Written evidence submitted by Baby Lifeline (MSE0075)

Submission by Baby Lifeline

About Baby Lifeline

Baby Lifeline is a unique national charity which supports frontline NHS staff to prevent injuries and deaths in and around childbirth. Our aim is to improve safety in maternity for mothers, babies and the staff who care for them.

Our main focus is on training and equipment provision, and national and local research in areas shown to improve care and reduce harm.

Executive Summary

Improving maternity care has been a priority for some time, owing to its high-stakes nature and justly positive expectations of pregnancy, birth, and the postnatal period – when things go wrong, the consequences are catastrophic for families and those caring for them. Equally, the value of maternity claims received in 2019/20 was around £2.4 billion, which is around £6.5 million a day, and accounts for 50% of the total value of claims reported to NHS Resolution1.

We Can Do Better

It is a sobering fact that most baby deaths and injuries investigated by national bodies are reported to have been avoidable with different care. Maternity reports have identified that poor outcomes “could have been different with different care” in around 3 out of 4 babies who died or had an acquired brain injury at birth 2 3. In the latest MBRRACE-UK rapid report looking at maternity mortality during the current pandemic, a third of the women who died may have had a different outcome with different care4.

A Start

Improving safety in maternity is not as simple as changing one thing alone, as shown by the complexity of factors identified in national reports examining perinatal mortality and morbidity 2 3; however, frustratingly, the same themes and recommendations recur time and time again.

A place to start to learn and improve care nationally, and to reduce avoidable harm, is to properly implement recommendations from previous thorough investigations into poor care.

Major themes identified as contributing to the avoidable deaths and injuries of babies and mothers seem not to be isolated and unique to specific “problem trusts” and could reflect wider systemic problems across the maternity system as a whole. For example, the majority of themes identified at Shrewsbury and Telford Hospital NHS trust were also highlighted in the Morecambe Bay Investigation in 2015 5. Similarly, HSIB noted that the themes were “not unique” to East Kent NHS Trust and “have been observed by other HSIB maternity investigations throughout England” 6.

Implementation Issues

Baby Lifeline’s Mind the Gap report looked at multi-professional training across the UK, which is a central recommendation throughout all maternity reports 7. It identified serious gaps in training for the frontline, and little/no standardisation in the way maternity training is prioritised, provided, funded, assessed, or attended. A number of trusts were not providing training in key topics, such as cardiac disease in pregnant women – the leading cause of death in pregnancy.

There are a number of barriers, such as culture and resource which need to be urgently addressed in order to enable rapid learning.

Data

The proper analysis of data is an invaluable tool in improving maternity safety, and there exist opportunities to improve the way that data are collected, analysed, and published. If properly recorded and analysed data become integral parts of learning and transparency for maternity services.

Maternity Services – Reported Improvements

In March 2020, NHSE/I published a report of the progress made four years after the publication of Better Births 8. It stated:

• A 21% fall in stillbirth rates in England.
• The triennial maternal mortality rate has reduced by 14% up to 2015-17.
• The neonatal mortality rate fell by only 5.1% from 2010-2018, which is below the trajectory required to meet the 2025 ambition.
• The picture of improvements to brain injuries remains unclear due to a change in definition.

Despite these improvements, the majority of tragedies in maternity remain avoidable – and we are still falling short of the national ambition to halve stillbirths, neonatal deaths, brain injuries, and maternal deaths by 2025.

Getting Safer Faster

The Care Quality Commission’s (CQC) report, published this year, Getting safer faster: key areas for improvement in maternity services identified maternity services as being “one of the core services… that is not making improvements in safety fast enough” 9.

Over a third of maternity units have been ranked as ‘requires improvement’ or ‘inadequate’ for the question ‘are maternity services safe?’ by the CQC. Disappointingly, the same themes from The Morecambe Bay Inquiry – a huge opportunity for national learning and improvement – were found to be “…still affecting the safety of maternity today”:

         Staff not having the right skills or knowledge

         Poor working relationships between obstetricians, midwives, and neonatologists

         Poor risk assessments

         Failures to ensure that there is an investigation

         Learning from when things go wrong

Equally, recurrent themes in poor care from national reports are being identified time and time again and across maternity services – these are not unique to a particular trust or time (e.g. poor teamworking, communication, delay in escalating).

Repeated Widespread Systemic Failings

Major concerns have been raised relating to systemic issues affecting the safety of maternity services at specific trusts, more recently East Kent NHS Trust and Shrewsbury and Telford Hospital NHS Trust. Both organisations are now subject to comprehensive independent investigative processes.

Importantly, the major themes identified as contributing to the avoidable deaths and injuries of babies and mothers seem not to be isolated and unique to these trusts and could reflect wider systemic problems across the maternity system as a whole.

