MBRRACE-UK - Delivering the National Maternal, Newborn and Infant Clinical Outcome Review Programme - National Surveillance of Maternal and Perinatal Deaths

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

Objective for processing

[21 paragraphs unchanged] The University of Oxford already hold data relating to women and babies for births from 1st January 2013 (the start of the MBRRACE-UK run MNI-CORP programme) to 30th September 2022. 31st March 2025. The University will receive the same period of data again to obtain [50 words unchanged] The University of Oxford will also continue to receive annual data refreshes. [11 paragraphs unchanged]

Benefits reported

Between 2013 and 2019 across the UK, taking into account the changing birth rate, there have been an estimated 2,910 fewer perinatal deaths. More than half of this reduction was achieved since the introduction of national initiatives such as the Saving Babies’ Live Care Bundle, versions 1 and 2 in 2016. This represents a clear improvement in outcomes due to improvements in the quality of care provided. 1. The impact of MBRRACE-UK reports on national policy and practice: Example benefits: The findings of the high rates of perinatal deaths in England, the variation between trusts and the results of the Kirkup enquiry resulted in an independent national maternity services review, launched in 2015. The findings of this review were published as the ‘Better Birth’ Report in 2016 and MBRRACE-UK surveillance and confidential enquiry findings were highly cited throughout the report. 1. The impact of MBRRACE-UK reports on national policy and practice This led to, in 2015, the Secretary of State for Health announcing additional funding for maternity services and the national ambition to reduce the maternal and perinatal mortality rate by half by 2030; this was subsequently redefined in 2016 to achieve this ambition by 2025, with a 20% reduction by 2020. In March 2015 Dr Bill Kirkup published his report of the investigation of perinatal and maternal deaths in the Universities Hospitals of Morecambe Bay – the ‘Morecambe Bay Inquiry’ Report (1). As part of the report recommendations, it was noted that good information on pregnancy outcomes (including deaths) is a key driver for improvements in the quality of care provided for pregnant women and newborn babies. During the COVID-19 pandemic MBRRACE-UK monitored maternal and perinatal deaths directly due to or complicated COVID-19 and produced rapid maternal reports detailing the care of women with COVID-19. MBRRACE-UK also conducted two rapid reports into 1) maternal deaths of women whose care was affected by the COVID-19 pandemic, and 2) the deaths of women who died by suicide and homicide in the first national lock down. Both perinatal and maternal data on COVID-19 were also shared on a weekly basis with central organisations who were responsible for developing the national pandemic control measures, guidance for health professionals and advice for pregnant and recently pregnant women, and parents. This included a change to JCVI vaccine recommendations for inclusion of pregnant women as a high risk group in the vaccination programme. The findings of the high rates of perinatal deaths in England, the variation between trusts and the results of the Kirkup enquiry resulted in an independent national maternity services review, launched in 2015. The findings of this review were published as the ‘Better Birth’ Report in 2016 and MBRRACE-UK surveillance and confidential enquiry findings were highly cited throughout the report as evidence of the need for changes to maternity services to improve the care provided and as a consequence the outcomes for mothers and babies. MBRACE-UK has consistently identified ethnic inequalities in maternal and perinatal deaths. These findings have led to lots of policy activity by NHS England, including the development of the Equity and Equality Steering Group in 2024; the Royal College of Obstetricians and Gynaecologists who established a Race Equality Task Force and published a position statement on racial and ethnic inequality (Oct 2024); and the growth of third sector organisations such as Five X More. Further evidence of impact were evident in the 2024 Labour Party manifesto and Lord Darzi’s report on the state of the National Health Service in England produced in September 2024 which made numerous references to MBRRACE-UK figures on ethnic inequalities in maternity care. The NIHR Challenge Maternity Disparities Consortium was also announced in November 2024 in direct response to a recommendation from the 2024 MBRRACE-UK maternal mortality report. This led to, in 2015, the Secretary of State for Health announcing additional funding for maternity services and the national ambition to reduce the maternal and perinatal mortality rate by half by 2030; this was subsequently redefined in 2016 to achieve this ambition by 2025, with a 20% reduction by 2020. The 20% reduction in overall perinatal mortality was achieved in 2020. The maternal mortality rate has not reduced. Since 2013, the stillbirth rate in England has decreased by 22% and the neonatal mortality rate in England has decreased by 15%. In 2019, the majority of Trusts in England had a stabilised and adjusted stillbirth rate within +/- 5% of the national average. In 2020, despite the effects of the pandemic on clinical services, a local review of 94% of perinatal deaths was undertaken to identify areas for local quality improvement to prevent future deaths. This is compared with an estimated 10% in 2013. To date in 2022, despite the continuing effects of the pandemic on maternity and neonatal services, 99% of perinatal deaths have been notified to MBRRACE-UK within 7 days of the death which, with Birth Notification Data, enables more rapid surveillance of perinatal deaths. In the 2018 maternal mortality report, reiterated in the 2019 report, MBRACE-UK identified the continuing ethnic inequalities in maternal death (there are similar inequalities in perinatal deaths) where women who are Black are four times more likely to die and women who are Asian are over twice as likely to die as a maternal death than their white counterparts. Disseminating this information via their technical report, lay reports and selected information via twitter has led to lots of policy activity by NHS England/Improvement; the Department of Health and Social Care; the Cabinet office; the Royal College of Obstetricians and Gynaecologist established a Race Equality Task Force; and groups of individual Black women have set up their own campaigns, for example, the first Black Women’s Maternal Health Awareness Week was run in 2020 organised by the 'Five X More' campaign. [1 paragraph unchanged] Along with NICE, the Royal College of Obstetricians and Gynaecologist (RCOG) are responsible for producing national guidance for care during pregnancy, labour, birth and postpartum. Various guidelines have been developed or updated due to MBRRACE-UK findings. For [17 words unchanged] and 2017 maternal reports: (i) Prevention and management of post-partum haemorrhage (GTG 52) (RCOG 2016a); 52); and (ii) Blood transfusion in obstetrics (GTG 47) (RCOG 2015)). 47). In response to findings in the 2024 maternal mortality report the RCOG guideline committee are working to update two guidelines: i) Reducing the Risk of Thrombosis and Embolism during Pregnancy and the Puerperium (gtg 37a) and ii) Thrombosis and Embolism during Pregnancy and the Puerperium: Acute Management (gtg 37b). NHS England are also looking to redesign the thrombosis risk assessment tool, which was identified as needing improvement by MBRRACE-UK. MBRRACE-UK data have also been used to update other guidance from the Chief Coroner Guidance, Scottish Intercollegiate Guidelines Network (SIGN) and NICE. Also, in response to MBRRACE-UK findings of high rates of maternal deaths from sepsis, the UK Sepsis Trust released six new clinical toolkits specifically for women in pregnancy. In response to MBRRACE-UK findings of high rates of maternal deaths from sepsis, the UK Sepsis Trust released six new clinical toolkits specifically for women in pregnancy. Tools are available for out of hours/telephone triage, community midwives, pre-hospital/ambulance services, general practice, emergency departments and acute medical units, and acute hospital inpatients. Following publication of the first MBRRACE-UK national perinatal surveillance report in 2015, NHS England launched the ‘Saving Babies’ Lives Care Bundle’ in 2016. When version two of the Care Bundle was released in 2019, it included a new action and target aimed at the prevention of pre-term birth based on MBRRACE-UK reports that the majority of perinatal deaths occur in preterm births. Following publication of the first MBRRACE-UK national perinatal surveillance report in 2015, NHS England launched the ‘Saving Babies’ Lives Care Bundle’ in 2016. The identification in the MBRRACE-UK reports that the majority of perinatal deaths occur in preterm births. Therefore, when version two of the Care Bundle was released in 2019, it included a new action and target aimed at the prevention of pre-term birth. Due to the continuing unwarranted variation in perinatal mortality rates between Trusts and Health Boards and the poor quality of local reviews identified in the MBRRACE-UK perinatal confidential enquiries, in 2017, the Department of Health and Social Care commissioned MBRRACE-UK, via the Healthcare Quality Improvement Programme, to develop a national Perinatal Mortality Review Tool (PMRT). Launched in 2018, the PMRT supports Trusts to carry out robust, systematic reviews of their local perinatal deaths ensuring every stage of mother and baby care is reviewed from pre-conception through to bereavement and follow-up care. Over 19,000 (2022) perinatal deaths have been through the process of local review using the PMRT. There has been a demonstrable improvement in the quality of reviews conducted and demonstrable improvements in care have been instituted in Trusts due to their local review findings. Furthermore, due to the report produced following each review, bereaved parents are provided with a clearer explanation of why their baby died and any relevant advice and information regarding the care of any future pregnancies. [1 paragraph unchanged] MBRRACE-UK surveillance data demonstrated that over 60% of all maternal deaths are [19 words unchanged] maternal medicine networks in England. These have now been established with funding to support both training and new posts to develop a hub and spoke model to ensure that pregnant women with medical complications in pregnancy can receive consultant level care from obstetric physicians country-wide. An an evaluation of the impact of the maternal medicine networks is now planned. Throughout the pandemic, MBRRACE-UK worked directly with the RCOG/RCM guideline cell to ensure that findings from the ongoing surveillance and enquiries were rapidly translated into guidelines for professional practice and advice to pregnant UK women and families (Royal College of Obstetricians and Gynaecologists and The Royal College of Midwives 2021/2). The second MBRRACE-UK rapid report into SARS-CoV-2-associated COVID-19-associated maternal deaths highlighted the lower standard of care which women received simply because they were pregnant or postpartum, leading to further actions from the Royal Colleges to ensure this additional inequity was addressed. [15 words unchanged] you would a non-pregnant woman unless there is clear reason not to'. This message was reemphasised in the 2023 maternal mortality report. [2 paragraphs unchanged] Data sharing of 12-monthly estimated maternal mortality figures with the Department of Health and Social Care (DHSC), Secretary of State for Health and Social Care and NHS England began in May 2024 and is ongoing. [1 paragraph unchanged] The first report of national perinatal mortality surveillance by MBRRACE-UK for deaths [141 words unchanged] them to put actions in place to prevent such deaths in future. Evidence of action in individual units came from the submission of abstracts to the MBRRACE-UK conference in 2016, where the second national MBRRACE-UK report was launched. On the back of their review, one small district general hospital introduced a new referral form for antenatal booking to enable risk factors for stillbirths to be clearly identified, so that timely consultant review can be arranged if required and any women meeting the NICE criteria for risk of gestational diabetes have an appropriately timed glucose tolerance test. The MBRRACE-UK team has now also developed a real-time data monitoring (RTDM) tool linked to perinatal surveillance data. This tool enables trusts and health boards to view their organisation’s data and monitor perinatal deaths on a real time basis as soon as the surveillance information is entered. Recent re-specification of the RTDM tool in autumn 2024 allows users to use interactive ‘run charts’ to monitor the time between deaths and subsets of deaths to identify clusters. Local quality improvement initiatives have embedded the RTDM tool into reporting processes and rapid review systems. MBRRACE-UK continues to endeavour to produce more timely surveillance figures. In May 2023, for the first time there was an early release of the trust and health board level perinatal mortality data in the form of maps and tables. This release has moved earlier with the most recent data made available in March 2025, a little over a year after reporting concluded and two months ahead of the full report that was available in May 2025. For maternal mortality, MBRRACE first began producing a data brief in 2023 for maternal deaths in 2019-21 and has continued to do so including the most recent release of 2021-23 data in January 2025. This data brief contains headline figures produced nine months ahead of the full report, which permits earlier detection of trends and inequalities in maternal mortality. 6. Other impact activities In the autumn of 2023 MBRRACE-UK shared information about the programme along with data on perinatal deaths with the Thirlwall Inquiry investigating the crimes of Lucy Letby at the Countess of Chester Hospital. In January 2025, Marian Knight, the national programme lead, testified as an expert witness in front of the Inquiry. MBRRACE-UK’s participation as witnesses to this inquiry will offer bereaved parents the justice needed to help them grieve and provide the public with information to prevent such a situation from occurring in in the future.

Unchanged: Processing activities, Expected output, Expected measurable benefits.

