• The use of risk assessment tools that provide a high, medium, or low risk score is no longer acceptable but continue to be used contrary to national guidelines for self-harm assessment.
• Patients who had expressed suicidal thinking, and their families and carers, said that they were not listened to when sharing their safety needs and their perceptions of risk were disregarded.
• Investigations into death by suicide and near misses often refer to questions and evidence associated with high, medium, and low risk stratification. These include, for example, coroners’ investigations, local and regional serious incident investigations and public inquiries.
• Staff described a fear of being blamed if a risk assessment, including risk stratification, is not completed and a patient later comes to harm.
• Some digital patient record systems still require staff to categorise risk assessments as high, medium or low risk.
• Successful implementation of person-centred approaches to patient safety assessment and safety planning is dependent on many different factors including an organisations’ leadership culture, the people that work within organisations and the emphasis on involving the patient and their families and carers, in the assessment and planning processes.
• Organisations have involved ‘digital experts’ in their electronic patient record system improvement projects. Examples of changes made include the removal of automated predictive elements of risk stratification, free-text boxes with an increased character limit for improved narrative, and added space for family/carer views.

HSSIB notes the following safety actions, commenced in 2024 by NHS England

• NHS England, working with the National Collaborating Centre for Mental Health, is identifying 10 organisations to lead work to co-produce personalised approaches to safety planning in inpatient services. The learning will be shared through national learning networks. This is expected to be complete by March 2026.
• NHS England is producing national guidance on Safety Assessment and Safety Planning, specifically relating to person-centred safety assessment and planning, to support organisations in complying with the National Institute for Health and Care Excellence guidance ‘Self-harm: assessment, management and preventing recurrence’. This is expected to be complete in April 2025.

HSSIB makes the following safety observations

• Organisations can improve patient safety by taking a person-centred approach to biopsychosocial assessments and safety planning and stop asking for evidence of risk assessment tools that stratify an individual’s risk of suicide or self-harm as high, medium, or low risk.
• Organisations can improve patient safety by ensuring that a person centred approach to biopsychosocial assessment should be offered for all patients who have contact with mental health services, when a patient has an episode of self-harm or suicidal thinking, every time they make a transition between mental health services, and at key important times in the person’s life. This is line with current guidance from the National Institute of Health and Care guidance.
• Organisations can improve patient safety by involving ‘digital experts’ in their electronic patient record system improvement projects. This will support any digital configuration and infrastructure changes required to record person-centred approaches to psychosocial assessments and safety planning.
• Organisations can improve patient safety by listening to and communicating with patients, their families and carers, about the safety and wellbeing of people who have self-harmed and/or are expressing suicidal thoughts. It is important that this involvement starts from the point of a patient’s admission through to their discharge from inpatient mental health wards and during follow up.

• Temporary workers are being discriminated against by some staff, organisations, and national bodies because of their working status, and in some cases because of their ethnicity. This can affect the support they receive and their ability to ask questions, which can in turn impact on patient safety.
• Some temporary workers feel unable to raise concerns about patient safety with the organisation in which they are working because they fear they will lose future opportunities to work in that organisation. Staff from ethnic minority backgrounds face known barriers to speaking up because of their ethnicity; their status as temporary workers adds an additional challenge to raising patient safety concerns.
• Where temporary workers are needed to fill gaps in the workforce, these gaps are advertised with limited information about the knowledge and skills required of the worker to help maintain safe care. This makes identification of suitably trained and qualified workers challenging.
• The knowledge, skills, and levels of experience of temporary workers may be unknown to their place of deployment. This affects an organisation’s ability to deploy workers in ways that make best use of their abilities, and can create patient safety risks when workers are placed in situations they are not confident to manage.
• Temporary workers are often redeployed to different areas of an organisation to meet the fluctuating demands on that organisation. This redeployment may also not take into account the abilities of the worker or the impact on patient safety.
• Local inductions to a new place of work for temporary workers are not always effective in preparing the worker to provide safe care in that particular environment.
• Temporary staff do not always have the necessary access to electronic clinical systems which can mean they are unable to access vital patient information, record details of patient care or request tests.

Local-level learning

HSSIB suggests that healthcare providers can use the findings from this investigation as prompts to help them consider how to integrate temporary staff into their workforce:

• How do you enable temporary workers to feed back on their experiences of working in your organisation, to understand the organisational culture in relation to this group?
• How do you ensure that temporary staff know how to speak up and that they feel safe to raise concerns?
• How do you ensure that you are clearly advertising the skills required of a temporary worker to fill a rota gap?
• How do you ensure that the skills and experience of temporary workers are taken into account when redeployments are being considered?
• How do you work with providers of temporary staff to understand the skills and experience of temporary workers so they can be used most effectively?
• How do you ensure that temporary workers can access electronic systems and physical environments that are vital to providing safe care?
• How do you ensure that inductions are carried out and that the time needed to complete local inductions is factored into the workload of staff?
• Do you have a dedicated and accountable professional lead for ensuring that local inductions are carried out?

HSSIB made the following safety recommendation

HSSIB recommends that the National Guardian’s Office, working with relevant stakeholders, identify the barriers that prevent temporary staff from speaking up and develops mechanisms to address those barriers. This will build on their work to explore barriers for other staff groups and enable all workers to contribute to patient safety improvements without fear of reprisal.

HSSIB made the following safety observations

• National bodies can support patient safety by developing credentialing systems which enable staff to verify their competencies when moving between NHS organisations.
• Organisations that provide temporary staff to the NHS can improve patient safety by including information about the NHS England Learn from Patient Safety Events service to temporary staff as part of their onboarding process. This is to enable temporary staff to record patient safety risks if they do not have access to a healthcare provider’s reporting system. 

Findings of this report include:

• Ambulance services spent significant time diverting resources to callouts in prisons that were then cancelled, or attending medical emergencies that were not serious enough to have warranted the presence of an ambulance crew.
• Prisons are making large numbers of 999 calls for non-emergency incidents, because of a low-risk approach caused by fear among prison staff of having to attend an HM Coroner’s court and being blamed for making a wrong decision.
• No situational information about patients experiencing a medical emergency is provided direct from the scene to the 999 call handlers. Information is passed from the scene via multiple handovers before it is received by the call handlers, which can result in misrepresentation of the situation.
• Response categories of ambulances attending prisons are regularly assessed using minimal information and ambulance services spoken to therefore defaulted to category 2 (18-minute response time). This is often not the appropriate categorisation for the nature of the situation, which has delayed appropriate care to patients both in the community and in prisons.
• The emergency response card (code blue/code red card) that prison staff are given is not designed to best support staff in identifying a medical emergency and supplying the situational information that the emergency services need to triage the situation properly.
• There is no embedded recurring training to support prison staff to recognise medical emergencies that require a 999 response, to help reduce the number of calls for scenarios that are not emergencies.

