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Prioritising patient safety is a blog series from the Parliamentary and Health Service Ombudsman (PHSO). PHSO's strategy is built around three priorities: driving public service improvement, improving the user experience, and raising awareness and trust. You’ll see all three reflected in this edition which.  shares news of an exciting new partnership with two medical schools in the north-west, and what it means for the future of the clinician-patient relationship  provides an update on Andy’s case, which was first mentioned in the Winter blog, including the positive changes the Trust has made  shares a new case involving an avoidable death and the constructive way the Trust responded to the findings. 

This Parliamentary and Health Service Ombudsman (PHSO) short paper shares insights from senior leaders at NHS trusts across England on how they handle complaints, what complaints reveal and how they use that learning to make improvements.  It draws on conversations with NHS trust leaders and covers themes including:  leadership and complaints culture  rising complaint volumes and the patient-clinician relationship  defensive culture and its impact on behaviour  the role of regulation in supporting improvement  prioritising patient experience  digital transformation and patient-centred design.  The findings highlight good practice and persistent challenges, with a shared message that patient experience must remain central to improvement in care and patient safety across the NHS. 

Edition 13 of the After Action Review newsletter shares an example of a new application of the SEIPS tool. SEIPS was meant to help us review incidents. But what if it’s quietly changing how we think about safety every day? The use of the System Engineering Initiative in Patient Safety, mostly commonly known as SEIPS is now widely applied in the learning responses to healthcare incidents. What makes it really interesting is how it is now also working reduce risk proactively and influence how we think in healthcare.

This Health Services Safety Investigation Body (HSSIB) report examines patient safety in relation to electronic prescribing and medicines administration (ePMA). ePMA is software used to prescribe medication and create a record of the medication: that has been given, or due and not given to a patient. Most people admitted to hospital will receive medication, and most acute hospital trusts in England have ePMA functionality in at least part of their organisations. This report focuses on the procurement process used by acute hospital trusts to purchase new ePMA functionality and/or upgrade their existing ePMA functionality and how patient safety learning about ePMA is identified and shared across the healthcare system. It considers how legal, regulatory, standards and assurance functions apply in relation to ePMA safety. ePMA functionality has been shown to reduce some medication errors. However, the current national mechanisms (legislation, regulation, standards and assurance) for ensuring patient safety in relation to ePMA functionality may not adequately provide staff and healthcare organisations with the assurance that risk and hazard identification process are robust and/or share learning associated with the use of ePMA in an acute hospital setting. Findings There are no core national patient safety standards that inform either the design or procurement of ePMA. This can lead to unwarranted variation in functionality across and between ePMA, other electronic systems, and acute hospital trusts, which may pose challenges for staff when prescribing and administering medication. Current assurance mechanisms do not provide national oversight or enforcement of either manufacturer or healthcare provider compliance with legally mandated standards relating to digital clinical safety and interoperability of digital health technology. The safety risks associated with software such as ePMA are complex and may change rapidly. Legislation, regulation and standards may not keep up with the speed of technological change. Manufacturers must self-assess and report whether their ePMA is compliant with relevant standards for their products to be included on an NHS procurement framework. There is variation in the core safety standards identified by acute hospital trusts when procuring and contracting for ePMA functionality. This leads to trusts identifying safety requirements individually, with limited consistency in the approach taken across trusts. Reliance is placed on acute hospital trusts to determine whether ePMA manufacturers have interpreted the medical device regulations appropriately, and to assure themselves that the trust complies with relevant standards. Some trusts do not have the resources, skills and expertise to do this effectively. Digital safety and patient safety teams at local and national level may work in silos, with limited ability to share information or collaborate on ePMA-related decisions that impact on patient safety. There are challenges with identifying national safety learning relating to ePMA as this is not reliably captured, shared or identified through formal reporting routes. There is ongoing work to improve the NHS reporting system to capture digital-related patient safety incidents. There is a reliance on informal networks for sharing ePMA safety issues which means safety concerns may not always be shared with those who need to be aware. Some ePMA manufacturers, whose ePMA functionality is not registered as a medical device choose to apply equivalent governance and assurance measures as if it is a medical device. This is in addition to complying with the digital clinical safety standard (DCB0129). Acute hospital trusts face challenges prioritising and resourcing procurement decisions for ePMA functionality. This leads to challenges and patient safety issues when ePMA is implemented. Clinical safety officers (CSOs) may not be adequately resourced, meaning they have limited capacity to support in managing clinical risks associated with ePMA. There is variation in how the CSO responsibilities set out in the digital clinical standards are interpreted and implemented by trusts. NHS England is working on plans for a formal curriculum and potential accreditation to improve CSO skills and capabilities. HSSIB makes the following safety recommendations Safety recommendation R/2026/086: HSSIB recommends that the Medicines and Healthcare products Regulatory Agency ensures that: routes for manufacturers and healthcare organisations to engage with them are clear and accessible it reviews and provides further guidance and clarification on when electronic prescribing and medicines administration (ePMA) software should be considered a medical device. This will support how ePMA software can be appropriately classified and regulated to improve patient safety. Safety recommendation R/2026/087: HSSIB recommends that NHS England/Department of Health and Social Care establishes a national framework for core electronic prescribing and medicines administration (ePMA) safety. This will provide a clear set of minimum patient safety requirements, helping to reduce unwarranted variation in the safety of ePMA functionality. Safety recommendation R/2026/088: HSSIB recommends that NHS England/Department of Health and Social Care develops an external assurance framework for information standards notices relating to electronic prescribing and medicines administration (ePMA). This is to reduce unwarranted variation and improve patient safety through expert-led assurance processes. Safety recommendation R/2026/089: HSSIB recommends that NHS England/Department of Health and Social Care provides additional support to acute hospital trusts, in relation to: supporting healthcare providers to access digital clinical safety knowledge, capacity and capability integrating digital clinical safety and patient safety, including the associated terminology supporting robust assurance of whether electronic prescribing and medicines administration (ePMA) manufacturers comply with relevant standards in order to be considered for inclusion on an NHS procurement framework. This will support effective decision making and oversight by acute hospital trusts and reduce unwarranted variation in the understanding of, and approach to, adopting ePMA. Safety recommendation R/2026/090: HSSIB recommends that the Care Quality Commission reviews the sector-level assessment frameworks it is developing to include assurance of ongoing compliance with the digital clinical safety standard (DCB0160) for electronic prescribing and medicines administration (ePMA) software. This will help to ensure oversight of ePMA functionality to improve patient safety. HSSIB makes the following safety observations Safety observation O/2026/086: Commercial manufacturers can improve patient safety by applying the standards and expectations for a medical device when developing electronic prescribing and medicines administration (ePMA) functionality, to help provide further assurance to acute hospital trusts procuring or updating ePMA functionality. Safety observation O/2026/087: Commercial manufacturers and NHS organisations can improve patient safety by ensuring the sharing of safety learning about electronic prescribing and medicines administration (ePMA) functionality nationally via incident reporting systems and relevant safety forums. Safety observation O/2026/088: Commercial manufacturers and NHS organisations can improve patient safety by contributing to and engaging with ePRaSE (ePrescribing Risk and Safety Evaluation) processes to support ongoing improvement and optimisation of electronic prescribing and medicines administration (ePMA) functionality across the NHS.

