Specific evidence needed

Has the recommendation been implemented? Or (in the case of a

recommendation whose deadline has not yet been reached) Is the

recommendation on track to be implemented?

Data from national scrutiny of perinatal and maternity deaths:

PMRT compliance as evidenced by MIS year 4 Safety action 1 compliance attached at appendix 1

Member of LMNS Safety team attends provider Trusts PMRT reviews   acting as external reviewer.

The Perinatal Quality Surveillance model (PQSM) national guidance document set out key principles with actions for immediate effect (Implementing a revised perinatal quality surveillance model, Dec 2020). There is a SNEE LMNS PQSM SOP to support local processes. More information attached at appendix 2.

HSIB reports and LMNS dashboard collects HSIB referral data 

LMNS dashboard data includes perinatal and maternal deaths data discussed monthly at safety forum and exceptions to LMNS Strategic board

PSERP and PSII and PSR investigations discussed monthly

Examples of independent scrutiny of perinatal deaths and maternal deaths and its application at local, regional, and national levels.

Processes within Maternity system for scrutinising perinatal and maternal deaths include

• Coroner referrals
• Post-mortems offered 

• Placental histology offered for stillbirths/perinatal deaths

Maternal and perinatal deaths meeting the referral criteria of MNSI (Maternity and Newborn Safety Investigations), a fully independent arm's length body of DH formerly known as HSIB (Healthcare Safety Investigation Branch) are referred to MNSI by provider Trusts. Accepted cases are scrutinised independently through MNSI investigation.  Safety recommendations are provided to Trusts following investigation and reports also shared to the ICB. The referral criteria for MNSI is:

• Early neonatal deaths
• Intrapartum stillbirths
• Severe brain injuries in babies born at term following labour
• Maternal deaths

HSIB reports -shared with ICB Safety Lead, oversight at safety forum.

HSIB thematic review presented at safety forum

SNEE ICB Child Death Overview Panel present cases, identify learning and actions. Member of maternity safety team attends. Reports shared at safety forum and learning/actions discussed.

SNEE ICB Serious incidents and Never Event Panel meet monthly and attended by LMNS safety team. Acts as a point of assurance, peer review and review of action planning. Terms of reference attached at appendix 3.

Reciprocal arrangement for external review is provided by buddy LMNS Mid Essex attached at appendix 4.

Evidence of adoption and quality of review:

Perinatal Mortality Review Tool (PMRT) introduced as part of the PMRT programme by NPEU to support the standardised perinatal reviews across NHS maternity and neonatal units in the UK. The tool has been implemented by Trust Providers and the LMNS safety team attend PMRT reviews to act as external reviewers. 

LMNS scrutiny of PMRT compliance is in line with MIS requirement.

The Patient Safety Incident Response Framework Aug 2022 (PSIRF) sets out the NHS’ approach developing and maintaining effective systems and processes for responding to patient safety incidents for the purpose of learning and improving patient safety. SNEE LMNS have implemented this framework as PSIRF early adopters.

National reporting to MBRRACE UK- perinatal and maternal mortality surveillance reporting requirements for all Provider Trusts. Reporting criteria includes:

All deaths of pregnant women up to one year post -natal

Perinatal and infant deaths including late fetal losses, stillbirths, early neonatal deaths, late neonatal deaths.

Ockenden immediate and essential actions being implemented by Trust providers in line with for key pillars:

• LMNS Safe staffing levels
• A well -trained workforce
• Learning from incidents
• Listening to families

LMNS has scrutiny of Provider Trusts compliance with Ockenden immediate essential action at safety forum and LMNS Strategic Group.

60 steps to safety assurance visits at each maternity unit undertaken by LMNS, regional chief midwife, regional maternity quality lead, Trust MIA’s in partnership with senior maternity leaders. Staff and service user input is gained.

Progress following the consultation on coronial investigations of stillbirths in 2019

We are unaware of any processes regarding the consultation on coronial investigations of stillbirths in 2019

Progress of the statutory medical examiner scheme and its application to perinatal and maternal deaths.

SNEE ICB holds regular system meetings with Medical Examiners for oversight of the medical examiner scheme across Suffolk and Northeast Essex. This includes MEO updates from all our acute hospitals. In addition, SNEE ICB is in process of establishing a trauma informed mortality review group to bring together learning from deaths within our ICS. This will include maternity services and maternal deaths and is due to commence in early 2024.

More information attached at Appendix 2

Perinatal and maternal mortality surveillance data post 2021. 

LMNS dashboard contains the national and local mortality data, scrutinised monthly both locally and regionally. Scrutiny of data at safety forum and shared learning and case reviews at Regional shared learning events.