A leaked copy of an interim report by Donna Ockenden investigating poor care at Shrewsbury and Telford Hospital NHS Trust highlighted the following issues:

•                 A long-term lack of informed consent for mothers choosing to deliver their babies in midwifery-led units – where risks can be higher if problems occur – which “continues to the present day”.

• A long-term lack of transparency, honesty and communication with families when things go wrong. This supported a culture that was “disrespectful” to families who had been “damaged” as a result.
• Failure to recognise serious incidents. Many families who had undergone horrific experiences were told they were the only ones and lessons would be learnt. The report said: “It is clear this is not correct”
• A long-term failure to involve families in investigations that were often poor and described as “extremely brief” and “overly defensive of staff”
• Not sharing learning, meaning “repeated mistakes that are often similar from case to case”. Failure to learn was present from the earliest case of a neonatal death in 1979 to cases occurring at the end of 2017.
• A lack of support for families who have “experienced significant loss and tragedy”.
• A long-standing culture at the trust “that is toxic to improvement effort”.

The majority of these themes were also highlighted in the Morecambe Bay Investigation5 into maternity services at Furness General Hospital in 2015.

In addition, the Healthcare Safety Investigation Branch (HSIB) published a report into maternity services in East Kent NHS Trust which identified recurrent safety risks 10:

• CTG interpretation
• Neonatal resuscitation
• Recognition of deterioration
• Escalation of concerns and responses

HSIB highlighted that the themes were “not unique” to the trust and “have been observed by other HSIB maternity investigations throughout England”. The latest national report by HSIB, published in March this year, notes these alongside other familiar themes as “prominent themes that have emerged through analysis completed maternity investigations” 6.

How Well Do We Respond to Recommendations?

There have been many investigations into maternity care which carefully and thoroughly state recommendations to improve safety for individual trusts and the system as a whole. In order to understand why themes and recommendations recur, Baby Lifeline looked at one central recommendation spanning over two decades – the need for high-quality multi-professional training.

Baby Lifeline’s Mind the Gap series of research has identified serious gaps in training for the frontline, and little/no standardisation in the way maternity training is prioritised, provided, funded, assessed, or attended 7. In order to illustrate this, we have commented on some specific aspects of maternity care below.

A Spotlight on Antenatal Care

Co-Morbidities in Pregnancy/High-Risk Pregnancies

Enquiries have highlighted evidence of sub-optimal care provided during pregnancy that may have contributed to the deaths of mothers and babies 2 11, and issues for improvements remain similar to those in previous enquiries into babies who died 2.

Most mothers who died during or shortly after pregnancy in the UK between 2013 and 2015 were known to have pre-existing physical or mental health problems 11. As the maternal population is becoming more complex, and women are giving birth later in life; maternity professionals must be prepared to support women with pre-existing conditions or high-risk pregnancies to access the care they need to ensure that preventable adverse maternal outcomes are not repeated.

Varied and Missing Content

Not all trusts mandated training in this area, and there was variation in the content of this training across maternity services (see Figure 1). Significantly, cardiovascular disease was covered in training in less than a third of trusts, and it is the leading cause of death during pregnancy and up to 6 weeks after birth. 

Figure 1: Specific training content provided in co-morbidities in pregnancy/management of high-risk pregnancies.

A Spotlight on Intrapartum Care

Emergency Skills Drills Training

Issues with timely recognition and appropriate management of emergency situations such as uterine rupture 2 and breech birth 12 have been highlighted as contributary factors in instances of harm. Training is recommended as one way to address these issues 12. In order to encourage safety in maternity care and achieve government targets, trusts are currently financially incentivised by NHS Resolution to implement criteria to reduce risk of harm; one aspect of this is ensuring annual in-house whole-team training on ‘maternity emergencies’ by trusts 13.

A Spotlight on Learning Culture

Risk, Patient Experience, Clinical Incidents/Governance, and Professionalism

The way in which healthcare organisations respond and learn following patient safety incidents has been highlighted as a cause for concern repeatedly:

• Earlier this year, the CQC published a briefing document aimed to improve maternity safety which highlighted ‘…a lack of investigation and learning when things go wrong’ 9.
• In 2018, the Royal College of Obstetricians and Gynaecologists’ Each Baby Counts report highlighted significant variability in the quality of local maternity investigations, the lack of family involvement, and the tendency to blame individuals rather than fully seeking to understand and address systemic issues 14.
• The Better Births report (2016) called for a ‘national standardised investigation process when things go wrong’ and highlighted a lack of national training as a concern 8.

