• 84 national reports completed
• 236 national safety recommendations issued to 57 organisations
• 6,354 enrolments on HSIB safety investigation education programmes since January 2022
• 3,181 people have attended three HSIB safety investigations conferences
• 2,949 reports produced by the Maternity Investigation Team
• 6,998 maternity safety recommendations made.

Teri had chronic kidney disease and needed regular haemodialysis. He had previously received haemodialysis via a connection between an artery and a vein. However, this connection was failing due to narrowing of the blood vessels and she needed to have a vascular graft implanted so that her treatment could continue.

Teri was referred to her local hospital for insertion of a ‘rapid access’ type of vascular graft, to enable her haemodialysis treatment to be carried out as planned. Before Teri’s operation, a consultant vascular surgeon and members of the operating theatre team went to the store cupboard to look at the types of vascular grafts stocked. The consultant vascular surgeon was not sure which size would be needed, so two different sized vascular grafts were selected. However, it was not recognised at the time that they were different types of vascular graft, with one being the intended rapid access type and the other a delayed use graft.

Following surgery, the consultant vascular surgeon immediately realised that a delayed use vascular graft had been inserted instead of a rapid access graft.

Because the wrong type of vascular graft was inserted, Teri needed to have another surgical procedure and an overnight stay in hospital, which may not have otherwise been needed.

Findings

• The packaging of rapid access and delayed use vascular grafts may be very similar, resulting in an increased risk of staff selecting and inserting the wrong type of graft.
• The wording used on packaging and labels to describe vascular grafts does not reflect the terminology used by clinicians in the operating theatre.
• There is Medicines and Healthcare products Regulatory Agency (MHRA) guidance for the labelling and packaging of medicines, but not for medical devices such as vascular grafts.
• There was a lack of standardisation and therefore variation in how checklists and ‘team briefs’ (procedures that aim to ensure patient safety) were completed/ conducted and recorded in different operating theatres.
• The incorporation of national safety standards alone may not be successful without an embedded safety culture being in place.
• Barcode scanning technology (Scan4Safety) can be used to mitigate the risk of an incorrect medical device being selected/inserted. Due to the reduced central management of the Scan4Safety programme, trusts have been developing applications and using adaptations of the scanning technology, resulting in inconsistent use and variable effectiveness.

Safety recommendations

HSIB made four safety recommendations as a result of this investigation.

1. HSIB recommends that NHS England reviews system requirements for barcode scanning technology, in order to support local organisations to reduce the risk of incorrect selection and insertion of prostheses/implants.
2. HSIB recommends that the British Standards Institution updates the applicable standard/s, and raises with the International Organization for Standardization, to state that medical device labelling and packaging should detail the specific use of an item. This should be developed with user input to drive consistency in the terminology used on medical device labelling/packaging.
3. HSIB recommends that the Medicines and Healthcare products Regulatory Agency ensures the assurance processes for designated approved bodies (to check medical device manufacturers conform to packaging standards) are amended to consider context of use and usability guidelines, to reduce the risk of selecting and inserting the incorrect device.
4. HSIB recommends that the Medicines and Healthcare products Regulatory Agency publishes guidance on the labelling and packaging of medical devices, to promote best practice and reduce selection of the incorrect item.

Safety observations

HSIB makes the following safety observations:

• It may be beneficial if the term ‘user’ in the context of medical devices was defined in international and national standards to incorporate all staff who interact with the device, including those who select the device, check it before use and use it.
• It may be beneficial for healthcare organisations to deliver multi-disciplinary team training on the key principles of the revised ‘National safety standards for invasive procedures’ to support the implementation and embedding of these standards.
• It may be beneficial for trusts to assign experienced operating theatre clinicians to lead on the implementation of the ‘National safety standards for invasive procedures’, to address the cultural issues hindering implementation.

Related resources on the hub: 

• NatSSIP2 sequential steps: The NatSSIPs Eight – Flow chart
• Error traps gallery

Dermot was 77 years old and lived at home with his wife. He had been diagnosed with a myxofibrosarcoma (cancer of the soft tissues) in his armpit. Following surgery and radiotherapy, which were hoped would cure the cancer, the cancer returned and was found to have spread to other parts of his body. It was no longer possible to cure Dermot’s cancer and so he was referred to specialist palliative care services.

Dermot initially received specialist palliative care at home from a team of specialist nurses. An assessment of his needs identified his main issues as nausea, anxiety, insomnia, and constipation. The assessment also resulted in a referral to a support organisation for Dermot’s wife, but the referral did not progress and so support was not provided.

During the 9 days following his assessment, Dermot’s health deteriorated, and it was not possible to control his symptoms at home. He was admitted for inpatient specialist palliative care at his local community hospital. The aim of the admission was to manage Dermot’s symptoms and then discharge him home. However, his health rapidly deteriorated and he remained at the community hospital until the end of his life. Two days before Dermot died, his consciousness level decreased, and he became more settled and free of pain.