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

Objective for processing

The University of Oxford requires access to NHS England data for the purpose of the following programme: MBRRACE-UK – Delivering the Maternal, Newborn and Infant Clinical Outcome Review Programme (MNI-CORP). DATA CONTROLLERSHIP: HQIP commissions the University of Oxford to carry out this work on behalf NHS England, NHS Wales, the Health and Social Care Division of the Scottish government, the Department of Health, Social Services and Public Safety, Northern Ireland (DHSSPS), the States of Jersey, Guernsey, and the Isle of Man. University of Oxford, as the lead organisation, sub-contracts the University of Leicester to assist in data processing. This Agreement relates only to data for England and Wales, as such, NHS England and HQIP are the Controllers. The MBRRACE-UK (Mothers and Babies: Reducing Risk through Audits and Confidential Enquiries across the UK) collaboration is led from the National Perinatal Epidemiology Unit (NPEU) in the Nuffield Department of Population Health at the University of Oxford and the Health Sciences Department at the University of Leicester. University of Oxford and University of Leicester are therefore the Processors. The NPEU is the MBRRACE-UK data hub with all programming and data storage carried out at University of Oxford; analysis and reporting is split between the two sites. University of Oxford leads on the maternal work and University of Leicester leads on the newborn and infant work. All processing activities all happen at the University of Oxford and University of Leicester. Other MBRRACE-UK collaborators include clinicians, researchers and PPI specialists from: the Universities of Birmingham, Chelsea and Westminster NHS Foundation Trust, Newcastle Hospitals NHS Foundation Trust and the Stillbirth and neonatal death charity Sands. They provide clinical input into the programme, methodological advice and Sands represents the voice of parents who have experienced baby loss. The other collaborative organisations provide intellectual input into the programme, but do not receive, have access to, or process any of the data from NHS England as such are not considered Controller nor Processor. The MBRRACE-UK team does not have direct responsibility for carrying out any actions which follow from this national learning; their role is to produce the findings, recommendations, and ensure appropriate dissemination to the bodies responsible for changing policy and practice to ensure that the national maternal and perinatal mortality rates reduce over time in line with the national ambition. [1 paragraph unchanged] Purpose 1: Processing for MBRRACE-UK purposes MBRRACE-UK' MBRRACE-UK is the collaboration appointed by the Healthcare Quality Improvement Partnership (HQIP) to [42 words unchanged] robust national information to support the delivery of safe, equitable, high quality, patient-centred women and person-centred maternal, newborn and infant health services. The Maternal, Newborn and Infant Clinical Outcome Review Programme (MNI-CORP) aim is a national programme, delivered by the MBRRACE-UK collaboration, which aims to systematically assess quality and stimulate improvement in safety and effectiveness of [15 words unchanged] adverse events and good practice. The purpose of the programme is to: (1) monitor, through population surveillance of the frequency of maternal, perinatal and infant deaths; (2) review clinical practice and assess quality of care for women and babies who have died and those who are seriously ill (mortality and morbidity) through confidential enquiries, with the aim of identify factors that can be attributed to suboptimal clinical care and be improved in the future, and also examples of good practice. HQIP commissions this work on behalf NHS England, NHS Wales, the Health and Social Care Division of the Scottish government, the Department of Health, Social Services and Public Safety, Northern Ireland (DHSSPS), the States of Jersey, Guernsey, and the Isle of Man. The MBRRACE-UK collaboration is led from the National Perinatal Epidemiology Unit in the Nuffield Department of Population Health at the University of Oxford. (1) monitor, through population surveillance, the frequency of maternal, perinatal and infant deaths; The MBRRACE-UK team does not have direct responsibility for carrying out any actions which follow from this national learning; their role is to produce the findings and ensure appropriate dissemination to the bodies responsible for changing policy and practice to ensure that the national maternal perinatal mortality rate reduces over time in line with the national ambition. (2) review clinical practice and assess quality of care for women and babies who have died and those who are seriously ill (mortality and morbidity) through confidential enquiries, with the aim of identifying factors that can be attributed to suboptimal clinical care and be improved in the future, and also examples of good practice. This Agreement relates only to data for England and Wales so for the data under this Data Sharing Agreement, NHS England and HQIP are the data controllers. Surveillance and monitoring of perinatal mortality rates started in 1993 and was run by various predecessor organisations. The current MBRRACE-UK surveillance and current methods of analysis stated in 2013 and thus MBRRACE-UK now generate and publish longitudinal mortality rates enabling MBRRACE-UK to interrogate time trends and evaluate these against population level interventions, for example the Saving Babies’ Lives Care Bundles 1 and 2 which have been implemented in England. The MBRRACE-UK collaboration includes members from the Universities of Oxford, Leicester, Birmingham, Liverpool, Bradford Teaching Hospitals NHS Foundation Trust, University College London and representatives from Sands the Stillbirth and neonatal death charity. The operational arrangements are focused at the National Perinatal Epidemiology Unit (NPEU), University of Oxford and the Health Sciences Department, University of Leicester. The NPEU is the MBRRACE-UK data hub with all programming and data storage carried out in Oxford; analysis and reporting is split between the two sites. University of Oxford leads on the maternal work and University of Leicester leads on the newborn and infant work. All processing activities all happen at the University of Oxford and University of Leicester. The other collaborative organisations Universities provide intellectual input into the programme, but do not receive, have access to, or process any of the data from NHS Digital. The perinatal mortality surveillance forms one part of the MNI-CORP programme of work run by MBRRACE-UK. Alongside the surveillance is the programme of perinatal confidential enquiries which involve a rigorous qualitative evaluation of the care provided to a sample of individual mothers and babies where the baby died (perinatal deaths), was seriously ill (serious morbidity) or formed part the comparator group. The aim of this aspect of the programme (which does not require the NHS England Birth Notification Data) is to identify where care may have affected the outcome and if different care had been provided the outcome (death or serious morbidity) may have been averted. MBRRACE-UK also run the maternal mortality surveillance and confidential enquiries of maternal deaths and serious maternal morbidity using similar methods. MBRRACE-UK received from NHS Digital data extracts from the NHS Numbers for Babies (NN4B) dataset (2013 & 2014 births) and the Personal Demographic Services (PDS) dataset (2015 birth and onwards each year to latest available) and needs to retain these copies to carry out time trend analyses. They also require further extracts of equivalent annual data going forward to until the end of the Data Sharing Agreement. DATA: MBRRACE-UK will link these datasets with statutory birth, stillbirth and infant death notification data supplied by the Office for National Statistics (ONS) in order that essential additional data items are available on an individual level. Most importantly these are gestational age at birth and ethnicity (not available in the ONS data and can only be obtained from NN4B/PDS data). This linkage process generates the denominator data for the calculation of 'crude' and 'stabilised & adjusted' perinatal mortality rates; individual level data are required for these calculations. The numerator data come from clinical data about perinatal deaths collected directly by MBRRACE-UK from NHS Trusts and Health Boards. The following NHS England data will be accessed: The two additional variables derived from PDS data are essential to enable 'adjusted' perinatal mortality rates to be calculated for commissioning and service delivery organisations down to individual hospital level which take into account the risk profile of the population served by those commissioning and service delivery organisations. The risk profile includes high risk pregnancies which are defined by gestational age at birth and the ethnicity of the population served, as well as other risk factors for example maternal age. > Birth Notification Data which contains gestational age and ethnicity of the baby for all births (live and stillbirths). Ethnicity data is not always complete or accurate but is the best available data from NHS England. Additional information is required to carry out the linkage to the data MBRRACE-UK collected and birth notification data. This enables 'fairer' comparisons of mortality rates between hospitals and organisations which deal with 'high risk' cases, for example tertiary referral centres which have a higher proportion of preterm births compared with smaller 'district general hospital' type hospitals which would refer high risk pregnancies (for example those at risk of preterm birth) to tertiary hospitals. 'Crude' comparisons which fail to take the risk profile of the different patient populations into account lead to spurious conclusions concerning relative mortality rates and variations in outcomes. Data are required at an individual identifiable level to enable both the linkage and adjusted analyses to be performed. The MNI-COPR programme is UK-wide and these are the data needed for England and Wales. The linkage to the linked ONS/PDS data also allows MBRRACE-UK to identify deaths and missing information which have not been notified directly to MBRRACE-UK and using this information MBRRACE-UK is able to chase up missing cases to collect the relevant clinical information. There is no other source from which The University of Oxford can obtain gestational age and ethnicity data for all births in England and Wales that are able to be linked to two other sources of data (those MBRRACE-UK collect and ONS data). To support the delivery of MNI-CORP MBRRACE they will continue to receive NHS Numbers for Babies (NN4B) data quarterly. The applicant is satisfied that there is no other reasonable means for the data processor to achieve their purpose that is less intrusive to the data subjects COHORT: Purpose 2: Processing for NNAP purposes The cohort for this Agreement is all women giving birth and their babies born (live born, stillbirth and those who die in the neonatal period (first 28 days after birth) from 1st January 2013 on an ongoing basis, subject to contract extension for the project, in England and Wales. MBRRACE-UK will produce aggregated data with small number suppression, in line with HES analysis guide, and supply it to the National Neonatal Audit Programme (NNAP) based at the Chelsea and Westminster Hospital who are acting as data processors for the National Neonatal Audit Programme under contract to HQIP and the Royal College of Paediatrics and Child Health. This activity is separate to the primary purpose for MBRRACE-UK receiving and processing the data. However, as a consequence of the processing activities involved in MBRRACE-UK’s primary purpose, MBRRACE-UK will produce a dataset that, with minimal additional processing, would meet NNAP’s requirements and thus negate the need for NNAP to duplicate this complex data processing. Further details relating to the use of the aggregated data in support of the aims of NNAP can be found in the latest NNAP Annual Report published on the NNAP website. The University of Oxford already hold data relating to women and babies for births from 1st January 2013 (the start of the MBRRACE-UK run MNI-CORP programme) to 30th September 2022. The University will receive the same period of data again to obtain data for the National Data Opt Outs (NDOOs), which were previously excluded from disseminations, but that the study now has CAG approval to receive. Upon receipt of the resupply data without patient objections applied, University of Oxford will destroy the historic data they already hold for the same data periods. The University of Oxford will also continue to receive annual data refreshes. http://www.rcpch.ac.uk/improving-child-health/quality-improvement-and-clinical-audit/national-neonatal-audit-programme-nn-3 DATA LINKAGE: HQIP and NHS England both rely on the Article 6 (1) (e) of the GDPR as the lawful basis of processing - "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. MBRRACE-UK will link these NHS England datasets with statutory birth, stillbirth and infant death notification data supplied by the Office for National Statistics (ONS) in order that essential additional data items are available on an individual level. Most importantly, these are gestational age at birth and ethnicity. This linkage process generates the denominator data for the calculation of 'crude' and 'stabilised & adjusted' perinatal mortality rates; individual level data are required for these calculations. The numerator data come from clinical data about perinatal deaths collected directly by MBRRACE-UK from NHS Trusts and Health Boards. 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. The two additional variables derived from Birth Notification Data are essential to enable 'adjusted' perinatal mortality rates to be calculated for commissioning and service delivery organisations down to individual hospital level which take into account the risk profile of the population served by those commissioning and service delivery organisations. The risk profile includes high risk pregnancies such as women with high gestational age at birth and the women who are put at risk because of their ethnicity, as well as other risk factors, for example, maternal age. NHS England rely on Article 9(2)(h) of the GDPR as the legal basis for processing. "Processing is necessary for the purposes of preventive or occupational medicine, for the assessment of the working capacity of the employee, medical diagnosis, the provision of health or social care or treatment or the management of health or social care systems and services on the basis of Union or Member State law or pursuant to contract with a health professional and subject to the conditions and safeguards referred to in paragraph 3". NHS England are responsible for provision of health and social care, and management of systems and compliance. This enables 'fairer' comparisons of mortality rates between hospitals and organisations which deal with 'high risk' cases, for example tertiary referral centres which have a higher proportion of preterm births compared with smaller 'district general hospital' type hospitals which would refer high risk pregnancies (for example those at risk of preterm birth) to tertiary hospitals. 'Crude' comparisons which fail to take the risk profile of the different populations being cared for into account lead to spurious conclusions concerning relative mortality rates and variations in outcomes. Data are required at an individual identifiable level to enable both the linkage and adjusted analyses to be performed. The main ethical issue raised is of information about mothers and babies, including identifiable information being used without the consent of the individual involved. MBRRACE-UK has a national purpose and thus the need to process information from all birth notifications for England and Wales and the need for access to identifiable information for linkage purposes MBRRACE-UK have sought and received s251 approval to set aside the common law duty of confidence for this purpose. Following the Information Commissioners advice MBRRACE-UK use a layered approach to information provision with posters displayed in maternity and neonatal units, information on their website and a privacy notice. The linkage to the linked ONS/Birth Notification Data also allows MBRRACE-UK to identify deaths and missing information which have not been notified directly to MBRRACE-UK and using this information MBRRACE-UK is able to chase up missing cases to collect the relevant clinical information. The potential risk of harm comes from the potential lack of public trust in the use of information without specific consent. MBRRACE-UK have tested the acceptability of the use of identifiable data for these purposes with their Public and Patient Involvement (PPI) stakeholder group who have confirmed that they believe that the use of the data in identifiable format is both proportionate to the benefit and in the public interest. The PPI stakeholder group co-designed the information poster with MBRRACE-UK. To support the delivery of MNI-CORP MBRRACE, the University of Oxford are seeking to continue to receive Birth notification data quarterly. The applicant is satisfied that there is no other reasonable means for the data processor to achieve their purpose that is less intrusive to the data subjects The main ethical issue raised is of information about mothers and babies, including identifiable information being used without the consent of the individual involved. MBRRACE-UK has a national purpose and thus the need to process information from all birth notifications for England and Wales and the need for access to identifiable information for linkage purposes. MBRRACE-UK have sought and received s251 approval to set aside the common law duty of confidence for this purpose. Although MBRRACE-UK have sought approval to have the National Data Opt Out (NDOO) waived, MBRRACE-UK will honour specific requests by parents for their data not to be used in the case of late miscarriages and stillbirths; the collection of neonatal mortality data has an alternative statutory basis through the Child Act. The detailed justification of why data about all births and deaths is required is fundamentally on the basis that the exclusion of births and deaths will lead to an under estimate and thus biases mortality rates and since different trusts/health boards have populations with different rates of opt out this will lead to the incorrect identification of apparently high and low mortality rates between trusts/health boards. Following the Information Commissioners advice, MBRRACE-UK use a layered approach to information provision with posters displayed in maternity and neonatal units, information on the MBRRACE-UK study website (https://www.npeu.ox.ac.uk/mbrrace-uk) and the privacy notice. MBRRACE-UK have tested the acceptability of the use of identifiable data for these purposes with their Public and Patient Involvement (PPI) stakeholder group who have confirmed they believe that the use of the data in identifiable format is both proportionate to the benefit and in the public interest. The PPI stakeholder group co-designed the information poster with MBRRACE-UK. HQIP and NHS England both rely on the Article 6 (1) (e) of the UK GDPR as the lawful basis of processing - "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 UK 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 UK 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