Figure 2: Reported content within learning from risk, patient experience, clinical incidents/governance, and professionalism (% of trusts)

Implementing Evidence-Based Best Practice

The National Ambition – Saving Babies’ Lives

To assess whether maternity training for frontline professionals is responding adequately to national recommendations to improve maternity care, Baby Lifeline’s Mind the Gap Report (2018) looked at one of the Government’s initiatives to reduce stillbirths – the Saving Babies’ Lives Care Bundle. This was published in 2016 and outlined evidence-based best practice in care to tackle variation in stillbirth rates across regions.

An evaluation of the importance of the bundle showed clinical improvements across each of the 19 early adopter sites, saving more than 160 babies’ lives. This bundle appears to be a key element to achieving the Government target of reducing stillbirths by half by 2025.

When looking at just the training elements of the bundle, fewer than 8% of trusts were providing all training set out within the bundle. In some regions no trusts were seen to be doing all training needed (Figure 3).

As a bundle of interventions shown to improve care and outcomes, each element should be implemented to achieve the desired outcome.

Barriers

Implementing Training

Baby Lifeline’s Mind the Gap report found that the main barriers to implementing training for the frontline were limited finance, staffing and resource.

“Releasing frontline staff to receive training when maternity units are extremely busy often leads to staff being called back from training to deliver clinical care.”

“Going forward to sustain level of training we have had in last 18 months will require extra funding.”

-          Quotes from Mind the Gap (2018) from Frontline Professionals

Assessing the Impact of Training

Assessment of effectiveness is an important element of providing training, with the evaluation of a course identifying areas of improvement and general impact on practice, and subsequently patient care and staff satisfaction.

Year-on-year surveillance into mortality, morbidity, and adverse events has identified the need for training in pertinent areas, often concluding similar recommendations in several reports across a couple of decades. In the recent Five Years of Cerebral Palsy Claims report by NHS Resolution “inadequate quality assurances around staff competency and training” was a principle theme in clinical care leading to avoidable cases of cerebral palsy in babies 12 (p. 61). The report went on to recommend that each trust needs to “urgently review whether the training provided in their trust allows staff to reach and maintain their competence” (p. 68). It also recommended that staff do not provide unsupervised care until “competencies have been achieved” (p. 11).

Cultural Barriers & Failure to Learn

Multi-Professional Working

Multiple reports have highlighted poor multi-professional working is a contributory factor in poor care and avoidable harm. Different approaches and, in some extreme cases tribalism, can impact on decisions being made around a woman’s care. Poor multi-professional working can also lead to a delay in escalating concerns – which is also something often reported as a contributory factor.

Training together can improve communication and multi-professional working, and combat tribalism.

Supporting Staff to Give Good Care

Retention of staff in maternity is a considerable problem and impacts safe care. In 2018, Health Education England (HEE) told the Health Select Committee that ‘if we had kept the 2012 retention figure right the way through, we would have 16,000 more nurses now than we do at the moment, which is about 50% of all the vacancies we have in the NHS. These numbers are very large’.

Since 2012, Continuing Professional Development (CPD) budgets for nurses and midwives have been cut year-on-year. This has been described as a ‘trade-off’ to allow more training of new staff, though closer inspection of the figures would suggest that such a trade-off is not an effective way to increase the size of the workforce to required levels.

Since 2009, the number of midwives employed by the NHS in England has continued to rise year on year. Since around September 2012, a cyclical pattern has started to emerge showing increases and decreases that repeat each year 15 (Figure 6).

Another factor of retention is undoubtedly burnout due to increased pressures and lack of support. Patient safety and staff wellbeing are intrinsically linked – there cannot be safe care without first ensuring the wellbeing of the staff. There must be more support within the system to ensure safe working hours and appropriate staffing levels.  

Figure 6: Number of registered midwives by month

Litigation

Maternity cases account for only a small number of the total cases settled by NHS Resolution, yet account for over 50% of the total annual litigation bill (£2.4 billion in 2019/20) 1. 

Baby Lifeline believes that the current system of litigation does not serve families impacted by avoidable harm in maternity services well and that the adversarial nature of litigation processes can be a significant barrier to efforts to create a culture of openness and learning.

This issue is powerfully highlighted in the introduction to the 2017 Rapid Resolution and Redress (RRR) consultation16.

“Evidence tells us that the current system for providing redress for these birth injuries is not working as well as it could. Currently when substandard care occurs during labour and delivery which results in the most severe forms of birth injury (cerebral palsy/brain damage), the only means by which families can secure compensation is through the adversarial and often lengthy process of litigation. The average length of time between an incident occurring and an award for compensation being made is 11.5 years. This process takes time because the Court has to wait until the injured child’s prognosis is clear in order to decide a full and final compensation settlement. This is amplified by the adversarial culture associated with litigation, and adds further uncertainty and stress for the families involved.”

Baby Lifeline broadly supports the principles set out in the RRR consultation but note that there appears to have been no further progress since 2017. The Government needs to urgently move forward with the RRR proposals.