Are there any mitigating factors or conflicting policy decisions that may have led to the recommendation not being implemented or not being on track to be implemented? How significant are these? Was appropriate action taken to account for any mitigating factors?

The processes as above (coroner referrals, post-mortem offers, placental histology, MNSI referrals, PMRT, Ockenden IEA, across LMNS’s reciprocal agreement, PQSM, PSIRF framework, MBRRACE national reporting) are all implemented. This does not mean that all deaths are independently reviewed.

There is a limitation regarding compliance with placental histology guidance (Tissue pathway for histopathological examination of the placenta, The Royal College of Pathologists Oct 2019) due to shortage of specialist trained pathologists nationally. This was added to the SNEE LMNS risk register, however following further discussion due to the cause being a lack of specially trained pathologists nationally, the risk has been categorised as an accepted risk. Local mitigation is in place:  whereby cases are triaged in line with appendix C of the guidance and local clinician agreement and those of greatest priority e.g., stillbirths are prioritised for trained specialist pathologist placental histology. Other cases where placental histology is indicated may currently not receive this as due to limited resource mortality cases are prioritised in line with the imperative to scrutinise perinatal deaths. 

To what extent has the NHS’s Covid-19 response affected progress on implementing the recommendation?

HSIB (now known as MNSI) reduced what they investigated during the COVID pandemic. During this period (from March 2020) they no longer routinely investigated maternity events involving cooled babies where there is no apparent neurological injury confirmed following therapy.

Due to the prioritisation of clinical work due to staffing pressures during the Covid-19 pandemic, work undertaken by the Trust governance teams may have been impacted, possibly resulting in less timely investigation during that unprecedented period.

During this time SNEE LMNS benchmarked against the national Four Actions document, co-producing an operational policy for how they will manage the risks of COVID-19 for pregnant women from a BAME background and implemented this to support at-risk pregnant women
.

How has this recommendation been interpreted in practice at trust/patient level?

This recommendation has been interpreted and implemented as per national Ockenden, PQSM, MNSI, PMRT and PSIRF guidance and in line with the CNST Maternity incentive scheme.

At Trust and ICS Level– both local Provider Trusts have implemented the PSIRF framework and share PSII reports with their Trust boards and the ICB Safety Lead in line with their PSIRF plan and Ockenden and PQSM recommendations. 

A monthly PSIRF report from each Trust is presented at the monthly LMNS Safety Forum attended by members across the LMNS and the ICB Safety lead. A summary of PSIRF escalations are then included in the LMNS Safety & Performance report which is shared monthly to LMNS Strategic group. Further escalations are to the ICB Safety oversight assurance committee. 

A reciprocal agreement in line with Ockenden and PQSM is in place across the LMNS and neighbouring LMNS for external review of non MNSI cases.

A SNEE LMNS PQSM SOP supports the processes of intelligence sharing, identification and escalation of concerns. It provides a detailed guide of the LMNS wide processes to meet the governance and assurance requirements following scrutiny of shared intelligence. It includes how intelligence, learning and escalations take place from within maternity provider services to Trusts boards and to the LMNS/ ICB via safety forum, strategic group and Safety oversight assurance committee (SOAC) and onwards to regional and national quality and safety teams. The SOP is reviewed annually with a 6 monthly review of PQSM evidence across the LMNS.

Thematic findings and learning from reviews are shared with the MDT at LMNS Safety Forum and to all maternity staff within Provider Trusts via Maternity newsletters, audit and training days. The LMNS organised a shared learning event across x2 LMNS to share learning from investigations and plans to repeat these 6 monthlies.

At Provider level Trust identify cases that require referral to HSIB and cases that require PMRT review. PMRT at birth Trusts is attended by a LMNS Safety team member for external review purposes. Compliance with PMRT reporting is measured for the Maternity Incentive scheme which the LMNS Safety team provide scrutiny for.

Pregnant people are invited to participate in PSII investigations and patient feedback also sought as part of PMRT process. Following investigation, pregnant people are offered sharing of the report and/or face to face feedback of the investigation, and a supportive/bereavement appointment such as Teardrop.  

Does data show achievement against implementing the recommendation (if applicable)?

The following data sources demonstrate achievement against the recommendation:

HSIB data demonstrates the number of HSIB referrals. 

SNEE compliance with Safety Action 1 for MIS year 4 demonstrates PMRT compliance 

Have there been any important developments since the recommendation was made or accepted that affect its implementation? For example, has the implementation of the recommendation been superseded, and if so, has the superseding recommendation been implemented?

As detailed above, since the publication of this recommendation there have been several national and local developments in the way in which stillbirths, neonatal death and maternal deaths are investigated, either within a Trust or by an external agency. 

