Learning from others
A collation of key reports and alerts on adverse events and patient safety issues in paediatrics and child health. Learning from what is going well in a system drives forward improvement (safety II), however it is still vital to investigate and learn when things go wrong.
If an inquest finds there is a risk of other deaths occurring in similar circumstances the Coroner has a legal power and duty to write a report which is known as a Preventing Future Deaths report or a ‘report under regulation 28’ because the power comes from regulation 28 of the Coroners (Inquests) Regulations 2013.
The report is sent to the people or organisations who are in a position to take action to reduce the risk. They then must reply within 56 days to say what action they plan to take.
These reports raises issues and concerns that may be more broadly applicable and offer an opportunity to identify and mitigate safety risks before an incident occurs at your healthcare trust. Here you will find a series of summaries of the Reports to Prevent future death with key themes pulled out and suggestions for healthcare focussed improvement initiatives.
Allison Aules: Report to Prevent Future Deaths
Manhareen Kaur: Report to Prevent Future Deaths
Rohan Godhania: Report to Prevent Future Deaths
Harry Richford: Report to Prevent Future Deaths
Bonnie Webster: Report to Prevent Future Deaths
Rita Hirani: Report to Prevent Future Deaths
Juanita Nti: Report to Prevent Future Deaths:
Louis Rogers: Report to Prevent Future Deaths
James Manning: Report to Prevent Future Deaths
Katie Wilkins: Report to Prevent Future Deaths
Funded by the Department of Health and Social Care and hosted by NHS England and NHS Improvement (now known as NHS Impact), the HSIB aims to improve patient safety through effective and independent investigations that don’t apportion blame or liability. The safety recommendations outlined within their reports seek to improve healthcare systems and processes in order to reduce risk and improve safety.
Here you will find a series of brief summaries of the HSIB reports relevant to paediatrics. Broad themes are highlighted along with some suggestions for local improvement initiatives specific to paediatrics to address some of the safety issues.
- HSIB: Detection of Jaundice in Newborn Babies
- HSIB: Provision of care for children and young people when accessing specialist gender dysphoria services
- HSIB: Recognition of the Acutely Unwell Infant
The HSIB welcome information about NHS patient safety concerns from all healthcare professionals working in the NHS – visit the HSIB website to find out more here.
HSSIB
In October 2023 HSIB will officially become the Health Services Safety Investigations Body (HSSIB). Now that the Health and Care Act 2022 has received Royal Assent it means HSIB will transform to become HSSIB, a fully independent non-departmental public body, commonly known as an arm’s length body (ALB), of the Department of Health & Social Care.
HSSIB will have increased powers including the power to seize assets and the power to compel people to speak with them
HSSIB will remain impartial and continue to investigate without apportioning blame, solely to learn with a goal of supporting patient safety improvement across the whole healthcare system in England.
The NHS Learn From Patient Safety Events service (LFPSE) is a new, central service for the recording and analysis of healthcare patient safety events. It replaces the current National Reporting and Learning System (NRLS) and Strategic Executive Information System (StEIS).
LFPSE will enable 2 things:
- Recording a patient safety event– organisations, staff and patients will be able to record the details of patient safety events, contributing to a national NHS-wide data source to support learning and improvement.
- Accessing data about recorded patient safety events – Providers can access data that has been submitted by their teams, in order to better understand their local recording practices and culture, and to support local safety improvement work.
Recording safety events provides vital insight into what can go wrong in healthcare and the reasons why. At a national level, this enables quick identifications of safety issues and improvements implemented to counter them on an NHS-wide scale. The LFPSE data can support ongoing national patient safety improvement programmes, as well as improvement work at a more local or speciality-specific level.
The LFPSE’s single NHS system for recording patient safety events will:
- make it easier for staff across all healthcare settings to record safety events, with automated uploads from local systems to save time and effort and introducing new tools for non-hospital care where reporting levels have historically been lower.
- collect information that is better suited to learning for improvement than what is currently gathered by existing systems.
- make data on safety events easier to access, to support local and specialty-specific improvement work.
- use new technology to support higher quality and more timely data, machine learning, and provide better feedback for staff and organisations.
LFPSE will make recording safety events easier in all care settings, including primary care with simple online forms, and a dedicated portal to access, review and update previously recorded incidents. This supports good incident response practice, by allowing smaller organisations to see all their safety events through one dashboard.
Please see the NHS England LFPSE webpage for full details
The NHS National Patient Safety Team have published their latest case studies on safety issues identified through the review of patient safety events recorded on a range of sources, including the NHS National Reporting Systems. The case studies show actions taken working with partners to support organisations and staff across the NHS to
address identified risks and protect patients from harm.
These case studies are shared with healthcare professionals to show staff the importance of recording patient safety events in helping to keep patients safe. Find out more about this work and how recording incidents also supports the development of National Patient Safety Alerts here.