In 2017 NHS Resolution (NHSR) launched an Early Notification Scheme17 (ENS) with the following aims:

1. Carry out early liability investigations where indicated to improve the experience for both families and staff affected and provide early support
2. Reduce formal litigation in the courts and the associated legal costs
3. Identify learning and share at national, regional and local levels

Baby Lifeline welcomes the introduction of the Early Notification Scheme; however, the scheme falls short of the independent Rapid Resolution and Redress proposals.

NHSR could improve the impact of the Early Notification Scheme by focusing on ensuring early high-quality investigation (fully involving families), expanding the remit of the scheme, early settlement of cases that meet the appropriate threshold and disseminating learning from cases across the system.

‘Just’ and Learning Culture

The focus on ‘just culture’ for patients and healthcare workers in recent years is a positive step towards creating a more open learning environment in maternity services; however, more must be done to ensure healthcare staff can raise safety concerns and are treated fairly in serious incident investigations.

There is a need to improve the skills, capability and understanding of key principles of patient safety across the healthcare systems (including human factors and system thinking) so that healthcare workers and senior leaders are able to apply the principles and behaviours that support a true just and learning culture.

The development of the Patient Safety Syllabus is a positive step; however, organisations should ensure that staff who are responsible for responding to safety incidents are supported with the right competency-based training whilst this is still in development.

Baby Lifeline has recently partnered with Cranfield University to develop a specialist course in this area but there is currently no national standard relating to the training, and as a consequence there remains considerable variation from trust to trust.

Transparency

A key to creating a safe maternity unit is transparency – the “cover-up culture” of watering down reports stating critical patient safety issues, and lacking candour are not conducive to patient safety improvement. Leaders in trusts should support and live the values of an open and honest culture.

Initiatives such as the maternity incentive scheme can serve an important purpose in improving safety in maternity. It is however important that there is sufficient transparency in schemes such as this that involve self-reporting from trusts. Any instances of misleading or inaccurate declarations from trusts risk undermining the scheme as a whole, and so a thorough verification process is essential.

Patient Voices at the Centre of Care

Many significant problems relating to maternity care have only come to light due to the extraordinary persistence of harmed families. This was a key theme of the Morecambe Bay Investigation and at both at East Kent and Shrewsbury and Telford Hospital NHS Trust.

The ‘First Do No Harm’ report 18 yet again highlights the crucial role harmed patients played in exposing significant systemic patient safety issues. The report recommended the creation of a new ‘Patient Safety Commissioner’ role. Baby Lifeline strong supports this proposal but also believe that the remit of the role should be extended beyond the remit of ‘medicines and devices’ to include other areas of healthcare, including maternity.

Families affected by harm in maternity services should also be offered professional support, including bereavement care and funded independent advocacy.

The Importance of Data in Improving Maternity Safety

The proper analysis of data is an invaluable tool in improving maternity safety, and there exist opportunities to improve the way that data are collected, analysed, and published. This is particularly true of the major publicly available datasets, i.e. the Hospital Episode Statistics (HES) and the newer Maternity Services Data Set (MSDS).

There are two key reasons why we should strive for the highest possible quality of published data:

Transparency

Maternity data are published and available to the public, and as such there is a responsibility to ensure that they are as accurate and as thorough as possible. These data may well influence the choices that are being made by service users, such as the location or method of delivery. For maternal choice to be truly informed, it is essential that all of the information available is credible and precise.

Learning

The strength of both the HES and MSDS data is that they allow for national comparisons between trusts and units, which serves as an opportunity to identify outliers in how care is provided (i.e. if a maternity unit has a high rate of caesarean sections – what can this unit and others learn from this). The fact that trusts are reporting on the same 70 or so parameters (in the case of HES) year after year allows for straightforward comparisons and identification of trends.

Equally, trends in outcomes and possible influencing factors (i.e. instrumental delivery rate being high and third-degree tears being high) will inform how to intervene and improve a service.

Outliers behaviour is not in itself an indicator of poor practice; indeed, it is quite possible that it could indicate the opposite. It should, however, be thoroughly investigated to allow trusts to truly understand the service they are providing, and subsequently disseminate any findings amongst the health service as a whole.

If trusts believe that these published data are not accurate representations of the services that they are providing, then they should take steps to address why this might be.

Case Studies

Baby Lifeline has conducted analyses of the last 9 years of HES data and identified dozens of instances of trusts displaying outlying behaviour in one way or another. The following case studies are some of the more striking examples 19. Further analysis and explanations can be found in Appendix II.

