications cohort - Supply the birth registrations / birth notifications linked extract. - Quarterly HES extracts will continue for the duration of the DSA based on the HES created cohort only (created from ICD/OPCS codes). Historical HES APC data will be provided from 2000 onwards. -Annual refresh extracts to be provided when available. The National Maternity and Perinatal Audit (NMPA) stores data on a secure server within the secure NHS N3 network/Health and Social Care Network (HSCN). The secure server is leased from RedCentric by the RCOG and is based at the RedCentric site in Reading, with backups located at the RedCentric Harrogate site. Files can only be transferred onto/off the server by four individuals on the NMPA team with ‘Data manager permissions’. These individuals are the NMPA data manager, NMPA analysts (x2) and the NMPA senior methodologist. When data are received from NHS Digital via the SEFT system, the nominated individual (NMPA Senior Methodologist) will immediately securely transfer (via SFTP) the data to the secure NMPA server. The NMPA have access to data destruction software (Blancco) for the destruction of any data when necessary. All analysis of the data takes place on the secure server hosted by RedCentric.

Expected output

From the start of the audit, a reporting framework has been developed that produces frequent, individualised individualised, and timely outputs using online feedback to NHS providers, commissioners commissioners, and networks. All the outputs are written in a language that is accessible to the public. There are a number of different approaches to report the results: 1. Audit reports Annual Clinical Reports are used by NHS trusts to monitor the quality of maternity care [28 words unchanged] 9th November 2017, with the second report published in July 2019. The next 2021 annual report is due to be published in early 2021 and will be was based on the 2017/18 Maternity Services Data Set (MSDS) (MSDS v1.5) which was received under v4 of this agreement. agreement and published in October 2021. The 2022 annual report is based on the 2018/19 Maternity Services Data Set (MSDS v1.5) which was received under v5 of this agreement and will be published in Spring/Summer 2022. The reports are available on the audit website and do not contain [10 words unchanged] aggregated with small number suppression in line with the HES analysis guide. 2. Annual stakeholder meetings are arranged to share and disseminate audit findings and promote quality improvement amongst a large number and range of stakeholders. The next event will be held in late 2021, with a view to sharing the results of the first report using MSDS data. The Annual Reports are written to be public and patient friendly. The governance of the audit includes patient and public representatives who advise on dissemination of the outputs. 2. Rapid Quarterly Reporting feature, launched in March 2022 provides timely and more frequent data for providers. This is provided on the audit website and provides timely information on maternity care practices and the outcomes of women and families using NHS maternity services in England. It reports results for each English Trust as well as nationally. The data is more timely but less detailed than the data used for the Clinical Audit results for England. 3. Online The above online reports have been set up that to allow individual providers, commissioners commissioners, and relevant clinical networks to benchmark their process and outcomes indicators against [30 words unchanged] the Quality Accounts. The reports do not contain any patient identifiable information. 4 3. Reports of periodic time-limited, topic-specific audits are produced at least annually, allowing a more detailed and in-depth insight into specific aspects of the care provided by maternity services. Reports on the first three topics Several of these reports have now been published. Two further reports, published, including a report on perinatal mental health, and maternity care for women with a BMI>30 will be published before the end of June 2021. and a report on Inequalities by ethnicity and socio-economic deprivation. The aim of each sprint “sprint” audit is to investigate the extent to which further insight into the [25 words unchanged] they will be incorporated into the continuous clinical audit in future years. 5. 4. The audit team are currently producing several have produced and continue to produce manuscripts to submit to for peer-reviewed publications, especially related to the additional analyses aiming to identify determinants of variation in maternity services and methodological development work (e.g. (e.g., risk adjustment, handling of missing data, continuous monitoring, combining multiple linked indicators to assess maternity unit performance, design of outputs that are most effective in local quality improvement). Three manuscripts have been submitted to clinical journals for peer review and publication. Further analysis plans are being developed and scheduled throughout the remainder of the audit. The types of journals the audit submits to has been published in include clinical journals such as the The Lancet, Plos Med, American Journal of Obstetrics and Gynecology, British Journal of Obstetrics and Gynaecology or British Medical Journal, and Gynaecology, as well as methodological journals such as the Journal of Clinical Epidemiology and the BMC Health Services Research. 6. The current data request (which includes data requested up until the most recent available period) will allow for monitoring the quality of maternity care in the COVID-19 pandemic period.

Expected measurable benefits

[1 paragraph unchanged] The audit provides robust and rigorous evidence to NHS maternity service providers and to inform decisions on prioritising services for commissioning. commissioning through its website (www.maternityaudit.org.uk) and various other communications channels. In the future, it is hoped that results from the audit will relate patterns of care to maternal and neonatal outcomes, guiding policies on, for example, the situations in which induction of labour, instrumental delivery and caesarean section labour lead to better or worse clinical outcomes. This will have a direct impact on clinical practice. The evidence-based clinical indicators derived in the audit are used by maternity [10 words unchanged] Information is made publicly available, including key results at individual maternity unit level. level where available via the NMPA ‘results’ area of the website, data are made available to registered users from Trusts and Sites two weeks before the data is publicly available in this area of the website. This informs decisions made by local managers on policies and procedures within [34 words unchanged] assessment of whether local maternity units are meeting relevant standards of care. The audit’s reports include recommendations to enable NHS Trusts and Health Boards to drive effective local quality improvement initiatives. The recommendations are aimed at the full spectrum of stakeholders (e.g. (e.g., individual clinicians, maternity units, commissioners commissioners, or higher levels, depending on the issues). These recommendations also feed into [49 words unchanged] most common reason for admission to hospital in the UK, with approximately 800,000 700,000 births per year throughout England, Scotland Scotland, and Wales. Thus, each benefit described above has the potential to positively affect the experience of maternity care for a very large number of women and their families. The NMPA ensures the voices of service users are heard throughout this work, not least by incorporating women and families in the advisory groups of all the outputs. The NMPA thread these voices though the reports in the form of qualitative quotations, helping to add a narrative to the findings from those who use services. This also supports quality improvement by enabling service providers and wider stakeholder groups to hear from a range of people who have accessed maternity care and how they interpret and understand the NMPA findings.