In this report HSSIB recommends that:

• HM Prison and Probation Service, in collaboration with the Association of Ambulance Chief Executives, reviews and amends the design of the medical emergency response card, to better support staff in identifying emergency situations and providing the situational information required by ambulance service call handlers. In scenarios where direct communication between staff at the scene and the ambulance service emergency centre call handlers is not possible, this will ensure that the control room receives and can provide sufficient information to the call handlers to triage the situation.
• HM Prison and Probation Service enhances the existing training delivered to prison officers, to increase their ability to identify medical emergencies that require 999 calls to be made by prisons, thereby reducing the number of calls and diverted ambulances and easing the burden on the emergency care system. The training should be delivered on a recurrent basis.
• HM Prison and Probation Service reviews and implements changes to current communication methods between staff at the scene of an incident and the ambulance service call centre. This is to ensure that situational information about the patient is passed directly from the scene to the call handlers, meaning faster and more accurate triage and categorisation of the emergency response.
• The Association of Ambulance Chief Executives, in collaboration with HM Prison and Probation Service, sets up formal communication routes, at both national and regional levels, between prison and ambulance services to escalate concerns, review risks and improve systems for emergency care response and ensure continuous improvement of the service. 

• Where actual and potential harm to patients has been contributed to by the use of online consultation tools, these incidents are not always reported. There is underreporting of patient safety incidents in general practice.
• Harm can result to patients where they are unable to use an online consultation tool due to their personal circumstances. This may also result in inequitable access to care if patients are not aware of or unable to use other access routes.
• General practitioners have not always had specific training to undertake online consultations, resulting in some having concerns about the making of decisions based on the limited clinical information provided through an online tool.
• The design and configuration of an online consultation tool may mean it is not always able to safely deliver the task(s) it is being used for, nor address and meet the needs of its users (patients, carers and staff).
• The explicit needs of users are not always identified and incorporated into the design and configuration of online consultation tools. The needs of patients and staff may be different in respect to how a tool collects information about a patient’s medical problem.
• General practices engaged with during the investigation have had limited oversight and support from their former clinical commissioning groups and current integrated care boards when procuring and implementing online consultation tools. This has contributed to variation in how tools have been implemented.
• Limited patient engagement and education can lead to misinterpretation about how to access care. The investigation found examples in different parts of the country where patients believed they could no longer access general practice care if they could not use the online route.

In this report HSSIB recommends that:

• NHS England undertakes an evaluation of the risks to patient safety of online consultation tools in general practice, taking into account the findings of this investigation, recent research, and the experiences of general practices. This is to identify and implement actions to support the safe delivery of care using online consultation tools in line with best practice.
• NHS England develops mechanisms for assuring that integrated care boards support general practices when implementing online consultation. This is to ensure online consultation tools are procured and implemented in ways that best support patient safety.

• There was limited national guidance about how paediatric wards should be adapted for children and young people with mental health needs.
• Paediatric wards in acute hospitals tended to focus on adapting their environments to improve the physical safety of a room for children and young people with a mental health need. Rooms would be stripped of items deemed to be a risk.
• Evidence indicated that removing items and creating a more restrictive environment can create more conflict situations including increased aggression, physical and verbal abuse, rule breaking, medication refusal, leaving the hospital without permission (absconding), and self-harm.
• There are opportunities to better support children and young people on acute paediatric wards by improving the environment to support therapeutic care and patient safety.
• Evaluating the learning from innovations and adaptations that individual hospitals around the country have made to their acute paediatric wards for children and young people with mental health needs can improve patient safety.
• There is a gap in the communication, escalation and management and oversight of risks associated with the acute paediatric ward environment for children and young people with mental health needs.

In this report HSSIB makes the following safety recommendations:

• NHS England, in collaboration with key stakeholders, including young people with lived experience and their families, develops guidance on how acute paediatric wards could be adapted to support children and young people with mental health needs. This work should focus on improving the therapeutic environment.
• NHS England, in collaboration with key stakeholders, updates ‘Health Building Note 23: Hospital accommodation for children and young people’ to include the therapeutic environment for supporting children and young people with mental health needs.
• The Care Quality Commission uses the findings of this report to ensure healthcare providers and integrated care boards implement a robust way for risks associated with the adaptations made to acute paediatric wards to be escalated and managed.

It also proposes the following safety response for integrated care boards and healthcare providers:

• HSSIB suggests that integrated care boards work in collaboration with healthcare providers to implement a robust way for risks associated with the adaptations made to acute paediatric wards to be understood, escalated and managed to ensure that adaptations enhance patient safety.

• There is a lack of evidence about how to optimise the safety and quality of continuous observations of adults, or when it is most appropriate to use this intervention.
• There are limited national guidelines and standards on when and how continuous observation should be carried out, and a lack of clear guidance on the training needs and competencies of staff doing this.
• Formal processes are often not in place to anticipate and support effective collaborative working where mental health staff work alongside physical health staff in an acute hospital to provide care to a patient at risk of self-harm.

For local-level learning, the report includes a series of prompts that are designed to help acute (physical) hospital and mental healthcare providers to work in collaboration whilst continuously observing a patient at risk of self-harm. It also includes a series of prompts for healthcare providers to consider how they can support staff caring for these patients.

In this report HSSIB makes the following safety recommendations:

• The Department of Health and Social Care, through the National Institute for Health and Care Research (NIHR), assesses the priority, feasibility and impact of future research into the efficacy and acceptability of continuous observation of mentally unwell adult patients. The research should take into account different care settings in which continuous observation may take place (including physical and mental health hospitals) and the different staff groups involved in carrying it out.
• NHS England, working with relevant stakeholders, produces national guidance for staff undertaking continuous observation of mentally unwell adult patients, along with a training and competency framework to provide staff with the necessary skills for this intervention in different care settings (including physical and mental health hospitals). Development of this guidance should include engagement with human factors principles to understand the complexities of the task of continuous observation and the environments in which it may take place. 