The Health Services Safety Investigation Body (HSSIB) released a new briefing, in partnership with the NHS Race and Health Observatory (NHSRHO), to raise awareness and encourage positive change around bias and discrimination in patient safety investigations at all levels across the NHS. This briefing is informed by contributions from a national roundtable held in November 2025. This collaborative event brought together individuals with lived experience, patient advocates, clinicians and senior healthcare leaders. The briefing identified a series of recommendations, which include: embedding explicit consideration of racism within investigation standards improving expectations for family involvement strengthening leadership accountability for equity ensuring more consistent use of data to identify inequalities anti-racism to be a core component of patient safety investigations robust mechanisms to monitor implementation and impact.

This Health Services Safety Investigation Body (HSSIB) report is the second in a series considering the self-administration of insulin by people with diabetes mellitus (diabetes) in community settings. Many people with diabetes manage and administer their own insulin, either by injection or using a combined monitor/pump device (a hybrid closed loop system). However, a disability or impairment may affect their ability to safely manage their own insulin if they are not supported. This can lead to short-term and long-term health problems, which can be life threatening. HSSIB identified incidents where a person with diabetes or their family/carer had administered insulin incorrectly (the patient safety issue of focus). In these incidents, a disability – such as a visual or memory problem – had influenced how someone had administered insulin. The investigation explored the following areas in relation to the patient safety issue: supporting the development of people’s competency – that is, their skills, experience, knowledge and ability – to manage insulin recognising and responding when people’s circumstances change, such as deterioration in a disability assessment of people’s mental capacity to make decisions in relation to insulin. Findings People with diabetes (who require insulin) are at risk of harm through the administration of insulin when pre-existing or new disabilities/impairments have not been recognised or adjusted for. People are not always empowered to become competent to manage their insulin, with assumptions made that a person is not competent to do so because of a disability/impairment. Supporting people to safely self-manage their health, including insulin, requires integrated working across community services. Where this is limited, such as due to resource challenges or limited collaboration, people are put at risk. Efforts to empower and enable people to self-manage insulin are affected by the competing demands on, and the capacity and accessibility of the community services that provide this type of support. Designated and protected resource aimed at supporting the development of insulin self-management skills have shown benefits for patient experience and have reduced demand on community services. There is no national competency framework for the management of insulin by patients and families that supports community services to identify and make reasonable adjustments for a disability/impairment. Administration of insulin by staff in care homes (delegated administration) may reduce demand on community teams but is limited by barriers to implementation, including high turnover of care home staff. Some people with type 2 diabetes may be prescribed insulin without first optimising other diabetes treatments and/or exploring preferences. This means a person may be exposed to the risks of insulin unnecessarily. There are people with diabetes (who require insulin) whose circumstances mean they are not monitored for changes in a disability/impairment, including via long-term condition reviews in general practice. People may not engage with healthcare services to enable the regular monitoring of their condition. Engagement is affected by the ability of services to meet patient needs but may also represent other situations that require a response, such as in relation to patient safeguarding. Electronic systems in general practice may not alert users when people have not requested repeat prescriptions of insulin, removing a potential opportunity to identify patients who need support. Diabetes technology, such as insulin pen devices, are not always designed in a way that supports people to administer insulin when they have a disability/impairment, such as visual impairment or problems with dexterity. There are concerns about the future competence of the healthcare workforce to support the increasing numbers of people with hybrid closed loop systems. Healthcare workers may not identify when a patient’s mental capacity to make decisions in relation to their insulin may be compromised, meaning a more in-depth assessment in line with the Mental Capacity Act (2005) may not occur. Limited education and practical support for application of the Mental Capacity Act (2005) by healthcare staff means its principles are sometimes misunderstood. Patients with diabetes (who require insulin) and who experience fluctuations in their mental capacity, are at risk of harm when services do not proactively plan for a time when the patient may lose the ability to manage their insulin safely. HSSIB makes the following safety recommendations HSSIB recommends that NHS England/Department of Health and Social Care provides guidance to integrated care boards and community providers setting out expectations for service models that empower and support people to manage and administer