I want to begin by apologising for the distress caused by the delay in our announcing a new Chair and to take this opportunity to update you on how the work to replace the existing Review has been developing as we have taken on board various views that you have shared with us.

We have listened to the concerns that you raised with the Secretary of State when you met him in person and through recent correspondence that you have shared with us. Our work has been centred on ensuring that the new Review addresses those concerns, learns from other reviews, and provides a mechanism by which you can share your experiences and your views, so that real improvements can be experienced by people accessing maternity services in Nottingham now or in the future.

After careful consideration and in light of the concerns from some families, our own concerns, and those of stakeholders including in the wider NHS that the current Review is not fit for purpose, we have taken the decision to ask the current Review team to conclude all of their work by Friday 10 June.

This means that the publication later today of the interim report by the current Review team and the accompanying briefing sessions by the team planned for next week and week commencing 6 June will bring their work to a conclusion. Nottingham University Hospitals NHS Trust needs to urgently consider the findings of this interim report and make the immediate changes necessary to ensure the safety of mothers and babies in their care, and we will ensure that they do so.

We will be asking the new national Review team to begin afresh, drawing a line under the work undertaken to date by the current local Review team, and we are using this opportunity to communicate that to you clearly. I should add that, where you actively give consent, the new Review team will be able to access documentation such as the transcripts from your listening sessions. The new team will communicate with you about this in due course once it is established.

We have reflected on the strength of feeling from families and stakeholders to this Independent Review about the appointment of a new Chair, and I would like to restate that we feel it imperative for this new Review to have the confidence of all families involved and families who may also come forward in the future. We have listened to your concerns. I can confirm that Donna Ockenden has agreed to chair the new Review and we will work with her to develop a new Terms of Reference that reflects the need to both drive urgent improvements to local maternity care and the need to deliver actionable recommendations that can be implemented as quickly as possible.

You have highlighted the need to ensure that families as well as NHS staff are supported to speak up, and we need to ensure that the lessons from previous reviews are learnt. We want to see a report concluded in a thorough but timely way with strong engagement with families, clinical experts, the Trust, and others, in order to enable immediate learning and rapid action to improve services for mothers and babies on a continuous basis.

In addition, we are developing a new standardised formal approach to appointing review chairs. We are absolutely committed to learning from feedback from this and other reviews to get that right, and from the challenges and shortcomings in this case, especially through the transition from regional to national oversight.

You will of course want to know further details as to the timescales and next steps for the new Review and we will set these out as soon as possible. In order to enable us to communicate with you directly following the conclusion of the current Review, and ahead of Donna formally beginning her role as Chair of the new Review, we would please ask you to email england.nuhtindrev@nhs.net with your contact details confirming that you are happy to be contacted by the national team at NHS England and NHS Improvement.

I would like to reiterate that we recognise the distressing impact this process has had on you and your families and the NHS is committed to providing the support that you need. The specialist psychological support remains in place and I would encourage you to contact Trent PTS at fpss@trentpts.co.uk or on 0115 200 1000 for more information.

Yours sincerely,

Sir David Sloman

Chief Operating Officer NHS England and NHS Improvement

Today the Independent review of maternity services at Shrewsbury and Telford Hospital NHS Trust published its final report into cases of maternal and neonatal harm.[1]

When this Review was commissioned in 2017, it concerned 23 families’ cases. Subsequently it has grown significantly, as families contacted the Review team with their concerns about maternity care and treatment at the Trust. The final report relates to 1,486 families, some with multiple clinical incidents, with the earliest case in 1973 and the latest in 2020.

The Review found:

“… repeated failures in the quality of care and governance at the Trust throughout the last two decades, as well as failures from external bodies to effectively monitor the care provided. This final report identifies hundreds of cases where the Trust failed to undertake serious incident investigations, with even cases of death not being examined appropriately. The review found that where investigations did take place they did not meet the expected standards at that time and failed to identify areas for improvement in care”[2]

It outlines a shocking degree of avoidable harm in maternal and neonatal care. This includes cases of stillbirth, neonatal death, maternal death and other serious complications. The Review had initially published an interim report with findings and safety recommendations based on 250 cases in December 2020.[3] The final report today includes a further 64 local actions for the Trust and 15 actions to improve care and safety in maternity services across England.