Benefits reported

[2 paragraphs unchanged] • Two Four continuous clinical audit Clinical Report cycles completed using the most recent data available to the NMPA (births in 2015/16 2015/16, 2016/17, 2017/18 and 2016/17), 2018/19), with reports published in November 2017 2017, September 2019, October 2021 and September 2019. May 2022 (expected). • Two organisational reports Organisational Survey Reports (2017 and 2019) completed and published. Both organisational reports received a 100% [12 words unchanged] to work with the NMPA for the purpose of improving care provision. The NMPA has also developed several sprint audits which have provided valuable information and timely recommendations on specific topics: • Rapid Quarterly Reporting was launched in March 2022, with the first set of results covering September 2020 to September 2021. The quarterly update, covering births up to January 2022 is expected to be online in June 2022. The NMPA has also developed several sprint audits which have provided valuable information and timely recommendations on specific topics. These reports share findings and generate recommendations for various audiences including Trusts, data providers and policy makers: • Ethnic and Socio-economic Inequalities in NHS Maternity and Perinatal Care for Women and their Babies: Assessing care using data from births between 1 April 2015 and 31 March 2018 across England, Scotland and Wales (published in 2021) • NHS Maternity Care for Women with a Body Mass Index of 30 kg/m2 or Above, births between 1 April 2015 and 31 March 2017 in England, Wales and Scotland (published in 2020) • Technical report: Feasibility of evaluating perinatal mental health services, based on births between 1 April 2014 and 31 March 2017 in Scotland (published 2021) [3 paragraphs unchanged] • ‘Perinatal Mental Health in Scotland’ Sprint Audit (to be published December 2020) • Sprint audits on the topics of blood stream infections and induction of labour are currently in development. • Sprint audits on the topics of maternity care for women with a BMI>30 and blood stream infections are currently in development. [1 paragraph unchanged] • Lay summaries and infographics have been created for a number of key NMPA reports. The infographics for the 2019 Organisational Audit, and the Lay Summary for the 2019 Clinical Report have been particularly well received by the NMPA Women and Families Involvement Group. • The NMPA’s Family Gateway is a new coproduced online resource, aiming to provide printable content, aimed at women and birthing people, with the purpose of improving access to NMPA information and facilitating conversations between service users and healthcare professionals • Lay/accessible summaries including professionally designed infographics are now produced for all NMPA outputs, most recently for the sprint audits on perinatal mental health, inequalities and BMI. These summaries are coproduced with experts by experience and have been particularly well supported and received by the NMPA Women and Families Involvement Group [1 paragraph unchanged] • Information for each site and trust/board are available on the NMPA [14 words unchanged] but also in the context of other relevant measures at the same site/trust/board. site or trust/board. Findings from the latest NMPA Organisational Survey show that NMPA data has been used in the following ways: • To make improvements in clinical practice or organisation of care within the Trust/Board (59% of respondents). • To make improvements in clinical practice or organisation of care in collaboration with other Trusts/Boards, the Local Maternity System or network (32% of respondents). • To inform women using the service (15% of respondents). • To guide local audit (50% of respondents). • To make improvements to data (44% of respondents). Furthermore, vignettes from NHS organisations were used throughout the NMPA clinical report published in 2019 to showcase how NMPA data is being used locally to drive improvements in the quality of maternity care. Such vignettes included Stockport NHS Foundation Trust who were identified as an outlier for the proportion of vaginal births in the previous year of data with severe perineal tears. In response to the NMPA findings, they implemented the Stockport Perineal Care Bundle within clinical practice. The local bundle was based upon the elements of the OASI (obstetric anal sphincter injury) care bundle and following implementation, the Trust have noted a reduction in the incidence of severe perineal tears. Luton and Dunstable University Hospital NHS Foundation Trust identified increased rates in a number of areas including, the proportion of small-for-gestational-age babies not born by their estimated due date, third and fourth degree tears and a high Caesarean birth rate. The Trust have implemented a range of solutions comprising GROW [customised growth charts as recommended by the GAP protocol33], with midwives being trained in scanning to increase capacity and a dedicated midwife for GROW in post; dedicated consultant-led scanning sessions, the utilisation of Episcissors, along with a masterclass in instrumental delivery and new caesarean section review meetings every 2 weeks, where all category 1 sections and caesareans at full dilatation are reviewed by an obstetric consultant and midwifery manager. The NMPA has worked closely with the Care Quality Commission (CQC) and HQIP to manage a successful outlier process for the first two NMPA Annual Clinical reports and remain in close contact regarding potential future collaboration. The CQC has used a number of NMPA measures within their own service inspections, and NMPA have provided methodological expertise to ensure a clear understanding of the technical specification of the measures provided. Several of the NMPA measures (including low Apgar and perineal tears) have been used within the Maternity Transformation Programme. These data are now available in the National Maternity Dashboard - https://digital.nhs.uk/data-and-information/data-collections-and-data-sets/data-sets/maternity-services-data-set/maternity-services-dashboard NMPA data is provided for the National Clinical Audit Benchmarking (NCAB) online portal – https://ncab.hqip.org.uk There is close discussion and collaboration with other perinatal audits, e.g. NNAP and MBRRACE, with cross-linking to each other’s websites. A shared portal where these audit data may be published is under discussion, allowing the viewer to see the full suite of measures and outcomes from individual providers. NMPA data has been used by Tommy’s Charity as part of the development of their tool. The NMPA has also assisted the Insights Group which has developed the CREATED SMART recommendation framework and online registry of recommendations. The NMPA has supported the Avoiding Brain injury in Childbirth (ABC) collaboration (funded by the Department of Health), a new maternity safety project led by the RCOG, the Royal College of Midwives and The Healthcare Improvement Studies Institute

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Changed only in punctuation, spacing or capitalisation: Processing activities.

Unchanged: Objective for processing, Expected output, Expected measurable benefits, Benefits reported.

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Datasets: + Birth Notification Data