• Strategy: the strategy document outlines our mission, vision, and themes.
• Investigation criteria: the 'what we investigate' webpage outlines the criteria and principles for HSSIB investigations.
• Glossary: the 'safety investigation jargon buster' webpage provides a list of words and terms with definitions relevant to this consultation, to assist readers with their response to the consultation.
• Equalities Impact Assessment (EIA): the strategy EIA assesses the potential impact for disadvantage on any protected groups.

• A range of complex and interrelated system (tools, technology, organisation, task, environment, and people) factors routinely influence the reliability of the swab count and the achievability of the overall reconciliation process.
• The reconciliation process has not been formally analysed or designed using human factors expertise (where the interactions between people and other elements of the system in which they work are explored) or any other process design expertise.
• Blame can be inappropriately placed on scrub practitioners and/or the surgeon when an item goes missing, rather than the reconciliation process being seen as a team activity and one that can be influenced by a wide range of interrelating factors.
• The design of swabs does not help staff to locate, identify, or track swabs during the reconciliation process.
• There are technologies and tools that could be used to improve the accuracy of the swab count; however, these have not been embedded into UK healthcare.

Safety recommendations

The report makes the following recommendations:

• The Centre for Perioperative Care and Association for Perioperative Practice work together with other key stakeholders to review and amend the process and standards for the reconciliation of swabs, using human factors expertise and user-centred design principles, to reduce the risk of retained swabs to as low as reasonably practicable. Any changes to either organisation’s processes should consider potential unintended consequences and the influence on other safety-critical tasks and include consideration of professional roles and responsibilities in relation to swab reconciliation.
• NHS England develops a framework to assess whether risks, such as retained swabs, are acceptable, tolerable and have been reduced to as low as reasonably practicable. This will allow organisations to develop their risk strategies and document their risk acceptance criteria and tolerance.
• The National Institute for Health and Care Research assesses the priority and feasibility of commissioning research to review the viability of implementing technology that could support reducing the risk of retained swabs. The review should balance patient safety, costs, benefits, design, implementation, and the various ways in which the technology could be used to reduce other patient safety concerns to as low as reasonably practicable.

Safety observations

The report makes the following observations:

• Manufacturers of swabs can improve patient safety by facilitating better detection of retained swabs through user-centred design.
• The NHS can improve patient safety by ensuring procurement decisions about swabs are made on a risk-informed basis that incorporates evaluation trials and user-centred design processes in the design, manufacture and testing of products.
• Multidisciplinary team training can improve patient safety by increasing the understanding of team roles, responsibilities, teamwork, the interrelationships between the work system and people and ultimately improve the care of patients undergoing an invasive procedure.
• A user-centred evaluation of non-technical tools to aid the swab count can improve patient safety by helping national organisations and trusts assess whether their risk of retained swabs is as low as reasonably practicable.

Further reading on the hub:

• Swab safe management to prevent retained swabs
• Oxford University surgical lectures: Retained swabs

• Limited engagement of temporary staff in patient safety investigations may limit the potential for learning and undermine an investigation’s ability to influence future safety improvements.
• Patient safety investigations are being concluded without vital information because of observed and perceived barriers to engaging with temporary staff.
• Temporary staff are not always able to report patient safety incidents, and this impacts on the development of an open reporting culture and the ability to learn from patient safety incidents.
• The extent to which patient safety investigation findings are fed back to temporary staff varies, limiting the ability for all of those involved to learn.
• Support is not always provided for temporary staff following a patient safety incident; this can have an impact on staff members’ welfare and on patient safety.
• NHS England’s approved framework agreements for agency staff do not specifically refer to patient safety, or to support for staff following patient safety incidents.

Local-level learning

Healthcare providers can use the findings from this investigation as prompts to help them consider how they involve temporary staff in patient safety investigations:

• How do you ensure that temporary staff are aware of how to record patient safety incidents?
• If an incident takes place, how do you ensure that temporary staff are able to record it?
• How do you engage temporary staff in a learning response?
• Do you have processes in place so you can conduct interviews with temporary staff?
• Can you work with employment agencies to create agreed methods of including temporary staff in learning responses through your contractual arrangements?
• How do you ensure that learning is fed back to those staff involved, including temporary staff?

HSSIB makes the following safety recommendations

• HSSIB recommends that NHS England includes guidance on engaging temporary staff in learning responses within their 'engaging and involving patients, families and staff following a patient safety incident'. This should be developed in collaboration with providers of temporary staff to the NHS to help assist healthcare providers being able to fully investigate incidents from a systems perspective, enabling learning that can improve patient care.
• HSSIB recommends that NHS England updates the agency worker framework agreement criteria to explicitly require framework agreements to adhere to the staff support principles of the NHS England Patient Safety Incident Response Framework. This will improve patient safety as there is a recognised link between staff having wellbeing concerns and the delivery of patient care.

HSSIB makes the following safety observation

• Agencies providing temporary staff to the NHS can improve patient safety by facilitating the involvement of temporary staff in investigation processes, including interviews. This is to enable the investigation of patient safety incidents in line with the Patient Safety Incident Response Framework.

• Patient misidentification is challenging to address and previous efforts to reduce the risk have not been as successful as hoped. There may be a benefit in proactively ensuring that processes for identifying patients are safe, rather than reacting to incidents of harm.
• Positive patient identification is seen as a routine task, but is common, complex and critical for patient safety. It relies on staff following instructions described in policies and procedures, which might not always be fully appropriate to the circumstances within which staff are identifying patients.
• Patients are at higher risk of being misidentified in certain situations and settings. Examples include handovers and when care is transferred between different healthcare organisations.
• The risk of patient misidentification is underestimated and patient misidentification can result in significant harm to patients. Under-recognition of the risk is preventing allocation of already limited safety resources to further mitigate the risk.
• The main control in preventing patient misidentification in England is the NHS number. However, there is sometimes no, varied or limited use of the NHS number in clinical practice due to various factors.
• Technology alone is unlikely to reduce the risk of patient misidentification. Work systems involving people, technology and tools need to be designed to improve identification processes.
• The designs of current software and identification processes may be disadvantaging some patient groups (for example, patients with a disability or of certain cultural backgrounds) due to limited consideration of their needs.
• It is not yet possible to eliminate the risk of patient misidentification. However, a series of interventions – including using new technologies and optimising workplaces – may help to reduce the risk.
• When a patient is misidentified, it is difficult to correct the misidentification and ensure their records are made accurate.