Over the coming days Patient Safety Learning will be looking in more detail at the findings of this report and its implications for patient safety, both in maternity care and wider healthcare. In this blog we set out our initial response, reflecting on some of the key patient safety issues that this highlights.

Patient concerns dismissed

A recurring theme that comes up time and again in major patient safety scandals is that concerns raised by patients and family members are not acted on and, if harm occurs, they are left out of the investigation process. Related to this, patients’ complaints can often either be dismissed or not given a high enough priority to identify and address emerging patient safety issues.

One area where this report highlights similar concerns is in relation to patient complaints received by the maternity service at the Trust. Discussing the approach take to such complaints, it states:

“There is evidence that complaint responses lacked transparency and honesty, especially with regards to clinical care. The review team has identified families where care was sub-optimal, where different management would likely have made a difference to the outcome, however the complaint responses justified actions, delays and omissions in care. In addition, they often lacked compassion and in a number of responses it was implied that the woman herself was to blame.”

The report notes cases where families were not included in investigations where they should have been and a lack of compassion in Trust’s complaints process. They also highlight situations where complaints were dismissed, only for external investigations years later to identify failings which should have been evident at the time.

Having an effective complaints system provides an important opportunity to learn from incidents of unsafe care. Patients’ experiences can be used to help identify patient safety problems, ascertain the causes of these issues and put in place remedial measures to prevent them from recurring. It is positive to see that one of the report’s national actions is aimed at increasing patient and family involvement and in the design and development of maternity complaints processes nationally and at local level.

Failing to learn lessons from cases of avoidable harm

Taking a comprehensive approach to investigating patient safety incidents, identifying what went wrong and the actions needed to prevent a similar incident taking place in future, is vital to improving patient safety.

Unfortunately, a significant part of this report’s findings is centred on poor quality investigation processes. The Review’s assessment of the clinical governance processes and documents at the Trust revealed that investigations often fell below the standard expected. Concerningly, it states that:

“The reviews were often cursory, not multidisciplinary and did not identify the underlying systemic failings and some significant cases of concern were not investigated at all. In fact, the maternity governance team inappropriately downgraded serious incidents to a local investigation methodology in order to avoid external scrutiny, so that the true scale of serious incidents at the Trust went unknown until this review was undertaken.”

The report notes that both internal and external reports had pointed out the need to improve maternity investigations at the Trust, with a report by the Royal College of Obstetricians and Gynaecologists in July 2017 finding:

“… the Trust’s process of investigating SIs was complex and failed to adhere to recommended timescales; in one case reviewed by the RCOG team some 8 months after a stillbirth the report was still incomplete. The RCOG team also identified that the Trust’s internal team conducting the investigations was not appropriately resourced or trained in RCA methodology. It also identified that there was no culture of shared learning, that the RCAs often focused on the wrong issues, lacked system wide actions and focused instead on non-specific actions such as ‘share report widely’ and ‘learn from events’. There was no documentation that action plans were completed and recommendations often focused on individuals, rather than recommendations for system changes.”

One of the report’s key national actions to improve care and safety contains a number of provisions aimed at ensuring that future maternity investigations are meaningful for families and staff and that lessons are learned and implemented in a timely manner.

Lack of leadership

Good leadership plays a key role in shaping an organisations culture. Leaders can help to drive patient safety performance, support learning from unsafe care and put in place clear governance processes to enable this.

A key area of concern highlighted by this Review is the failure at a leadership level to identify and tackle patient safety issues. The Review stated that this was an problem at the highest levels of the organisation:

“The review has found the Trust leadership team up to Board level to be in a constant state of churn and change. Therefore it failed to foster a positive environment to support and encourage service improvement at all levels. In addition the Trust Board did not have oversight, or a full understanding of issues and concerns within the maternity service, resulting in a lack of strategic direction and effective change, nor the development of accountable implementation plans.”

The report also refers to leadership deficiencies at a clinical level and how in some cases this was interconnected with staff shortages, noting that an inadequate number of consultants for a maternity unit of the Trust’s size may have deterred midwives from escalating clinical concerns.