Purpose 1: Processing for MBRRACE-UK purposes No cohort is being supplied to NHS England under this Agreement. Identifiable health data (birth notification data) flows out of NHS England to the MBRRACE-UK data hub which is at the National Perinatal Epidemiology Unit (NPEU) at University of Oxford. The birth notification data are stored on the National Perinatal Epidemiology Unit (NPEU) NPEU secure high compliance servers which are used solely for MBRRACE-UK data processing activities. The servers are accessed only at the National Perinatal Epidemiology Unit (NPEU), University of Oxford. Processing of ONS and NN4B/PDS birth notification identifiable data occurs in the high compliance area. The servers are accessed only at the NPEU, University of Oxford. Processing of ONS and NHS Number For Babies (NN4B) replaced by PDS/Birth Notification Data birth notification identifiable data occurs in the High Compliance (HC) system. This is an isolated server system that is accessed from the NPEU desktops using terminal services login or through secure remote working. The login is separate and requires a secondary username and password under separate control. The system is used for the secure storage of any data that may be used for analysis or comparison or any legacy information or information held that is not captured through the MBRRACE-UK data collection system. The birth notification data are linked to the ONS births and stillbirth data in order to add the key variables gestational age and ethnicity of the baby to the ONS births/stillbirths information. information to create a combined dataset. Once a combined ONS/NN4B replaced by PDS or PDS birth notification Birth Notification Data dataset has been generated and cleaned (incorrect, corrupted, incorrectly formatted, duplicated, or incomplete data removed / fixed within the dataset) by the clinical data on late fetal losses (in utero deaths 22-23 completed [15 words unchanged] birth) collected by MBRRACE-UK are linked to the combined ONS/birth notification dataset. This is so MBRRACE-UK can double check that they have ascertained all the deaths during the provision of information by trusts to the MBRRACE-UK system (and if this is not the case than the MBRRACE-UK team can go back to trusts to check these deaths and so that they can provide the full surveillance information required). MBRRACE-UK also need the level of linkage at the individual level because the analysis that is carried out (stabilised and adjusted) using logistic regression require individual level data. It is not possible to carry out the linkage using only month and year. It is not possible to do the analysis on aggregated data which would be the consequence only month and year are available. [1 paragraph unchanged] 1. The PDS birth notification data is linked to ONS total births data (live births plus stillbirths) so that all information about all the key variables are gathered for the analysis – PDS provides baby ethnicity and gestational age at birth. analysis. 2. Clinical data is collected about the deaths to the linked ONS/PDS data, ONS/Birth Notification Data to check that the study's ascertainment of all deaths, deaths is complete. For example, if the study identifies a death in the linked ONS/PDS data ONS/Birth Notification Data that has not been notified, then the trust will be contacted to [32 words unchanged] 500 deaths had not been notified of the expected deaths for that year., year. MBRRACE-UK need the level of linkage at the individual level because the statistical analysis that is carried out requires individual level data. It is not possible to carry out the linkage using only month and year. It is not possible to do the analysis on aggregated data which would be the consequence if only month and year are available. [1 paragraph unchanged] An extract dataset containing a limited number of identifiers (referred to here [18 words unchanged] Oxford secure electronic data transfer mechanism Oxfile. This dataset extract has all identifiers identifiers, other than the babies' dates of birth and dates of death death, removed. These identifiable data items remain as they are required to generate [20 words unchanged] items are removed before transfer (e.g. name, address, postcode, NHS number etc). Purpose 2: Processing for NNAP purposes Data processing is only carried out by substantive employees of the University of Oxford and the University of Leicester who have been appropriately trained in data protection and confidentiality. MBRRACE-UK will produce aggregated data with small number suppression, in line with HES analysis guide, and supply it to the National Neonatal Audit Programme (NNAP). The data requested is to be used for the performance of services under contract to the Healthcare Quality Improvement Partnership (HQIP). All IPRs (Intellectual Property Rights) in any guidance, specifications, instructions, toolkits, plans, data, drawings, databases, patents, patterns, models, design or other material, furnished or made available to the NHS England as part of the application of this request remains vested solely in HQIP. This IPR is in turn vested to NHS England through HQIP’s headline contract with them.

Expected output

Purpose 1: MBRRACE-UK recent outputs MBRRACE-UK has produced the following recent outputs: a. Reports: The primary outputs from the processing with be the annual national MBRRACE-UK reports. MBRRACE-UK published in December 2020 the MBRRACE-UK perinatal mortality surveillance report which reports 2018 data. This report includes a time trend analysis from 2013 onward. a. Reports: The primary outputs from the processing will be the annual national MBRRACE-UK reports. MBRRACE-UK published in November 2021 the MBRRACE-UK perinatal mortality surveillance report which reports 2019 data. This report includes a time trend analysis from 2013 onward. Copyright of the annual report is owned by HQIP. Future annual reports will be published (subject to sign off by NHS England) annually - the contract between the University of Oxford and HQIP will end 30th September 2025. For improved ease of access, the perinatal mortality surveillance data for Trusts and Health Boards will also be presented as interactive maps and tables on the MBRRACE-UK website (https://timms.le.ac.uk/mbrrace-uk-perinatal-mortality/. The slides set based on each annual report will be released once the report is published. Trust/health board specific reports and slide sets will be released one week ahead of the publication of the relevant annual report – this is to ensure that the trusts/health boards are aware of their findings before they are made publicly available. The study has also published: Dissemination of the annual reports (and accompanying lay version and infographic) and the findings will continue as the main dissemination activity. Draft versions of each report will be reviewed by the commissioner HQIP, the funders (including NHS England and the Welsh government), the Department of Health and Social Care and the devolved governments. This is part of the commissioning process but it also ensure that as the main policy stakeholders they are aware of the contents prior to publication. The continued focus will be dissemination meetings around the publication of each annual report and the target audience will continue to be frontline staff in trusts and health boards who provide maternity and neonatal care, as well as commissioners of services. The target audience for the dissemination meetings are frontline staff in trusts and health boards, as well as commissioners of services, researchers and lay stakeholders. As an example, the annual maternal meeting will be held to disseminate the upcoming maternal report on 10th November, and to date, 695 delegates have registered. Peer review publications will be used to ensure that the findings continue to come to the attention of the scientific and clinical community. Publication happens in a range of journals which are focused on the target audiences of, generally, frontline clinical staff such as obstetricians and midwives. Such journals include the British Journal of Obstetrics and Gynaecology. Publication also occurs in more general journals such as the British Medical Journal Open. The decision about which journals to submit to is made based on the contents of each particular paper written. Furthermore, as with any researchers submitting papers to peer-reviewed journals, the journals do not always accept the papers submitted to them and it is then necessary to try another journal. Regular meetings are held with the PPI group (representatives from all the main national mother and baby charities) to ensure they are involved in the wider programme and they will continue to be invited to be directly involved in the development of the lay version of the annual report. Examples of other publications: [3 paragraphs unchanged] On 14/1/2021 14/01/2021 MBRRACE-UK also published: [2 paragraphs unchanged] In October 2021 2021, MBRRACE-UK published the study will publish the MBRRACE-UK perinatal mortality surveillance report which will report reported 2019 death. deaths. MBRRACE-UK will also release released the trust and health board specific reports two weeks ahead of the national report; these are were released solely to the Trust/Health Board where the deaths occurred . occurred. In November 2021 MBRRACE-UK will published the MBRRACE-UK maternal mortality surveillance and confidential enquiry report including data for 2017-2019. Future annual reporting will continue with this pattern of publication until 2025. [1 paragraph unchanged] c. Infographics: Each of the study’s national reports are also accompanied by an infographic which highlights the main findings in pictorial format which are tweetable. format. d. Social media: The study make extensive use of social media (mainly [19 words unchanged] study’s infographics are designed so that individual elements make ideal images for tweeting. tweeting (#mbrrace). e. Submissions to peer reviewed journals: The study is planning to publish the detailed analysis of adjusted maternal mortality rates with a specific focus on maternal ethnicity. The study is also planning to publish a detailed analysis of perinatal mortality rates by cause of death and by ethnicity. Publication is likely to be in 2021. When a report is published, the report will be press released and Twitter will be used as the main social media channel to highlight main findings. Invitations to give lectures and presentations are expected to continue at relevant events being hosted by organisations such as the Royal College of Obstetricians and Gynaecologists, specialist societies and PPI organisations. f. Dashboards: MBRRACE-UK have a real-time data monitoring system which presents individual trust/health board level data which the trusts and health boards can access to view their own data. However, this system does not use the NN4B/PDS derived data. As part of the budget for the contract going forward from 1st October 2022, funds have been included for a part-time communications officer to help expand and further develop communication channels and audience reach. e. Submissions to peer reviewed journals: The study is planning to publish the detailed analysis of adjusted maternal mortality rates with a specific focus on maternal ethnicity. The study is also planning to publish a detailed analysis of perinatal mortality rates by cause of death and by ethnicity. Publication is likely to be in 2023. Papers in peer reviewed journal will be published subject to acceptance and the publication schedules of journals. f. Dashboards: As part of the wider MBRRACE-UK programme, a trust/health board specific real-time data monitoring tool (RDMT) has been developed where authorised staff in trusts/health boards are able to view their data in real time. Of note, these data do not include information from the data sought from NHS England in this Agreement. This enables relevant staff to monitor their perinatal deaths identifying where possible clusters of deaths have occurred so that they can be investigated further and also the RDMT has value in evaluating the impact of interventions aimed at reducing perinatal deaths. The plan is to continue to develop this tool during the lifetime of the newly awarded contract. In addition to the interactive maps and tables, new methods of presenting results simultaneously in several dimensions (for example mortality rates by ethnicity, gestational age and maternal age) have also been developed using ‘heat maps’. These use the data sourced from NHS England for the calculation of mortality rates which are presented. It is anticipated that other methods of presenting data will be developed in the future programme. [1 paragraph unchanged] Purpose 2: Outputs for the National Neonatal Audit Programme (NNAP) All national outputs are aggregated with small numbers suppressed adhering to the HES analysis guide. The local MBRRACE-UK Trust/Health Board level reports do not involve small number suppression because the reports give the Trusts/Health Boards feed back information about the deaths they were responsible for caring for and reporting to MBRRACE-UK so they already know how many deaths there are together with all their individual clinical characteristics. MBRRACE-UK provide an analysis to support their clinical care delivery with the aim of assisting them to reduce the number of babies who die in their Trust/Health Board in the future. 2A. Data processing by MBRRACE-UK of the 2013, 2014, 2015, 2016, 2017, 2018, 2019 and 2020 birth notification data to generate aggregated tables of live births by gestational age by hospital by year was carried out enabling NNAP to further analyse the audit measures published in the NNAP report for 2013 through 2020 reports. 2B. Data processing by MBRRACE-UK of the 2020 and 2021 births as per the format above will continue to support the NNAP outputs. All national outputs (for Purposes 1 and 2) are aggregated with small numbers suppressed adhering to the HES analysis guide. The local MBRRACE-UK Trust/Health Board level reports do not involve small number suppression because the reports give the Trusts/Health Boards back information about the deaths they were responsible for caring for and reporting to MBRACE-UK so they already know how many deaths there are together with all their individual clinical characteristics. We provide an analysis to support their clinical care delivery with the aim of assisting them to reduce the number of babies who die in their Trust/Health Board in the future. During 2022 it is expected that MBRRACE-UK will publish the annual perinatal mortality surveillance report which will include perinatal deaths from 2019. MBRRACE-UK will also publish the annual maternal mortality and confidential enquiry report which will include maternal deaths from 2017 to 2019. Each will make a series of recommendations based on the evidence presented in each report. Examples of the types of benefits which are likely to arise from publication of these reports and our dissemination efforts are illustrated in the section below which outlines examples of the policy and practice changes which have resulted from the previous activities and reports. Purpose 2 This data is processed for the University of Oxford’s purpose and not for this additional purpose