insulin in community settings. This is to support recognition of models that have safely, effectively and equitably engaged patients, their families and carers, including through the use of modern diabetes technology for self-management. HSSIB recommends that NHS England/Department of Health and Social Care develops a tool for use in community settings to support the assessment of competency of patients, their families and carers to manage and administer insulin and care for people with diabetes. This should include recognition of a person’s circumstances, the impact of disabilities and impairments, and potential adjustments to support administration where safe to do so. This is to support consistency in how competency is assessed for the safe management of insulin within the context of modern diabetes care. HSSIB makes the following safety observation National bodies can improve patient safety by providing clarity on expectations around 1) how staff recognise that a patient’s mental capacity may be compromised in relation to decisions about their self-management of insulin, and 2) the undertaking of a mental capacity assessment by the most appropriate person. This should include clarification on the practical application of the Mental Capacity Act (2005) to situations where a patient’s capacity may fluctuate and where sharing confidential information to support patient safety may be appropriate. HSSIB suggests safety learning for integrated care boards HSSIB investigations include safety learning for integrated care boards where this may help organisations think about how to respond to a patient safety issue that relates to integrated care across a geographical footprint. Informed by the findings in this report, the investigation proposes the following safety learning. HSSIB suggests that integrated care boards develop data-driven approaches to effectively identify the diversity of their populations’ characteristics and social circumstances, and use this data to support community providers to design services that empower and enable people to be involved in a patient’s care, including through supporting self-management of medications and conditions. HSSIB suggests that integrated care boards, through future planning for neighbourhood health services, include consideration of how patients who may be at greater risk of harm from insulin administration due to their specific circumstances – for example co-existing disabilities, social isolation or receiving home-delivered medications – are proactively monitored to identify changes in their circumstances. This may include using technology such as remote monitoring. Local-level learning HSSIB investigations include local-level learning where this may help providers/organisations respond to a patient safety issue at the local level. Informed by the findings in this report, the investigation shares the following local-level learning. How does your organisation create the conditions for staff to empower and enable patients, their families and carers – through a person-centred approach – to self-manage insulin where appropriate? How does your organisation proactively identify the varying needs of people with diabetes in its local population, and ensure these are met to enable their management of insulin? How does your organisation promote patient-centred care and facilitate self-care models that empower and enable patients, such as those with diabetes? Does your organisation allocate specific resources to support patients, families and carers to develop competency to self-manage insulin, and ensure those resources are protected to empower and enable people? How does your organisation ensure that staff supporting the development of a person’s competency have the required knowledge and skills to provide that training and education in relation to diabetes and insulin? How does your organisation support staff to identify and code a person’s disabilities/impairments that may influence their competency to self-manage insulin, and ensure these are considered and adjusted for when deciding whether a person is competent? Does your organisation have systems and processes to identify where patients have not requested their repeat medication prescription, or the frequency of the requests have changed, which may indicate changes in their circumstances? How does your organisation ensure long-term condition reviews reliably take place for patients who may be at a higher risk of deterioration due to their circumstances, for example those with multiple long-term conditions? How does your organisation identify and code patients – who may be more vulnerable to harm from insulin due to their circumstances – for increased monitoring? This may include patients who have their medications delivered to their home, who do not have family nearby, or who are housebound. Does your organisation provide practical training and guidance to support staff to consider the mental capacity of patients to make decisions around their insulin when there are concerns capacity may be compromised? Does your organisation provide practical guidance to staff to help identify when it is lawful, ethical and appropriate to share confidential information about a patient to mitigate risks to their safety, including with family members? Does your organisation have accessible routes via which staff can seek urgent support when they are concerned a patient’s mental capacity to make decisions about their self-care may be compromised, particularly in high-risk situations? How does your organisation support staff to develop ‘crisis plans’ for patients who self-manage insulin to protect their safety at a later point when their capacity to make decisions in relation to their care may change?