Findings

• Health and care services in England are not always able to provide individualised, equitable and co-ordinated PEoLC to meet the holistic needs of people and their families. They are unable to consistently provide what people have been led to expect from PEoLC.
• Holistic assessments for PEoLC may focus on physical care needs, with more limited attention to identifying, understanding and addressing other care needs, particularly psychological needs.
• The availability of PEoLC across England is variable and inequitable. This is influenced by the location of third-sector organisations, available charitable donations and NHS commissioning, and workforce shortages. There is no stated minimum standard for PEoLC that all people must be able to access.
• There is limited information to help the public and health and care staff to identify, access, and understand the roles of different aspects of PEoLC, with variation in words and definitions.
• PEoLC services are not always able to proactively plan care for people whose condition will deteriorate because of limited inpatient PEoLC and the unpredictability of some diagnoses.
• There is limited, specific guidance to support integrated care boards to identify the PEoLC needs of their populations in line with the expectations of the Health and Care Act 2022, and what could/should be done to address those needs.
• There is limited support available for health and care professionals to have honest conversations with people around death and what to expect, and to plan for the end of life.

HSIB recommendations

1. HSIB recommends that NHS England specifies a palliative and end of life care data set to help integrated care boards to understand their populations’ demographics and needs, in order to support commissioning and improvement of services.
2. HSIB recommends that NHS England develops and promotes a minimum expected service specification for specialist palliative care in England to clarify the minimum services a person can expect to be available to them no matter where they live.
3. HSIB recommends that NHS England commissions palliative and end of life care career pathways, ensuring that they include staff from the allied health professions, in order to build specialist workforce capacity.

Safety actions

HSIB suggests the following actions for integrated care boards:

• Identify and describe the palliative and end of life care services in their areas through engagement with integrated care partnerships and third-sector organisations. This is to provide the public and health and care professionals with accessible and accurate information about available services.
• Support collaboration between health and care organisations to define clear routes of support for people in and out of normal working hours to ensure they know how to access help for palliative care and end of life needs.
• Work with integrated care partnerships to account for capacity and resource in social care when planning palliative and end of life care services.
• Support collaboration between health and care organisations, including those in the voluntary and charitable sectors, to encourage more open discussions about death and dying in their local communities, accounting for their population demographics.
• Include palliative and end of life care in strategic workforce plans to ensure staffing of services is appropriately capable and can provide the capacity needed to meet demand.

Further reading on the hub;

Sarcoma UK: Family insights from Dermot’s experience (reflections on the HSIB report)

Due to heavy, painful and frequent menstrual periods she was scheduled for a surgical procedure to help ease her symptoms. The haematology team were made aware of the procedure but were not told when it was occurring, the procedure was conducted 1 week before the patient was due to have her regular exchange transfusion. Her haemoglobin levels were low.

The patient experienced a significant amount of pain during the procedure and was transferred to the haematology ward afterwards for treatment of a sickle cell crisis.

Findings

• The treatment people with sickle cell disease receive varies depending on where they live and the number of patients that clinicians see.
• Guidance on the treatment of sickle cell disease is limited to specific circumstances, such as sickle cell crisis or blood transfusion, with limited wider guidance available on the through-life management of sickle cell disease.
• Compared to other conditions that affect similar numbers of people, there has been limited research into the lifelong management of sickle cell disease. This may indicate a health inequality.
• There is no national information system for storing and sharing clinical information for patients with sickle cell disease.
• Currently the main way in which haematology consultants are made aware that a patient with sickle cell disease is having treatment in another area of healthcare is when they are notified of this by the patient.
• It may be possible to set up healthcare IT systems so that they alert haematology consultants when one of their patients accesses another type of healthcare. However, consultants in areas with a high prevalence of sickle cell disease may then receive so many alerts that such a system would be ineffective.

Recommendations

HSIB recommends that NHS England identifies and implements a system for sharing clinical information about patients with sickle cell disease to improve access to this information for clinicians, and reduce the risk of a patient’s sickle cell disease not being treated consistently.

HSIB recommends that the National Institute for Health and Care Research assesses the priority and feasibility of commissioning research into the management of patients with sickle cell disease, encompassing the requirements of patient-controlled-analgesia (pain relief) pumps. This will contribute towards building an evidence base for the generation of national clinical guidance and will reduce unnecessary variance in treatment for patients with sickle cell disease.

Observations

HSIB makes the following safety observations:

• It may be beneficial if trusts included a sickle cell disease notification within their electronic patient record systems, to ensure that clinicians treating patients with the disease consider it and seek advice from haematology teams about the impact of any planned treatments, such as invasive procedures.
• It may be beneficial if the healthcare sector explores, researches and fully understands the care provision to all patients with sickle cell disease, at all points in their life, encompassing day-to-day treatment through to sickle cell crisis.

He called an ambulance because of the amount of pain he was experiencing. Tyrone was put onto a PCA pump, which was programmed to deliver morphine at a continuous dose (background rate) per hour, and also allowed him to press a button to deliver a dose at a regulated maximum rate.

He was in pain and was restless throughout the night, but he was found unresponsive the following morning. A post-mortem report stated that Tyrone died from cardiorespiratory failure (his heart and breathing stopped) caused by acute sickle cell crisis and morphine toxicity. The record of inquest stated that ‘the nursing staff had insufficient training to manage and monitor [Tyrone] and his PCA pump’.