Objective for processing

[1 paragraph unchanged] The majority of women giving birth and babies born in the UK receive safe and effective care. However, the stillbirth rate is higher in the UK than in many other European countries. [http://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(10)62310-0.pdf] There is also evidence of substantial variation in the maternity care received by women during pregnancy and delivery across hospitals, as well as the outcomes. These patterns of variation are also not the same for women from different socio-economic and ethnic backgrounds. [Patterns of Maternity Care in English NHS Hospitals 2013/14. Royal College of Obstetricians and Gynaecologists. London, 2016: https://www.rcog.org.uk/globalassets/documents/guidelines/research--audit/maternity-indicators-2013-14_report2.pdf] While the majority of women giving birth in the UK receive a safe and effective service and the stillbirth rate for England and Wales has decreased by nearly a fifth over the last decade, it is still at the higher end of the spectrum across European countries (European Perinatal Heath Report, 2015). There is also evidence of substantial variation in the maternity care received by women during pregnancy and delivery across hospitals, as well as the outcomes. These patterns of variation are also not the same for women from different socio-economic and ethnic backgrounds. (Maternity Indicators Report, RCOG). [2 paragraphs unchanged] The aim of this NMPA is a Healthcare Quality Improvement Partnership (HQIP) National Clinical Audit and Patient Outcomes Programme (NCAPOP) audit, established in July 2016, is 2016. it was established to deliver a clinically meaningful and methodologically robust audit of all NHS maternity services in England, Scotland and Wales, to inform decision making by Clinical Commissioning Groups (CCGs), Groups, policy makers and clinicians, and support maternity services to improve the quality of care and outcomes for mothers and babies. The NMPA is commissioned by the Health Quality Improvement Partnership (HQIP) HQIP on behalf of the English and Welsh Governments and the Health Department [39 words unchanged] of Hygiene and Tropical Medicine (LSHTM), all of which are registered charities. One of the key aims of the audit is to create a nationwide database containing all deliveries to enable the development of robust and clinically meaningful quality indicators for maternity care. The database will only contain pseudonymised data and is only accessible to the NMPA team. The team working day-to-day on the NMPA who have access to the NMPA data are based at the RCOG and London School of Hygiene and Tropical Medicine (LSHTM), hence including both organisations as data processors. The application has previously requested HES data and ONS mortality data linked to data from NHS trusts’ maternity IT systems. For mothers who gave birth and babies born from 1 April 2017, the NMPA will be using the Maternity Services Data Set (MSDS) as the primary source for maternity data, since MSDS data is now available. In this way NHS trusts no longer need to submit data directly to the NMPA as well as the MSDS. Since ONS birth, stillbirth and neonatal death registration and PDS birth notification data is now available, the NMPA requires linkage with these datasets for validation of key fields in maternity and hospital episode data for births in England and Wales, and to calculate case ascertainment. In order to carry out an in-depth study into perinatal mental health, the NMPA requires linkage with the Mental Health data sets: MHSDS, MHLDDS and MHMDS. [1 paragraph unchanged] Format of the Audit One of the key objectives of the audit is to create and maintain a nationwide database containing all deliveries to enable the development of robust and clinically meaningful quality indicators for maternity care. The team working day-to-day on the NMPA database who have access to the NMPA data are based at the RCOG and the LSHTM, hence including both organisations as data processors. The commissioned audit programme consists of three phases of work: Very few auditable standards exist in maternity care that can be measured via a national audit, and for many outcomes there are no clear acceptable ranges. Without such standards it can be challenging for those providing NHS maternity care to understand how to compare the care they deliver and what constitutes best practice. The NMPA aims to address these issues by providing a balanced set of clinical measures that are meaningful, valid, fair, and have sufficient statistical power and precise technical specification. - An ‘organisational survey’ to collect provider-level information on service delivery and the organisation of maternity care, which will contribute to a better understanding of the care provided to pregnant women. The first organisational survey report was published on 10th August 201 and the second was published in June 2019. DATA CONTROLLERSHIP: - A continuous clinical audit that produces information for maternity units to monitor patterns of care and maternal and perinatal outcomes. - A series of in-depth topic-specific, time-limited audits (‘sprint audits’), predominantly focusing on specific types of maternal and neonatal outcomes. Until now the continuous clinical audit has used the following sources of patient-level data in England: • Data extracted from NHS hospitals’ electronic maternity record systems/maternity information systems (MISs), which is granted through a Section 251 approval. These databases include information along the complete care pathway, from antenatal booking through to postnatal care. Data extracts from individual providers was requested annually, which was sent directly to the RCOG via secure file transfer. • Routinely collected data from HES, was also used, which contains administrative information about each hospital admission, including deliveries. This data is necessary for several reasons. Firstly, knowledge of hospital admissions and diagnoses during and after delivery allows an understanding of maternal and neonatal outcomes, and gives a greater level of detail on treatments that took place during delivery. Secondly, knowledge of diagnoses before delivery sheds light on case-mix, which is essential in performing risk-adjustment of the audit results (which enables a fair comparison between providers). Finally, the completeness of routine hospital episode datasets is very high, and thus it is used to validate data extracts from providers’ Maternity Information Systems (MISs). In Wales the following sources of patient-level data were used: • The Maternity Indicators data set (MIds), which collates extracts from NHS hospitals’ MISs in Wales. This is held by the NHS Wales Informatics Service (NWIS). • The Patient Episode Database for Wales (PEDW), containing data on each hospital admission in Wales, including deliveries. Current Data Request It is requested that, on receipt of cohort identifiers (for women and babies in the NMPA cohort for the 2014-15, 2015-16 and 2016-17 financial years) from the Maternity Information Systems (MIS) data provided by the NMPA team, NHS Digital sends the following files to the NMPA team: • Annually refreshed extracts from the Civil Registration data of live births covering all babies born alive in England between 1 April 2000 and 31 March 2018. The NMPA team will require the following fields: ~ baby’s date of birth ~ baby’s place of birth ~ baby’s gender ~ singleton or multiple birth ~ total number of previous live births for mother ~ total number of previous stillbirths for mother. • Annually refreshed extracts from the civil registration data of stillbirths covering all babies who were stillborn in England between 1 April 2000 and 31 March 2018 (fields required are the same as those for live births). • Annually refreshed extracts from the civil registration data of neonatal deaths covering all babies who were born in England between 1 April 2000 and 31 March 2018 and died within 28 days of birth (fields required are the same as those for live births). • Annually refreshed extracts from the Civil Registration data covering any women who gave birth and any babies born in England between 1 April 2000 and 31 March 2018 who have died. • Annually refreshed extracts from the PDS birth notification data set covering all babies born in England between 1 April 2000 and 31 March 2018. The NMPA team will require the following fields from the PDS birth notification data set: baby’s date of birth, baby’s time of birth, baby’s gender, baby’s date of death (if applicable), baby’s time of death (if applicable), baby’s birth order, baby’s birth weight, mother’s ethnic category code, mother’s gestation length, number of births in confinement, live or still birth code, suspected congenital abnormality indication code, delivery place type code (actual), organisation identifier (actual delivery place). • Bridge file from linkage of civil registration data with extracts from PDS birth notification data set for England requested above. • Annually refreshed extracts from HES covering all women who gave birth, and all babies born, in England between 1 April 2000 31 March 2018. • Bridge file from linkage of civil registration data with extracts from HES requested above, covering all women who gave birth, and all babies born, in England between 1 April 2000 and 31 March 2018. • Annually refreshed extracts from the Maternity Services Data Set (MSDS) covering all women who gave birth, and all babies born, between 1 April 2015 and 31 March 2018. • Bridge file from linkage of civil registration data with extracts from MSDS requested above, covering all women who gave birth, and all babies born, in England between 1 April 2015 and 31 March 2018. • Bridge file from linkage of civil registration data with patient identifiers from MIS data. • Annually refreshed extracts from the Mental Health Minimum Data Set (MHMDS), Mental Health and Learning Disabilities Data Set (MHLDDS) and Mental Health Services Data Set (MHSDS) covering all women who gave birth between 1 April 2006 and 31 March 2018. • Bridge file from linkage of civil registration data with extracts from the MHMDS requested above. • Bridge file from linkage of civil registration data with extracts from the MHLDDS requested above. • Bridge file from linkage of civil registration data with extracts from the MHSDS requested above. It is also requested that on receipt of patient identifiers from the Maternity Indicators Data Set (MIds), National Community Child Health Data Set (NCCHDS) and Patient Episode Database for Wales from NHS Wales Informatics Service (NWIS), NHS Digital provides the NMPA team with the following: • Annually refreshed extracts from the civil registration data of live births covering all babies born alive in Wales between 1 April 2000 and 31 March 2018. • Annually refreshed extracts from the civil registration data of stillbirths covering all babies who were stillborn in Wales between 1 April 2000 31 March 2018. • Annually refreshed extracts from the civil registration data of neonatal deaths covering all babies who were born in Wales between 1 April 2000 and 31 March 2018 and died within 28 days of birth. • Annually refreshed extracts from the civil registration data covering all women who gave birth and babies born in Wales between 1 April 2000 and 31 March 2018 who died. • Annually refreshed extracts from the PDS birth notification data set covering all babies born in Wales between 1 April 2000 and 31 March 2018. • Bridge file from linkage of civil registration data with extracts from the PDS birth notification data set for Wales requested above. • Bridge file from linkage of civil registration data with extracts from the Maternity Indicators Data Set (MIds) requested above, covering all women who gave birth, and all babies born, in Wales, between 1 April 2015 and 31 March 2018. • Bridge file from linkage of civil registration data with extracts from the Community Child Health Data Set (NCCHDS) requested above, covering all women who gave birth, and all babies born in Wales, between 1 April 2015 and 31 March 2018. It is hoped that the civil registration birth/stillbirth data and the PDS birth notification dataset will form the spine to which all other women’s and babies’ records are linked. It is required that extracts from each dataset contain all records from the specified cohorts, both linked and unlinked. The unlinked data will enable the audit to assess their case ascertainment and whether maternity units are submitting all of their cases accordingly. The PDS birth notification dataset allows mothers' and babies' records to be linked since it contains the NHS number for the mother as well as for the baby. This will enable the production of an civil registration-PDS-HES-MSDS-MIS-MHSDS-MHLDDS-MHSDS linked database for England and an civil registration-PDS-PEDW-NCCHDS-MIds linked database for Wales. In particular, the date and time of delivery field is required. This is the only identifiable field requested. Reason for Requiring this Data Linkage of the maternity data with hospital episode data, civil registration and PDS data at a patient level has several advantages for the Audit. It will: 1) minimise – if not eliminate – the burden on clinical staff of data collection for the sole purpose of the audit; 2) enable information to be provided on longitudinal patterns of care, for example, hospital readmission following delivery, (3) enable validation of data from each source, and (4) enable information to be collected on the clinical history of the women before pregnancy, their comorbidities and their health service use during pregnancy which is important for case-mix adjustment. A similar methodology was found to be effective in a pilot study conducted by the RCOG in 2013/14, which involved 18 NHS hospitals across the UK supplying MIS data to create a database consisting of 120,000 delivery records from 2012/13 (CAG 2-06(a)/2013), which was then linked to the HES database. The study positively demonstrated the feasibility of this approach and showed a very high level of completeness of essential data items (>98%) and data linkage. As specified at the outset of the NMPA, MIS data collected directly from hospitals has been used to derive clinical measures for women giving birth and babies born within the first period of the audit. For women giving birth and babies born later in the audit, it is to be replaced by the use of the Maternity Services Data Set (MSDS). This eliminates the burden on NHS staff to produce a data extract from their trust’s MIS. The date and time of delivery field is essential to the audit for the following reasons: • Without date and time of delivery it is impossible for us to derive audit measures such as readmission within 6 weeks of delivery (which requires comparing hospital episode dates with the date of delivery); • In order to validate other data fields such as OxytocinAdministeredDateTime; • To assist with determining whether there has been a multiple birth, or whether records are duplicates. One of the periodic, time-limited audits will examine perinatal mental health within the NMPA cohort by linking the mental health databases to the linked dataset for this cohort for England. This will require mental health data for secondary care, to allow a feasibility study on whether maternity data linked to mental health datasets can provide insights into how aspects of pregnancy and delivery may be associated with a woman's mental health. Linked mental health data covering the cohort of women who gave birth between 1 April 2014 and 31 March 2018, including historical and future records for these women, between 1 April 2006 and 31 March 2018 is required. This means that access to the Mental Health Minimum Data Set, Mental Health and Learning Disabilities Data Set and the Mental Health Services Data Set to cover this time period is required. The audit will provide all NHS providers, commissioners and clinical networks with individualised and timely feedback on the quality of care provided and maternal and neonatal outcomes. Patients and the wider public will have access to lay summaries of all audit outputs. The NMPA was commissioned on the basis that the above datasets would be linked for the purposes of the audit and this is reflected in the audit contract with HQIP. 