Expected measurable benefits

Target date: annual ongoing benefits as below with an end date of 30th September 2022 [4 paragraphs unchanged] The MNI-CORP programme is commissioned by HQIP on behalf of NHS England. MBRRACE-UK delivers the programme and is responsible for conducting national surveillance of maternal deaths and late fetal losses (late miscarriages), stillbirths and infant deaths to contribute to national learning to reduce these rates. The MBRRACE-UK team does not have direct responsibility for carrying out any actions which follow from this national learning; our role is to produce the findings, ensure appropriate dissemination to the bodies responsible for changing policy and practice to encourage appropriate changes in policy and practice to reduce the national maternal and perinatal mortality rates. The dissemination of the birth notification derived information from NHS England will be used to calculate perinatal mortality rates which take into account the gestational age at birth/pregnancy end and ethnicity of the baby. These are factors that affect perinatal mortality rates over which trusts and health boards have no direct control. These factors are therefore taken into account in the analysis of rates (‘adjusted’ rates) to enable fair, ‘level playing field’ comparisons of mortality at different organisational levels (trusts/health boards, commissioners, local authorities, regional and national). Perinatal mortality is one of the key indicators of the quality of functioning of health services and a measure of a societies concern for mothers and babies. In recognition of this, the various government levels in the UK have set in place specific initiatives, as well as ambitions and targets, to reduce perinatal mortality rates. The rates which published are used to monitor the achievements of these initiatives (e.g. Saving Babies Lives’ (versions 1 and 2) in England) (www.england.nhs.uk/publication/saving-babies-lives-version-two-a-care-bundle-for-reducing-perinatal-mortality/) against these ambitions and targets. Perinatal mortality is a key national, regional and local indicator of health services in general and is used as a ‘hard’ indicator of the quality of maternity and neonatal services. As such, there is a clear public interest in monitoring perinatal mortality rates and to do this appropriately requires the data disseminated by NHS England to allow the calculation of ‘adjusted’ perinatal mortality rates. ‘Crude’ and ‘adjusted’ perinatal mortality rates are published, against which, comparisons are made by the various levels of organisations that are accountable for service provision including trusts/health boards, commissioners, providers of public health services (local authorities), NHS England/Improvement, Department of Health and Social Care, and Regulators (e.g. CQC in England). The anticipated impact of the outputs includes changes to maternal and neonatal care provision at local (trust and health board level); changes to service requirements and support for changes provided by regional organisations (e.g. regional chief midwives and obstetricians); implementation of national initiatives to improve care provision (e.g. Saving Babies’ Lives V2 in England by NHS England/Improvement, the Maternity and Neonatal Patient Safety Initiative Programme (NHSE/I) and the Maternity Patient Safety Incentive Scheme (NHS Resolution)). Each year in England ~613,000 babies are born of which nearly 3,000 are stillborn or die in the first month after birth. In Wales the figures are 30,000 and nearly 200 respectively. This demonstrates the challenges of the benefits expected from this work.

Benefits reported

Using the birth notification data enables researchers to calculate Trust-level standardised and adjusted perinatal mortality rates and to identify Trusts with higher rates than peer organisations. Using this standard methodology since 2013, researchers at the University of Oxford have tracked Trust-specific rates and identified Trusts with concerning rising rates and those with reassuring decreasing rates. Data are provided to the regulator Care Quality Commission for their inspections. Information based on these rates has been provided to support investigations and enquiries. Between 2013 and 2019 across the UK, taking into account the changing birth rate, there have been an estimated 2,910 fewer perinatal deaths. More than half of this reduction was achieved since the introduction of national initiatives such as the Saving Babies’ Live Care Bundle, versions 1 and 2 in 2016. This represents a clear improvement in outcomes due to improvements in the quality of care provided. The following provides some examples (not an exhaustive list) of the benefits arising from the findings of the MBRRACE-UK programme. Example benefits: [1 paragraph unchanged] In March 2015 Dr Bill Kirkup published his report of the investigation [11 words unchanged] Bay – the ‘Morecambe Bay Inquiry’ Report (1). As part of the recommendations of that report recommendations, it was noted that good information on pregnancy outcomes (including deaths) is [5 words unchanged] in the quality of care provided for pregnant women and newborn babies. This is the role of the MBRRACE-UK programme. The findings of the high rates of perinatal deaths in England, the [5 words unchanged] results of the Kirkup enquiry resulted in an independent national maternity services review which was review, launched in March 2015. The findings of this review were published as the ‘Better Birth’ [29 words unchanged] care provided and as a consequence the outcomes for mothers and babies. It was against this background that This led to, in November 2015 2015, the Secretary of State for Health announced announcing additional funding for maternity services and the national ambition to reduce the [15 words unchanged] to achieve this ambition by 2025, with a 20% reduction by 2020. The 20% reduction in overall perinatal mortality was achieved in 2020. The maternal mortality rate has not reduced. Since 2013 2013, the stillbirth rate in England has decreased by 22% and the neonatal mortality rate in England has decreased by 15%. In 2019 2019, the majority of Trusts in England had a stabilised and adjusted stillbirth [36 words unchanged] to prevent future deaths. This is compared with an estimated 10% in 2013.To 2013. To date in 2021, 2022, despite the continuing effects of the pandemic in on maternity and neonatal services, 99% of perinatal deaths have been notified to [7 words unchanged] which, with Birth Notification Data, enables more rapid surveillance of perinatal deaths. In the 2018 maternal mortality report, reiterated in the 2019 report, MBRACE-UK [52 words unchanged] technical report, lay reports and selected information via twitter has led to an enormous amount lots of policy activity by NHS England/Improvement; the Department of Health and Social [18 words unchanged] groups of individual Black women have set up their own campaigns, for example example, the first Black Women’s Maternal Health Awareness Week was run in 2020 organised by the 'Five X More' campaign. 2. The impact of MBRRACE-UK findings impact on national guidelines and clinical toolkits: Along with NICE, the Royal College of Obstetricians and Gynaecologist (RCOG) are responsible for producing national guidance for care during pregnancy, labour, birth and postpartum. A number of Various guidelines have been developed or updated as a consequence of due to MBRRACE-UK findings. For example, two updated RCOG ‘Green-Top Guidelines’ were released with [21 words unchanged] (RCOG 2016a); and (ii) Blood transfusion in obstetrics (GTG 47) (RCOG 2015)). In response to MBRRACE-UK findings of high rates of maternal deaths from sepsis from MBRRACE-UK reports, sepsis, the UK Sepsis Trust released six new clinical toolkits specifically for women [10 words unchanged] community midwives, pre-hospital/ambulance services, general practice, emergency departments and acute medical units, as well as and acute hospital inpatients. Following the publication of the first MBRRACE-UK national perinatal surveillance report in June 2015 2015, NHS England launched the ‘Saving Babies’ Lives Care Bundle’ in March 2016 which was aimed specifically at ensuring Trusts put in place a series of key actions to prevent stillbirths which will also have an impact on neonatal and infant morbidity. 2016. The identification in the MBRRACE-UK reports that the majority of perinatal deaths occur in preterm births, births. Therefore, when version two of the Care Bundle was released in March 2019, it included a new action and target aimed at the prevention of pre-term birth. As a consequence of Due to the continuing unwarranted variation in perinatal mortality rates between Trusts and Health Boards and the poor quality of local reviews identified in the MBRRACE-UK perinatal confidential enquiries, in 2017 2017, the Department of Health and Social Care commissioned MBRRACE-UK, via the Healthcare Quality Improvement Programme, to develop a national Perinatal Mortality Review Tool (PMRT). Launched in January 2018 2018, the PMRT supports Trusts to carry our out robust, systematic reviews of their local perinatal deaths ensuring that every stage of the care of the mother and baby care is reviewed from pre-conception through to bereavement and follow-up care. Over 12,000 19,000 (2022) perinatal deaths have now been through the process of local review using the PMRT, there PMRT. There has been a demonstrable improvement in the quality of reviews conducted and demonstrable improvements in care have been instituted in Trusts as a consequence of due to their local review findings. Furthermore, as a consequence of due to the report which is produced following each review review, bereaved parents are provided with a clearer explanation of why their baby died and any relevant advice and information regarding the care of any future pregnancies they may plan. pregnancies. 3. The impact of MBRRACE-UK findings impact on service delivery: MBRRACE-UK surveillance data demonstrated that over 60% of all maternal deaths are as a consequence of due to pregnancy exacerbated medical complications. As a consequence of Due to the MBRRACE-UK findings, in 2017, NHS England committed to developing 12 maternal [23 words unchanged] spoke model to ensure that pregnant women with medical complications in pregnancy are able to can receive consultant level care from obstetric physicians all around country-wide. An evaluation of the country. impact of the maternal medicine networks is now planned. 4. The impact of MBRRACE-UK findings on the activities of the regulator: Throughout the pandemic, MBRRACE-UK worked directly with the RCOG/RCM guideline cell to ensure that findings from the ongoing surveillance and enquiries were rapidly translated into guidelines for professional practice and advice to pregnant UK women and families (Royal College of Obstetricians and Gynaecologists and The Royal College of Midwives 2021/2). The second MBRRACE-UK rapid report into SARS-CoV-2-associated maternal deaths highlighted the lower standard of care which women received simply because they were pregnant or postpartum, leading to further actions from the Royal Colleges to ensure this additional inequity was addressed. One key message from these reports has been and remains ‘treat a pregnant woman as you would a non-pregnant woman unless there is clear reason not to'. MBRRACE-UK has an ongoing arrangement to provide aggregated maternal and perinatal data to the Care Quality Commission. This key mortality information is included in CQC inspection packs to support their regulatory activities and visits to inspect maternity and neonatal services. 4. MBRRACE-UK findings impact on the activities of the regulator: 5. Impacts of MBRRACE-UK findings on local activities in trusts: MBRRACE-UK has an ongoing arrangement to provide aggregated maternal and perinatal data to the Care Quality Commission. This key mortality information is included in CQC inspection packs to support their regulatory activities and visits to inspect maternity and neonatal services. MBRRACE-UK provided enhanced data to CQC during the pandemic. The first report of national perinatal mortality surveillance by MBRRACE-UK for deaths in 2013, reported for the first time ‘stabilised and adjusted’ perinatal mortality rates for individuals Trusts which enables appropriate comparison of mortality rates across health care organisations, taking into account the fact that some hospitals provide care for high risk women and hospitals care of vastly different numbers of pregnant women each year. This analysis has enabled MBRRACE -UK to not only report the national perinatal mortality rate but also to identify variation in death rates between Trusts. Using comparisons by level of care provided, MBRRACE-UK has identified those Trusts with higher-than-average mortality rates and published the findings using a traffic light, RAG rating system. For those Trusts with ‘red’ and ‘amber’ mortality rates it is recommended that in addition to reviewing all their perinatal deaths individually using the PMRT they explore system level issues with the delivery of care to identify potentially preventable causes of death. The purpose being to enable them to put actions in place to prevent such deaths in the future. Evidence of action in individual units came from the submission of abstracts to the MBRRACE-UK conference in May 2016 where the second national MBRRACE-UK report was launched. 5. MBRRACE-UK findings impact on local activities in trusts: For example, on the back of their review, one small district general hospital introduced a new referral form for antenatal booking to enable risk factors for stillbirths to be clearly identified, so that timely consultant review can be arranged if required and any women meeting the NICE criteria for risk of gestational diabetes have an appropriately timed glucose tolerance test arranged at their dating scan appointment (which ensures that the test is not missed). As a consequence of these and other actions this hospital had seen a reduction in the number of stillbirths over the previous 12 months. The first report of national perinatal mortality surveillance by MBRRACE-UK for deaths in 2013, reported ‘stabilised and adjusted’ perinatal mortality rates for individuals Trusts which enables appropriate comparison of mortality rates across health care organisations, taking into account that some hospitals provide care for high risk women and hospitals care of vastly different numbers of pregnant women each year. This analysis enabled MBRRACE -UK to report the national perinatal mortality rate, and also, identify variation in death rates between Trusts. Using comparisons by level of care provided, MBRRACE-UK has identified Trusts with higher-than-average mortality rates and published the findings using a traffic light, RAG rating system. For those Trusts with ‘red’ and ‘amber’ mortality rates, it is recommended that in addition to reviewing all their perinatal deaths individually using the PMRT, they explore system level issues with the delivery of care to identify potentially preventable causes of death. The purpose being to enable them to put actions in place to prevent such deaths in future. Evidence of action in individual units came from the submission of abstracts to the MBRRACE-UK conference in 2016, where the second national MBRRACE-UK report was launched. (1) Kirkup B. The Report of the Morecambe Bay Inquiry. March 2015. The Stationery Office, London. 2015. [https://www.gov.uk/government/publications/morecambe-bay-investigation-report] On the back of their review, one small district general hospital introduced a new referral form for antenatal booking to enable risk factors for stillbirths to be clearly identified, so that timely consultant review can be arranged if required and any women meeting the NICE criteria for risk of gestational diabetes have an appropriately timed glucose tolerance test.