Findings

• There is no minimum training requirement or nationally agreed content for Haemoglobinopathy Coordinating Centres to deliver to provide staff with knowledge about sickle cell disease or sickle cell crisis.
• Haemoglobinopathy Coordinating Centres are required to deliver training in line with their service specifications; however, they report finding it challenging to engage NHS trusts and NHS staff in this process in areas where the prevalence of sickle cell disease is lower.
• Trusts faced competing priorities during the COVID-19 pandemic and many trusts may have needed to alter the normal pathway of care for patients with sickle cell disease.
• Where reconfiguration of services requires patients in sickle cell crisis to be cared for in alternative wards/departments within the hospital or by new staff, there may not be the necessary equipment, knowledge or staff training required for care to be delivered safely.
• Staff workload, particularly during the COVID-19 pandemic and in emergency departments, impacted on the ability of staff to conduct increased monitoring requirements, such as the monitoring of patients on high-strength opiates delivered using a PCA pump.

Recommendation

HSIB recommends that NHS England reviews the existing training and competence requirements within sickle cell care provision and specifies the minimum training requirements and content for staff. The content can then be delivered by Haemoglobinopathy Coordinating Centres to increase knowledge about sickle cell disease and how to treat patients in sickle cell crisis.

The Trust’s booking system was only able to produce appointment letters in English, and there were no Trust processes or policies to routinely translate written appointment information.

The family recognised key details in the written information, including the time, date and location of the scan. However, they were not able to understand the instructions about the child not eating or drinking (fasting) for a certain amount of time before the scan.

When the family attended the appointment for the scan, the child had eaten. This meant the MRI scan could not be completed and it was therefore cancelled. When the scan was finally carried out cancer was diagnosed. The child received treatment, but sadly the disease progressed and they were placed on a palliative care pathway and died.

Findings

• Written communications to patients about radiology appointments are routinely sent in English only.
• Healthcare staff expect that written appointment information will be translated by a patient’s friend or family member.
• NHS England standards do not require written appointment information to begiven in any non-English language, other than for people with a disability.
• Confusion about the requirements for appointments can result in delayed care and additional costs if appointments need to be rebooked.
• The language needs of patients are not always clearly understood. There is differing national guidance as to whether written communication needs should be recorded.
• The national NHS system that holds patient information and populates it into many trust systems (the Personal Demographics Service) can store information on patients’ preferred written communication methods. However, this information is often not entered into the system.
• Administrative staff are not routinely involved in assessing and testing electronic booking systems before they are implemented.

Recommendations

• HSIB recommends that NHS England develops and implements a standard for healthcare providers on supplying written appointment information in languages other than English.

Safety observations

• It may be beneficial for NHS care providers to explore options for the translation of written appointment communications, including pre-attendance guidance, for patients whose preferred written language is not English.

Safety actions

• It may be beneficial if the ‘preferred written communication method’ field of the Personal Demographics Service system is completed for patients who require written communications in a language other than English.
• It may be beneficial if NHS trusts identify mechanisms to appreciate the language needs of their patient demographic and adjust the written communications accordingly.
• It may be beneficial to clarify the roles and functions of national organisations in supporting the health inequalities landscape.
• It may be beneficial for NHS healthcare providers to incorporate the NHS Service Standard into agreements with third-party developers of electronic clinical investigation booking systems.

• There is no specific guidance for ED clinicians on the identification of suspected non-accidental injuries and what to do if they suspect an infant has a non-accidental injury.
• There may be barriers to routinely escalating cases of children with a potential non-accidental injury to paediatric (child specialist) and safeguarding teams.
• Delays in the availability of information about potential safeguarding concerns add to the pressures on ED staff when making decisions about infants with potential non-accidental injuries.
• There remain concerns about, and an inconsistent approach to, sharing safeguarding information between organisations.
• The Emergency Care Data Set (ECDS) gathers information about ED attendances and includes a field for when such attendances are related to safeguarding.
• The ECDS safeguarding information collected is not currently utilised within the NHS and there is minimal quality assurance in place to ensure that it is reliable.
• Risk factors for non-accidental injuries which do not meet the criteria to be included on the Child Protection – Information Sharing system (the electronic system designed for information sharing between the NHS and social services) are not included in a patient’s summary care record and may therefore remain unknown to clinicians.
• The investigation identified mechanisms which could enable safeguarding information that is not currently available to ED clinicians, to be made available through existing national and regional digital systems.
• Safeguarding teams are often located physically distant from EDs. This can create a barrier to communication and liaison with the team.

Safety recommendations

• HSIB recommends that the Royal College of Emergency Medicine, working with relevant stakeholders, develops guidance to support clinicians in the diagnosis and management of non-accidental injuries.
• HSIB recommends that NHS England, working with relevant stakeholders, reviews the utility of the safeguarding data in the Emergency Care Data Set and agrees a process for assuring the quality of any data to be captured.

Safety observations

HSIB makes the following safety recommendations:

• It may be beneficial if there was an electronic system available for clinicians to view any safeguarding information to assist in decision making.
• It would be beneficial if the safeguarding operating model, to be tested through pathfinders, included a response time for advice when sought by professionals such as emergency department clinicians
• It may be beneficial if safeguarding teams are either physically located near to, or make efforts to promote their visibility in, emergency departments.