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). DATA CONTROLLERSHIP [1 paragraph unchanged] 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. [4 paragraphs unchanged] HQIP rely on Article 9 (2) (i) (2)(i) as the legal basis for processing special category data under GDPR - "processing is necessary for reasons of public interest in [73 words unchanged] 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 special category data - "Processing is necessary for the purposes of preventive or occupational medicine, for [65 words unchanged] provision of health and social care, and management of systems and compliance. Format of the audit The NMPA collects data on all registrable births (including live births before 24 weeks of gestation and stillbirths after 24 weeks of gestation) delivered under NHS care (including NHS home births) in England, Scotland and Wales. Data are reported at hospital, trust/board, regional and national level. The NMPA is also working to include Northern Ireland as part of the audit. The selection of measures for the NMPA was guided by a panel of clinical and academic experts, including obstetricians, midwives, statisticians and health service researchers, as well as the NMPA Women and Families Involvement Group and organisations representing maternity and neonatal service users. A range of measures is available and reported via accessible and interactive tables/charts on the NMPA website and in the clinical reports. Three of these measures (third and fourth degree tears, obstetric haemorrhage and Apgar score at five minutes of age) are used for potential outlier reporting. The NMPA does not rely upon bespoke data collection methods and does not limit the set of performance indicators produced by the continuous prospective audit to those indicators that have ‘auditable standards.’ There are three main reasons for this: • Maternity care is complex and focusing on a small number of care processes would inappropriately ignore some strong associations between the processes and outcomes of maternity care; • A wider set of indicators will allow maternity units to compare their antenatal, intrapartum and postnatal care patterns, which will prompt units to reflect on less common patterns, even in the absence of evidence-based guidelines; • Additional analyses aiming to identify determinants of variation in maternity services (‘epidemiology of the quality of maternity care’) will be possible, which will provide explicit guidance for quality improvement initiatives. The NMPA delivers clinically meaningful and methodologically robust outputs that guide quality improvement initiatives at local and national level. This is accomplished by providing: • An "organisational audit” that collects provider-level information on service availability, delivery and the organisation of maternity care, which contribute to a better understanding of the care provided to pregnant women. Data for the organisational audit are collected via an NHS maternity service survey in England, Scotland and Wales. To date, two organisational audit reports have been published (2017 and 2019). • A continuous clinical audit that produces information for maternity units to monitor patterns of care and maternal and perinatal outcomes. Data for the continuous clinical audit include maternity data (such as Maternity Services Data Set (MSDS) for England and MIds for Wales) and routinely collected data on hospital episodes (such as Hospital Episode Statistics for England and PEDW for Wales) • A series of in-depth topic-specific, time-limited audits “sprint audits” predominantly focusing on specific types of maternal and neonatal outcomes. Data for the sprint audits are collected following permission and approvals for access to datasets relevant to selected topics. Sprint audits on perinatal mental health, bloodstream infections and maternity care for women with Body Mass Index (BMI) over 30 are currently in development. Sprint audits on multiple births, maternal admissions to intensive care and neonatal data linkage have already been published. The NMPA first used the MSDS as the main source of maternity data for reporting on English births in 2017/18, with the data currently undergoing analysis at the time of submission of this agreement (V5) to the Data Access Request Service (DARS). Prior to this, the NMPA used data extracted from NHS hospitals’ electronic maternity record systems/maternity information systems (MIS) for reporting in England for 2015/16 and 2016/17 reports. These databases include information along the complete care pathway, from antenatal booking through to postnatal care. For England, NMPA also uses routinely collected data from HES which contains administrative information about each hospital admission, including deliveries. This data is necessary for several reasons. Firstly, knowledge of hospital admissions and diagnoses during and after delivery allows an understanding of maternal and neonatal outcomes and gives a greater level of detail on treatments that took place during delivery. Secondly, knowledge of diagnoses before delivery sheds light on case-mix, which is essential in performing risk-adjustment of the audit results (which enables a fair comparison between providers). Finally, the completeness of routine hospital episode datasets is very high, and thus it is used to validate data extracts from MSDS. Current data request (v5 - 2020) A number of single site studies in the UK have highlighted the adverse impact of the COVID19 pandemic on maternal health services and outcomes, including an increase in stillbirths rate (Khalil et al, Lancet). Other processes and outcomes reported include preterm births, mode of birth and low birthweight babies. In light of the emerging evidence, the NMPA has prioritised the COVID19 work theme. The NMPA aims to report on variations and trends in care in the pre- and post-pandemic periods for relevant indicators, and to provide timely updates at the national, regional and provider levels as appropriate. Therefore - The NMPA plan to reduce the complexity of the data request compared to the previous iterations of this agreement with the aim of ensuring data can be produced for those using NMPA data as quickly as possible. The key changes the NMPA propose for English data are: The NMPA plan to reduce the complexity of the data request compared to the previous DARS agreements with the aim of ensuring data can be produced for those using NMPA data as quickly as possible (ie quicker updates - less linkage time). This is especially important due to the COVID-19 pandemic. The key changes the NMPA propose for English data are: - The NMPA will not provide a cohort for linkage to current or previous data extracts. The data cohort will be restricted to babies/mothers identified in the PDS Birth Notification dataset for the requested time period as available from NHS Digital. The PDS Birth Notification dataset will be the “spine” to which all other NHS datasets will link to and furthermore will allow mothers' and babies' records to be linked since it contains the NHS number for the mother as well as for the baby. For this data dissemination - the NHS number will be pseudonymised and encrypted before being returned to the NMPA team. - This initial cohort will also be created from deriving a HES created cohort of maternity related ICD10/OPCS4 codes. - Quarterly updates of HES data will be provided by NHS Digital based on a HES created cohort of maternity related ICD10/OPCS4 codes. - To improve the timeliness and relevance of outputs for maternity services providers and users, the NMPA will produce indicators using the most recent available data, with plans for quarterly data production and dissemination in the future. Therefore, the current data request includes PDS Birth Notifications linked with HES APC and Civil Registration Data Set from 1st January 2018 to latest available data - The NMPA will process the data in two stages. For the first stage, the requested datasets for the cohort are restricted to HES APC and Civil Registration Mortality Data Secondary Care Cut linked via the PDS Birth Notification dataset. In the second stage, mental health datasets and linkage to neonatal data (if available) will be added to the request. . As MSDS v2.0 is not currently available at present, MSDS will be restricted to a one-off request covering all births from 1 April 2018 to 31 March 2019 for now. - The NMPA requests that pseudo NHS numbers for mothers and babies, generated from PDS Birth Notification Data are added to each dataset provided to the NMPA It is requested that NHS Digital provides the following files as an initial data request and quarterly updates to the NMPA team via secure transfer: Initial data request (1A) - PDS Birth notification data set covering all babies born in England between 1st January 2018 to latest available data. - HES APC data covering all women who gave birth, and all babies born, in England between 1st January 2018 to the latest available date - this cohort is to be based on both PDS Birth Notification data and a HES data specification provided by the NMPA (ICD10/OPCS4 Codes relating to Maternity episodes) - Civil Registration Data Set (covering all women who gave birth, and all babies born, in England between 1st January 2018 to latest available data. Initial Data Request (1B) - Maternity Services Data Set (MSDS) covering all women who gave birth, and all babies born, between 1 April 2018 and 31 March 2019. - Mental Health Minimum Data Set (MHMDS), and Mental Health Services Data Set (MHSDS) covering all women who gave birth between 1 April 2018 and 31 March 2019. - The historical (from 1 April 2000 or earliest available date) and future (up to most recent available date) records in PDS Birth Notification data, HES APC, Civil Registration data, Mental Health datasets for all individuals (mothers and babies as relevant) in the cohort. PDS birth notification dataset will form the spine to which all other women’s and babies’ records are linked. It is required that extracts from each dataset contain all records from the specified cohorts, both linked and unlinked. The unlinked data will enable the audit to assess their case ascertainment and whether maternity units are submitting all of their cases accordingly. In particular, the date and time of delivery field is required. This is the only identifiable field requested. Quarterly updates - Quarterly refreshed extracts of HES APC covering all women who gave birth and all babies born in England; cohort to be based on the HES data specification provided by the NMPA. This includes ICD10 codes and OPCS4 codes relating to maternity - Civil Registration Mortality data covering all women who gave birth, and all babies born, in England between 1st January 2018 to the latest available data - The historical (from 1 April 2000 or earliest available date) and future (up to most recent available date) records in HES APC and Civil Registration data for all individuals (mothers and babies as relevant) in the cohort. Annual refreshes of data to be provided at the relevant time points within the year. Reason for requiring these data Linkage of the maternity data with NHS Digital data at a patient level has several advantages for the Audit. It will: 1) minimise - if not eliminate - the burden on clinical staff of data collection for the sole purpose of the audit; 2) enable information to be provided on longitudinal patterns of care, for example, hospital readmission following delivery, (3) enable validation of data from each source, and (4) enable information to be collected on the clinical history of the women before pregnancy, their comorbidities and their health service use during pregnancy which is important for case-mix adjustment. The date and time of delivery field is essential to the audit for the following reasons: - Without date and time of delivery it is impossible for the NMPA to derive audit measures such as readmission within 6 weeks of delivery (which requires comparing hospital episode dates with the date of delivery) - In order to validate other data fields such as OxytocinAdministeredDateTime; - To assist with determining whether there has been a multiple birth, or whether records are duplicates. The audit will provide all NHS providers, commissioners and clinical networks with individualised feedback on the quality of care provided and maternal and neonatal outcomes. Patients and the wider public will have access to lay summaries of all audit outputs. A national report will also be created, written by clinicians, to provide key insights into the data with key messages and recommendations provided. The NMPA was commissioned on the basis that the above datasets would be linked for the purposes of the audit and this is reflected in the audit contract with HQIP. Requesting these data also minimises the data burden on NHS staff by ensuring the audit team use routinely collected data.