HSSIB makes the following safety recommendations

• HSSIB recommends that NHS England assesses the priority, feasibility and impact of future research to quantify and qualify the risk of patient misidentification. This is to support future prioritisation of work programmes to improve safety in high-risk situations and settings.
• HSSIB recommends that the Care Quality Commission develops its methodology for assessment of integrated care systems and organisations to include arrangements for the positive identification of patients at transfer between healthcare organisations. This is to reduce variability in processes and what information is used for identification.
• HSSIB recommends that NHS England reviews and identifies system-wide requirements for scanning in positive patient identification. This is to support local organisations to use scanning technology to reduce misidentification incidents.

HSSIB makes the following safety observations

• Future improvement programmes considering the risk of patient misidentification can improve patient safety by prioritising high-risk situations and settings, such as handovers and transfers of patient care. Multiple controls may need to be introduced, including new technologies and standardising of processes.
• Healthcare organisations can improve patient safety through the use of principles of ‘user-centred design’ to help them understand and optimise clinical work settings for positive patient identification.
• Healthcare organisations can improve patient safety by assessing and addressing their local barriers to using the NHS number for patient identification.
• Those designing patient identification processes, including related software, can improve patient safety by undertaking effective equality impact assessments and by considering the needs of specific patient groups that are at high risk of being misidentified.
• Those purchasing and implementing electronic patient record systems in healthcare organisations can improve patient safety by ensuring those systems are compliant with relevant risk management standards (such as DCB0129, DCB0160 and DCB1077).
• Healthcare services can improve patient safety by seeking to better understand and address the risks associated with positive patient identification through a safety management system approach.

HSSIB suggests the following safety actions for integrated care boards

• HSSIB suggests that integrated care boards assure processes for the transfer of patient care between healthcare organisations in their geographical footprints to reduce variation in processes for patient identification.
• HSSIB suggests that integrated care boards assure that where a patient misidentification has occurred, healthcare organisations in their geographical footprints have collaborative processes to learn why and to ensure health records are correctly allocated.

• roles
• responsibilities
• governance
• accountability arrangements.

The investigation used as a reference event the case of Ethan who was taken to an emergency department (ED) by ambulance after his sister found him struggling to breathe and moving in a strange way. The ED staff thought that he was fitting and that this was likely caused by a lack of oxygen to his brain.

It was thought that Ethan may need to be intubated to help keep his airway open, but the procedure was predicted to be difficult because of his Hunter syndrome and severe obstructive sleep apnoea (a sleep disorder where the airway becomes blocked). Ethan was monitored for several hours and the risks of intubation versus managing his airway using basic airway management techniques were continually assessed.

To ensure the best possible conditions for a potentially difficult intubation, Ethan was taken to one of the hospital’s operating theatres. Intubation using a camera (videolaryngoscopy) was attempted but was unsuccessful. Ethan was given oxygen between consecutive

attempts at intubation. The difficult airway guidance was followed, and an emergency opening was created at the front of his neck so a tube could be inserted into his windpipe.

This was also unsuccessful. An on-call ear, nose and throat (ENT) consultant was contacted as the team was unable to intubate Ethan. Attempts at creating an airway using surgical techniques were unsuccessful and Ethan died.

Findings

Key findings from the investigation included:

• There is no nationally recognised system for sharing clinical information about people with a known difficult airway between primary, secondary, and tertiary care.
• There is no standard process for documenting and sharing an individualised airway management plan for people with a complex disease to all health care professionals and services involved in their care.
• Multidisciplinary team meetings to discuss the care of people with a complex disease and who have a known difficult airway are not happening consistently between primary, secondary, and tertiary care.
• Existing guidance for healthcare professionals on how to care for people who have a complex disease and may have a difficult airway is not always co-ordinated and consistent.
• There is currently no national standard for treating people with a known potentially ‘life threatening’ difficult airway who require advanced airway management.
• The requirement for additional skills, for example a head and neck specialist or ENT specialist, in emergency situations where a patient requires advanced airway management is challenging as 24-hour on-site ENT provision is not available in every hospital.
• Training and competency assessment in videolaryngoscopy is not standardised and there is variability in how and when videolaryngoscopy is used.
• Training and competency assessment for anaesthetists on airway rescue techniques such as emergency front of neck airway (eFONA) is variable.
• The design of equipment to support advanced airway management does not consistently include robust user testing at a national level to help identify and understand risks.

Safety recommendations

HSSIB made the following recommendations:

• NHS England identifies and implements a system for sharing clinical information about people with a known difficult airway. This is to improve access to this information for healthcare professionals and reduce the risk of a person’s known difficult airway not being recognised.
• The Royal College of Anaesthetists works with the Difficult Airway Society and other key stakeholders to produce a framework on the management of a potentially ‘life threatening’ difficult airway for people with a known difficult airway who require advanced airway management. This work should consider the adoption of a common language which defines and explains principles for treating people with a known potentially ‘life threatening’ difficult airway who require advanced airway management. This could optimise the chances of survival for people who experience a life-threatening airway emergency.
• The Royal College of Anaesthetists makes changes to its Guidelines for the Provision of Anaesthetic Services (GPAS) requirements for all anaesthetists, to include guidance on: requirements for anaesthetists to have access to videolaryngoscopes in all locations where anaesthesia is delivered and airway management takes place, requirements for all anaesthetists to be competent and skilled in the use of videolaryngoscopes; requirements for anaesthetists to be regularly updated on airway rescue techniques, such as emergency front of neck airway; requirements for anaesthetists and anaesthetic assistants to be regularly updated on other equipment that may be used in airway emergencies.
• The Royal College of Anaesthetists works with the Association of Anaesthetists and relevant key stakeholders to implement critical incident training for all anaesthetists and anaesthetic assistants. This should include consideration of scenario-based training and include the principles for the management of an expected or unexpected difficult airway using advanced airway techniques, including videolaryngoscopy and emergency front of neck airway.