• The investigation found there are currently no long-term haemodialysis catheters on the UK market, or being developed, that have integrated ‘safety-valves’.
• Manual clamps on haemodialysis catheters rely on people ensuring that the clamp is on before accessing the haemodialysis catheter ports and do not mitigate against design-induced error.
• A review of patient safety risks associated with other haemodialysis devices (for example, fistulas) showed several mitigations which are not consistently used for haemodialysis catheters. These include a coloured patient wristband, line labelling, alert cards being carried by the patient and educating patients/family members.
• The training and education of all grades of medical staff has not been consistent in relation to the risks of catheter-related air embolism.
• There is currently no recognised national training or national training guidelines regarding the safe access of haemodialysis catheters.
• Incidents appear to be under-reported to the Medicines and Healthcare products Regulatory Agency, due to misconceptions about ‘human error’ being the cause, rather than the design of the equipment.
• The Medicines and Healthcare products Regulatory Agency, in partnership with NHS England, have explored integrated incident reporting system possibilities. While a recent funding bid to support full development for an in-service solution was unsuccessful, the organisations are committed to drive this project forward.
• There is a general lack of literature on, and knowledge of, catheter-related air embolism in relation to access when the catheter is in situ (in position), rather than during insertion or removal of the catheter.

Safety recommendations

• HSIB recommends that the General Medical Council engages with relevant stakeholders to amend the procedure for taking blood cultures in its ‘Practical skills and procedures’ guidance, making clear that the procedure relates to taking blood from a peripheral site, so mitigating the risks to patient safety associated with central lines.
• HSIB recommends that the General Medical Council, supported by the Medical Schools Council, revises ‘Achieving good medical practice’ to include guidance for medical students on how to handle uncertainty in clinical settings, including challenging a culture, or an expectation, that a learner undertake unfamiliar tasks to gain competencies without appropriate supervision or support.
• HSIB recommends that the Medicines and Healthcare products Regulatory Agency amends its 2022 ‘Dialysis guidance’ to include the safety risk of air emboli associated with unclamped haemodialysis catheters.

Safety observations

• It may be beneficial for manufacturers of haemodialysis catheters to develop an engineering solution to maintain a sealed system upon disconnection, thereby reducing the risk of an air embolism.
• It may be beneficial to consider how junior doctors can be supported to work safely within their level of competence and feel empowered to decline tasks they are not competent to undertake, with specific reference to the safety risks associated with accessing haemodialysis catheters if not trained and competent.
• It may be beneficial to explore the design of a visual alert which prompts healthcare professionals to the increased safety risks associated with in situ haemodialysis catheters and the access to this medical device by staff specifically trained in their use.
• It may be beneficial if the approach outlined in the White Paper published by the National Infusion and Vascular Access Society in 2022 was adopted for wider bore lines such as haemodialysis catheters. This is in relation to a standardised structure and approach for the NHS to deliver vascular access services in every hospital.

• While national guidance says that a patient’s risk of harm should not be stratified into categories such as high, medium or low, such stratification remains common in many trusts. This is because other methods of assessing and documenting risk are not available, and because staff fear being blamed if a patient comes to harm without a risk assessment, including risk stratification, having been completed.
• Current research only demonstrates a link between menopause and low mood, and not between menopause and more severe mental health symptoms.
• Women are frequently prescribed antidepressant medication when hormone replacement therapy may be a more appropriate treatment for their symptoms.
• Menopause is not routinely considered as a contributing factor in women with low mood who are assessed by mental health services, and staff do not receive training in this area as standard.
• While there is a significant amount of national guidance relating to family engagement when treating patients with mental health conditions, mental health practitioners often find it difficult to know how and when to engage with families with complicated relationships or when the patient withdraws their consent for information sharing. There is a lack of training in this area to support staff with decision making.
• National guidance raised the upper age limit for referral to the Early Intervention in Psychosis pathway in 2016. Some trusts continue to prioritise younger patients for a variety of reasons – including funding, capacity and misconceptions about whether an older person can actually be experiencing a true first episode of psychosis in later life.

Safety recommendations

HSIB has made four safety recommendations as a result of this investigation.

1. NHS England: HSIB recommends that NHS England works with appropriate stakeholders, including experts with appropriate experience, to create guidance on culture change. A quality improvement programme should also be developed to support practitioners in undertaking psychosocial assessments that are in line with guidance from the National Institute for Health and Care Excellence. Person-centred safety planning should be embedded within the process.
2. Care Quality Commission (CQC): HSIB recommends that the Care Quality Commission evaluates the way in which it reviews how community mental health services assess risk of harm, to ensure its inspections are in line with the latest national guidance.
3. National Institute for Health and Care Excellence (NICE): HSIB recommends that the National Institute for Health and Care Excellence evaluates the available research relating to the risks associated with menopause on mental health and if appropriate, updates existing guidance.
4. Royal College of Psychiatrists (RCPsych): HSIB recommends that the Royal College of Psychiatrists forms a working group with relevant stakeholders to identify ways in which menopause can be considered during mental health assessments.