Processing activities

The eligible cohort of individuals whose data is to be collected by the National Maternity and Perinatal Audit during the period of the proposed Data Sharing Agreement with NHS Digital is all women who gave birth between 1 April 2014 onwards, and babies whose birth was registered in this period. Therefore, the data requested covers the currently available records in this cohort. The additional data on deliveries between 1 April 2000 and 1 April 2014 is requested in order to establish a baseline position and determine trends over time in both patterns of maternity care and also in data quality and completeness. The cohort has been restricted in this way in order to minimise the amount of data requested. 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). Furthermore, only data items which are necessary for the Audit are requested, with one or more of the following purposes: In previous iterations of this agreement - the following was permitted (up to and including v4): For women who delivered, and babies born up until 31 March 2017, English maternity units supplied the NMPA team with an annual extract of patient-level data relating to the deliveries that occurred at their unit in the previous financial year period (12 months) from their maternity information systems. NHS Trusts provided data from their maternity information systems by transferring it to the NMPA’s secure server within the N3 network using a Secure File Transfer Protocol. All data processing took place on this server. The secure server is leased from RedCentric by the RCOG and is based at the RedCentric site in Reading, with backups located at the RedCentric Harrogate site. Data was pseudonymised by the audit’s data managers, who separated the patient identifiers contained within the data extracts from maternity record and treatment MIS (Maternity Information Sytems) data. The data managers were based at the RCOG and held full contracts of employment there. No other individuals have access to patient identifiers. The records belonging to the same individual could only be identified by the project team with an NMPA-derived study ID. The audit’s data managers securely transferred the patient identifiers of a cohort of patients in the audit to NHS Digital. The following identifiers were sent in; this covered the earlier part of the audit cohort (women giving birth and babies born between 1 April 2014 and 31 March 2017): - Mother’s NHS Number - Baby’s NHS Number - Postcode - Mother’s Date of Birth - Baby’s Date of Birth - Baby’s Gender All available data from the civil registration of live births, stillbirths, neonatal deaths and mortalities, PDS birth notification data set, HES, MSDS, MHSDS, MHLDDS and MHMDS for this cohort was returned to the RCOG. A derived civil registration cohort of births and deliveries between 1 April 2000 and 31 March 2018 was created by NHS Digital and returned to the RCOG. This cohort contained records from the civil registration of live births and stillbirths. This cohort was linked to the requested civil registration data of neonatal deaths and mortalities, PDS birth notification data set, HES, MSDS, MHSDS, MHLDDS, MHMDS and MIS identifiers. Both the linked and unlinked records from these datasets were requested. The resulting database was be returned to the NMPA’s data managers at the RCOG who linked it to MIS data using the NMPA study ID, resulting in a linked dataset. In addition, the NMPA also required civil registration birth registration data and PDS birth notification data for babies born in Wales and their mothers. This was obtained using the following process. The NHS Wales Informatics Service (NWIS) securely transferred patient identifiers for women who gave birth, and babies born between 1 April 2000 and 31 March 2018, to NHS Digital, along with a pseudonymised study ID for these individuals. The following identifiers were sent in: - Mother’s NHS Number - Baby’s NHS Number - Postcode - Mother’s Date of Birth - Baby’s Date of Birth - Baby’s Gender All available data from the civil registration of live births, stillbirths, neonatal deaths and mortalities and PDS birth notification data set for this cohort was returned to the RCOG, linked with the pseudonymised study IDs by NHS Digital. The NMPA team received a linked NCCHDS-MIds-PEDW dataset from NWIS, for women who gave birth, and babies born between 1 April 2000 and 31 March 2018,, using the same pseudonymised study IDs as sent to NHS Digital. Both the linked and unlinked records from these datasets were requsted. The NMPA data managers used the pseudonymised study IDs to combine the civil registration-PDS data sent by NHS Digital and the NCCHDS-MIds-PEDW dataset set by NWIS and created a linked dataset. The NMPA collected the data of all women who give/gave birth in England between 1 April 2014 and 31 March 2019, and all babies born in this time period. Longitudinal data allows for the detection of trends in patterns of care and in data quality over time, which is important in order to understand the audit’s results and to put them into context. Update - December 2020: Due to increased pressures of COVID-19, the NMPA are choosing to simplify the data request for v5 of this agreement. The eligible cohort of individuals whose data is to be collected by the National Maternity and Perinatal Audit during the period of this version of the proposed Data Sharing Agreement with NHS Digital (v5) is all women who gave birth from 1st January 2018, and babies whose birth was registered in this period. Therefore, the data requested covers the currently available records in this cohort. Unlike the previous NMPA data request, the NMPA team will not provide a cohort for linkage to current or previous data extracts, this will simplify the process of the linkage and the data request. s251 support still remains valid and in place for the NMPA to continue to hold and process the data that was facilitated via this linkage of a specified cohort under previous iterations of this agreement - however it has been decided by the NMPA that future data dissemination (starting with what is approved under this version of the agreement (v5)) can facilitate the purpose of the audit without this specific cohort being provided by NMPA to NHS Digital. Instead - NHS Digital will create the cohort based on criteria of women who gave birth from 1st January 2018. Only data items which are necessary for the Audit are requested, with one or more of the following purposes: [6 paragraphs unchanged] Data Flows For England, a derived cohort of all babies born between 1st January 2018 to the latest available month and their mothers will be created by NHS Digital using the PDS birth notification dataset, combined with an extract of HES data filered via ICD10/OPCS Codes For women who delivered, and babies born up until 31 March 2017, English maternity units have supplied the NMPA team with an annual extract of patient-level data relating to the deliveries that occurred at their unit in the previous financial year period (12 months) from their maternity information systems. All available data from the PDS birth notification data set, HES APC, MSDS, MHSDS,and MHMDS for this cohort (including babies’ and mothers’ data) will be returned to the RCOG. NHS Trusts provided data from their maternity information systems by transferring it to the NMPA’s secure server within the N3 network using a Secure File Transfer Protocol. All data processing takes place on this server. The secure server is leased from RedCentric by the RCOG and is based at the RedCentric site in Reading, with backups located at the RedCentric Harrogate site. All historical and future data (up to most recent available date) from these same individuals is required. There are two main reasons for requiring the historical data: Data was pseudonymised by the audit’s data managers, who separated the patient identifiers contained within the data extracts from maternity record and treatment MIS data. The data managers are based at the RCOG and hold full contracts of employment there. No other individuals have access to patient identifiers. The records belonging to the same individual can only be identified by the project team with an NMPA-derived study ID. 1) it enables information to be provided on longitudinal patterns of care, for example, maternal or neonatal hospital readmission following delivery, The audit’s data managers will securely transfer the patient identifiers to NHS Digital. The following identifiers will be sent in; this covers the earlier part of the audit cohort (women giving birth and babies born between 1 April 2014 and 31 March 2017): (2) it enables information to be collected on the clinical history of the women before pregnancy, their comorbidities and their health service use during pregnancy which is important for case-mix adjustment. - Mother’s NHS Number Both the linked and unlinked records from these datasets have been requested. - Baby’s NHS Number All available data from PDS birth notification data set for this cohort will be returned to the RCOG, linked with the pseudonymised nhs number by NHS Digital. - Postcode NHS Digital will only provide the data extracts to the RCOG with a pseudonymised NHS number for mother and baby. The only identifier that will be disseminated across the extracts is babies’ dates of birth - for which s251 support is in place. - Mother’s Date of Birth All other patient identifiers will be removed. - Baby’s Date of Birth No further patient identifiers will be sent from NHS Digital to the RCOG. - Baby’s Gender The NMPA data managers will keep patient