Recent case studies in paediatrics:
- Delayed oxygenation of neonate during resuscitation when oxygen not ‘flicked’ on
- HIV prophylaxis in women and newborns
- Ensuring compatibility between defibrillators and associated defibrillator pads
- Risk of babies becoming unwell following move to virtual home midwifery visits
- Unintentional perforation of oesophagus in neonates from invasive procedures
- Chemical burn to a neonate from use of chlorhexidine
NCEPOD is a charity and limited company which is commissioned by the Healthcare Quality Improvement Partnership (HQIP) and the Health Foundation.
NCEPOD asks the question: “What standard does this service achieve?”
Currently practising clinicians review the management of patients through confidential surveys and appraisal of care provision & resources in the units carrying out the care. A report is produced in which comments and recommendations are made to suggest ways in which healthcare practice can be improved to the public benefit. Primarily, the organisation exists to alert clinicians and hospital management to practice which may not have been of the best quality and to recommend improvements. It does not audit individual clinician’s performance.
NCEPOD Common Themes reports describe the recurrent, common themes that have been identified throughout care reviews since 1989, with associated recommendations.
NCEPOD and Child health:
NCEPOD took over child health outcome reviews in 2014. They followed on from prior commissioned reports including:
CEMACH, 2008 ‘Why children Die’
RCPCH, 2013 ‘Overview of child deaths in the four UK countries; A retrospective epidemiological review of all-cause mortality’
Since 2014 the child health clinical outcomes review program have been conducted by NCEPOD. Please find links to succinct summaries below (or visit NCEPOD for the full reports)
Balancing the Pressures: Long Term Ventilation
Mental Healthcare in Young People and Young Adults
On the right course: Cancer care in children, teens and young adults
Each and Every need: Chronic Neurodisability.
Upcoming review include
- Transition
- Testicular Torsion
Getting It Right First Time (GIRFT) is a national health service review programme which aims to improve treatment and care. Specialities are reviewed through wide-ranging data analysis along with senior clinician input with the aim of describing what is currently happening and how things could be improved.
Working to the principle that a patient should expect to receive equally timely and effective investigations, treatment and outcomes wherever care is delivered irrespective of who delivers that care, GIRFT identifies approaches from across the NHS that improve outcomes and patient experience without the need for radical change or additional investment. Whilst the gains for each patient and procedure appear marginal they can when multiplied across an entire trust deliver substantial cumulative benefits.
The model consists of 4 key strands:
- Broad data gathering and analysis exercise generating a detailed picture of current national practice, outcomes and other related factors
- Data-based discussion between clinical specialists and hospital trusts examining individual trust behaviour and performance in the context of national data. This then enables the trust to understand where it is performing well and what it could do better
- A national report to identify opportunities for improvement across the relevant services
- Implementation phase where the GIRFT team supports providers to deliver the improvements.
To find out more see GIRFT
Paediatric focused reports include:
Serious Hazards of Transfusion (SHOT) is the UK’s independent, professionally-led haemovigilance scheme. Since 1996, SHOT has been collecting and analysing anonymised information on adverse events and reactions in blood transfusion from all healthcare organisations involved in the transfusion of blood and blood components in the UK.
Working collaboratively with the Medicines and Healthcare Products Regulatory Agency (MHRA), SHOT collects reports of serious adverse reactions and serious adverse events relating to transfusion of blood components and some blood products, identifying areas for improvement and providing recommendations for safer transfusion practices.
SHOT safety alert
Transfusion delays are preventable, and the urgent provision of blood components and/or blood products is vital for life threatening bleeding and severe anaemia. Serious harm related to delayed transfusion have been reported to SHOT with the number of incidents increasing each year.
A safety alert has been published by SHOT following review of delayed transfusions reported to SHOT between 2010-2020. This is the first alert to have been issued from SHOT, and details can be found on the MHRA Central Alerting System here.
SHOT resources
Three quarters of all incidents reported to SHOT are related to errors, and patient safety incidents and errors in transfusion can lead to fatal outcomes. Effective investigation of these incidents is essential to optimise learning and prevent further incidents occurring.
In 2021, SHOT incorporated and amended The Yorkshire Contributory Factors Framework into a Human Factors Investigation Tool (HFIT). This tool aims to optimise learning and address causes of patient safety incidents by supporting SHOT, clinicians, risk managers and patient safety officers to identify contributory factors that can help prevent future adverse incidents. Visit the Human Factors section on the SHOT website for more information and to download the HFIT Training Package.
More resources can also be found on the SHOT website, including the ‘SHOTcasts’ podcast series, ‘SHOT Bites’ information leaflets, educational videos and webinar recordings. Watch the ‘Paediatric SHOT’ video below, in which SHOT paediatric experts explain how paediatric haemovigilance reports differ from those in adults, and the key messages from the last 10 years of paediatric SHOT reporting:
There are lots of different organisations that hold safety information and previously they were independently issuing safety alerts and communications (e.g. MHRA, NHSE patient safety team). Alerts are mainly delivered via the Central Alerting System (CAS) which is a web-based cascading system for issuing patient safety alerts, important public health messages and other safety critical information and guidance to the NHS and others, including independent providers of health and social care.