Safety observations

HSIB has made the following safety observations:

• It may be beneficial for mental health organisations to have a dedicated liaison officer who acts as a point of contact for both families and clinicians when navigating involvement in a patient’s care and decision making.
• It may be beneficial for organisations to involve families in care planning and assessments, and that practitioners are appropriately trained in working with families.
• It may be beneficial for education bodies to develop training programmes in safety planning and psychosocial assessments, once NHS England has provided guidance on how such assessments should be conducted.
• It may be beneficial for mental health organisations to ensure their Early Intervention in Psychosis referral process is in line with the national guidance, and that staff are clear about the upper age limit of patients accepted onto the pathway.

Safety actions

HSIB has noted the following safety action:

• NHS England has written to all mental health trusts in England to highlight the importance of taking a person-centred approach to psychosocial assessments and safety planning. The communication asks trusts to move away from risk assessment tools that stratify an individual’s risk of suicide or self-harm.

The review identified seven key areas:

1. The language used to discuss and document risk assessments should encourage a dynamic and holistic assessment of the individual pregnant woman/person’s risk (‘dynamic’ means the risk is continually assessed to allow for unknown factors and to handle uncertainty, while ‘holistic’ refers to looking at other factors that might be relevant) that promotes the need for maternity care to be provided by multi-professional teams.
2. Telephone triage services should support 24-hour access to a systematic structured risk assessment of pregnant women/people’s needs.
3. Telephone triage services should be operated by appropriately trained and competent clinicians who are skilled in the specific needs required for effective telephone triage.
4. Face-to-face triage in maternity units should use a structured approach to prioritise pregnant women/people to be seen in order of clinical need.
5. Clinicians should be enabled to proactively monitor and recommend the place of labour care and birth for pregnant women/people based on the individual’s specific care needs during the course of their pregnancy and labour.
6. Each pregnant woman/person should be helped to understand their individualised risk associated with a vaginal or caesarean birth after a previous caesarean birth, based on their specific risk factors and care needs.
7. Pregnant women/people whose labour has been induced need clinical oversight and an individualised plan of care for maternal and fetal monitoring.

Prompts for NHS trusts

This thematic review also includes prompts for NHS trusts to consider how these risks may be mitigated:

• Are risk assessment and screening documents designed and presented in a consistent and logical way?
• Does the language used in risk assessment and screening documents avoid binary definitions of risk, and instead promote dynamic and holistic risk assessments supporting a multi-professional approach?
• Does risk assessment and screening documentation support a holistic consideration and documentation of risk, or does it focus on only single risk factors?
• Do telephone triage services facilitate 24-hour support for systematic risk assessment?
• Are clinicians equipped with the appropriate training, skills and competencies to manage an effective telephone triage service?
• Is a structured approach used so that pregnant women/people are seen in order of clinical need within your maternity face-to-face triage service?
• Are there frequent opportunities to revisit and recommend the place of birth based on the pregnant woman/person’s individual needs?
• Does your risk assessment tool encourage clinicians to think about the most suitable place of birth when a pregnant woman/person in labour is admitted?
• Do processes support holistic risk assessments to be revisited during labour to proactively assess the most suitable place for fetal monitoring and birth?
• In antenatal discussions with pregnant woman/people, are structured tools used to support individualised care planning and decision-making when planning a birth after a previous caesarean birth?
• Is there an opportunity to revisit these discussions when there is a change in circumstance, such as induction of labour?
• Are clinicians encouraged to make individual plans, taking into consideration a pregnant woman/person’s and baby’s risk during the induction of labour process and including frequency of observations, fetal monitoring and place of induction?
• Is there a system to prioritise pregnant women/people requiring induction of labour according to clinical need, and to ensure appropriate escalation and action when there are delays?

• access to computer systems
• the display of information around the bed
• the sharing of information among staff to support familiarity with their patients.

Findings

• Clinical staff are not always able to access accurate, critical patient information at bedsides to support decision making in emergencies.
• Patient identity wristbands are not consistently checked by staff during the undertaking of clinical tasks.
• The expectations of how staff should identify patients in an emergency and access critical information in relation to their care cannot always be met in practice because of limitations of technology and the work environment.
• Concerns around confidentiality can prevent the display of critical patient information at bedsides that may be needed to support safe care, particularly in emergencies.
• What and how critical patient information is displayed at the bedside varies across hospitals, with differences in positioning, visibility, readability and legibility.
• There is no national guidance to support consistency and visibility of critical patient information on low-technology displays (whiteboards/posters) or high-technology displays (via digital systems).
• Lighting on hospital wards can make it difficult for staff to see critical patient information, either through too little light, or too much light causing glare.
• Clinical staff consistently report difficulties accessing digital systems because of limited or poorly functioning hardware. This can result in the use of less reliable, paper-based systems for accessing critical patient information.
• Limited interoperability of multiple digital systems means critical patient information may not be accessible or consistent across all systems used in the care of a patient. Staff need to know which systems contain the information they need.
• Limited ability at a national level to influence the functionality of digital systems and their procurement means healthcare organisations are implementing systems with varying design and functionality.
• At the hospital level, the configuration of electronic patient record systems can introduce further safety risks where the infrastructure and staff training needs necessary for successful implementation have not been fully considered, and the needs of the clinical users have not been fully established.
• There is variation in the words and symbols used to indicate CPR recommendations, and in the level of understanding of CPR recommendations across hospitals, that may influence responses to cardiac arrests.
• Nursing handovers (where information about patients is passed between nursing staff at shift changes) may not provide the information staff need to care for their patients because of where and how they are undertaken. There is no national guidance on how best to undertake handovers of care.
• The implementation of electronic handover systems in clinical workplaces is limited by digital infrastructure, and systems that do not meet the needs of their users.