identifiers separate from the pseudonymised clinical data sent by NHS Digital. There will be no attempts to re-link the data to the identifiers for re-identification. All available data from the civil registration of live births, stillbirths, neonatal deaths and mortalities, PDS birth notification data set, HES, MSDS, MHSDS, MHLDDS and MHMDS for this cohort will be returned to the RCOG. A derived civil registration cohort of births and deliveries between 1 April 2000 and 31 March 2018 will also be created by NHS Digital and returned to the RCOG. This cohort will contain records from the civil registration of live births and stillbirths. This cohort will be linked to the requested civil registration data of neonatal deaths and mortalities, PDS birth notification data set, HES, MSDS, MHSDS, MHLDDS, MHMDS and MIS identifiers. Please note that a derived civil registration cohort is now required rather than the derived HES cohort requested previously. This is due to the civil registration birth registration data now being available (which has a higher data quality and completeness than HES). Both the linked and unlinked records from these datasets have been requested. The resulting database will be returned to the NMPA’s data managers at the RCOG who will link it to MIS data using the NMPA study ID, resulting in a linked dataset. In addition, the NMPA now require civil registration birth registration data and PDS birth notification data for babies born in Wales and their mothers. This will be obtained using the following process. The NHS Wales Informatics Service (NWIS) will securely transfer patient identifiers for women who gave birth, and babies born between 1 April 2000 and 31 March 2018, to NHS Digital, along with a pseudonymised study ID for these individuals. The following identifiers will be sent in: - Mother’s NHS Number - Baby’s NHS Number - Postcode - Mother’s Date of Birth - Baby’s Date of Birth - Baby’s Gender All available data from the civil registration of live births, stillbirths, neonatal deaths and mortalities and PDS birth notification data set for this cohort will be returned to the RCOG, linked with the pseudonymised study IDs by NHS Digital. The NMPA team will receive a linked NCCHDS-MIds-PEDW dataset from NWIS, for women who gave birth, and babies born between 1 April 2000 and 31 March 2018,, using the same pseudonymised study IDs as sent to NHS Digital. Both the linked and unlinked records from these datasets have been requested. The NMPA data managers will use the pseudonymised study IDs to combine the civil registration-PDS data sent by NHS Digital and the NCCHDS-MIds-PEDW dataset set by NWIS and create a linked dataset. NHS Digital will only provide the data extracts to the RCOG with a study ID and babies’ dates of birth. All other patient identifiers will be removed. No further patient identifiers will be sent from NHS Digital to the RCOG. The NMPA data managers will keep patient identifiers separate from the pseudonymised clinical data sent by NHS Digital. There will be no attempts to re-link the data to the identifiers for re-identification. [1 paragraph unchanged] • - Rates of spontaneous vaginal, instrumental and caesarean section births; • - Rates of third third- and fourth degree tears among vaginal births; • - Rates of singleton babies born at term with a five minute Apgar score below 7. [1 paragraph unchanged] The NMPA collects the data of all women who give/gave birth in England between 1 April 2014 and 31 March 2019, and all babies born in this time period. Longitudinal data allows for the detection of trends in patterns of care [10 words unchanged] order to understand the audit’s results and to put them into context. All historical and future data (up to 1 April 2018) from these same individuals is required. There are two main reasons for requiring the historical data: 1) it enables information to be provided on longitudinal patterns of care, for example, maternal or neonatal hospital readmission following delivery, (2) it enables information to be collected on the clinical history of the women before pregnancy, their comorbidities and their health service use during pregnancy which is important for case-mix adjustment. [3 paragraphs unchanged] In previous iterations of this agreement - HES Critical Care, HES Outpatients and HES Accident and Emergency data sets were requested. The NMPA team have determined these are not required for continuation of the audit -and will not be requested again. The NMPA team will continue to hold previously disseminated extracts of these datasets - but they will not be requesting a renewal of these datasets under v5 of this agreement. Data Minimisation HES filters/data minimisation: The cohort will be restricted to all as identified in a) PDS Birth Notification data and b) HES specification as provided by the NMPA, for births between 1st January 2018 to latest available and updated quarterly. There are approximately 650,000 births in England and Wales per annum, therefore the cohort will include 1.3 million individuals (mothers and babies) per year - e.g. approximately 3 million individuals from 1st January 2018 to 31 July 2020, and 325,000 individuals for each quarterly update. MSDS filters/data minimisation: All non-sensitive / high risk variables have been requested as it is imperative for the audit to capture the maternity care pathway and pregnancy outcomes for all births in England. The only identifiable information requested is baby's date of birth: The date and time of delivery field is essential to the audit for the following reasons: - Without date and time of delivery it is impossible for the NMPA to derive audit measures such as readmission within 6 weeks of delivery (which requires comparing hospital episode dates with the date of delivery) - In order to validate other data fields such as OxytocinAdministeredDateTime; - To assist with determining whether there has been a multiple birth, or whether records are duplicates. All historical and future HES APC data (from 2000/2001 up to most recent available date) from these same individuals is required. There are two main reasons for requiring the historical data: 1) it enables information to be provided on longitudinal patterns of care, for example, maternal or neonatal hospital readmission following delivery, (2) it enables information to be collected on the clinical history of the women before pregnancy, their comorbidities and their health service use during pregnancy which is important for case-mix adjustment. Only variables required for the audit will be requested. Mental health data filters/data minimisation The cohort will be restricted to all mothers who have given birth between 1 April 2018 to 31 March 2019 as identified by the PDS Birth Notification data for the same period and all historical / future records for this cohort. Approximately 650,000 individuals. 3 packages selected: Package 1d) Mental Health Services: Community Activity - Admin Data, Clinical Data, Demographics in one package. Package 2d) Mental Health Services Inpatient Activity, Uses of the Mental Health Act, Forensic Pathways, Individual incidents of assault, restrictive intervention and self harm. Package 4) Mental Health Services: Currencies - Detailed information about MH Currency Assessments and assignments. Summary: Data will be delivered as follows by NHS Digital For births/deliveries in England: Data drop 1 split into 1a and 1b. 1a. - NHS Digital to create the requested cohort using data from the birth notifications data set, using births from 01/01/2018 to latest available. NHS Digital will exclude any invalid dates of birth. - NHS Digital will supply HES APC data using both the birth notifications cohort created above, and a HES created cohort made from maternity related ICD10/OPCS4 codes in HES for the same period.. Historical data will be provided from 2000 onwards for this cohort - Supply mortality data linked to the combined cohort - Supply the bridge file of mother nhs number to baby nhs number (pseudonymised) - Quarterly HES extracts will continue for the duration of the DSA based on the HES created cohort only (created from ICD/OPCS codes). Historical HES APC data will be provided from 2000 onwards. 1b. - Supply 18/19 Maternity Services Data Set linked to the birth notifications cohort - Supply Mental Health data (MHSDS/MHMDS) linked to the birth notifications cohort - Supply the birth registrations / birth notifications linked extract. - Quarterly HES extracts will continue for the duration of the DSA based on the HES created cohort only (created from ICD/OPCS codes). Historical HES APC data will be provided from 2000 onwards. -Annual refresh extracts to be provided when available. The National Maternity and Perinatal Audit (NMPA) stores data on a secure server within the secure NHS N3 network/Health and Social Care Network (HSCN). The secure server is leased from RedCentric by the RCOG and is based at the RedCentric site in Reading, with backups located at the RedCentric Harrogate site. Files can only be transferred onto/off the server by four individuals on the NMPA team with ‘Data manager permissions’. These individuals are the NMPA data manager, NMPA analysts (x2) and the NMPA senior methodologist. When data are received from NHS Digital via the SEFT system, the nominated individual (NMPA Senior Methodologist) will immediately securely transfer (via SFTP) the data to the secure NMPA server. The NMPA have access to data destruction software (Blancco) for the destruction of any data when necessary. All analysis of the data takes place on the secure server hosted by RedCentric.