The Maternity and Newborn Safety Investigation (MNSI) has reviewed 20 investigations into the cooling of term babies across England. The findings show that national guidance on continuous temperature monitoring during cooling was not followed in half of cases. Ensuring continuous temperature monitoring during newborn cooling is an important area of learning identified through our neonatal investigations. A review of 20 investigations found opportunities to strengthen practice in line with national guidance in half of cases. The new MNSI safety briefing draws on what we have learned through our investigations and aims to support the safe care of babies undergoing cooling in maternity and neonatal settings. The briefing shares our evidence and insight on this topic and provides prompts for maternity and neonatal providers to consider: Whether local guidance on cooling aligns with national guidance, including when to commence passive cooling and the use of rectal temperature probes. Whether staff have the training and equipment they need to initiate cooling safely and consistently.

This Maternity and Newborn Safety Investigation (MNSI) safety spotlight shares what they found regarding nitrous oxide decommissioning and offers prompts to help providers keep staff informed and equipment checks consistent.

In this blog, Ted Baker discusses a new paper by Health Services Safety Investigation Body (HSSIB) colleagues and highlights the call for a fundamental rethink of how the NHS views and prioritises patient safety. Ted argues that healthcare has long confused quality with safety, often treating safety as just one dimension alongside outcomes and patient experience. This framing has encouraged a false idea that trade‑offs are acceptable, particularly under pressure, even though safety and outcomes are interdependent and should never be weighed against one another. A new HSSIB research paper reviewing 118 national investigation reports, found that where trade‑offs occurred, safety almost always lost out to efficiency, timeliness or experience initiatives, and there were no examples where prioritising safety harmed other aspects of quality. This directly challenges claims that the NHS has focused too much on safety.

A witness statement provides the Coroner with important evidence to consider as part of their investigation. It is important to ensure that all of the relevant information is included in your statement and that the statement is clear, thorough, truthful and accurate. This guide from the law firm Browne Jacobson gives you advice on writing the statement for an inquest.

Coroners have an important patient safety role under Regulation 28 of the Coroner’s (Investigations) Regulations 2013. This creates a statutory duty for Coroners not just to decide how somebody came by their death but also, where appropriate, to report about that death with a view to preventing future deaths (PFD report). In certain cases you may wish to provide the Coroner with evidence to explain the outcome of any internal investigation and provide assurance that organisational learning has been, or is being, implemented. This guide from the law firm Browne Jacobson has been produced to assist with the preparation of that evidence, and supplements their previous 'inquest guide for witnesses' and 'guide to writing statements for an inquest'.

A guide from Browne Jacobson, a law firm, to support staff involved in a coroners' inquest. It covers: When does the Coroner hold an inquest? What is an inquest? The inquest hearing Court day checklist Giving oral evidence Giving evidence remotely Inquest conclusions Regulation 28 / Preventing Future Deaths Further guidance and resources