In 2018, the maternity investigation programme was established as part of the Healthcare Safety Investigation Branch (HSIB). Known as the MNSI since October 2023, they undertake independent investigations in the following circumstances:

• Direct or indirect maternal deaths of women while pregnant or within 42 days of the end of pregnancy.

Babies born following labour after 37 weeks and where the outcome is:

• A baby dies during labour and before birth (intrapartum stillbirth).
• A baby born alive and dies in the first week (0-6 days) of life (early neonatal death).
• A baby born with a potential severe brain injury diagnosed as occurring in the first 7 days of life.

Where the death of a baby (stillbirth or neonatal) does not meet the above criteria, the investigation is led by the Trust at which the mortality occurred. Since 2018, the process of reviewing mortality in maternity has been via the Perinatal Mortality Review Tool. The tool integrates within the MBRRACE-UK programme of work and is designed to facilitate a standardised and thorough mortality review. These reviews are considered by an MDT panel, which should also include an external reviewer. The SNEE LMNS safety team members regularly attend PMRT meetings in both our Provider Trusts, and the two Provider Trusts within SNEE have also offered to be external reviewers for each other when an independent opinion is required. SNEE have also partnered with neighbouring LMNS of Mid and South Essex to have a reciprocal review process which facilitates external review from outside the LMNS when required, as has been already outlined above. This also aligns with the Ockenden (2020) recommendations – Essential action 1 – relating to neighbouring Trust working collaboratively with LMNS oversight. 

Has there been specific and adequate funding to enable the recommendation to be implemented?

Has there been a positive impact on patients and people in receipt of social care as a result of the recommendation being implemented?

Were specific funding arrangements made to support the implementation of the recommendation? If not, why? If so, what were these, when and where were they made?

Funding for perinatal safety is allocated from several sources:

1. ICB funding for Maternity & Neonatal Services – The ICB commissions both Acute Trusts on a Guaranteed Income Contract which is mutually agreed upon, to fund the Trusts to deliver safe and effective services. The annual value for the maternity element is approximately £46.5 million per annum.

2. NHSE allocated maternity and neonatal transformation funds are received on an annual non-recurring Service Development Fund (SDF), to support the implementation of National transformation priorities and guidance such as the Three-Year Delivery Plan. SNEE ICB received approximately £420k in 2023/24 to ensure that the LMNS team were able to provide leadership and assurance of safe services, transform services, address inequalities, and ensure coproduction is embedded within the LMNS via MNVP’s. SNEE LMNS attribute approx. 55% of this funding to a 1 wte Senior Clinical Lead Midwife, a 0.6 wte Safety & Assurance Lead, a 0.8 wte Safety & Assurance Manager, and 1 wte Neonatal Quality Improvement Lead who all have a role in scrutinising clinical outcomes, leading the LMNS Safety Forum, participating in PMRT reviews/Child Death Oversight Panels/Clinical incident reviews etc...and raising areas of concern to the LMNS Strategic Group, ICB Safety Lead, and NHSE Regional team as per the PQSM.

3. Additional funds were received from NHSE for the implementation of the Immediate and Essential Ockenden Inquiry recommendations. In 2022/23, £1,378,000 funding was provided to the SNEE system, and this has continued to be funded in 23/24. An additional £376,203 was awarded in 2023/24 for Bereavement, Retention MW, MSSW competencies, preceptorship standards & Obstetric Leadership Capacity. 

What factors were considered when funding arrangements were being determined?

The ICB and Acute Trusts work collaboratively to agree the value of the Guaranteed Income Contract, ensuring all National guidance and the implications are considered when agreeing it. The ICB Board approve the value, which includes scrutiny from senior Clinical leaders from across the system. 

The LMNS capacity for safety and perinatal mortality scrutiny was based upon the PQSM requirements and the National Maternity Capability and Capacity tool.

The NHSE Ockenden funding was allocated from central NHSE. Initially the LMNS and Trusts were required to report clinical and leadership staffing numbers and MDT training capacity in relation to the immediate actions outlined within the Ockenden enquiry. Central NHSE used this information from all LMNS within the UK to allocate appropriate funding levels. 

Do healthcare stakeholders view the funding as sufficient?

The investment of £1.6 million to maternity services within SNEE was seen as significant and made an impact on funding the new roles and capacity required at the time. The LMNS system is aware that demand and acuity continually changes and would therefore request that the funding levels be reviewed on a regular basis to ensure they are appropriate for the need. 

In 22/23 the National Maternity transformation team suggested what a LMNS team structure would include and therefore how the financial allocation was calculated. This team structure did not include safety team members. SNEE assumed that the national team believed this to be provided within the main ICB safety & quality team structure. This was not the case in SNEE and therefore the LMNS apportioned half of its budget to clinical leadership and safety due to the priority of this function. Given the ICB running cost reduction programme for 23/24 - 24/25 LMNS allocations are likely to require inflation to accommodate safety roles which may no longer be present within ICB structures. SNEE LMNS will continue to need to prioritise safety over other maternity & neonatal transformation projects.