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

Data controllers: + NHS ENGLAND

Objective for processing

The national perinatal mortality surveillance is conducted by MBRRACE-UK in the context that the UK has one of the highest rates of perinatal death (deaths around the time of births which include late fetal losses, stillbirths and neonatal deaths) and infant deaths (deaths from birth to one year of age) in Europe. [1 paragraph unchanged] The Maternal, Newborn and Infant Clinical Outcome Review Programme (MNI-CORP) is a national programme, delivered by the MBRRACE-UK collaboration, which aims to systematically assess quality and stimulate improvement in safety and effectiveness of maternal, newborn and infant healthcare by enabling clinicians, commissioners and policy makers to learn from adverse events and good practice. The purpose of the programme is to (1) monitor, through population surveillance, the frequency of deaths in relation to maternal, perinatal and infant mortality (2) review clinical practice and assess quality of care for women and babies who have died and those who are seriously ill (mortality and morbidity) through confidential enquiries, with the aim of identify factors that can be attributed to suboptimal clinical care, and also examples of good practice. MBRRACE-UK' is the collaboration appointed by the Healthcare Quality Improvement Partnership (HQIP) to run the national Maternal, Newborn and Infant clinical Outcome Review Programme (MNI-CORP) which continues the national programme of work conducting surveillance and investigates the causes of maternal deaths, stillbirths and infant deaths. The aim of the MNI-CORP MBRRACE-UK programme is to provide robust national information to support the delivery of safe, equitable, high quality, patient-centred maternal, newborn and infant health services. MBRRACE-UK received from the HSCIC data extracts from the NHS Numbers for Babies (NN4B) dataset (2013 & 2014 births) and the Personal Demographic Services (PDS) dataset (2015, 2016 and 2017 births to date) and needs to retain these copies (to carry out time trend analyses) and also requires further extracts of equivalent annual data going forward to 2021. MBRRACE-UK will link these dataset with statutory birth, stillbirth and infant death notification data supplied under a separate Data Access Agreement with University of Oxford from the Office for National Statistics in order that essential additional data items are available on an individual level, most importantly gestational age at birth and ethnicity (these are not available in the ONS data and can only be obtained from NN4B/PDS data). This linkage process generates the denominator data for the calculation of 'crude' and 'stabilised & adjusted' perinatal mortality rates; individual level data are required for these calculations. The numerator data come from clinical data about perinatal deaths collected directly by MBRRACE-UK from NHS Trusts and Health Boards. The two additional variables derived from PDS data are essential to enable 'adjusted' perinatal mortality rates to be calculated for commissioning and service delivery organisations down to individual hospital level which take into account the risk profile of the population served by those commissioning and service delivery organisations. The risk profile includes high risk pregnancies which are defined by gestational age at birth and the ethnicity of the population served, as well as other risk factors for example maternal age. This enables 'fairer' comparisons of mortality rates between hospitals and organisations which deal with 'high risk' cases, for example tertiary referral centres which have a higher proportion of preterm births compared with smaller 'district general hospital' type hospitals which would refer high risk pregnancies (for example those at risk of preterm birth) to tertiary hospitals. 'Crude' comparisons which fail to take the risk profile of the different patient populations into account lead to spurious conclusions concerning relative mortality rates and variations in outcomes. Data are required at an individual identifiable level to enable both the linkage and adjusted analyses to be performed. The Maternal, Newborn and Infant Clinical Outcome Review Programme (MNI-CORP) is a national programme, delivered by the MBRRACE-UK collaboration, which aims to systematically assess quality and stimulate improvement in safety and effectiveness of maternal, newborn and infant healthcare by enabling clinicians, commissioners and policy makers to learn from adverse events and good practice. The purpose of the programme is to: (1) monitor, through population surveillance of the frequency of maternal, perinatal and infant deaths; (2) review clinical practice and assess quality of care for women and babies who have died and those who are seriously ill (mortality and morbidity) through confidential enquiries, with the aim of identify factors that can be attributed to suboptimal clinical care and be improved in the future, and also examples of good practice. HQIP commissions this work on behalf NHS England, NHS Wales, the Health and Social Care Division of the Scottish government, the Department of Health, Social Services and Public Safety, Northern Ireland (DHSSPS), the States of Jersey, Guernsey, and the Isle of Man. The MBRRACE-UK collaboration is led from the National Perinatal Epidemiology Unit in the Nuffield Department of Population Health at the University of Oxford. The MBRRACE-UK team does not have direct responsibility for carrying out any actions which follow from this national learning; their role is to produce the findings and ensure appropriate dissemination to the bodies responsible for changing policy and practice to ensure that the national maternal perinatal mortality rate reduces over time in line with the national ambition. This Agreement relates only to data for England and Wales so for the data under this Data Sharing Agreement, NHS England and HQIP are the data controllers. The MBRRACE-UK collaboration includes members from the Universities of Oxford, Leicester, Birmingham, Liverpool, Bradford Teaching Hospitals NHS Foundation Trust, University College London and representatives from Sands the Stillbirth and neonatal death charity. The operational arrangements are focused at the National Perinatal Epidemiology Unit (NPEU), University of Oxford and the Health Sciences Department, University of Leicester. The NPEU is the MBRRACE-UK data hub with all programming and data storage carried out in Oxford; analysis and reporting is split between the two sites. University of Oxford leads on the maternal work and University of Leicester leads on the newborn and infant work. All processing activities all happen at the University of Oxford and University of Leicester. The other collaborative organisations Universities provide intellectual input into the programme, but do not receive, have access to, or process any of the data from NHS Digital. MBRRACE-UK received from NHS Digital data extracts from the NHS Numbers for Babies (NN4B) dataset (2013 & 2014 births) and the Personal Demographic Services (PDS) dataset (2015 birth and onwards each year to latest available) and needs to retain these copies to carry out time trend analyses. They also require further extracts of equivalent annual data going forward to until the end of the Data Sharing Agreement. MBRRACE-UK will link these datasets with statutory birth, stillbirth and infant death notification data supplied by the Office for National Statistics (ONS) in order that essential additional data items are available on an individual level. Most importantly these are gestational age at birth and ethnicity (not available in the ONS data and can only be obtained from NN4B/PDS data). This linkage process generates the denominator data for the calculation of 'crude' and 'stabilised & adjusted' perinatal mortality rates; individual level data are required for these calculations. The numerator data come from clinical data about perinatal deaths collected directly by MBRRACE-UK from NHS Trusts and Health Boards. The two additional variables derived from PDS data are essential to enable 'adjusted' perinatal mortality rates to be calculated for commissioning and service delivery organisations down to individual hospital level which take into account the risk profile of the population served by those commissioning and service delivery organisations. The risk profile includes high risk pregnancies which are defined by gestational age at birth and the ethnicity of the population served, as well as other risk factors for example maternal age. This enables 'fairer' comparisons of mortality rates between hospitals and organisations which deal with 'high risk' cases, for example tertiary referral centres which have a higher proportion of preterm births compared with smaller 'district general hospital' type hospitals which would refer high risk pregnancies (for example those at risk of preterm birth) to tertiary hospitals. 'Crude' comparisons which fail to take the risk profile of the different patient populations into account lead to spurious conclusions concerning relative mortality rates and variations in outcomes. Data are required at an individual identifiable level to enable both the linkage and adjusted analyses to be performed. [1 paragraph unchanged] To support the delivery of MNI-CORP MBRRACE they will continue to receive NHS Numbers for Babies (NN4B) data quarterly. The applicant is satisfied that there is no other reasonable means for the data processor to achieve their purpose that is less intrusive to the data subjects [3 paragraphs unchanged] HQIP and NHS England both rely on the Article 6 (1) (e) of the GDPR as the lawful basis of processing - "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. The main ethical issue raised is of information about mothers and babies, including identifiable information being used without the consent of the individual involved. MBRRACE-UK has a national purpose and thus the need to process information from all birth notifications for England and Wales and the need for access to identifiable information for linkage purposes MBRRACE-UK have sought and received s251 approval to set aside the common law duty of confidence for this purpose. Following the Information Commissioners advice MBRRACE-UK use a layered approach to information provision with posters displayed in maternity and neonatal units, information on their website and a privacy notice. The potential risk of harm comes from the potential lack of public trust in the use of information without specific consent. MBRRACE-UK have tested the acceptability of the use of identifiable data for these purposes with their Public and Patient Involvement (PPI) stakeholder group who have confirmed that they believe that the use of the data in identifiable format is both proportionate to the benefit and in the public interest. The PPI stakeholder group co-designed the information poster with MBRRACE-UK.