Example 1: Method of Delivery

Shrewsbury and Telford Hospital NHS Trust has been a major outlier for method of delivery over the period examined. The trust has had one of the top 3 highest rates of spontaneous delivery for each of the last 9 years and has had the highest rate in 5 of the years. It has had the lowest, or close to the lowest, rate of caesarean section during the same period. It is worth considering whether early identification and interrogation of these findings might have led to a change in care.

Example 2: Forceps:Ventouse Ratio

Sometimes it is necessary to dig slightly deeper into the raw data in order to draw meaningful conclusions. Though not a significant outlier in terms of instrumental delivery, ventouse use, or forceps use, Leeds Teaching Hospitals NHS Trust consistently had by far the highest ratio of forceps to ventouse use between 2010 and 2016 (though data are not available for 2 of these years).

NMPA data show that in 2015-16, the trust had one of the highest rates of 3rd and 4th degree tears. Since then, the ratio has reduced and is now much more in line with national averages, as is the rate of 3rd and 4th degree tears. It is possible that a trend may have been spotted earlier had the HES data been thoroughly examined – particularly if there weren’t years with missing data.

Example 3: Gestation Length 44+ Weeks

Royal Devon and Exeter NHS Foundation Trust has reported by far the highest rate of deliveries at 44+ weeks for each of the last 9 years. Whereas the national average is roughly 0.1%, the trust has consistently had figures of between 2% and 3%. In 2018-19, almost half of all births reported at 44+ weeks occurred at 2 trusts. Baby Lifeline has not identified any adverse impact on outcomes, though such results should be carefully investigated.

Recommendations

In order to answer the call for evidence thoroughly, recommendations have been included below for each of the points noted by the Health and Social Care Committee.

Maternity Training

1. A Maternity Safety Training Fund should be re-instated immediately. The absolute minimum value of this fund should be £6.6million per year for direct costs of training. It is crucial that a commitment is made to ensure that this is an ongoing resource for NHS trusts. Failing to make this commitment will reduce the efficacy and efficiency of the intervention immeasurably.

2. Trusts must also be remunerated appropriately to allow them to backfill the workforce when training is taking place. The value of this remuneration should be at least £12.4million per year. Without this financial support it will be far more difficult to provide the necessary levels of training, which will lead to a fall in attendance rates and a reduction in value for money.

3. The extent of the funding should be based on the specific needs of each individual NHS organisation. The foremost factors are the size of the organisation in terms of maternity workforce, and a comprehensive review of training needs determined by a multi-professional Training Needs Analysis. Every professional group should be considered and involved in what they determine their training priorities to be.

4. A rigorous independent audit must take place every year. This will ensure that all funds are being utilised as intended and will allow effective evaluation to take place.

The Healthcare Safety Investigations Branch (HSIB)

5. The HSSIB Bill should be ratified in statute at the earliest opportunity. However, the Bill needs to be amended to ensure that the programme of independent maternity investigations can continue.

6. The Government should commit to a continuation of HSIB’s maternity programme until an alternative has been put in place, to ensure high-quality investigations continue.

7. HSIB’s thematic reports in maternity services serve as an excellent learning tool for services. There is an opportunity for rapid and more specific learning from individual trust investigation reports. If confidentiality was upheld, individual trust investigation reports could be shared with other trusts to increase learning potential.

Implementing Recommendations

8. Crucial patient safety recommendations from previous thorough investigation reports, most notably the 2015 Morecambe Bay Investigation have not been fully implemented (see Appendix I). Timely work needs to be carried out to review this and report on progress.

9. Ongoing investigations in maternity create numerous recommendations, which can be a barrier to implementation due to the volume of work for a short-staffed workforce. A process should be designed to centralise recommendations. Implementation of recommendations should be monitored.

Litigation and Culture

10. Baby Lifeline broadly supports the Rapid Resolution and Redress proposals and believe that the government should urgently consider moving forward with the scheme.

11. In lieu of full implementation of RRR, NHS Resolution could strengthen the Early Notification Scheme (ENS) by widening the inclusion criteria and focusing on high quality investigation, family engagement and involvement, and the early settlement of cases that meet the appropriate criteria.

12. Baby Lifeline supports the focus on creating a ‘just culture’ in healthcare. To achieve this, there needs to be a greater appreciation and application of safety science at all levels of the system. The development of the Patient Safety Syllabus is a welcome step in this direction, but more could be done in the shorter term to improve patient safety skills and capability - including the better provision of high-quality training to support incident investigation and better local systems for responding and learning from harm.

13. Formal structures and processes should be put into place to ensure transparency within the maternity sector, and avoid any further instances of cover-ups.

14. Patient voices need to be at the heart of service delivery and safer care. Baby Lifeline supports recommendations in Cumberlege Review for a Patient Safety Commissioner, and this should extend to maternity services.

