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Two-thirds of women at the heart of a review into maternity services at a Welsh health board could have had very different outcomes if they had received better care, a report has found. The Independent Maternity Services Oversight Panel (Imsop) focused on the experiences of pregnant women at Cwm Taf Morgannwg health board. Its maternity services have been in special measures since "serious failings" were found two years ago. Concerns emerged in late 2018 that women and babies may have come to harm because of staff shortages and failures to report serious incidents. This sparked a major independent review, which gave a damning verdict on maternity services in Cwm Taf Morgannwg health board. Published on Monday, the Imsop report focuses on the care of mothers between January 2016 and September 2018. It found that 19 reviews of maternal care (68%) revealed at least one factor where "different management would reasonably have been expected to alter the outcome". The panel's chairman, Mick Giannasi, said: "These findings will be concerning and potentially distressing for the women and families involved, and it will be difficult for staff." "Of the 28 episodes of care, we concluded that in 27 of them, our independent teams who reviewed the care would have done something differently. Put simply, what went wrong, might not have gone wrong if things had been done differently." Read full story Source: BBC News, 25 January 2021

Hundreds of senior midwives are to be given new training to help improve culture and leadership across 126 NHS trusts. Patient safety minister Nadine Dorries said a new £500,000 maternity leadership programme would be rolled out later this year aimed at giving senior staff running maternity wards the skills and knowledge they need to boost culture and safety. Its one step towards improving the working relationships between midwives and obstetricians and follows the damning report by the Ockenden inquiry into decades of poor care at Shrewsbury and Telford Hospitals Trust. The report, published last month, highlighted leadership on maternity wards as a key factor in cases at the trust which led to preventable baby deaths and cases of neglect over many years. Announcing the fund, Nadine Dorries said: “The shocking and tragic findings of the Ockenden Review highlighted the importance of strengthening maternity leadership and oversight as well as fostering more collaborative approaches within maternity and neonatal services. “I’m pleased to announce a new training programme for NHS maternity leaders, which will empower nurses, midwives and obstetricians to get the best out of their teams, and deliver safe, world-class care to mothers and their babies.” Read full story Source: The Independent, 12 January 2021 Government press release

Some trusts in London and the South East are closing standalone birth centres and warning they cannot support home births because of high levels of demand for ambulance services from covid patients. Women in East Sussex who planned to give birth at Eastbourne District General Hospital and Crowborough Birth Centre have been told they need to go to other units. Both Eastbourne and Crowborough have standalone midwife-led units and women who have a difficult labour would need to be transferred by ambulance to another hospital. Both East Sussex Healthcare Trust and Maidstone and Tunbridge Wells Trust, which run the services, cited pressure on the ambulance services as the reason for the closures. The trusts, both of which are served by South East Coast Ambulance Service Foundation Trust, have also suspended support for home births. Services are continuing at a similar birthing unit at Maidstone Hospital, with private ambulances transferring women to Tunbridge Wells Hospital if needed. However, Maidstone and Tunbridge Wells Trust has posted on Facebook to warn women the situation may change and it is monitoring ambulance response times to determine “the safety of our out of hospital birthing choices”. Read full story (paywalled) Source: HSJ, 6 January 2021

In a Letter to the Editor published in The Times yesterday, the All Party Parliamentary Group on First Do No Harm Co-Chair Baroness Julia Cumberlege argues in favour of the work of the Independent Medicines and Medical Devices Safety (IMMDS) Review and its report 'First Do No Harm'. "Inquiries are only as good as the change for the better that results from their work." Read full letter (paywalled) Source: The Times, 5 January 2021

People with allergies and pregnant women can now be given the country’s two approved COVID-19 vaccines, the medical regulator said on Wednesday. Previous advice from the Medicines and Healthcare products Regulatory Agency (MHRA) said people with a range of allergies to food and medicines should not be given the Pfizer vaccine. Dr June Raine, the MHRA’s chief executive, said growing evidence from a pool of at least 800,000 people in the UK and around 1.5 million people in the US who have had the vaccine has "raised no additional concerns". This, she continued, "gives us further assurance that the risk of anaphylaxis can be managed through standard clinical guidance and an observation period following vaccination of at least 15 minutes. Read full story Source: The Independent, 30 December 2020