Processing activities

[3 paragraphs unchanged] The birth notification data are linked to the ONS births and stillbirths stillbirth data in order to add the key variables gestational age and ethnicity [46 words unchanged] birth) collected by MBRRACE-UK are linked to the combined ONS/birth notification dataset. This is so MBRRACE-UK can double check that they have ascertained all the deaths during the provision of information by trusts to the MBRRACE-UK system (and if this is not the case than the MBRRACE-UK team can go back to trusts to check these deaths and so that they can provide the full surveillance information required). MBRRACE-UK also need the level of linkage at the individual level because the analysis that is carried out (stabilised and adjusted) using logistic regression require individual level data. It is not possible to carry out the linkage using only month and year. It is not possible to do the analysis on aggregated data which would be the consequence only month and year are available. The data is linked in several different ways: 1. The PDS data is linked to ONS total births data (live births plus stillbirths) so that all information about all the key variables are gathered for the analysis – PDS provides baby ethnicity and gestational age at birth. 2. Clinical data is collected about the deaths to the linked ONS/PDS data, to check that the study's ascertainment of all deaths, is complete. For example, if the study identifies a death in the linked ONS/PDS data that has not been notified, then the trust will be contacted to ask them to notify the study and complete the surveillance data collection. To facilitate this request the identifiers are needed to identify the missing cases. In 2019 it was estimated that over 500 deaths had not been notified of the expected deaths for that year., [1 paragraph unchanged] An extract dataset containing a limited number of identifiers (referred to here [22 words unchanged] transfer mechanism Oxfile. This dataset extract has all identifiers other than the babies babies' dates of birth and dates of death removed. These identifiable data items [27 words unchanged] items are removed before transfer (e.g. name, address, postcode, NHS number etc). [2 paragraphs unchanged]

Expected output

Purpose 1: MBRRACE-UK recent outputs 1A. Data processing by MBRRACE-UK of the 2013 birth notification data has resulted in findings which have been included in Trust level reports which were issued to Trusts/Health Boards in autumn 2015. Findings were also reported in peer-reviewed scientific outputs reporting the methods and results from the analyses. Findings were also published in the 'Perinatal Mortality Surveillance Report - UK Perinatal Deaths for births from January to December 2013' issued on 10th June 2014. a. Reports: The primary outputs from the processing with be the annual national MBRRACE-UK reports. MBRRACE-UK published in December 2020 the MBRRACE-UK perinatal mortality surveillance report which reports 2018 data. This report includes a time trend analysis from 2013 onward. 1B. Data processing by MBRRACE-UK of the 2014 birth notification data has resulted in findings which were included in the 'Perinatal Mortality Surveillance Report - UK Perinatal Deaths for births from January to December 2014' which was been issued on 17th May 2016.; this was accompanied by further relevant scientific reports of methodological developments and further in-depth analyses. The data were also be used to generate Trust/Health Board Level reports for issue to Trusts/Health Boards a week before the public release of the national report.. The study has also published: 1C. Data processing by MBRRACE-UK of the 2015 birth notification data has resulted in findings which have been included in the 'Perinatal Mortality Surveillance Report - UK Perinatal Deaths for births from January to December 2015' which was issued on 22nd June 2017. As the third set of analyses conducted, this report also included for the first time trend data using the 2013 and 2014 data. The national report was accompanied by scientific reports of relevant methodological developments and further in-depth analyses. The data were also used to generate Trust/Health Board Level reports which were issued on 15th June 2017. MBRRACE-UK: Saving Lives, Improving Mothers' Care: 1D. Data processing by MBRRACE-UK of the 2016 birth notification data resulted in the publication of national report, local Trust/Health Board level reports and scientific peer-reviewed papers. The national and local reports was issued in June 2018. As well as reporting the 2016 data these outputs also included trend data incorporating the 2013, 2014 and 2015 data. Rapid report 2020: Learning from SARS-CoV-2-related and associated maternal deaths in the UK March-May 2020 1E. Data processing by MBRRACE-UK of the 2017 birth notification data resulted in the publication of national report, local Trust/Health Board level reports and scientific peer-reviewed papers. The national and local reports was issued in October 2019. As well as reporting the 2017 data these outputs also included trend data incorporating the 2013, 2014, 2015 and 2016 data. Rapid report 2021: Learning from SARS-CoV-2-related and associated maternal deaths in the UK June 2020 - March 2021 1F. Data processing by MBRRACE-UK of the 2018 birth notification data has just been completed and the national report has been submitted to the funders prior to publication in December 2020 along with local Trust/Health Board level reports and scientific peer-reviewed papers. As well as reporting the 2018 data these outputs will also include trend data incorporating the 2013, 2014, 2015, 2016 and 2017 data. On 14/1/2021 MBRRACE-UK also published: 1G. Future data processing by MBRRACE-UK will continue for the 2019, 2020 and 2021 births as per the format above with the outputs being the national annual report (including time trend data), the local reporting and scientific peer-reviewed papers. The national and local reports along with relevant scientific peer-reviewed papers will be issued in autumn 2021. MBRRACE-UK Perinatal Confidential Enquiry: Stillbirths and Neonatal Deaths in Twin Pregnancies MBRRACE-UK: Saving Lives, Improving Mothers' Care 2020: Lessons to inform maternity care from the UK and Ireland Confidential Enquiries in Maternal Death and Morbidity 2016-18 In October 2021 the study will publish the MBRRACE-UK perinatal mortality surveillance report which will report 2019 death. MBRRACE-UK will also release the trust and health board specific reports two weeks ahead of the national report; these are released solely to the Trust/Health Board where the deaths occurred . In November 2021 MBRRACE-UK will published the MBRRACE-UK maternal mortality surveillance and confidential enquiry report including data for 2017-2019. b. Lay reports: Each of the study’s national reports are accompanied by a lay report which is co-produced with members of the MBRRACE-UK 3rd sector stakeholder group. Each report is authored by individuals who are professionals in writing for lay audiences. The lay reports are targeted with specific messages for women, families and parents. c. Infographics: Each of the study’s national reports are also accompanied by an infographic which highlights the main findings in pictorial format which are tweetable. d. Social media: The study make extensive use of social media (mainly twitter) to ensure that the key message and findings from their reports are disseminated as widely as possible. The study’s infographics are designed so that individual elements make ideal images for tweeting. e. Submissions to peer reviewed journals: The study is planning to publish the detailed analysis of adjusted maternal mortality rates with a specific focus on maternal ethnicity. The study is also planning to publish a detailed analysis of perinatal mortality rates by cause of death and by ethnicity. Publication is likely to be in 2021. f. Dashboards: MBRRACE-UK have a real-time data monitoring system which presents individual trust/health board level data which the trusts and health boards can access to view their own data. However, this system does not use the NN4B/PDS derived data. g. Messages targeted at specific audiences: MBRRACE-UK ensure that specific key messages are written in a format which makes it clear who the target audience is. Where these, are for example, Royal Colleges, MBRRACE-UK ensure that the specific messages are directed at the particular audience. This is through both written communications, but also through their work as members of key committees and organisations for example, The Royal College of Obstetricians and Gynaecologists Standing Committee on Patient Safety. [1 paragraph unchanged] 2A. Data processing by MBRRACE-UK of the 2013, 2014, 2015, 2016, 2017, 2018 2018, 2019 and 2019 2020 birth notification data to generate aggregated tables of live births by gestational [12 words unchanged] analyse the audit measures published in the NNAP report for 2013 through 2019 2020 reports. [1 paragraph unchanged] All national outputs (for Purposes 1 and 2) are aggregated with small [20 words unchanged] suppression because the reports give the Trusts/Health Boards back information about the cases deaths they were responsible for caring for and reporting to MBRACE-UK so they already know how many cases deaths there are together with all their individual clinical characteristics. We provide an analysis to support their clinical care delivery with the aim of assisting them to reduce the number of babies who die in their Trust/Health Board in the future. During 2022 it is expected that MBRRACE-UK will publish the annual perinatal mortality surveillance report which will include perinatal deaths from 2019. MBRRACE-UK will also publish the annual maternal mortality and confidential enquiry report which will include maternal deaths from 2017 to 2019. Each will make a series of recommendations based on the evidence presented in each report. Examples of the types of benefits which are likely to arise from publication of these reports and our dissemination efforts are illustrated in the section below which outlines examples of the policy and practice changes which have resulted from the previous activities and reports. Purpose 2 This data is processed for the University of Oxford’s purpose and not for this additional purpose

Expected measurable benefits

Target date: annual ongoing benefits as below with an end date of 30th September 2021 2022 [4 paragraphs unchanged] The MNI-CORP programme is commissioned by HQIP on behalf of NHS England. [46 words unchanged] which follow from this national learning; our role is to produce the findings and findings, ensure appropriate dissemination to the bodies responsible for changing policy and practice to ensure that encourage appropriate changes in policy and practice to reduce the national maternal and perinatal mortality rate reduces over time. rates. During the one year extension we will publish the 2020 perinatal mortality surveillance report which will include perinatal deaths from 2018. We will also publish the 2020 maternal mortality and confidential enquiry report which will include maternal deaths from 2016 to 2018. Each will make a series of recommendations based on the evidence presented in each report. Examples of the types of benefits which are likely to arise from publication of these reports and our dissemination efforts are illustrated in the section below which outlines examples of the policy and practice changes which have resulted from our previous activities and reports.

Benefits reported

The national perinatal mortality surveillance is conducted by MBRRACE-UK in the context that the UK has one of the highest rates of perinatal death (deaths around the time of births which include late fetal losses, stillbirths and neonatal deaths) and infant deaths (deaths from birth to one year of age) in Europe. Recent figures published in the Lancet places the UK 20th out of 28 for highest stillbirth rates in Europe and it has been estimated that had the UK had a similar neonatal mortality rate to the rate in Sweden, in 2013 1,000 fewer babies would have died. Using the birth notification data enables researchers to calculate Trust-level standardised and adjusted perinatal mortality rates and to identify Trusts with higher rates than peer organisations. Using this standard methodology since 2013, researchers at the University of Oxford have tracked Trust-specific rates and identified Trusts with concerning rising rates and those with reassuring decreasing rates. Data are provided to the regulator Care Quality Commission for their inspections. Information based on these rates has been provided to support investigations and enquiries. [4 paragraphs unchanged] It was against this background that in November 2015 the Secretary of [31 words unchanged] to achieve this ambition by 2025, with a 20% reduction by 2020. This ambition was re-iterated in the NHS five year forward plan in 2018. MBRRACE-UK provides the mechanism by which the achievement of the ambition can be monitored. It is the role of MBRRACE-UK to monitor progress towards the national ambition and to identify Trusts which are failing to achieve adequate progress. For the MBRRACE-UK second national perinatal surveillance report (published in May 2016), Ben Gummer, the then Parliamentary Under-Secretary of State for Care Quality wrote in his Foreword to the report: “I want to pay tribute to the remarkable academic achievement that is MBRRACE-UK and underline the influence it is now having on the formulation of policy and impact on services. By providing a consistent and robust evidence base on which to take decisions, MBRRACE-UK is already saving lives.” Since 2013 the stillbirth rate in England has decreased by 22% and the neonatal mortality rate in England has decreased by 15%. In 2019 the majority of Trusts in England had a stabilised and adjusted stillbirth rate within +/- 5% of the national average. In 2020, despite the effects of the pandemic on clinical services, a local review of 94% of perinatal deaths was undertaken to identify areas for local quality improvement to prevent future deaths. This is compared with an estimated 10% in 2013.To date in 2021, despite the continuing effects of the pandemic in maternity and neonatal services, 99% of perinatal deaths have been notified to MBRRACE-UK within 7 days of the death which, with Birth Notification Data, enables more rapid surveillance of perinatal deaths. In the 2018 maternal mortality report, reiterated in the 2019 report, we MBRACE-UK identified the continuing ethnic inequalities in maternal death (there are similar inequalities in perinatal deaths) where women who are Black are five four times more likely to die and women who are Asian are over [5 words unchanged] as a maternal death than their white counterparts. Disseminating this information via our their technical report, lay reports and selected information via twitter has led to [7 words unchanged] NHS England/Improvement; the Department of Health and Social Care; the Cabinet office; the Royal College of Obstetricians and Gynaecologist established a Race Equality Task Force; and groups of individual Black women who have set up their own campaigns, for example the first Black Women’s Maternal Health Awareness Week was run this year in 2020 organised by the Five 'Five X More More' campaign. [2 paragraphs unchanged] In response to findings of high rates of maternal deaths from sepsis from our reports MBRRACE-UK reports, the UK Sepsis Trust released six new clinical toolkits specifically for women [16 words unchanged] emergency departments and acute medical units, as well as acute hospital inpatients. [1 paragraph unchanged] As a consequence of the continuing unwarranted variation in perinatal mortality rates [72 words unchanged] baby is reviewed from pre-conception through to bereavement and follow-up care. Over 10,000 12,000 perinatal deaths have now been through the process of local review using [62 words unchanged] and information regarding the care of any future pregnancies they may plan. [3 paragraphs unchanged] MBRRACE-UK has an ongoing relationship arrangement to provide aggregated maternal and perinatal data to the Care Quality Commission. This key mortality [8 words unchanged] support their regulatory activities and visits to inspect maternity and neonatal services. [1 paragraph unchanged] The first report of national perinatal mortality surveillance by MBRRACE-UK for deaths [79 words unchanged] comparisons by level of care provided, MBRRACE-UK has identified those Trusts with higher than average higher-than-average mortality rates and published the findings using a traffic light, RAG rating [76 words unchanged] conference in May 2016 where the second national MBRRACE-UK report was launched. [2 paragraphs unchanged]