Expected output

From the start of the audit, a reporting framework has been developed [20 words unchanged] written in a language that is accessible to the public. There are six a number of different approaches to report the results: 1. The biennial organisational survey reports give provider-level information on service delivery and the organisation of maternity care, which contributes to a better understanding of the care provided to pregnant women. The first organisational survey report was published on 10th August 2017, with the second published in June 2019. 1. Audit reports are used by NHS trusts to monitor the quality of maternity care they provide, maternal and perinatal outcomes and trends over time. Variation in outcomes is reported, carefully adjusted for differences in case-mix. The first annual report was published on 9th November 2017, with the second report published in July 2019. The next report is due to be published in early 2021 and will be based on the 2017/18 Maternity Services Data Set (MSDS) which was received under v4 of this agreement. The reports are available on the audit website and do not contain any identifiable data. All data displayed in the report is aggregated with small number suppression in line with the HES analysis guide. 2. Audit reports are used by NHS trusts to monitor the quality of maternity care they provide, maternal and perinatal outcomes and trends over time. Variation in outcomes is reported, carefully adjusted for differences in case-mix. The first annual report was published on 9th November 2017, with the second report published in July 2019, the subsequent report to be published in December 2019 relies on the 2017/18 MSDS data which is being disseminated under the re-run request in this application. The reports are available on the audit website and do not contain any identifiable data – all data is aggregated with small number suppression in line with the HES analysis guide. These reports will be enhanced by the use of civil registration and PDS data. The MSDS will be used in future annual audit reports in the place of MIS data as the source of maternity data. 2. Annual stakeholder meetings are arranged to share and disseminate audit findings and promote quality improvement amongst a large number and range of stakeholders. The next event will be held in late 2021, with a view to sharing the results of the first report using MSDS data. The Annual Reports are written to be public and patient friendly. The governance of the audit includes patient and public representatives who advise on dissemination of the outputs. 3. Annual stakeholder meetings are arranged to disseminate audit findings and promote quality improvement. The first two of these were held on 9th November 2017 and 15 November 2018. A further Clinical Reference Group meeting took place on 5th February 2019 with the next event to be held by January 2020. This event was postponed to April 2020 which again has had to be postponed due to COVID-19. The Annual Reports are written to be public and patient friendly. The governance of the audit includes patient and public representatives who advise on dissemination of the outputs. 3. Online reports have been set up that allow individual providers, commissioners and relevant clinical networks to benchmark their process and outcomes indicators against care provided nationally and regionally. These reports are designed to facilitate the use of national data for local audit activities. Moreover, the audit supports English maternity units to contribute to the Quality Accounts. The reports do not contain any patient identifiable information. 4. Online reports have been set up that allow individual providers, commissioners and relevant clinical networks to benchmark their process and outcomes indicators against care provided nationally and regionally. These reports are designed to facilitate the use of national data for local audit activities. Moreover, the audit supports English maternity units to contribute to the Quality Accounts. The reports do not contain any patient identifiable information. 4 Reports of periodic time-limited, topic-specific audits are produced at least annually, allowing a more detailed and in-depth insight into specific aspects of the care provided by maternity services. Reports on the first three topics have now been published. Two further reports, including a report on perinatal mental health, and maternity care for women with a BMI>30 will be published before the end of June 2021. The aim of each sprint audit is to investigate the extent to which further insight into the quality of maternity care can be gained by using additional datasets. If the datasets used in the sprint audits are found to add significant value, they will be incorporated into the continuous clinical audit in future years. 5. At least two reports of periodic time-limited, topic-specific audits are produced annually, allowing a more detailed and in-depth insight into specific aspects of the care provided by maternity services. Reports on the first two periodic time-limited, topic-specific audits, on maternal admission to intensive care, and neonatal care, have been submitted for review by HQIP, and are to be published by March 2019. Two further reports, including a report on perinatal mental health, were published in March 2020. A further report is due for publication in Summer/Autumn 2020. The aim of each sprint audit is to investigate the extent to which further insight into the quality of maternity care can be gained by using additional datasets. If the datasets used in the sprint audits are found to add significant value, they will be incorporated into the continuous clinical audit in future years. 5. The audit team are currently producing several manuscripts to submit to peer-reviewed publications, especially related to the additional analyses aiming to identify determinants of variation in maternity services and methodological development work (e.g. risk adjustment, handling missing data, continuous monitoring, combining multiple linked indicators to assess maternity unit performance, design of outputs that are most effective in local quality improvement). Three manuscripts have been submitted to clinical journals for peer review and publication. Further analysis plans are being developed and scheduled throughout the remainder of the audit. The types of journals the audit submits to include clinical journals such as the British Journal of Obstetrics and Gynaecology or British Medical Journal, and methodological journals such as the Journal of Clinical Epidemiology and the BMC Health Services Research. 6. The audit team are currently producing several manuscripts to submit to peer-reviewed publications, especially related to the additional analyses aiming to identify determinants of variation in maternity services and methodological development work (e.g. risk adjustment, handling missing data, continuous monitoring, combining multiple linked indicators to assess maternity units’ performance, design of outputs that are most effective in local quality improvement). Three manuscripts have been submitted to clinical journals for peer review and publication. Further analysis plans are being developed and scheduled throughout the remainder of the audit. The types of journals the audit submits to include clinical journals such as the British Journal of Obstetrics and Gynaecology or British Medical Journal, and methodological journals such as the Journal of Clinical Epidemiology and the BMC Health Services Research. 6. The current data request (which includes data requested up until the most recent available period) will allow for monitoring the quality of maternity care in the COVID-19 pandemic period. All published outputs will be aggregated with small number suppression in line with the HES analysis guide.

Expected measurable benefits

[1 paragraph unchanged] The audit provides robust and rigorous evidence to NHS maternity service providers, providers and to inform decisions on prioritising services for commissioning, and advises on the most effective ways to improve access to antenatal care. commissioning. In the future future, results from the audit will relate patterns of care to maternal and [23 words unchanged] worse clinical outcomes. This will have a direct impact on clinical practice. Use of the civil registration birth register and PDS birth notification data will allow the NMPA to derive case ascertainment in various subgroups of the population, for example, small and premature babies. The evidence-based clinical indicators derived in the audit are used by maternity units to assess their performance and compare it with others. Information is made publicly available, including key results at individual maternity unit level. This informs decisions made by local managers on policies and procedures within maternity units, and also enables women and families using services to engage in informed conversations with health service providers regarding their care. The audit ensures that appropriate comparisons can be made to allow an assessment of whether local maternity units are meeting relevant standards of care. The evidence-based clinical indicators derived in the audit are used by maternity units to assess their performance and compare it with others. Information is made publicly available, including key results at individual maternity unit level. This informs decisions made by local managers on policies and procedures within maternity units. The audit ensures that appropriate comparisons can be made to allow an assessment of whether local maternity units are meeting relevant standards of care. This informs decisions made by local managers on policies and procedures within maternity units. The audit’s reports include recommendations to enable NHS Trusts to drive effective local quality improvement initiatives. The recommendations are aimed at the full spectrum of stakeholders (e.g. individual clinicians, maternity units, commissioners or higher levels, depending on the issues). These recommendations also feed into quality improvement programmes in maternity care organised by the RCOG, RCM and RCPCH. Each College runs regular regional meetings and the audit results feed into their processes with the aim of standardising the delivery of care and improving the culture of safety for service users. Giving birth is the most common reason for admission to hospital in the UK, with approximately 800,000 births per year throughout England, Scotland and Wales. Thus, each benefit described above has the potential to positively affect the experience of maternity care for a very large number of women and their families. The perinatal mental health sprint audit will produce a set of methodologically robust, clinically relevant measures. Maternity providers will be able to use their results to address areas of variation at trust and unit level. The results will provide, to services, the first measures available relating aspects of maternity care to perinatal mental health. The sprint audit will also offer a national picture of both the quality of data used and the proportions of women for whom the measures apply. The audit’s reports include recommendations to enable NHS Trusts to drive effective local quality improvement initiatives. In future some of these recommendations will be guided by providers who have been demonstrated to have superior performance according to the results of the audit. The recommendations are aimed at the full spectrum of stakeholders (e.g. individual clinicians, maternity units, commissioners or higher levels, depending on the issues). These recommendations also feed into quality improvement programmes in maternity care organised by the RCOG, RCM and RCPCH. Each College runs regular regional meetings and the audit results feed into their processes with the aim of standardising the delivery of care and improving the culture of safety for service users. Giving birth is the most common reason for admission to hospital in the UK, with approximately 800,000 births per year throughout England, Scotland and Wales. Thus, each benefit described above has the potential to positively affect the experience of maternity care for a very large number of women and their families.