In its national actions the report states the need for Trust boards to have oversight and of the quality and performance of maternity services and contains specific provisions relating to improving clinical governance leadership in maternity services.

Culture

Too often in healthcare we see organisational cultures which seek to assign blame when things go wrong, making patient harm more likely to happen again. It is widely acknowledged that to ensure patient safety issues are consistently reported and acted on, staff need to feel safe to do so and work in an organisational culture that supports and promotes this.

The Review highlights a range of issues regarding culture at Shrewsbury and Telford Hospital NHS Trust. It states:

“The review team has also heard directly from staff that there was a culture of ‘them and us’ between the midwifery and obstetric staff, which engendered fear amongst midwives to escalate concerns to consultants. This demonstrates a lack of psychological safety in the workplace, and limited the ability of the service to make positive changes”

It also noted serious concerns, which we seem repeatedly in cases of serious patient safety failings, about staff not feeling able to speak up about safety issues. The Review team said they found evidence of staff being encouraged not to complain or raise awareness of poor practice within both personal and professional capacities, noting that:

“During the staff voices interviews some staff stated to the review team that there was a culture of bullying within the leadership team, and that this was not confined to the senior maternity management team but went across the Trust management structure.”

Safe staffing

Without safe staffing levels, healthcare professionals are unable to deliver the quality care required to keeping patients safe from avoidable harm.

This is a major area of concern highlighted in this report. It points to significant staffing and training gaps within maternity services at the Trust and the negative impact that this had on its performance, noting that:

“Staff also cited suboptimal staffing levels and unsafe inpatient to staffing ratios to the review team, and said they often felt fearful and stressed at work due to poor staffing levels.”

In its actions to improve care and safety in maternity services across England, the report makes recommendations for change around both safe staffing and longer-term workforce planning and sustainability.

It specifically highlights the rollout of the new Midwifery Continuity of Carer model, aimed at improving safety in outcomes, and the need to pause this if Trust’s are unable to meet safe staffing requirements. As with any new innovations aimed at improving care, it is vital that we have the resources and staffing in place to support their implementation and robustly assess the impact of this on patient safety. Without this, the intended benefits and improvements of such changes will be lost.

Systemic problem

Commenting on the publication of the report, its Chair, Donna Ockenden, acknowledged the systemic nature of the issues uncovered, stating:

“What is astounding is that for more than two decades these issues have not been challenged internally and the Trust was not held to account by external bodies. This highlights that systemic change is needed locally, and nationally, to ensure that care provided to families is always professional and compassionate, and that teams from ward to board are aware of and accountable for the values and standards that they should be upholding.”

Over the last decade there have been multiple inquiries and reviews into serious patient safety failings in maternity care, with similar themes to the ones above being outlined being highlighted repeatedly. These reports are consistently followed with assurances that ‘lessons will be learned’ and that this will ‘never happen again’.

While the Government and NHS continue to respond to these issues in isolation, failing to tackle their underlying systemic causes, patients and their families will continue to suffer from a tragic loss and life and long-term effects of avoidable harm in healthcare. We need to fundamentally transform our approach to patient safety, making this a core purpose of health and social care.

References

1. Independent review of maternity services at Shrewsbury and Telford Hospital NHS Trust. Ockenden Report: Findings, conclusions and essential actions from the independent review of maternity services at The Shrewsbury and Telford Hospital NHS Trust, 30 March 2022.
2. Independent review of maternity services at Shrewsbury and Telford Hospital NHS Trust, Press Release: Final report of the Independent Review of Maternity Services at The Shrewsbury and Telford Hospital NHS Trust published, 30 March 2022.
3.  Independent review of maternity services at Shrewsbury and Telford Hospital NHS Trust, Ockenden Report: Emerging findings and recommendations from the independent review of maternity services at Shrewsbury and Telford Hospital NHS Trust, 10 December 2020.