A new training aid, developed in Fife, is helping to equip trainee medical staff from around the world with the skills to prevent late miscarriage and premature labour. It was invented by Dr Graham Tydeman, consultant in obstetrics and gynaecology at Kirkcaldy’s Victoria Hospital, in conjunction with the St Thomas’ Hospital, London, and Limbs and Things. The lifelike simulator allows trainees to perform hands on cervical cerclage in advance of a real-life emergency. The procedure involves an emergency stitching around the cervix and is necessary when the cervix shortens or opens too early during pregnancy, helping to prevent late miscarriage or extreme premature labour. It is not a common event and the simulator was developed by Dr Tydeman following a request from medical trainees across the UK. The device has already been warmly received by hospitals and training institutions across the world – with orders from countries including New Zealand and India. Dr Tydeman said: “The reason this was developed is that it is not a common procedure and is very difficult to teach trainees." “Increasingly women are understandably asking about the experience of their surgeon and anyone having this procedure understandably does not want it to be the first one that a doctor has ever done because if it goes wrong there could be tragic consequences with loss of the baby. However, if a trainee has shown suitable skills using this simulator, I would be able to confidently reassure women that the doctor had been adequately trained, although a more experienced person would always help during the actual operation for the first few procedures on real women." Read full story Source: The Courier, 19 December 2020

All NHS trusts in England have been given a deadline of Monday to enact safety improvements in maternity care amid Shropshire's baby deaths scandal. Heath chiefs have told hospitals they must have the 12 "urgent clinical priorities" in place by 17:00 GMT. The move is to address "too much variation" in outcomes for families. It comes during a probe into the maternity care of more than 1,800 families in Shropshire. The inquiry, launched amid concerns of repeated failings at Shrewsbury and Telford Hospital NHS Trust (SaTH), focuses on the experience of 1,862 in total, and includes instances of infant fatality. An interim report published last week found poor care over nearly two decades had harmed dozens of women and their babies. The report called for seven "essential actions" to be implemented at maternity units across England. But that has since been transformed into 12 clinical tasks, including giving women with complex pregnancies a named consultant, ensuring regular training of fetal heart rate monitoring, and developing a proper process to gather the views of families. The directions are revealed in a letter in which NHS England says there is "too much variation in experience and outcomes for women and their families". Read full story Source: BBC News, 15 December 2020

Patient Safety Learning Press Release 10th December 2020 Today the Independent review of maternity services at Shrewsbury and Telford Hospital NHS Trust published its first report on its findings.[1] The report made recommendations for actions to be implemented by the Trust and “immediate and essential actions” for both the Trust and the wider NHS. The Review was formally commissioned in 2017 to assess “the quality of investigations relating to new-born, infant and maternal harm at The Shrewsbury and Telford Hospital NHS Trust”.[2] Initially it was focused on 23 cases but has been significantly expanded as families have subsequently contacted the review team with their concerns about maternity care and treatment at the Trust. The total number of families to be included in the final report is 1,862. These initial findings are drawn from 250 cases reviewed to date. This is another shocking report into avoidable harm. We welcome the publication of these interim findings and the sharing of early actions that have been identified to make improvements to patient safety in NHS maternity services. We commend the ambition for immediate responses and action. Reflecting on the report, there are a number of broad patient safety themes, many of which have been made time and time again in other reports and inquiries. A failure to listen to patients 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/

Strong leadership, challenging poor workplace culture, and ringfencing maternity funding are key to improving safety. That’s the message from two leading Royal Colleges as they respond to the independent review of maternity services at Shrewsbury and Telford NHS Trust led by Donna Ockenden. The RCOG and the Royal College of Midwives (RCM) have today welcomed the Ockenden Review and its recognition of the need to challenge poor working relationships, improve funding and access to multidisciplinary training and crucially to listen to women and their families to improve learning and to ensure tragedies such as those that have happened at Shrewsbury and Telford NHS Trust never occur again. The Colleges have said that the local actions for learning and the immediate and essential actions laid out in this report must be read and acted upon immediately in all Trusts and Health Boards delivering maternity services across the UK. Commenting, Dr Edward Morris, President of the Royal College of Obstetricians and Gynaecologists, said: “This report makes difficult reading for all of us working in maternity services and should be a watershed moment for the system. Reducing risk needs a holistic approach that targets the specific challenges of fetal monitoring interpretation and strengthens organisational functioning, culture and behaviour." Read press release Source: RCOG, 10 December 2020