15. Staff need to be better supported to improve safety and retention rates.

Data

16. There must be an increased emphasis on ensuring that all published maternity data sets are as accurate as possible. Failure to achieve this risks misleading the service users and wider public, and may result in missed opportunities for identifying outlier behaviour. Where trusts believe that the published data are a misrepresentation of the service being provided, they must work to identify and rectify the discrepancy as quickly as possible.

17. National comparisons should be made across as many metrics as possible in order that outlier behaviour is identified and investigated. Where appropriate, the findings from such investigations should be shared across the network.

References

1. NHS Resolution (2020). NHS Resolution: Annual report and accounts 2019/20. London: OGL. Accessed at: https://resolution.nhs.uk/wp-content/uploads/2020/07/NHS-Resolution-2019_20-Annual-report-and-accounts-WEB.pdf

2. Draper, E., Kurinczuk, J., and Kenyon, S. (Eds.) on behalf of MBRRACE-UK. (2017). MBRRACE-UK 2017 Perinatal Confidential Enquiry: Term, singleton, intrapartum stillbirth and intrapartum-related neonatal death. Leicester: The Infant Mortality and Morbidity Studies, Department of Health Sciences, University of Leicester.

3. The Royal College of Obstetricians and Gynaecologists. (2015). Each Baby Counts: 2015 full report. London: The Royal College of Obstetricians and Gynaecologists.

4. Knight M, Bunch K, Cairns A, Cantwell R, Cox P, Kenyon S, Kotnis R, Lucas DN, Lucas S, Marshall L, NelsonPiercy C, Page L, Rodger A, Shakespeare J, Tuffnell D, Kurinczuk JJ on behalf of MBRRACE-UK. Saving Lives, Improving Mothers’ Care Rapid Report: Learning from SARS-CoV-2-related and associated maternal deaths in the UK March – May 2020 Oxford: National Perinatal Epidemiology Unit, University of Oxford 2020.

5. Kirkup,B. 2015. The Report of the Morecambe Bay Investigation. London: The Stationery Office.

6. Healthcare Safety Investigation Branch (2020). Summary of Themes arising from the Healthcare Safety Investigation Branch Maternity Programme (NLR). [online] Available at: https://www.hsib.org.uk/documents/224/hsib-national-learning-report-summary-themes-maternity-programme.pdf.
7. Baby Lifeline (2018). MIND THE GAP An Investigation into Maternity Training for Frontline Professionals Across the UK (2017/18). [online] Available at: https://babylifeline.org.uk/home/wp-content/uploads/2014/07/Mind-the-Gap-2018-Investigation-into-Maternity-Training-Final-ELECTRONIC-VERSION-Final-v3.pdf [Accessed 4 Sep. 2020].
8. NHS England and Improvement (2020). Better Births Four Years On: A review of progress. NHS England.

9. Care Quality Commission (2020). Getting safer faster: key areas for improvement in maternity services | Care Quality Commission. [online] www.cqc.org.uk. Available at: https://www.cqc.org.uk/publications/themed-work/getting-safer-faster-key-areas-improvement-maternity-services [Accessed 4 Sep. 2020].
10. Healthcare Safety Investigation Branch (2020). East Kent Hospitals University NHS Foundation Trust HSIB summary report. [online] Available at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/878434/HSIB_East_Kent_report.pdf
11. Knight, M., Nair, M., Tuffnell, D., Shakespeare, J., Kenyon, S., and Kurinczuk, J. (Eds.) on behalf of MBRRACE-UK. (2017). Saving Lives, Improving Mothers’ Care - Lessons learned to inform maternity care from the UK and Ireland Confidential Enquiries into Maternal Deaths and Morbidity 2013–15. Oxford: National Perinatal Epidemiology Unit, University of Oxford.

12. Magro, M. (2017). Five Years of Cerebral Palsy Claims; A thematic review of NHS Resolution data. London: NHS Resolution

13. Maternity Safety Programme Team, Department of Health. (2017). Safer Maternity Care. Retrieved 31 October, 2018, from https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment data/file/560491/Safer_Maternity_Care_action_plan.pdf

14. The Royal College of Obstetricians and Gynaecologists. (2018). Each Baby Counts: Themed report on anaesthetic care, including lessons identified from Each Baby Counts babies born 2015 to 2017. London: The Royal College of Obstetricians and Gynaecologists.