Safety observations

HSSIB made the following observations:

• Healthcare organisations that commission elective (planned) surgical services for people with mucopolysaccharidoses (MPS) can improve safety by involving healthcare professionals from different disciplines who are experienced in airway evaluation and management, before, during and after a person’s surgery.
• Healthcare organisations could improve safety of the management of difficult airways by procuring equipment that has evidence of safety by design and robust user testing and assessment.
• Healthcare providers can improve patient safety by supporting and encouraging anaesthetic staff, anaesthetic assistants and operating department practitioners to become familiar with and experienced in the use of airway rescue equipment and techniques available locally, including videolaryngoscopy.

Since 2018, HSSIB has published nine investigations in which there were specific findings and safety recommendations relating to EPR systems:

Interoperability

A key finding in a number of our investigations was the lack of interoperability between the EPR and other IT systems across services. This relates to the ability of computer systems or software to exchange information.

Usability testing of software

A key finding in a number of our investigations was that EPR systems had not undergone usability testing. This is a method of testing the functionality of an EPR system by observing real users as they attempt to complete tasks in the environment they work in.

Standards and standardisation of the software and systems

It has been seen that the EPR systems staff are asked to use have not incorporated human factors engineering principles. Testing and standards can help ensure that staff and patient interactions with the EPR system can be better understood to help identify the systems strengths and weaknesses and identify potential errors that could result in harm to patients. HSSIB have made safety recommendations to national organisations to help improve EPR systems by:

• Ensuring EPR systems undergo human factors and usability assessments to ensure their functionality and safety for staff and patients.
• Ensuring manufacturers are provided with additional guidance to meet the above requirements.
• Commissioning research into how EPR systems can be best configured to avoid staff experiencing ‘alert fatigue’. This is where too many alerts may lead to users paying less attention to them.
• Ensuring EPR systems consider the whole patient pathway in relation to discharge from hospital and not just acute care.
• Improving interoperability between different systems in the prisons system.

The new NHS ‘federated’ data platform will enable every NHS trust and integrated care system to connect and share information between them. This type of digitised, connected system would enable services to be delivered more effectively and efficiently, with the patient front and centre.

For this system, or any EPR system, to help ensure improved patient safety, organisations need to:

• Plan for interoperability or what the process will be if EPR systems are not interoperable.
• Utilise human factors and user-centred design input to help design systems to be the best they can be.
• Commit to usability testing with the staff and patients who will use the system, in the environment the EPR system will be used in, to best reflect ‘real world’ work.

The reference event involves a patient who had undergone a triple coronary artery bypass graft surgery (heart surgery).

Following their surgery, a chest X-ray identified that a surgical swab had been retained. The patient returned to theatre and the surgical swab was removed. A subsequent chest X-ray identified that a further surgical swab remained in situ, in the same location within the chest. The patient returned to theatre and the second surgical swab was removed.

Safety recommendations

HSSIB recommends that NHS England incorporates the findings of this interim report into its review of the Never Events policy, with specific focus on considering removing retained surgical swabs as a sub-set of retained foreign object Never Events.

Safety observation

• Organisations can improve patient safety by using consistent terminology in national and local guidance when describing the responsibility for the reconciliation of items used in surgery and invasive areas, including swabs.
• Local-level observation: Healthcare providers can improve patient safety by using the findings of this report to consider potential challenges in their own systems and processes for unintentionally retained swabs following invasive procedures. This can help organisations to understand what people focused and system focused barriers may be implemented to help further mitigate against retained swab events.

Brian had a history of breast cancer and had been discharged from the breast cancer service. Two years later he began to have back pain. Initially the pain was so severe that Brian visited his local emergency department (ED). He was discharged from the ED with pain relief and was advised to contact his GP practice.

A month later, Brian telephoned his GP practice and saw his named GP. The GP referred Brian to the GP practice’s physiotherapist and requested a blood test. Brian saw the physiotherapist, who gave him advice about exercises to help relieve the back pain. The exercises did not relieve Brian’s pain and over the following 8 months he saw two out-of-hours GPs and six practice GPs, a nurse and a physiotherapist at the GP practice.

Brian also had consultations with healthcare professionals during this time for other conditions not relating to his back pain. When Brian saw a GP at end of the 8-month period, the GP found a lump on his spine and advised Brian to go to the local ED.

At the ED, Brian had a computerised tomography (CT) scan. A lump was found on his spine which was later diagnosed as metastatic breast cancer (that is, breast cancer that had spread to his spine).

Findings

• The GP contract, which sets out the mandatory requirements for GP services commissioned by the NHS, does not specifically require GP practices to adopt an approach that ensures continuity of care, but practices can do so voluntarily.
• Many GP practices do not operate a formalised system of continuity of care.
• There is no standard framework to deliver continuity of care in GP practices, so it is done differently across the country.
• Many GPs understand the benefits of continuity of care; however, some practices did not believe that it was possible to deliver such a system. Other practices were able to maintain continuity of care through systems developed by those practices.
• There is no requirement for GP IT systems to consider continuity of care or to ‘surface’ information (that is, identify and flag up relevant patient information) to GPs when they see a patient with unresolving symptoms.
• Patients told the investigation that they found it beneficial to see their named GP for long-term health conditions, including mental health conditions.
• GPs working in a practice with a system of continuity of care had more time to process information during consultations and to carry out any follow-on actions to ensure patients received the care they needed.
• GP practices that operated a system of continuity of care reported to have better staff welfare and retention, and fewer recruitment issues, than those that did not.

Safety recommendations

• HSSIB recommends that the Department of Health and Social Care ensures that the GP contract explicitly includes and supports the need for GP practices to deliver continuity of care. This is to improve patient safety by building clinician–patient relationships as well as providing continuity of information.
• HSSIB recommends that NHS England updates the GP IT standards to ensure that patient continuity of care is maintained, including the identification and prioritisation (technically known as ‘clear surfacing’) of information to health and care professionals, when patients visit GP practices multiple times with unresolving symptoms.

Safety observation

• GP practices can improve patient safety by aligning their staff wellbeing and patient safety policies to those of NHS England’s proposed patient safety strategy.

An investigation was carried out to explore factors that can affect the ability of patients to reliably receive their medication via an ambulatory infusion pump. The focus was on this specific type of device as they are used widely across healthcare providers in England for patients receiving palliative care. The investigation uses ‘hazard’ to describe something that has the potential to cause harm or have an adverse effect on a patient. A ‘control’ is a measure put in place to reduce the risk of a hazard occurring.