Health chiefs are designing an “early warning” system to detect and prevent future maternity care scandals before they happen, a health minister has said. Patient safety minister Nadine Dorries said she hoped the system would highlight hospitals and maternity units where mistakes were being made earlier. The former nurse also revealed the Department of Health and Social Care was drawing up a plan for a joint national curriculum for both midwives and obstetricians to make sure they had the skills to look after women safely. During a Parliamentary debate following the publication of a report into the Shrewsbury and Telford Hospital care scandal, the minister was challenged by MPs to take action to prevent future scandals. The former health secretary, Jeremy Hunt, warned the failings at the Shropshire trust, where dozens of babies died or were left with permanent brain damage, could be repeated elsewhere. He said: “The biggest mistake in interpreting this report would be to think that what happened at Shrewsbury and Telford is a one-off — it may well not be, and we mustn't assume that it is.” Ms Dorries said: “Every woman should own her birth plan, be in control of what is happening to her during her delivery and I really hope ... this report is fundamental in how it's going to reform the maternity services across the UK going forward. Read full story Source: The Independent, 11 December 2020

A new mother has spoken of her distress after wrongly-imposed Covid rules led to her being separated from her six-week-old baby for almost a week while she received treatment in hospital. Charlotte Jones, 29, was taken to Princess Royal University hospital in Kent by ambulance last Wednesday, after complications following the birth of her son, Leo. When she arrived, she asked whether she would be able to see her baby, whom she is breastfeeding, while in hospital, but was told it would not be allowed because of the threat of coronavirus. She did not see him until her release six days later. The restrictions as applied in Jones’s case, appear to contravene official guidance and go against the advice of NHS England, which specifies that mothers and babies should be kept together unless it is absolutely necessary to separate them. Separation at such a critical time can have an adverse impact on the physical and mental health of the mother, baby and wider family, say healthcare professionals and charities. King’s College NHS foundation trust, which manages the hospital, has admitted that although it is limiting the number of visitors during the pandemic, there is no policy stopping babies to be brought in to be breastfed. The trust has pledged to ensure staff are aware of its policies. Read full story Source: The Guardian, 4 December 2020

The Care Quality Commission (CQC) has raised serious concerns about a major teaching trust’s maternity services and taken action to prevent patients coming to harm. The watchdog has imposed conditions on the registration of Nottingham University Hospitals Trust’s maternity and midwifery services at Nottingham City Hospital and Queen’s Medical Centre and rated them “inadequate”. Following an inspection in October, the CQC identified several serious concerns, including leaders lacking the skills to effectively head up the service, a lack of an open culture where staff could raise concerns, and staff failing to complete patient risk assessments or identify women at risk of deterioration. In its findings, the CQC reported how “fragile” staff wanted to escalate their concerns directly to the regulator, particularly around the leadership’s response to the “verbal outcome of the inspection”. The regulator called this “further evidence of the deep-rooted cultural problems” and escalated these concerns directly to trust CEO Tracy Taylor, who would be “personally overseeing the improvement process required”. Inspectors also found the service did not have enough staff with the right skills, qualifications and experience to “keep women safe from avoidable harm”. The CQC also issued the trust a warning notice over concerns around documenting risk assessments and IT systems. The trust has three months to make improvements. Read full story (paywalled) Source: HSJ, 2 December 2020

The safety of maternity services at a major north London hospital has been criticised by the care watchdog after an inspection prompted by the death of a woman. The Care Quality Commission (CQC) has issued the Royal Free Hospital, in Hampstead with a warning notice after inspectors identified serious safety failings in its maternity unit. An unannounced inspection of the hospital’s maternity service took place in October, following the death of Malyun Karama, in February this year. The 34-year-old died while giving birth to her stillborn baby. She suffered a ruptured uterus after being given an overdose of misoprostol to induce her labour. In a report following an inquest into her death Coroner Mary Hassell said: “Abnormal observations were relayed by a midwife to a senior registrar, but the doctor failed to attend Ms Karama and instead ordered fluids. The uterine rupture would have been life threatening whatever the care rendered to Ms Karama, but if the doctor had attended immediately and had reviewed and treated appropriately, the likelihood is that Ms Karama’s life would have been saved.” The CQC has yet to publish a full report on its inspection of the hospital but confirmed it had taken enforcement action and issued the trust with a warning notice. The concerns relate to the trust being too slow to investigate and make changes after incidents of harm. It’s understood a panel to investigate Ms Karama’s death did not meet until June this year. Read full story Source: The Independent, 1 December 2020