15. NHS Digital – NHS Workforce Statistics; October 2019
16. Department of Health & Social Care. A Rapid Resolution and Redress Scheme for Severe Avoidable Birth Injury: a Consultation. 2017. [online] Available at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/595811/RRR_consultation_A.pdf [Accessed 4 September 2020].
17.                                NHS Resolution. 2019. The Early Notification scheme progress report: collaboration and improved experience for families [online] Available at: https://resolution.nhs.uk/wp-content/uploads/2019/09/NHS-Resolution-Early-Notification-report.pdf [Accessed 4 September 2020].
18. First Do No Harm The report of the Independent Medicines and Medical Devices Safety Review. (2020). [online] Available at: https://www.immdsreview.org.uk/downloads/IMMDSReview_Web.pdf [Accessed 4 Sep. 2020].
19. NHS Digital – NHS Maternity Statistics, England, 2010-2019. Available at: https://digital.nhs.uk/data-and-information/publications/statistical/nhs-maternity-statistics

Appendix I: Implementation of Morecambe Bay recommendations

The Morecambe Bay Investigation report was published in March 2015. The report made a total of 26 national recommendations for change. In this submission we highlight several key recommendations from the report that we believe have yet to be fully implemented.

Recommendation 23: Clear standards should be drawn up for incident reporting and investigation in maternity services. These should include the mandatory reporting and investigation as serious incidents of maternal deaths, late and intrapartum stillbirths and unexpected neonatal deaths. We believe that there is a strong case to include a requirement that investigation of these incidents be subject to a standardised process, which includes input from and feedback to families, and independent, multidisciplinary peer review, and should certainly be framed to exclude conflicts of interest between staff. We recommend that this build on national work already begun on how such a process would work. Action: the Care Quality Commission, NHS England, the Department of Health.

Baby Lifeline Comment:

Whilst Baby Lifeline strongly welcomes HSIB’s programme of maternity investigations, we do not believe that this work alone fully meets the requirements of this recommendation since local trusts are still required to carry out local investigations that fall outside the HSIB inclusion criteria and HSIB’s maternity work is not currently confirmed to run indefinitely.

We also welcome the introduction of the Perinatal Mortality Review Tool, but we do not believe that clear standards of the investigation of serious incidents (including the training that staff tasked with carrying out this work should be given) currently exist. There is still variation across the system regarding the methodology and quality of such investigations and the training and support provided to staff.

We note that the Better Births report (2016)1 recommended that the Health Care Safety Investigation Branch should ‘…devise a national standardised investigation process (for local use) for when things go wrong...’ and that ‘…the learning from reviews should be nationally collected and benchmarked so that learning can be spread.’ Although HSIB has made impressive progress with its maternity investigation programme, this recommendation has not yet been delivered.

Recommendation 24. We commend the introduction of the duty of candour for all NHS professionals. This should be extended to include the involvement of patients and relatives in the investigation of serious incidents, both to provide evidence that may otherwise be lacking and to receive personal feedback on the results. Action: the Care Quality Commission, NHS England.

Baby Lifeline Comment:

Baby Lifeline welcomes the HSIB’s positive work on family/patient involvement in their maternity investigations. However, the formal duty of candour (Regulation 20 of CQC’s fundamental standards)2 has not been extended to include a requirement for patient/relative involvement in investigation processes.

Furthermore, NHS Resolution found that of all cases notified to them in year 1 of the Early Notification Scheme, only in a minority of cases (30%) had trusts invited families/patients to be actively engaged in the investigation process3.

Recommendation 25: We recommend that a duty should be placed on all NHS Boards to report openly the findings of any external investigation into clinical services, governance or other aspects of the operation of the Trust, including prompt notification of relevant external bodies such as the Care Quality Commission and Monitor. The Care Quality Commission should develop a system to disseminate learning from investigations to other Trusts. Action: the Department of Health, the Care Quality Commission.

Baby Lifeline Comment:

Although the Morecambe Bay Investigation report was published in March 2015, sadly events widely reported in the national media have highlighted serious issues with external reviews not being shared in a timely way with CQC.

In relation to East Kent, an RCOG report which raised serious issues about the safety of maternity services at the trust was completed in Feb 2016, however, media reports4 state that the report was not shared with CQC until more than 3 years later.

We are aware that CQC now asks for such reports in the information requested as part of routine inspections, but the intent of this recommendation was clearly for CQC to be notified in real time. Furthermore, we are not aware of any system to disseminate the learning from such investigations to other trusts.

Recommendation 30: A national protocol should be drawn up setting out the duties of all Trusts and their staff in relation to inquests. This should include, but not be limited to, the avoidance of attempts to ‘fend off’ inquests, a mandatory requirement not to coach staff or provide ‘model answers’, the need to avoid collusion between staff on lines to take, and the inappropriateness of relying on coronial processes or expert opinions provided to coroners to substitute for incident investigation. Action: NHS England, the Care Quality Commission.

Baby Lifeline Comment:

We are aware that in 2016 NHS Improvement published a guidance note to NHS trusts on the coronial process5, however, this note falls short of a protocol and doesn’t directly provide guidance relating to the organisational approach to inquests that the Morecambe Bay Investigation report highlighted. Furthermore, since the publication of the Morecambe Bay Investigation, further concerns about the conduct of NHS organisations relating to inquests have been raised in the media6.