 The report contains 64 local actions for learning which are aimed at assisting The Shrewsbury and Telford Hospital NHS Trust with making immediate and significant improvements to the safety and quality of their maternity services. It also contains a number of immediate and essential actions to improve care and safety in maternity services across England, expanding on the recommendations made in its initial report, which are summarised below:

Workforce planning and sustainability

• Financing a safe maternity workforce. The recommendations from the Health and Social Care Committee Report: 'The safety of maternity services in England' must be implemented.
• Training. The Health and Social Care Select Committee view that a proportion of maternity budgets must be ring-fenced for training in every maternity unit should be implemented.

Safe staffing

• All trusts must maintain a clear escalation and mitigation policy where maternity staffing falls below the minimum staffing levels for all health professionals.

Escalation and accountability

• Staff must be able to escalate concerns if necessary There must be clear processes for ensuring that obstetric units are staffed by appropriately trained staff at all times. If not resident there must be clear guidelines for when a consultant obstetrician should attend.

Clinical governance – leadership

• Trust boards must have oversight of the quality and performance of their maternity services. In all maternity services the Director of Midwifery and Clinical Director for obstetrics must be jointly operationally responsible and accountable for the maternity governance systems.

Clinical governance – incident investigations and complaints

• Incident investigations must be meaningful for families and staff and lessons must be learned and implemented in practice in a timely manner.

Learning from maternal deaths

• Nationally all maternal post-mortem examinations must be conducted by a pathologist who is an expert in maternal physiology and pregnancy related pathologies. In the case of a maternal death a joint review panel/investigation of all services involved in the care must include representation from all applicable hospitals/clinical settings.

Multidisciplinary training

• Staff who work together must train together Staff should attend regular mandatory training and rotas. Job planning needs to ensure all staff can attend. Clinicians must not work on labour ward without appropriate regular CTG training and emergency skills training.

Complex antenatal care

• Local Maternity Systems, Maternal Medicine Networks and trusts must ensure that women have access to pre-conception care. Trusts must provide services for women with multiple pregnancy in line with national guidance Trusts must follow national guidance for managing women with diabetes and hypertension in pregnancy.

Preterm birth

• The LMNS, commissioners and trusts must work collaboratively to ensure systems are in place for the management of women at high risk of preterm birth. Trusts must implement NHS Saving Babies Lives Version 2 (2019).

Labour and birth

• Women who choose birth outside a hospital setting must receive accurate advice with regards to transfer times to an obstetric unit should this be necessary. Centralised CTG monitoring systems should be mandatory in obstetric units.

Obstetric anaesthesia

• In addition to routine inpatient obstetric anaesthesia follow-up, a pathway for outpatient postnatal anaesthetic follow-up must be available in every trust to address incidences of physical and psychological harm. Documentation of patient assessments and interactions by obstetric anaesthetists must improve. The determination of core datasets that must be recorded during every obstetric anaesthetic intervention would result in record-keeping that more accurately reflects events. Staffing shortages in obstetric anaesthesia must be highlighted and updated guidance for the planning and provision of safe obstetric anaesthesia services throughout England must be developed.

Postnatal care

• Trusts must ensure that women readmitted to a postnatal ward and all unwell postnatal women have timely consultant review. Postnatal wards must be adequately staffed at all times

Bereavement care

• Trusts must ensure that women who have suffered pregnancy loss have appropriate bereavement care services.

Neonatal care

• There must be clear pathways of care for provision of neonatal care. This review endorses the recommendations from the Neonatal Critical Care Review (December 2019) to expand neonatal critical care, increase neonatal cot numbers, develop the workforce and enhance the experience of families. This work must now progress at pace.

Supporting families

• Care and consideration of the mental health and wellbeing of mothers, their partners and the family as a whole must be integral to all aspects of maternity service provision. Maternity care providers must actively engage with the local community and those with lived experience, to deliver services that are informed by what women and their families say they need from their care.

Read Patient Safety Learning's initial response to the publication of the Ockenden Review here.

However, the report also says that since the building’s opening, measures have been put it place or are underway to ensure a sustained reduction in these risks.

The report also identifies a number of other issues which arose as a result of the infections, including the effect on public confidence, disruption to treatments, additional workloads for infection prevention and control teams and diverting resources away from the day-to-day running of the hospital.