Safety recommendations

HSIB makes the following safety recommendations.

Office of the National Data Guardian

HSIB recommends that the Office of the National Data Guardian supports local interpretation of the Caldicott Principles to give organisations and staff the confidence to display full patient names at the bedside to support correct patient identification for safer care.

NHS England

• HSIB recommends that NHS England develops guidance to providers, via any digital maturity assessments that are developed, to help ensure critical patient information (such as patient identifiers and cardiopulmonary resuscitation status) is available to clinical staff when accessing electronic patient record systems.
• HSIB recommends that NHS England provides guidance to healthcare organisations to support local design and configuration of electronic patient records to enable end users to access critical patient information (such as patient identifiers and cardiopulmonary resuscitation status).
• HSIB recommends that NHS England, during review of relevant Health Building Notes and Technical Memoranda, includes, as a consideration, that bedside patient information should be consistently visible.
• HSIB recommends that NHS England assesses the priority, feasibility, and impact of future research into what and how critical information pertaining to the emergency care of patients in the acute hospital setting can be readily and reliably accessed at a patient’s bedside.

Resuscitation Council (UK)

• HSIB recommends that the Resuscitation Council UK clarifies and promotes expectations around the sharing, presentation, and language of cardiopulmonary resuscitation recommendations in hospital ward environments in line with the findings of this investigation.

British Standards Institution (BSI)

• HSIB recommends that the British Standards Institution, with support from relevant stakeholders, provides symbology to standardise how information relating to a patient’s resuscitation status can be displayed in digital systems.

Royal College of Nursing

• HSIB recommends that the Royal College of Nursing develops guidance for ward-based nursing handovers with consideration of the following: how handovers are organised, their content, the environment in which they take place and the technology needed to support them.

Safety observations

HSIB notes the following safety observations.

• It may be beneficial for healthcare organisations to provide guidance to support decisions in clinical areas that balance confidentiality and the visibility of critical patient information for patient safety.
• It may be beneficial for healthcare organisations to assess their information technology infrastructure needs, such as equipment availability and network coverage, to enable staff to consistently access critical patient information.
• It may be beneficial if the language used to refer to cardiopulmonary resuscitation recommendations is standardised and clarified through the implementation of the Recommended Summary Plan for Emergency Care and Treatment.

• The assessment of visual signs of jaundice in newborn babies is subjective and more challenging with babies who have black or brown skin.
• Stakeholders have differing opinions about the reliability of visual signs to detect jaundice in newborn babies.
• Some neonatal units have introduced safety measures to mitigate the risk of reliance on visual signs of jaundice.
• National guidance does not recommend routinely measuring bilirubin levels in babies who are not visibly jaundiced.
• National guidance for jaundice in newborn babies maybe more applicable to term babies (those born after 37 weeks of pregnancy) than those born prematurely.
• National guidance does not contain information on how to address the challenges of detecting jaundice in newborn babies with black or brown skin.
• Some universities providing education to NHS students on the detection of jaundice are seeking to ensure that teaching aids and literature represent the diversity of the population.
• Levels of bilirubin can vary according to the gestational age of a baby (how long the baby was in the womb). Laboratory staff do not calculate the gestational age of a baby and therefore whether their bilirubin level is within the expected range.
• Laboratory practice varies in terms of whether they set specific reference ranges for bilirubin in newborn babies; whether they have a defined threshold for communicating results to neonatal units; and whether the telephone alert limit (the level of bilirubin that triggers laboratory staff to report the result to clinical staff by telephone) reflects the thresholds in national guidance.
• Neonatal staff may be unaware that laboratories analyse blood samples to see if they are icteric (indicate jaundice). These staff will not know to look for a comment about this on blood test reports.

Safety recommendations

HSIB recommends that the National Institute for Health and Care Excellence reviews the available evidence and updates its guidance if appropriate, regarding:

• the reliability of visual signs to detect jaundice in newborn babies, particularly in babies with black and brown skin
• risk factors for jaundice identified by this investigation, including prematurity.

HSIB recommends that the Royal College of Pathologists works with stakeholders to understand current practice and make any appropriate recommendations to promote the adoption of an icteric threshold at which a bilirubin test may be cascaded or reported.

HSIB recommends that the Royal College of Pathologists works with stakeholders to understand current practice and make any appropriate recommendations on neonatal specific reference ranges for total bilirubin and thresholds for direct communication of these results to clinicians.

Safety observations

HSIB makes the following safety observations:

• It may be beneficial for regulators of pathology services to consider the findings of the investigation and amend their guidance if necessary.
• It may be beneficial to develop a national standardised Early Warning System track and trigger observation chart for use in neonatal unit settings.