Recommendation 40: Given that the systematic review of deaths by medical examiners should be in place, as above, we recommend that this system be extended to stillbirths as well as neonatal deaths, thereby ensuring that appropriate recommendations are made to coroners concerning the occasional need for inquests in individual cases, including deaths following neonatal transfer. Action: the Department of Health.

Baby Lifeline Comment:

We note that current plans for the introduction of medical examiners in England exclude stillbirths. We are also aware of the current consultation into extending the remit of the coronial system to include stillbirths7. Baby Lifeline supports these proposals and believes that the medical examiners system should also be extended to cover stillbirths. 

Recommendation 44: This Investigation was hampered at the outset by the lack of an established framework covering such matters as access to documents, the duty of staff and former staff to cooperate, and the legal basis for handling evidence. These obstacles were overcome, but the need to do this from scratch each time an investigation of this format is set up is unnecessarily time-consuming. We believe that this is an effective investigation format that is capable of getting to the bottom of significant service and organisational problems without the need for a much more expensive, time-consuming and disruptive public inquiry. This being so, we believe that there is considerable merit in establishing a proper framework, if necessary statutory, on which future investigations could be promptly established. This would include setting out the arrangements necessary to maintain independence and work effectively and efficiently, as well as clarifying responsibilities of current and former health service staff to cooperate. Action: the Department of Health.

Baby Lifeline Comment:

Since the publication of the Morecambe Bay Investigation, major independent investigations into other maternity services have been instigated at SaTH and East Kent. Each of these investigations has had to develop a new framework covering approach and methodology. It is unlikely that Shrewsbury and Telford and East Kent will be the last investigations of this type and therefore we believe that there would be considerable merit in establishing a framework that could be adopted to support future investigations of this kind.

Summary

Whilst the response to the Morecambe Bay Investigation has trigged a large programme of work aimed at improving maternity safety, Baby Lifeline believes that there have been some significant gaps in terms of implementing specific national recommendations. There may be important leaning for current major maternity investigations relating to how recommendations are developed and the process by which once the investigation is complete, how implementation is monitored and scrutinised.

References:

1.                                    NHS England. 2016. Better Births Report [online] Available at: https://www.england.nhs.uk/wp-content/uploads/2016/02/national-maternity-review-report.pdf [Accessed 4 September 2020].
2.                                    Care Quality Commission.  Regulation 20: Duty Of Candour | Care Quality Commission. [online] Available at: https://www.cqc.org.uk/guidance-providers/regulations-enforcement/regulation-20-duty-candour [Accessed 4 September 2020].
3.                                    NHS Resolution. 2019. The Early Notification scheme progress report: collaboration and improved experience for families [online] Available at: https://resolution.nhs.uk/wp-content/uploads/2019/09/NHS-Resolution-Early-Notification-report.pdf [Accessed 4 September 2020].
4.                                    Health Service Journal. 2020. CQC Did Not See Damning Maternity Report For Three Years. [online] Available at: https://www.hsj.co.uk/quality-and-performance/cqc-did-not-see-damning-maternity-report-for-three-years/7026735.article [Accessed 4 September 2020].
5.                                    NHS Improvement. 2016. Guidance to Trusts on Coroners [online] Available at: https://improvement.nhs.uk/documents/70/Note_for_guidance_to_trusts_on_coroners_May_2016_FINAL_COPY.pdf [Accessed 4 September 2020].
6.                                    Independent.co.uk. 2020. Parents Of Baby Who Died Of Neglect At Maternity Unit Call For Inquiry. [online] Available at: https://www.independent.co.uk/news/health/east-kent-hospitals-maternity-safety-harry-richford-death-coroner-a9298841.html [Accessed 4 September 2020].
7.                                    Consult.justice.gov.uk. 2020. [online] Available at: https://consult.justice.gov.uk/digital-communications/coronial-investigations-of-stillbirths/supporting_documents/Consultation%20on%20coronial%20investigations%20of%20stillbirths%20web.pdf [Accessed 4 September 2020].

Appendix II: The Importance of Data – Case Studies

Baby Lifeline has analysed each year of HES provider level data between 2010-11 and 2018-19. The analysis has included trusts with more than 600 births per year. In line with HES practice, the rates are calculated excluding unknown data.

Example 1 (SaTH Method of delivery)

Spontaneous Delivery

sdf

Caesarean Delivery

Elective Caesarean

Emergency Caesarean

Example 2 (LTH Forceps:Ventouse Ratio)

2010-11

2013-14

2015-16

2016-17

2017-18

2018-19

Example 3: RD&E Gestation Length 44+ Weeks

15 September 2020