The Review did not establish a sound evidential basis for asserting that avoidable deaths resulted from failures in the design, build, commissioning or maintenance of the hospital. However, this is one of the areas which will also be considered during the forthcoming Public Inquiry.

The report outlines serious concerns about how the Trust engaged and involved women both in their care and after harm had occurred. This was particularly notable in the example of the option of having a caesarean section, where there was an impression that the Trust had a culture of wanting to keep the numbers of these low, regardless of patients’ wishes. They commented:

“The Review Team observed that women who accessed the Trust’s maternity service appeared to have little or no freedom to express a preference for caesarean section or exercise any choice on their mode of deliver.”

It also noted a theme in common with both Paterson Inquiry and Cumberlege Review relating to the Trusts’ poor response to patients raising concerns.[3] The report noted that “there have also been cases where women and their families raised concerns about their care and were dismissed or not listened to at all”.

The need for better investigations

Concerns about the quality of investigations into patient safety incidents at the Trust is another theme that emerges. The review reflected that in some cases no investigation happened at all, while in others these did take place but “no learning appears to have been identified and the cases were subsequently closed with it deemed that no further action was required”.

One of the most valuable sources for learning is the investigation of serious incidents and near misses. If these processes are absent or inadequate, then organisations will be unable to learn lessons and prevent future harm reoccurring. Patient Safety Learning believes it is vital that Trusts have the commitment, resources, and frameworks in place to support investigations and that the investigators themselves have the right skills and training so that these are done well and to a consistently high standard. This has not formed part of the Report’s recommendations and we hope that this is included in their final report.

Lack of leadership for patient safety

Another key issue highlighted by the report is the failure at a leadership level to identify and tackle the patient safety issues. Related to this one issue it notes is high levels of turnover in the roles of Chief Executive, executive directors and non-executive directors. As part of its wider recommendations, the Report suggests trust boards should identify a non-executive director who has oversight of maternity services.

Good leadership plays a key role in shaping an organisations culture. Patient Safety Leadership believes that leaders need to drive patient safety performance, support learning from unsafe care and put in place clear governance processes to enable this. Leaders need to be accountable for patient safety.

There are questions we hope will be answered in the final report that relate to whether leaders knew about patients’ safety concerns and the avoidable harm to women and their babies. If they did not know, why not? If they did know but did not act, why not?

Informed Consent and shared decision-making

The NHS defines informed consent as “the person must be given all of the information about what the treatment involves, including the benefits and risks, whether there are reasonable alternative treatments, and what will happen if treatment does not go ahead”.[4] The report highlights concerns around the absence of this, particularly on the issue of where women choose as a place of birth, noting:

“In many cases reviewed there appears to have been little or no discussion and limited evidence of joint decision making and informed consent concerning place of birth. There is evidence from interviews with women and their families, that it was not explained to them in case of a complication during childbirth, what the anticipated transfer time to the obstetric-led unit might be.”

Again this is another area of common ground with other recent patient safety reports such as the Cumberlege Review.[5] Patient Safety Learning believes it is important that patients are not simply treated as passive participants in the process of their care. Informed consent and shared decision making are vital to respecting the rights of patients, maintaining trust in the patient-clinician relationship, and ensuring safe care.

Implementation for action and improved patient safety

In its introduction, the report states:

“Having listened to families we state that there must be an end to investigations, reviews and reports that do not lead to lasting meaningful change. This is our call to action.”

Responding with an official statement in the House of Commons today, Nadine Dorries MP, Minister for Mental Health, Suicide Prevention and Patient Safety, did not outline a timetable for the implementation of this report’s recommendations.

In 2020 we have seen significant patient safety reports whose findings have been welcomed by the Department of Health and Social Care but where there has subsequently been no formal response nor clear timetable for the implementation of recommendations, most notably the Paterson Inquiry and Cumberlege Review.

Patient Safety Learning believes there is an urgent need to set out a plan for implementing the recommendations of the Ockenden Report and these other patient safety reports. Patients must be listened to and action taken to ensure patient safety.