• For healthcare staff, carrying out a robust assessment of risk factors for VTE is challenging, particularly in the complex and busy environment of antenatal clinics, the labour ward and on postnatal wards.
• Multiple competing demands, exacerbated by distractions and interruptions, mean healthcare professionals are constantly having to balance risk and safety for the pregnant women/pregnant people they care for and are trading off the thoroughness of assessments to improve efficiency.
• Midwives are asked to complete a number of risk assessments and screening tools to assess pregnant women’s/pregnant people’s risk at their first antenatal appointment (known as the booking appointment). However, the time needed to carry out these risks assessments may not be reflected in the time allocated for appointments.
• Risk assessments and screening tools are not all designed and presented in a consistent and logical way that would aid staff in completing the task.
• Assessment of VTE risk factors should take place routinely due to body changes in pregnancy and increased risk of VTE.
• Although assessing VTE risk is important, it is a relatively rare condition and there are a number of other competing risks that may take priority.
• Staff do not always involve pregnant women and pregnant people in, or discuss with them, the assessment of their risk factors for VTE. This means pregnant women and pregnant people may not be aware of the signs and symptoms of a possible VTE.
• The importance of knowing the signs and symptoms of VTE may not be fully understood or prioritised by pregnant women and pregnant people who may have other competing concerns and questions about their antenatal and postnatal care.
• National guidance recommends that assessment of VTE risk factors should be repeated when a pregnant woman/pregnant person presents with an ‘intercurrent problem’ (a new health issue which may or may not be related to the pregnancy). However, not all healthcare professionals understand the meaning of ‘intercurrent problem’ and therefore opportunities to reassess risk factors are missed.
• There is a mix of paper-based and electronic record keeping in antenatal and postnatal care. Electronic records systems may lack interoperability and suffer from poor connectivity which limits the ability of staff to access all the data, information, and knowledge they need at the time of assessment.
• Recommendations by MBRRACE-UK (Mothers and Babies: Reducing Risk through Audits and Confidential Enquiries across the UK) for the development of a tool to make the current assessment of VTE risk factors simpler and more reproducible, have not been acted on.

Safety observations

• It may be beneficial for organisations to consider guidance, such as the ‘principles for effectiveness and usability’ provided by the Chartered Institute of Ergonomics and Human Factors, when developing risk assessment tools. The aim being to ensure assessments are simple to use and therefore staff being more likely to do them thoroughly and avoid tick-box fatigue.
• It may be beneficial for organisations that make recommendations to improve the safety and care of pregnant women and pregnant people during their pregnancy and up to 6 weeks after birth, to have a process for reporting on responses to their recommendations. This would support transparency, making it easy to see what has been achieved and what remains outstanding. The aim being to enable tracking of the implementation of actions designed to improve safety and outcomes to ensure they happen.
• It may be beneficial if future research or funding is directed towards identifying the evidence base for the prescribing of low-molecular-weight heparin for venous thromboembolism risk in pregnancy and the first 6 weeks after birth. This will support the production of evidence-based clinical guidelines for the care and treatment of pregnant women and pregnant people at risk of VTE to ensure it is safe and effective.

I write this letter to raise people’s awareness of an imminent advert for a non-executive role at the new independent body, Health Services Safety Investigations Body (HSSIB), aiming to address harm in healthcare.

I urge people to think about and share this new role at HSSIB following my own very personal experience and experience from learning from others in trying to improve health service systems following patient harm events.

For the last 12 years I have played a role supporting four people, as a carer and advocate for frail older relatives and close friends, including my mother and brother-in-law, as they approached their final months, weeks and days of life. Each sadly had poorly met needs, at times with harm caused, in attempts to address common end of life and palliative care needs. In each case I have then engaged in attempts to get learning from these patient harm events to improve both end of life care services but also to improve the way services learn from such events. Very importantly and most relevant for this brief letter has been my growing awareness of the urgent need for services to listen, respect, and act on the concerns and insights of patients and their advocates, in order to get real learning and change in services.

This has been a frustrating long continuing journey, but fortunately I continue to meet inspiring people with similar experiences and goals.

At this point, my priority is to find some excellent, fearless, harmed patient campaigners to apply for this non-executive director role at HSSIB, which I have been involved in various advisory roles since its early conception. I believe HSIB (to become HSSIB) is a key cog in the development of a patient safety system.

This service has had many challenges and difficulties to contend with and has done some inspiring work in very difficult circumstances. There is a wide recognition from those involved that it needs to develop its patient engagement, involvement and inclusion, and safe care model.

I also believe a need to do this at all levels, not only from families referring cases and those being investigated, but also patient family and public involvement in the whole investigation, recommendations and system change process. I am informed also from experience as a family member subject to an investigation and feeding back in many roles.

I believe the valuable work of David Gilbert around patient leadership, and the work of those developing a restorative justice model, such as Murray Anderson Wallace and colleagues,[1] [2] when working with and learning from harmed patients is essential to seriously consider the evolution of this innovative, challenging and essential field of service development.

Please look out for the advert for a non-executive director at HSSIB in the coming days and consider who you know could apply. This will be an exciting opening for a patient advocate and for patient advocacy!