The investigation focused on:

• Equipment controls that enable effective delivery of medication.
• Environmental and staff factors that can influence the monitoring of medication delivery via ambulatory infusion pumps.

Findings

• Current ambulatory infusion pump alarms may not effectively notify staff of hazardous situations (situations where intervention by a healthcare professional is needed because there is potential for harm to a patient). Alarms may occur, but if staff are not alerted to them, the required interventions may not take place.
• Current national reporting systems are complicated and do not support the capture and sharing of medical device related incidents across appropriate national bodies.
• To enable the effective cross organisational sharing of incident data local incident reporting systems, which feed into the NHS England Learn from Patient Safety Events service, would need to meet the Medicines and Healthcare products Regulatory Agency (MHRA) data standards.
• The main factors that affect staff’s ability to hear an alarm and intervene in a hazardous situation are the infrastructure and working environment in which infusion pumps are used.
• When staff cannot hear or see an alarm, outside of the 4 hourly infusion pump staff checks, they are reliant on patients or families to alert them to issues with an ambulatory infusion pump. This is not always possible when the patient is unwell.
• International standards used by manufacturers of medical devices do not fully consider the environment in which the equipment is used.
• NHS staff are not always given guidance on how to use specific medical devices in the context of their varying environments, and how this may affect patient safety.
• The inability to access the Palliative Care Formulary (a best practice guide for medication prescribers), as a free resource, may have an impact on patient safety. This can be both in the palliative care specialism and across the wider healthcare system.

Safety recommendations

• HSSIB recommends that the British Standards Institution engages with appropriate stakeholders to develop national human factors guidance, including consideration of usability and environment of use, for medical devices. This is to support international medical device standards and help manufacturers and healthcare staff to recognise these elements for the improvement of patient safety.
• HSSIB recommends that the British Standards Institution engages with international standards committees to influence the inclusion of human factors, including usability and environment of use requirements, in medical device and medical electrical equipment standards.
• HSSIB recommends that NHS England and the Medicines and Healthcare products Regulatory Agency work together to develop an effective mechanism for sharing medical device related incident data, including where devices function as designed.

Safety observations

• Palliative care providers can improve patient safety by reviewing their ambulatory infusion pumps checks to determine whether they are in line with the Palliative Care Formulary guidance and the minimum expectations of NHS England.
• Ambulatory infusion pump manufacturers can improve patient safety by considering new technology to develop improved methods of alerting staff to hazardous situations.
• Care providers can improve patient safety for inpatients who are given medication using ambulatory infusion pumps by providing safety netting advice about alerting nursing staff to alarms, appropriate places to put ambulatory infusion pumps, and the consequences of patient interaction with the device.

HSSIB investigates patient safety concerns across the NHS in England and in independent healthcare settings. It initially started its life in 2017 as the Healthcare Safety Investigations Branch (HSIB), subsequently undergoing a period of transformation following new legislation in the Health and Care Act 2022 to become HSSIB on the 1 October 2023.[1]

Dr Ted Baker joins HSSIB as its first Chair. He was previously Chief Inspector of Hospitals at the Care Quality Commission and prior to this spent most of his career working in clinical practice for 35 years.

Dr Baker welcomed the invitation to the PSMN and commended the value of the forum both for its members and for the wider healthcare community.

Role and duties of HSSIB

Opening the meeting, Dr Ted Baker set out his background prior to becoming Chair of HSSIB and talked about the origins of the organisation. He explained that this was established as an arm’s length body of the Department of Health and Social Care to:

• Carry out independent investigations in health services.
• Not to apportion blame or liability.
• Focus on system-level (policy and regulatory) change.
• Professionalise the patient safety investigator role.

He noted that HSSIB will conduct investigations in what is commonly referred as a ‘safe space’ to ensure people feel able to speak up about safety concerns. This prohibits, on a legal basis, the unauthorised disclosure of protected material and applies to all HSSIB employees and anyone they provide information with as part of an investigation.

Approach to investigations

Dr Baker advised that the areas of investigation that HSSIB will focus on will be subject to a forthcoming strategic review to form their initial priorities. However, before this takes place, he highlighted that there are already several factors that influence how they approach investigations. This included the need to avoid incidents where their work would simply replicate already effective local investigations, and to focus on those cases that are likely to have widespread implications where they believe their approach can add value.

He outlined four key aspects of the HSSIB approach to investigations:

1. Wide-ranging expertise from safety-critical industries.
2. Multidisciplinary and inclusive teams; patient and family involvement.
3. Focus on learning not blame to reduce risk of harm.
4. Transparent and collaborative to support learning.

He outlined that HSSIB would be consulting widely on the criteria for investigation, and that he would welcomes input from the PSMN and its members.

Safety Management Systems

Dr Baker went on to speak about the first investigation report formally published by HSSIB, which considers the potential application of Safety Management Systems (SMSs) as an approach to managing safety in healthcare.[2]

In this report, HSSIB identifies the requirements for effective SMSs, how these are used in other safety-critical industries and considers the potential of application of this approach in healthcare. He emphasised the importance of different parts of the system working more collaboratively to achieve this and showed a brief video explaining more about this, which can be viewed below.

Network discussion

Discussing potential themes and areas that HSSIB could consider as part of its forthcoming strategic review, the following points were made by Network members:

• Importance of considering how the themes that emerge from individual organisation’s Patient Safety Incident Framework (PSIRF) plans may help inform HSSIB’s future priorities, particularly where these are not issues specific to a locality. Dr Baker emphasised that PSIRF is a significant opportunity for organisations, and there will be significant value from the insights gained in learning responses.
• A possible future area/theme to investigate may be why organisations struggle to collaborate with each other on patient safety issues, connected with the need for a wider SMS.
• Potential to look in detail at learning from near misses.
• Considering IT risks and their impact on patient safety.
• Looking at how resources are allocated in regard to safety. Particularly in cases where there are new safety innovations and initiatives that could be implemented, potentially saving lives, but are not prioritised.
• Procurement and its impact on patient safety. How findings and recommendations from patient safety reports actually translate into change, a key issue highlighted in Patient Safety Learning’s report Mind the implementation gap.