Benefits reported

The first annual report was published on 9 November 2017. This report was written in lay language, accessible to those working in all areas of the NHS and also to women giving birth and their families. The first two annual stakeholder meetings were held on 9 November 2017 and 15 November 2018, which further helped disseminate the audit results to a variety of stakeholders. The NMPA delivers a clinically meaningful and methodologically robust continuous clinical audit that guides quality improvement initiatives at local and national level. The results and reports generated by the NMPA can be used by clinicians, policymakers, commissioners and women to reflect on maternity and perinatal care in Britain. This has been welcomed across the three countries and three professions of obstetrics, midwifery and neonatology. An online reporting system was launched at the same time as the first annual report, enabling clinicians, maternity care providers, commissioners and managers to compare the quality of care provided at their maternity unit with others within England, Scotland and Wales on a wide variety of measures. A large number of clinicians and methodologists have contributed towards the derivation of these measures, ensuring they are clinically meaningful and methodologically robust. A number of key reports have been created: Intensive care and neonatal sprint audit reports were submitted to HQIP during 2018, for their review prior to publication by early 2019. • Two continuous clinical audit cycles completed using the most recent data available to the NMPA (births in 2015/16 and 2016/17), with reports published in November 2017 and September 2019. During 2018, three manuscripts have been submitted to clinical journals for peer review and publication. These relate to additional analyses aiming to identify determinants of variation in maternity services. Their publication will likely be during 2019, thought dates cannot be determined until peer reviews are complete. Several other manuscripts are currently in preparation. • Two organisational reports (2017 and 2019) completed and published. Both organisational reports received a 100% response rate, demonstrating the ongoing commitment of the maternity and neonatal services to work with the NMPA for the purpose of improving care provision. Feedback has been received from a number of maternity units detailing how initiatives have been set up to improve the quality of care provided in terms of specific measures published by the audit. Three examples of such initiatives were presented at the event on 15 November 2018, two of which were designed to reduce post-partum haemorrhage by improving processes during care, such as introducing risk assessments. Subsequent audit outputs will include examples and case studies of how clinical practice has been improved based on the audit results. The NMPA has also developed several sprint audits which have provided valuable information and timely recommendations on specific topics: Several reports have now been published (as per outputs section): • Maternity Admissions to Intensive Care in England, Wales and Scotland in 2015/16 (published 2019) The 2019 Organisational Report is published here https://maternityaudit.org.uk/FilesUploaded/NMPA%20Organisational%20Report%202019.pdf • Technical Report: Linking the National Maternity and Perinatal Audit Data Set to the National Neonatal Research Database for 2015/16, which then allowed reporting of neonatal unit data in 16/17 clinical report (published 2019) The second annual report was published in September 2019 and is available here https://maternityaudit.org.uk/FilesUploaded/NMPA%20Clinical%20Report%202019.pdf • NHS Maternity Care for Women with Multiple Births and Their Babies (published August 2020) Sprint audits on maternal admission to intensive care are published here - https://maternityaudit.org.uk/FilesUploaded/NMPA%20Intensive%20Care%20sprint%20report.pdf • ‘Perinatal Mental Health in Scotland’ Sprint Audit (to be published December 2020) and on linking to NNRD here - https://maternityaudit.org.uk/FilesUploaded/NMPA%20Neonatal%20sprint%20report.pdf • Sprint audits on the topics of maternity care for women with a BMI>30 and blood stream infections are currently in development. In addition to the above reports, the NMPA has developed a wealth of other resources for the wide range of audiences who use NMPA data, all with the goal of facilitating quality improvement in maternity care: • Lay summaries and infographics have been created for a number of key NMPA reports. The infographics for the 2019 Organisational Audit, and the Lay Summary for the 2019 Clinical Report have been particularly well received by the NMPA Women and Families Involvement Group. • An interactive table which displays a large range of NMPA data, allowing users to filter for certain measures and trusts. This also allows users to download ‘readymade’ Excel tables that include all measures. The tables can be used to find maternity services which are similar in terms of size, neonatal unit designation or available birth settings, offering a large amount of practical and relevant information for quality improvement purposes. • Information for each site and trust/board are available on the NMPA website, providing accessible and valuable data for easy comparison both against the national mean, but also in the context of other relevant measures at the same site/trust/board.

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

Data controllers: + NHS ENGLAND

Objective for processing

[10 paragraphs unchanged] - An ‘organisational survey’ to collect provider-level information on service delivery and [17 words unchanged] pregnant women. The first organisational survey report was published on 10th August 2017, with 201 and the next report due to be second was published in June 2019. [53 paragraphs unchanged] DATA CONTROLLERSHIP 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. 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.

Processing activities

[42 paragraphs unchanged] The audit's section 251 support lists several linkages that are permitted. These include linkage to ICNARC, ICNARC, PHE's Surveillance Systems and BadgerNet Neonatal Data. [2 paragraphs unchanged]

Expected output

[1 paragraph unchanged] 1. The biennial organisational survey reports give provider-level information on service delivery [20 words unchanged] first organisational survey report was published on 10th August 2017, with the next report due to be second published in June 2019. 2. Audit reports are used by NHS trusts to monitor the quality [23 words unchanged] case-mix. The first annual report was published on 9th November 2017, with the second report published in July 2019, the subsequent reports report to be published in July 2019 and December 2019 respectively. relies on the 2017/18 MSDS data which is being disseminated under the re-run request in this application. The reports are available on the audit website and do not contain [43 words unchanged] in the place of MIS data as the source of maternity data. 3. Annual stakeholder meetings are arranged to disseminate audit findings and promote quality improvement. The first two of these were held on 9th November 2017 and 15 November 2018, 2018. A further Clinical Reference Group meeting took place on 5th February 2019 with the next event to be held by January 2020. This event was postponed to April 2020 which again has had to be postponed due to COVID-19. The Annual Reports are written to be public and patient friendly. The governance of the audit includes patient and public representatives who advise on dissemination of the outputs. [1 paragraph unchanged] 5. At least two reports of periodic time-limited, topic-specific audits are produced [49 words unchanged] March 2019. Two further reports, including a report on perinatal mental health, will be were published by in March 2020. A further report is due for publication in Summer/Autumn 2020. The aim of each sprint audit is to investigate the extent [31 words unchanged] they will be incorporated into the continuous clinical audit in future years. [2 paragraphs unchanged]

Benefits reported

[5 paragraphs unchanged] Several reports have now been published (as per outputs section): The 2019 Organisational Report is published here https://maternityaudit.org.uk/FilesUploaded/NMPA%20Organisational%20Report%202019.pdf The second annual report was published in September 2019 and is available here https://maternityaudit.org.uk/FilesUploaded/NMPA%20Clinical%20Report%202019.pdf Sprint audits on maternal admission to intensive care are published here - https://maternityaudit.org.uk/FilesUploaded/NMPA%20Intensive%20Care%20sprint%20report.pdf and on linking to NNRD here - https://maternityaudit.org.uk/FilesUploaded/NMPA%20Neonatal%20sprint%20report.pdf

Unchanged: Expected measurable benefits.