Was any financial commitment a ‘new’ resource stream? If not, did reallocation of funds result in any unforeseen consequences/ undesirable ‘work arounds’ at local level?

1. Guaranteed Income Contract is recurring funding, with growth agreed each year

2. LMNS allocations are provided each annum as most of the funding is non recurrent

3. When initially provided, Ockenden funding was stated to be for two years, confirmation has not yet been received whether this funding will therefore recur in 24/25

What factors were considered when funding arrangements were being determined?

See above

Has (or will) there been (or be) a meaningful improvement in measurable outcomes, reasonably attributable to the implementation of the recommendation?

No. Due to relatively small numbers, there is fluctuation in the data each year. However, SNEE LMNS are not on trajectory to meet the national safety ambition of a 50% reduction in stillbirths, neonatal deaths, neonatal brain injuries and maternal deaths by 2025. 

Will (or have) service users benefit(ted) directly, indirectly or both?

There is now greater patient involvement in investigative processes and reviews including PMRT, HSIB and PSIRF and this will have benefitted service users in terms of feeling listened to and being able to contribute to the learning response. Being kept informed throughout an investigation is also valued by service users as thorough investigative processes take time, especially where post-mortem results are required, or external agencies are involved.  

Specifically, alongside the PSIRF guidance, there is national guidance detailing how Trusts can engage compassionately with service users after a patient safety incident (Patient Safety Incident Response Framework supporting guidance Engaging and involving patients, families and staff following a patient safety incident, August 2022). Likewise, the PMRT process offers families the opportunity to ask questions or provide information about their care for the review panel to consider during their review, and following PMRT, women are offered a consultant appointment to discuss the findings of the review as well as post-mortem findings if a post-mortem has been undertaken. The CNST MIS Year 5 requirement is for parents’ perspectives of care to be sought and parents given the opportunity to raise questions in at least 95% of cases. By detailing this within Safety Action 1, this enables Trust board and LMNS oversight to ensure that this is taking place. For those families whose cases are referred to and investigated by MNSI, or formerly HSIB, they are also asked to participate in the review and share their experiences, having a dedicated point of contact throughout the course of their review.

A Senior Independent Advocate role is commencing in Q4 2023/24 who will work with individual families where adverse outcomes have been experienced. They will be supported through a case review and facilitates discussion with the trust about the circumstances surrounding the clinical outcome. The advocate will be bringing service user voices and experiences to the LMNS safety forum, Trust Safety Committees/Boards and Strategic Group.

What category of service users have benefitted? And why?

Women, birthing people and families may feel that they have been listened to and their questions have been answered.

Have (some) service users been hindered by the recommendation being implemented?

We have no evidence that this is the case.

Was (or is) the recommendation likely to achieve meaningful improvement for service users, healthcare staff and/or the healthcare system as a whole?

Yes, women, birthing people and families are more involved in the process. This means that staff have the opportunity to hear direct lived experience, ensuring the learning is kept local and powerful. Service user feedback is gathered via LMNS co-production lead and fed back via the LMNS strategic group where stakeholders can benefit.

When PMRT reviews identify themes such as ethnicity or lack of cultural awareness  there are plans to include service users and VCFSE leaders in thematic reviews, improving the cultural and religious knowledge and looking beyond clinical outcomes.

Was the Government’s interpretation and implementation of the recommendation appropriate?

Has the implementation of the recommendation had any unintended consequences?

We have no evidence that this is the case.

Was the level of ambition as expressed by the implementation of the recommendation reasonable, or has it been surpassed by developments since?

The recommendation was reasonable and has resulted in further measures being implemented. The developments as described above are likely a consequence of the original recommendations. 

How has working to implement the recommendation affected other aspects of care?

Implementing the recommendations has led to enhanced learning from mortality reviews, which in turn has led to appropriate improvement action plans. It has been challenging when the maternity workforce has faced a significant shortage of staff. Resources required to benchmark, review and implement recommendations are significant. 

Did the system have the relevant tools to support the change?

PMRT process is supported by a national tool.

MNSI processes are supported by national guidance.

PSIRF has been supported by national guidance but thus far lacks maternity specific guidance although it is expected early in 2024. 

Ockenden and PQSM guidance supports the need for sharing of investigations to Trust and LMNS boards, and the importance of sharing and escalating intelligence, the important roles of non- executive directors and safety champions in improving independent oversight of maternity services. PQSM guidance also provides a framework for the sharing of safety intelligence including mortality data, concerns and learning to Trust and ICB boards.