There were also some issues raised by Network members about HSSIB’s role more broadly, including:

• Whether the scope of HSSIB investigations would extend into social care. Dr Baker noted that while their role is explicitly focused on healthcare, it may be that there are issues regarding health care services that fall within a social setting that need future investigation.
• How HSSIB will approach patient engagement, both working with patients directly and also how they take on board the wider patient/public view of what they should be prioritising.
• A question about the oversight arrangements for HSSIB, with Dr Baker noting that this is provided by Parliament.
• Discussion around the role of leadership in improving patient safety and what more needs to be done to ensure this is a core purpose for organisations.
• That HSSIB is supporting an international network of patient safety organisations from 17 different countries for shared learning.

How to get involved in the Patient Safety Management Network

Do you work in patient safety and are interested in joining the Patient Safety Management Network? You can join by signing up to the hub today. If you are already a member of the hub, please email support@PSLhub.org. And if you would like to discuss setting up other networks, we’d love to hear from you and support you.

References 

• HSSIB, HSIB legacy, Last Accessed 29 October 2023.
• HSSIB, Safety management systems: an introduction for healthcare, 18 October 2023.

The investigation used as a reference event a patient safety incident involving a 79-year-old man who was recorded on his GP’s learning disability register as having a mild learning disability. After being admitted to hospital due to his worsening health. Throughout the patient’s stay, up to his death following a cardiac arrest, his individual needs were not always identified and reasonable adjustments to meet his care needs were not always made.

Findings

• The health and care system is not always designed to effectively care for people with a learning disability.
• People with a learning disability who are admitted to an acute hospital are often cared for by staff without specialist training, skills and experience in working with people with a learning disability. These staff often have limited support and are unable to take the time they would like to meet the person’s needs.
• There is no standard model or national guidance for an acute learning disability liaison service (that is, teams that are specifically trained in caring for people with a learning disability). Consequently, there is variation in how these services are funded, their availability, the size of teams and what they are expected to do.
• The quality of learning disability services is currently monitored via the learning disability improvement standards annual benchmarking survey which is funded until the end of 2023/24. Decisions on future years have yet to be made.
• Staff in acute hospitals may lack confidence and support in assessing the mental capacity of people with a learning disability, in line with the Mental Capacity Act (2005).
• There is no national shared system with a single point of access for storing and managing information about the needs of people with a learning disability and the reasonable adjustments required for each individual.
• Current mechanisms for sharing information about a person – such as ‘care passports’ (a document that gives staff helpful information about the person’s health and social needs, including their preferred method of communication, likes and dislikes) and alert flags (a way to highlight key information to staff) on the electronic patient record – can be unreliable. Instead, information is often gathered from friends and family.
• Evidence exists that people with a learning disability experience health inequities. Long-held societal beliefs about the abilities of people with a learning disability may influence the provision of and decisions made around their care.

Safety recommendations

As a result of this investigation, HSSIB recommended that NHS England should:

• Develops and issues learning disability liaison nursing service best practice and workforce guidance to all acute hospitals. This is to help local decision making about specialist learning disability provision and enable appropriate support for people with a learning disability and the staff who care for them.
• Ensure that the national learning disability improvement standards annual benchmarking survey for the care of people with a learning disability is continued for acute hospitals in order to help assure that local population needs are met.
• Commission the development and dissemination of guidance on the practical assessment of the mental capacity of people with a learning disability in acute hospitals. This is to ensure that appropriate decisions are made about the person’s care.
• With support from key stakeholders including the Professional Record Standards Body, work collaboratively to develop and publish a set of guidelines on information to be included in a health and care passport (which could be paper based, digital, or both) for people with a learning disability with consideration of the reasonable adjustments that people may need. This is to ensure the most current and accurate information about reasonable adjustments to the person’s care is accessible when and wherever it is needed.

Safety observations

HSSIB made four safety observations as a result of this investigation:

• Health and care providers can improve patient safety by ensuring that local configuration of electronic patient record systems consider the accessibility and usability of the digital record reasonable adjustments flag in patient records.
• Health and care curricula can improve patient safety by aligning with the national code of practice on statutory learning disability and autism training, when finalised.
• Health and care providers can improve patient safety by advocating for all people with a learning disability to have an up-to-date care passport.

• Safety policy - establishes senior management's commitment to improve safety and outlines responsibilities; defining the way the organisation needs to be structured to meet safety goals.
• Safety risk management - which includes the identification of hazards (things that could cause harm) and risks (the likelihood of a hazard causing harm) and the assessment and mitigation of risks.
• Safety assurance - which involves the monitoring and measuring of safety performance (e.g., how effectively an organisation is managing risks), the continuous improvement of the SMS, and evaluating the continued effectiveness of implemented risk controls.
• Safety promotion - which includes training, communication and other actions to support a positive safety culture within all levels of the workforce.

Findings

Exploring this topic, the report identifies three opportunities for an organised approach to safety management in healthcare:

1.    SMS development in healthcare

•  There is an opportunity to improve safety activities in healthcare to increase proactivity and coordination across and within organisations.
• In other safety-critical industries an SMS is mandated in regulation, but healthcare organisations are not required to have all four areas of an SMS.
• There is an opportunity to improve standardisation in the coordination of safety activities within and between different organisations across healthcare, in terms of how risks are escalated and managed.
• An effective safety system and culture requires a shared understanding of safety management principles.
• There is variability in the current language and definitions that describe the safety activities, functions and processes already common across healthcare.

2.    Safety accountability frameworks across healthcare

• For effective safety management, clear lines of accountability and responsibility are needed. Within an SMS, everyone has some measure of responsibility, such as reporting unsafe conditions. Accountability takes responsibility to another level. When someone is accountable, they are responsible for systems and processes that assure safety.
• If there is no co-ordinated approach in place, accountability and responsibility can become misaligned, leading to gaps in the oversight of safety management.
• While there are clear accountabilities for safety at provider level through the Care Quality Commission regulation, there is no multi-level framework that specifies who should be accountable for the management of safety risks across the healthcare system.
• There is consensus within other safety-critical industries that effective safety management is only possible when there is a clear accountability framework that underpins the process.

3.    Safety maturity assessments across healthcare

• The term safety maturity is used to describe how far an organisation has developed and embedded its SMS.
• Existing maturity frameworks in healthcare do not promote the principles of SMSs, do not define the key components of a healthcare SMS, and do not provide organisations with a road map for incremental development of their safety activities.