However safety-critical information did not always stand out from other communications and the process for ensuring dissemination and action was not robust (see CQC’s Opening the door to change, 2018). So the NHS National Patient Safety Alerting Committee (NaPSAC) has been established and they now ensure a standardised method of alert generation through the NHS National patient safety alerting system. These alerts:
- Are only issued for safety-critical issues (risk of death or disability)
- Are concise with clear explanation of risk
- have had their required actions are assessed for feasibility, risk of unintended consequences, equalities impact, effectiveness, and cost-effectiveness
- have actions that are SMART (specific, measurable, achievable, realistic, and timely)
Alerts will be either:
- Complex: cannot be actioned by any single group in an organisation but needs an executive leader to coordinate response
- Straightforward: can be actioned by agreed specific senior leaders (e.g. chief pharmacists ensures that pharmacy stock recall occurs).
Now any organisation who wants to issue National Patient Safety Alerts need to be accredited by NaPSAC. The aim is to decrease the number of national alerts but increase the quality and impact. The actions indicated by the alert will be centrally coordinated with executive level oversight rather than fed out to multiple individual teams. Evidence that the required actions are completed is needed before recording ‘action completed’ on the CAS. Failure to take the actions required by any National Patient Safety Alert may lead to the Care Quality Commission (CQC) taking regulatory action in England
Each organisation has a CAS officer who is the person who receives the safety alert and takes responsibility for updating the CAS systems on the organisations progress in implementing an alerts required actions.
The following organisations are accredited to produce national patient safety alerts.
- NHS England national patient safety team
- Medicine and Healthcare products regulatory agency
- UK health security agency
- Office for health improvements and disparity
- NHS England screening quality assurance services
- NHS England commercial medicine unit and department of health and social care medicines supply team
- NHS England estates and facilities team.
Other safety alerts on CAS come from:
- Department of health ( including supply disruption & estates and facilities)
- National institute for health and clinical excellence
- NHS blood and transplant
- NHS digital
- NHS England
- NHS Estates
- NHS improvement
- SHOT
Read the alerts on the Central Alert System site
The Medicines and Healthcare products Regulatory Agency (MHRA) is part of the department of health and is responsible for the regulation of medicines, medical devices and blood components for transfusion in the UK.
MHRA responsibilities are to:
- ensure medicines, medical devices and blood components for transfusion meet applicable standards of safety, quality and efficacy
- secure safe supply chain
- promote international standardisation and harmonisation to assure the effectiveness and safety of biological medicines
- educate the public and healthcare professionals about the risks and benefits of medicines, medical devices and blood components, leading to safer and more effective use
- enable innovation and research and development
- collaborate with partners in the UK and internationally to support our mission to enable the earliest access to safe medicines and medical devices and to protect public health
In addition to the NaPSAC accredited alerts published through the Central Alerting system the MHRA publishes their own alerts when they are deemed less urgently safety-critical.
MHRA Drug Alerts were renamed in 2021. They now issue:
- National Patient safety alerts (previously class I)
- Medicines Recalls (previously Drug Alerts class 2-3)
- Medicines Notifications (previously Drug Alert: Caution in Use, Class 4).
MHRA Yellow Card Scheme
Patients or doctors can record medication issues with the MHRA that may require further investigation through the Yellow Card scheme. People report suspected side effects to medicines, vaccines, e-cigarettes, medical device incidents, defective or falsified (fake) products. The purpose of the Yellow Card scheme is to provide an early warning that the safety of a product may require more further investigation. Reports are used alongside other safety information and help the MHRA to take action if any trends associated to the safety or efficacy of a healthcare product are identified.
Case studies, relevant to paediatrics, highlighting the impact of yellow-card reporting are found here:
Gaviscon Infant and Constipation
The Francis Inquiry report was published on 6 .2. 2013 and examined the causes of the failings in care at Mid Staffordshire NHS Foundation Trust between 2005 and 2009. The report makes 290 recommendations, including:
- openness, transparency and candour throughout the health care system (including a statutory duty of candour)
- fundamental standards for health care providers
- improved support for compassionate caring and committed care and stronger health care leadership
Visit the King’s Fund for an interview with Sir Francis on this report
The Health Foundation summarise some of the steps taken by the government in response to this report
Don Berwick, founder of the Institute for Healthcare Improvement undertook a review into patient safety on behalf of the government following the publication of the Francis report into the breakdown of care at Mid Staffordshire hospitals. His recommendations for the NHS include
- embracing a culture of learning;
- placing quality at the top of priorities;
- making sure patients are present, powerful and involved;
- using quantitative targets with caution
- recognising that transparency is essential.
The UK government commissioned Dr Bill Kirkup to review of patient safety failings in maternity and neonatal care between 2009-2020 at East Kent Hospitals NHS Foundation Trust. The report was published 19.10.2022 and found that the outcome of 97 out of the 202 cases reviewed would have been different if nationally recognised standards were adhered to. Key action points have been summarised here by the Patient Safety Learning Hub
Ockenden Review & Final report 2022
The Ockenden report shares the findings of a inquiry into maternal and neonatal care at Shrewsbury and Telford NHS Trust. It started with 23 families and then grew to include 1486 families cared for between 2000 and 2019. The report contains a number of immediate and essential actions to improve care and safety in maternity services across England which are summarised here by the Patient Safety Learning hub