[1] Independent review of maternity services at Shrewsbury and Telford Hospital NHS Trust, Ockenden Report: Emerging findings and recommendations form the independent review of maternity services at Shrewsbury and Telford Hospital NHS Trust, 10 December 2020. https://www.ockendenmaternityreview.org.uk/wp-content/uploads/2020/12/ockenden-report.pdf

[2] Ibid.

[3] The Right Reverend Graham Jones, Report of the Independent Inquiry into the Issues raised by Paterson, 2020. https://assets.publishing.serv...; The Independent Medicines and Medical Devices Safety Review, First Do No Harm, 8 July 2020. https://www.immdsreview.org.uk/downloads/IMMDSReview_Web.pdf

[4] NHS England, Consent to treatment, Last Accessed 16 July 2020. https://www.nhs.uk/conditions/consent-to-treatment/

[5] Patient Safety Learning, Findings of the Cumberlege Review: informed consent, Patient Safety Learning’s the hub, 24 July 2020. https://www.pslhub.org/learn/patient-engagement/consent-and-privacy/consent-issues/findings-of-the-cumberlege-review-informed-consent-july-2020-r2683/

1) Enhanced safety

Essential action - Safety in maternity units across England must be strengthened by increasing partnerships between Trusts and within local networks. Neighbouring Trusts must work collaboratively to ensure that local investigations into Serious Incidents (SIs) have regional and Local Maternity System (LMS) oversight.

2) Listening to women and families

Essential action - Maternity services must ensure that women and their families are listened to with their voices heard.

3) Staff training and working together

Essential action - Staff who work together must train together.

4) Managing complex pregnancy

Essential action - There must be robust pathways in place for managing women with complex pregnancies Through the development of links with the tertiary level Maternal Medicine Centre there must be agreement reached on the criteria for those cases to be discussed and /or referred to a maternal medicine specialist centre.

5) Risk assessment throughout pregnancy

Essential action - Staff must ensure that women undergo a risk assessment at each contact throughout the pregnancy pathway,

6) Monitoring fetal wellbeing

Essential action - All maternity services must appoint a dedicated Lead Midwife and Lead Obstetrician both with demonstrated expertise to focus on and champion best practice in fetal monitoring.

7) Informed consent

Essential action - All Trusts must ensure women have ready access to accurate information to enable their informed choice of intended place of birth and mode of birth, including maternal choice for caesarean delivery.

Further reading

Reflections on the initial findings of the Ockenden Review

Ockenden review of maternity services – Update on urgent action (11 January 2021)

Midwifery Continuity of Carer: What does good look like?

• These recommendations fell under the following themes:
• Involvement of carers
• Support for carers
• Access to crisis/out of hours services
• Suicide and self-harm
• Engagement /Did not attend/discharge
• Care plans / Care Programme Approach /crisis plans
• Risk assessments 
• Dual diagnosis
• Serious incident investigations
• Complaints process 
• Involvement of patients
• Adult Mental Health services (secondary care)
• Shared Learning
• Training.

Follow the link below to access the full report, by Nigel Pascoe QC.

• They have improved the way clinical information is shared between different specialist teams, to make sure staff have as comprehensive a picture as possible when making complex decisions about a patient’s treatment. 
• They now use a single log-in electronic patient record system which means staff can quickly access clinical information about a patient and have the right information at the right time, rather than routinely having to use multiple systems.
• They have improved consultant availability. This means there is more consultant time for each patient being looked after in our paediatric intensive care unit.
• They have introduced a new process to make sure the care of patients, like Amy, who have both complex spinal and heart conditions is routinely considered by the hospital’s specialist joint cardiology committee.

• Many investigations were of poor quality and took too long to complete.
• There was a lack of leadership, focus and sufficient time spent in the Trust on carefully reporting and investigating deaths.
• There was a lack of family involvement in investigations after a death.
• Opportunities for the Trust to learn and improve were missed.

Of the 1,454 deaths recorded at the Trust during this period, 722 were categorised as unexpected by the Trust. Of these 540 were reviewed and 272 unexpected deaths received a significant investigation. 

• a serious incident flow chart
• a non serious incident flow chart
• 10 steps on how to conduct a serious incident investigation.