Future work and recommendations

Considering what would be needed to explore applying the SMS approach to healthcare, HSSIB suggest that this could involve:

• Mapping current safety management activities in healthcare to SMS principles and identifying opportunities for improvement.
• Determining if planned and ongoing changes to the way safety is managed in healthcare would be usefully guided by SMS principles.
• Further understanding how an accountability framework could support an SMS approach in healthcare.
• Understanding how safety issues and risks for inclusion health groups are identified and then managed through an SMS approach.

It makes the following safety recommendations:

• HSSIB recommends that NHS England explores, and if appropriate, supports the development and implementation of safety management systems (SMSs) through an SMS co-ordination group. This should be in collaboration with regulators, relevant arm’s length bodies and national organisations, academics, patient representatives and safety leaders from other safety-critical industries.
• HSSIB recommends that the Care Quality Commission is responsible for ensuring that its regulatory assessment approach effectively assesses safety management activities.

It also makes the following safety observation:

• The oversight of safety management can be improved if relevant bodies, such as providers, commissioners and regulators, adopt a multi-level safety accountability framework.

Related reading

• Five Cornerstones to an Effective Safety Management System (Andrew Ottaway, 2 August 2021)
• The involvement of patients and families in a healthcare safety management system: In conversation with Jono Broad (21 February 2023)
• What is a ‘safety management system’? A blog by Norman MacLeod (3 October 2023)
• Why healthcare needs to operate as a safety management system: In conversation with Keith Conradi (24 October 2022)

• The movement of patients into, through and out of hospitals has a direct impact on ambulances queuing at emergency departments and creates patient safety risks and issues throughout the healthcare system (see interim report 1).
• Patient safety is managed differently across the healthcare system and does not consider the ‘air gap’ (see interim report 2) between health and social care.
• There is not a patient safety accountability framework which identifies individuals accountable and responsible for patient safety (see interim report 2).
• Poor staff wellbeing due to stress, moral injury, incivility and burnout (see interim report 3).

Additional national investigation findings

The reference investigation highlighted several challenges that reflect those found across other acute trusts in England. These national challenges include:

• Acute trusts not being able to accept new patients because their hospital is full despite a significant number of patients being medically fit for discharge. This means patients in hospital who no longer need to be there but are unable to be safely discharged to the right place of care.
• Ambulance crews caring for patients in the back of their ambulances for over 12 hours.
• When hospitals are unable to accept new patients, this has a direct impact on flow on other hospitals who will see these patients in addition to their own.
• Planned procedures may be delayed and/or cancelled due to the number of emergency procedures.
• Previous initiatives to improve patient flow have focussed on performance targets in EDs, such as the 4-hour standard, rather than changes to the whole system to facilitate patient flow.
• A key contributor to the problems with patient flow into, through and out of hospitals is not being able to discharge patients who no longer require hospital care.
• Seven-day a week services are expected to include daily reviews however this is not happening across all healthcare providers.
• The criteria to reside tool (a tool that helps clinicians determine appropriate discharge pathways) expects that patients on general wards should be reviewed twice daily to determine suitability for discharge (or need for care in hospital). This has not been consistently implemented across healthcare settings in England.

Safety recommendations

Department of Health and Social Care (DHSC)

• HSIB recommends that the Department of Health and Social Care leads an immediate strategic national response to address patient safety issues across health and social care arising from flow through and out of hospitals to the right place of care.
• HSIB recommends that the Department of Health and Social Care conduct an integrated review of the health and social care system to identify risks to patient safety spanning the system arising from challenges in constraints, demand, capacity and flow of patients in and out of hospital and implement any changes as necessary.
• In interim report 2 a safety observation was made, following the collection of further evidence this has now been escalated to a safety recommendation: HSIB recommends that the Department of Health and Social Care develops and implements a patient safety accountability framework that spans the health and social care system. This is to help address the lack of accountability relating to patient safety risks spanning health and social care.

NHS England

• HSIB recommends that NHS England includes staff health and wellbeing as a critical component of patient safety in the NHS Patient Safety Strategy.

Safety observations

HSIB has made two safety observations to date as a result of this ongoing investigation. 

1. It may be beneficial for there to be a whole-system patient safety accountability and responsibility framework that spans health and social care.
2. It may be beneficial for NHS organisations to provide time and safe spaces for staff to engage in reflective practice and talk about the emotional impact of their work, with support from people with expertise in staff wellbeing.

• During 2022/23, the maternity investigation programme completed 702 reports. This was a similar figure to previous years. At any one time there were approximately 355 active investigations.
• The number of investigation referrals relating to brain injury indicate a sustained decrease in babies with abnormal MRI results or neurological damage.
• In the last year, the programme made more than 1,380 safety recommendations to trusts and other healthcare organisations, covering various topics.
• Families remain central to the work HSIB undertake. HSIB contact all families who give their consent; of these 86% agreed to participate and 14% declined further participation in the investigation.
• As part of HSIB’s initial engagement and ongoing communication with families they have been supported with interpretation/translation services on 670 occasions.
• Information provided to families about HSIB investigations has been translated into 36 languages. This helps families to make informed choices about participating in investigations and provides better support to enable their ongoing involvement.
• HSIB’s reports, and those of other organisations such as MBRRACE (Mothers and Babies: Reducing Risk through Audits and Confidential Enquiries across the UK), have identified racial differences in maternity outcomes. HSIB has formed a race equality group to develop the data from investigations to analyse demographics and understand the impact of racial diversity on experiences, access to care, and outcomes.
• The quarterly review meetings HSIB undertake with trusts have continued to develop with greater engagement from executive-level staff, board-level maternity safety champions, and the frontline perinatal teams. By working closely with trusts, the programme has helped to increase the involvement of perinatal teams in patient safety.
• The programme has deepened the understanding of the role of emerging themes and how they help to identify issues in the healthcare system as a whole that contribute to the harm experienced by pregnant women/people and their families.
• HSIB now publish a national newsletter three to four times a year to support trusts in sharing improvements they have made in response to safety recommendations, providing learning opportunities across England and beyond.
• A Maternity Quality Matrix is being rolled out to trusts to provide insight into their HSIB maternity investigations over time.
• Feedback is received from trusts and the HSIB Maternity Quality Improvement Team continues to improve investigations and support processes.
• During investigations, ‘soft intelligence’ relating to the investigation is captured in a maternity observational diary, which shares concerns as well as good practices with trusts, and information about ongoing challenges.
• Members of the maternity team ongoingly present at regional and national meetings to share their work and findings from reports.