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

Objective for processing

This Data Sharing Agreement permits the retention and processing of the data provided under previous iterations of this Agreement for an interim period. This is a pragmatic approach to provide an active Agreement whilst enabling the study to amend their application which meets the standards for approval. The study did not receive their Q4 2019 Birth Notifications extract before the previous iteration of this DSA expired and this will therefore be flowed under this interim Agreement. No additional data has been requested under this Agreement. Purpose 1: Processing for MBRRACE-UK purposes The following provides background information on the purpose of the original study: This is an Purpose 1: Processing for MBRRACE-UK purposes [6 paragraphs unchanged]

Processing activities

Under this Agreement, the study will continue to process data already provided under previous iterations of this Agreement. The study did not receive their Q4 2019 Birth Notifications extract before the previous iteration of this DSA expired and this will therefore be flowed under this interim Agreement. No additional data has been requested under this Agreement. [8 paragraphs unchanged]

Expected output

[1 paragraph unchanged] 1A. Data processing by MBRRACE-UK of the 2013 birth notification data has [28 words unchanged] reporting the methods and results from the analyses. Findings were also published and findings which were published in the 'Perinatal Mortality Surveillance Report - UK Perinatal Deaths for births from January to December 2013' issued on 10th June 2014: 2014. [https://www.npeu.ox.ac.uk/downloads/files/mbrrace-uk/reports/MBRRACE-UK%20Perinatal%20Surveillance%20Report%202013.pdf]. [1 paragraph unchanged] 1C. Data processing by MBRRACE-UK of the 2015 birth notification data has [13 words unchanged] - UK Perinatal Deaths for births from January to December 2015' which will be was issued on 22nd June 2017. As the third set of analyses conducted, this report also includes included for the first time trend data using the 2013 and 2014 data. The national report will be was accompanied by scientific reports of relevant methodological developments and further in-depth analyses. The data are were also being used to generate Trust/Health Board Level reports for issue to Trusts/Health Boards which were issued on 15th June 2017. 1D. Data processing by MBRRACE-UK of the 2016 birth notification data is underway resulted in preparation for the production publication of the national report, local Trust/Health Board level reports and scientific peer-reviewed papers. The national and local reports will be was issued in May June 2018. As well as reporting the 2016 data these outputs will also include included trend data incorporating the 2013, 2014 and 2015 data. 1E. Future data Data processing by MBRRACE-UK will continue for of the 2017, 2018 , 2019, 2020 and 2021 births as per 2017 birth notification data resulted in the format above with the outputs being the publication of national annual report (including time trend data), the report, local reporting Trust/Health Board level reports and scientific peer-reviewed papers. The national and local reports will be was issued from May 2019 onwards. in October 2019. As well as reporting the 2017 data these outputs also included trend data incorporating the 2013, 2014, 2015 and 2016 data. Purpose 2: Outputs for NNAP 1F. Data processing by MBRRACE-UK of the 2018 birth notification data has just been completed and the national report has been submitted to the funders prior to publication in December 2020 along with local Trust/Health Board level reports and scientific peer-reviewed papers. As well as reporting the 2018 data these outputs will also include trend data incorporating the 2013, 2014, 2015, 2016 and 2017 data. 2A. Data processing by MBRRACE-UK of the 2013 and 2014 birth notification data to generate aggregated tables of live births by gestational age by hospital by year will carried out to enable NNAP to further analyse the audit measure published in the NNAP report for 2013 and 2014 reports. 1G. Future data processing by MBRRACE-UK will continue for the 2019, 2020 and 2021 births as per the format above with the outputs being the national annual report (including time trend data), the local reporting and scientific peer-reviewed papers. The national and local reports along with relevant scientific peer-reviewed papers will be issued in autumn 2021. 2B. Data processing by MBRRACE-UK of the 2015 birth notification data to generate aggregated tables of live births by gestational age by hospital by year will be used in the production of audit measures for the measures generated by NNAP in the 2015 report. Purpose 2: Outputs for the National Neonatal Audit Programme (NNAP) 2C. 2A. Data processing by MBRRACE-UK of the 2016 2013, 2014, 2015, 2016, 2017, 2018 and 2019 birth notification data to generate aggregated tables of live births by gestational age by hospital by year will be used was carried out enabling NNAP to further analyse the audit measures published in the production of audit measure for the NNAP report for 2016 which will be issued by NNAP in October 2017. 2013 through 2019 reports. 2D. 2B. Data processing by MBRRACE-UK of the 2017, 2018 , 2019, 2020 and 2021 births as per the format above will continue to support the NNAP outputs. [1 paragraph unchanged]

Expected measurable benefits

Expected measurable benefits to health and/or social care including target date: [2 paragraphs unchanged] (1) To improve care provided to women during pregnancy and the care provided to their babies following birth; and (2) To reduce the rate of late fetal losses, stillbirths and infant deaths. and The MNI-CORP programme is commissioned by HQIP on behalf of NHS England. MBRRACE-UK delivers the programme and is responsible for conducting national surveillance of late fetal losses, stillbirths and infant deaths to contribute to national learning to reduce these rates. The MBRRACE-UK team does not have direct responsibility for carrying out any actions which follow from this national learning; our role is to produce the findings and ensure appropriate dissemination to the bodies responsible for changing practice to ensure that the national perinatal mortality rate reduces over time. (2) To reduce the rate of maternal deaths and late fetal losses (late miscarriages), stillbirths and infant deaths (perinatal deaths). The surveillance is conducted in the context that the UK has one of the highest rates of perinatal death (deaths around the time of births which include late fetal losses, stillbirths and neonatal deaths) and infant deaths (deaths from birth to one year of age) in Europe. Recent figures published in the Lancet places the UK 20th out of 28 for highest stillbirth rates in Europe and it has been estimated that had the UK had a similar neonatal mortality rate to the rate in Sweden, in 2013 1,000 fewer babies would have died. The MNI-CORP programme is commissioned by HQIP on behalf of NHS England. MBRRACE-UK delivers the programme and is responsible for conducting national surveillance of maternal deaths and late fetal losses (late miscarriages), stillbirths and infant deaths to contribute to national learning to reduce these rates. The MBRRACE-UK team does not have direct responsibility for carrying out any actions which follow from this national learning; our role is to produce the findings and ensure appropriate dissemination to the bodies responsible for changing policy and practice to ensure that the national perinatal mortality rate reduces over time. In March 2015 Bill Kirkup published his report of the investigation of perinatal and maternal deaths in the Universities Hospitals of Morecambe Bay – the ‘Morecambe Bay Enquiry’ Report (1). As part of the recommendations of that report it was noted that good information on pregnancy outcomes (including deaths) is a key driver for improvements in the quality of care provided for pregnant women and newborn babies. This is the role of the MBRRACE-UK programme. During the one year extension we will publish the 2020 perinatal mortality surveillance report which will include perinatal deaths from 2018. We will also publish the 2020 maternal mortality and confidential enquiry report which will include maternal deaths from 2016 to 2018. Each will make a series of recommendations based on the evidence presented in each report. Examples of the types of benefits which are likely to arise from publication of these reports and our dissemination efforts are illustrated in the section below which outlines examples of the policy and practice changes which have resulted from our previous activities and reports. The first report of national perinatal mortality surveillance by MBRRACE-UK for deaths in 2013, reported for the first time ‘stabilised and adjusted’ perinatal mortality rates for individuals Trusts which enabled appropriate comparison of mortality rates across health care organisations, taking into account the fact that some hospitals provide care for high risk women and hospitals care of vastly different numbers of pregnant women each year. This analysis has enabled MBRRACE -UK to not only report the national perinatal mortality rate but also to identify variation in death rates between Trusts. Using comparisons by level of care provided, MBRRACE-UK has identified those Trusts with higher than average mortality rates and published the findings using a traffic light system. For those Trusts with ‘red’ and ‘amber’ mortality rates it has been recommended that they review all their perinatal deaths individually to identify potentially preventable causes of death to enable them to put actions in place to prevent such deaths in the future. Evidence of action in individual units has come from the submission of abstracts to the MBRRACE-UK conference in May 2016 where the second national MBRRACE-UK report was launched. For example, on the back of their review, one small district general hospital has introduced a new referral form for antenatal booking to enable risk factors for stillbirths to be clearly identified, so that timely consultant review can be arranged if required and any women meeting the NICE criteria for risk of gestational diabetes have an appropriately timed glucose tolerance test arranged at their dating scan appointment (which ensures that the test is not missed). As a consequence of these and other actions this hospital has seen a reduction in the number of stillbirths in the past 12 months. There has also been action at national level. Following the publication of the first MBRRACE-UK national report in June 2015 NHS England launched the ‘Saving Babies’ Lives Care Bundle in March 2016 which is aimed specifically at ensuring Trusts put in place a series of key actions to prevent stillbirths which will also have an impact on neonatal and infant morbidity. It is against this background that on the 13th November 2015 the Secretary of State for Health announced additional funding for maternity services and the national ambition to reduce the perinatal mortality rate by half by 2030 with a 20% reduction by 2020. It is the role of MBRRACE-UK to monitor progress towards this ambition and to identify Trusts which are failing to achieve progress. For MBRRACE-UK’s second national report (published in May 2016), Ben Gummer, the then Parliamentary Under-Secretary of State for Care Quality wrote in his Foreword to the report: “I want to pay tribute to the remarkable academic achievement that is MBRRACE-UK and underline the influence it is now having on the formulation of policy and impact on services. By providing a consistent and robust evidence base on which to take decisions, MBRRACE-UK is already saving lives.” (1) Kirkup B. The Report of the Morecambe Bay Investigation. March 2015. The Stationery Office, London. 2015. [https://www.gov.uk/government/publications/morecambe-bay-investigation-report]

Benefits reported

In 2015 the Secretary of State for Health announced the national ambition to halve maternal and perinatal mortality rates by 2030; this was redefined in 2016 to achieve this ambition by 2025. This ambition was re-iterated in the NHS five year forward plan in 2018. MBRRACE-UK provides the mechanism by which the achievement of the ambition can be monitored. The national perinatal mortality surveillance is conducted by MBRRACE-UK in the context that the UK has one of the highest rates of perinatal death (deaths around the time of births which include late fetal losses, stillbirths and neonatal deaths) and infant deaths (deaths from birth to one year of age) in Europe. Recent figures published in the Lancet places the UK 20th out of 28 for highest stillbirth rates in Europe and it has been estimated that had the UK had a similar neonatal mortality rate to the rate in Sweden, in 2013 1,000 fewer babies would have died. [1 paragraph unchanged] 1. The impact of MBRRACE-UK findings reports on national policy and practice: practice The findings of the high rates of perinatal deaths in England, the variation between trusts and the results of the Kirkup enquiry resulted in the national maternity services review launched in 2015. The findings of this review were published as the ‘Better Birth’ Report in 2016 and MBRRACE-UK surveillance and confidential enquiry findings were highly cited throughout the report as evidence of the need for changes to maternity services to improve the care provided and outcomes for mothers and babies. MBRRACE-UK surveillance and confidential enquiry results also contributed to the development of the’ Saving Babies’ Lives Care Bundle’ which was implemented in March 2016. Version two of the care bundle (March 2019) was updated with a preterm birth reduction target to take account of the fact that, as highlighted in MBRRACE-UK reports, the majority of perinatal deaths are of stillbirths and babies who are born preterm. In March 2015 Dr Bill Kirkup published his report of the investigation of perinatal and maternal deaths in the Universities Hospitals of Morecambe Bay – the ‘Morecambe Bay Inquiry’ Report (1). As part of the recommendations of that report it was noted that good information on pregnancy outcomes (including deaths) is a key driver for improvements in the quality of care provided for pregnant women and newborn babies. This is the role of the MBRRACE-UK programme. The findings of the high rates of perinatal deaths in England, the variation between trusts and the results of the Kirkup enquiry resulted in an independent national maternity services review which was launched in March 2015. The findings of this review were published as the ‘Better Birth’ Report in 2016 and MBRRACE-UK surveillance and confidential enquiry findings were highly cited throughout the report as evidence of the need for changes to maternity services to improve the care provided and as a consequence the outcomes for mothers and babies. It was against this background that in November 2015 the Secretary of State for Health announced additional funding for maternity services and the national ambition to reduce the maternal and perinatal mortality rate by half by 2030; this was subsequently redefined in 2016 to achieve this ambition by 2025, with a 20% reduction by 2020. This ambition was re-iterated in the NHS five year forward plan in 2018. MBRRACE-UK provides the mechanism by which the achievement of the ambition can be monitored. It is the role of MBRRACE-UK to monitor progress towards the national ambition and to identify Trusts which are failing to achieve adequate progress. For the MBRRACE-UK second national perinatal surveillance report (published in May 2016), Ben Gummer, the then Parliamentary Under-Secretary of State for Care Quality wrote in his Foreword to the report: “I want to pay tribute to the remarkable academic achievement that is MBRRACE-UK and underline the influence it is now having on the formulation of policy and impact on services. By providing a consistent and robust evidence base on which to take decisions, MBRRACE-UK is already saving lives.” In the 2018 maternal mortality report, reiterated in the 2019 report, we identified the continuing ethnic inequalities in maternal death (there are similar inequalities in perinatal deaths) where women who are Black are five times more likely to die and women who are Asian are over twice as likely to die as a maternal death than their white counterparts. Disseminating this information via our technical report, lay reports and selected information via twitter has led to an enormous amount of policy activity by NHS England/Improvement; the Department of Health and Social Care; the Cabinet office; and groups of individual Black women who have set up their own campaigns, for example the first Black Women’s Maternal Health Awareness Week was run this year organised by the Five X More campaign. [1 paragraph unchanged] Along with NICE, the Royal College of Obstetricians and Gynaecologist (RCOG) are [20 words unchanged] or updated as a consequence of MBRRACE-UK findings. For example, two updated green-top guidelines RCOG ‘Green-Top Guidelines’ were released by the RCOG with direct relevance to findings reported in the 2014 and 2017 maternal [10 words unchanged] (RCOG 2016a); and (ii) Blood transfusion in obstetrics (GTG 47) (RCOG 2015)). [1 paragraph unchanged] 3. Impact of MBRRACE-UK findings on service delivery: Following the publication of the first MBRRACE-UK national perinatal surveillance report in June 2015 NHS England launched the ‘Saving Babies’ Lives Care Bundle’ in March 2016 which was aimed specifically at ensuring Trusts put in place a series of key actions to prevent stillbirths which will also have an impact on neonatal and infant morbidity. The identification in the MBRRACE-UK reports that the majority of perinatal deaths occur in preterm births, when version two of the Care Bundle was released in March 2019, it included a new action and target aimed at the prevention of pre-term birth. MBRRACE-UK surveillance data demonstrated that nearly two thirds of all maternal deaths are as a consequence of pregnancy exacerbated medical complications. As a consequence of the MBRRACE-UK findings, in 2017, NHS England committed to developing 12 maternal medicine networks in England. These have now been established with funding to support both training and new posts to develop a hub and spoke model to ensure that pregnant women with medical complications in pregnancy are able to receive consultant level care from obstetric physicians all around the country. As a consequence of the continuing unwarranted variation in perinatal mortality rates between Trusts and the poor quality of local reviews identified in the MBRRACE-UK perinatal confidential enquiries, in 2017 the Department of Health and Social Care commissioned MBRRACE-UK, via the Healthcare Quality Improvement Programme, to develop a national Perinatal Mortality Review Tool (PMRT). Launched in January 2018 the PMRT supports Trusts to carry our robust, systematic reviews of their local perinatal deaths ensuring that every stage of the care of the mother and baby is reviewed from pre-conception through to bereavement and follow-up care. Over 10,000 perinatal deaths have now been through the process of local review using the PMRT, there has been a demonstrable improvement in the quality of reviews conducted and demonstrable improvements in care have been instituted in Trusts as a consequence of their local review findings. Furthermore, as a consequence of the report which is produced following each review bereaved parents are provided with a clearer explanation of why their baby died and any relevant advice and information regarding the care of any future pregnancies they may plan. 4. Impact 3. The impact of MBRRACE-UK findings on the activities of the regulator: service delivery: MBRACE-UK have ongoing provision of maternal and perinatal data to the Care Quality Commission. This information is included in CQC inspection packs to support their regulatory activities and visits to inspect maternity and neonatal services. MBRRACE-UK surveillance data demonstrated that over 60% of all maternal deaths are as a consequence of pregnancy exacerbated medical complications. As a consequence of the MBRRACE-UK findings, in 2017, NHS England committed to developing 12 maternal medicine networks in England. These have now been established with funding to support both training and new posts to develop a hub and spoke model to ensure that pregnant women with medical complications in pregnancy are able to receive consultant level care from obstetric physicians all around the country. 4. The impact of MBRRACE-UK findings on the activities of the regulator: MBRRACE-UK has an ongoing relationship to provide maternal and perinatal data to the Care Quality Commission. This key mortality information is included in CQC inspection packs to support their regulatory activities and visits to inspect maternity and neonatal services. 5. Impacts of MBRRACE-UK findings on local activities in trusts: The first report of national perinatal mortality surveillance by MBRRACE-UK for deaths in 2013, reported for the first time ‘stabilised and adjusted’ perinatal mortality rates for individuals Trusts which enables appropriate comparison of mortality rates across health care organisations, taking into account the fact that some hospitals provide care for high risk women and hospitals care of vastly different numbers of pregnant women each year. This analysis has enabled MBRRACE -UK to not only report the national perinatal mortality rate but also to identify variation in death rates between Trusts. Using comparisons by level of care provided, MBRRACE-UK has identified those Trusts with higher than average mortality rates and published the findings using a traffic light, RAG rating system. For those Trusts with ‘red’ and ‘amber’ mortality rates it is recommended that in addition to reviewing all their perinatal deaths individually using the PMRT they explore system level issues with the delivery of care to identify potentially preventable causes of death. The purpose being to enable them to put actions in place to prevent such deaths in the future. Evidence of action in individual units came from the submission of abstracts to the MBRRACE-UK conference in May 2016 where the second national MBRRACE-UK report was launched. For example, on the back of their review, one small district general hospital introduced a new referral form for antenatal booking to enable risk factors for stillbirths to be clearly identified, so that timely consultant review can be arranged if required and any women meeting the NICE criteria for risk of gestational diabetes have an appropriately timed glucose tolerance test arranged at their dating scan appointment (which ensures that the test is not missed). As a consequence of these and other actions this hospital had seen a reduction in the number of stillbirths over the previous 12 months. (1) Kirkup B. The Report of the Morecambe Bay Inquiry. March 2015. The Stationery Office, London. 2015. [https://www.gov.uk/government/publications/morecambe-bay-investigation-report]

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

Objective for processing

Purpose 1: Processing for MBRRACE-UK purposes This Data Sharing Agreement permits the retention and processing of the data provided under previous iterations of this Agreement for an interim period. This is a pragmatic approach to provide an active Agreement whilst enabling the study to amend their application which meets the standards for approval. The study did not receive their Q4 2019 Birth Notifications extract before the previous iteration of this DSA expired and this will therefore be flowed under this interim Agreement. No additional data has been requested under this Agreement. The following provides background information on the purpose of the original study: This is an Purpose 1: Processing for MBRRACE-UK purposes [6 paragraphs unchanged]

Processing activities

Under this Agreement, the study will continue to process data already provided under previous iterations of this Agreement. The study did not receive their Q4 2019 Birth Notifications extract before the previous iteration of this DSA expired and this will therefore be flowed under this interim Agreement. No additional data has been requested under this Agreement. [8 paragraphs unchanged]

Expected output

[4 paragraphs unchanged] 1C. Data processing by MBRRACE-UK of the 2015 birth notification data has [26 words unchanged] be issued on 22nd June 2017. As the third set of analyses we have been able to conduct conducted, this report also includes for the first time trend data using the [30 words unchanged] Board Level reports for issue to Trusts/Health Boards on 15th June 2017. [7 paragraphs unchanged] All national outputs (for Purposes 1 and 2) are aggregated with small [10 words unchanged] MBRRACE-UK Trust/Health Board level reports do not involve small number suppression because we are giving the reports give the Trusts/Health Boards back information about the cases they were responsible for caring for and reporting to us MBRACE-UK so they already know how many cases there are together with all their individual clinical characteristics.

Benefits reported

Not stated in the previous version; added here.

In 2015 the Secretary of State for Health announced the national ambition to halve maternal and perinatal mortality rates by 2030; this was redefined in 2016 to achieve this ambition by 2025. This ambition was re-iterated in the NHS five year forward plan in 2018. MBRRACE-UK provides the mechanism by which the achievement of the ambition can be monitored.

The following provides some examples (not an exhaustive list) of the benefits arising from the findings of the MBRRACE-UK programme.

1. The impact of MBRRACE-UK findings on national policy and practice:

The findings of the high rates of perinatal deaths in England, the variation between trusts and the results of the Kirkup enquiry resulted in the national maternity services review launched in 2015. The findings of this review were published as the ‘Better Birth’ Report in 2016 and MBRRACE-UK surveillance and confidential enquiry findings were highly cited throughout the report as evidence of the need for changes to maternity services to improve the care provided and outcomes for mothers and babies. MBRRACE-UK surveillance and confidential enquiry results also contributed to the development of the’ Saving Babies’ Lives Care Bundle’ which was implemented in March 2016. Version two of the care bundle (March 2019) was updated with a preterm birth reduction target to take account of the fact that, as highlighted in MBRRACE-UK reports, the majority of perinatal deaths are of stillbirths and babies who are born preterm.

2. The impact of MBRRACE-UK findings on national guidelines and clinical toolkits:

Along with NICE, the Royal College of Obstetricians and Gynaecologist (RCOG) are responsible for producing national guidance for care during pregnancy, labour, birth and postpartum. A number of guidelines have been developed or updated as a consequence of MBRRACE-UK findings. For example, two updated green-top guidelines were released by the RCOG with direct relevance to findings reported in the 2014 and 2017 maternal reports: (i) Prevention and management of post-partum haemorrhage (GTG 52) (RCOG 2016a); and (ii) Blood transfusion in obstetrics (GTG 47) (RCOG 2015)).

In response to findings of high rates of maternal deaths from sepsis from our reports the UK Sepsis Trust released six new clinical toolkits specifically for women in pregnancy. Tools are available for out of hours/telephone triage, community midwives, pre-hospital/ambulance services, general practice, emergency departments and acute medical units, as well as acute hospital inpatients.

3. Impact of MBRRACE-UK findings on service delivery:

MBRRACE-UK surveillance data demonstrated that nearly two thirds of all maternal deaths are as a consequence of pregnancy exacerbated medical complications. As a consequence of the MBRRACE-UK findings, in 2017, NHS England committed to developing 12 maternal medicine networks in England. These have now been established with funding to support both training and new posts to develop a hub and spoke model to ensure that pregnant women with medical complications in pregnancy are able to receive consultant level care from obstetric physicians all around the country.

4. Impact of MBRRACE-UK findings on the activities of the regulator:

MBRACE-UK have ongoing provision of maternal and perinatal data to the Care Quality Commission. This information is included in CQC inspection packs to support their regulatory activities and visits to inspect maternity and neonatal services.

Changed only in punctuation, spacing or capitalisation: Expected measurable benefits.