Yours faithfully

Richard von Abendorff 

In personal capacity as an outgoing member of HSIB Advisory Panel and HSIB Citizen Partnership.

References

1. Anderson-Wallace M, Shale S. Restoring trust: What is ‘quality’in the aftermath of healthcare harm? Clinical Risk 2014;20(1-2):16-18.
2. Wailling J, Kooijman A, Hughes J, O'Hara JK. Humanizing harm: Using a restorative approach to heal and learn from adverse events. Health Expectations 2002.

The advert will be shared on the hub once available.

It may be beneficial for NHS care providers to explore options for the translation of written appointment communications, including pre-attendance guidance, for patients whose preferred written language is not English.

HSIB has made three safety recommendations so far as a result of this ongoing investigation:

1. 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.
2. 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.
3. 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

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.

• Conference agenda (PDF)
• Conference brochure (PDF)
• Conference slide deck (PDF)
• Conference investigation education breakout sessions slide deck (PDF)
• Video

• It may be beneficial if local healthcare systems consider how best to support the investigation of cross-organisation safety events as they implement the Patient Safety Incident Response Framework.
• It may be beneficial if national and regional bodies consider how healthcare organisations can be supported to develop effective systems-based solutions to identified patient safety risks.
• It may be beneficial if healthcare organisations develop processes to identify safety improvement themes from patient safety investigation reports.
• It may be beneficial if providers of NHS care consider low-harm and no-harm safety events as sources of learning in local patient safety incident response plans.

The pilot investigations made safety recommendations to the local healthcare organisations. They aimed to highlight issues identified, that if addressed would reduce the risk of future, similar events occurring.

• In March 2020, demand on the NHS 111 system increased. Demand exceeded the system’s capacity, and around half of calls were answered at that time.
• Evidence from families indicated that aspects of NHS 111 telephone triage, such as routing all Covid-19-related calls to the Covid-19 Response Service (CRS), did not function as intended.
• Strong national messaging advised people with suspected Covid-19 to stay at home. This may have impacted on patients’ willingness to seek medical advice from elsewhere, even if their condition deteriorated.
• The CRS algorithm did not allow for an assessment of caller’s comorbidities to establish whether a clinical assessment would be beneficial. Callers would only be transferred to a clinician/receive a clinical call back if they were “so ill that…[they’ve] stopped doing all of …[their] usual daily activities.”
• The healthcare system specified that patients with Covid-19 related symptoms and underlying conditions (including diabetes) who went through to core NHS 111 (instead of CRS) should be escalated to a clinician for assessment. However, some patients did not receive a clinical assessment.
• The intent was that Covid-19-related calls would be diverted to the CRS, which was operationally independent from NHS 111. Many Covid-19-related calls continued to go through the core NHS 111 service. Once callers had reached the core NHS 111 service, there was no way to route them to the CRS.
• Calls that went via the core NHS 111 service should have been audio-recorded, as per NHS 111 guidance. The CRS contract manager told the investigation that CRS calls were also required to be recorded, and all but one CRS provider were initially set up with a recording function. However, no recordings of CRS calls were made available to the investigation.
• NHS 111 call handlers do not usually have access to a patient’s medical history. This increases the importance of appropriate ‘safety netting’ – that is, telling a patient or their carer what they should do if their condition does not improve or they have further concerns about their health.
• Text messages that told a patient they had a positive polymerase chain reaction (PCR) test result included information about isolating and the legal requirements. It did not include sufficient safety-netting advice regarding symptoms to watch for and when and from where to seek medical advice. While this is not related to NHS 111 services, the investigation considers it important to highlight for the future.
• Ahead of the Covid-19 pandemic, there was limited understanding of the risks of such a novel virus to the healthcare system
• The decision to redirect the public to call NHS 111 rather than access healthcare advice in other ways (for example, through their GP) shifted the immediate burden of managing patients with Covid-19 in the community. This increased capacity, in the wider healthcare system, but risked disrupting continuity of care for patients with complex health needs.
• Learning and developments throughout the pandemic have led to improvements in how callers to NHS 111 are assessed and managed. These included recognising the importance of pulse oximetry (that is, measuring blood oxygen levels) to identify silent hypoxia (when a patient has low oxygen saturation levels without becoming breathless) in patients with Covid-19.

Safety recommendations for NHS England

• HSIB recommends that NHS England ensures any Single Service contract or additional services contracts reflects the minimum requirements of the core NHS 111 service for audio-recording calls.
• HSIB recommends that NHS England reviews the risks associated with increased use of telephone triage in response to national healthcare emergencies. Consideration should be given to applying any recommendations of this review across telephone triage services within the wider healthcare setting.

Safety observations

HSIB makes the following safety observations:

• It may be beneficial to review triage software and safety-netting/worsening advice to ensure the language used by health advisors does not deter seriously unwell people from calling back or seeking medical advice if necessary.
• It may be beneficial, when dealing with a novel virus, for consideration to be given to the benefits of a face-to-face assessment for callers with comorbidities.
• It may be beneficial for strategic stakeholders in the healthcare system to understand and articulate adjustments in risk tolerance and thresholds in critical situations.

Safety actions

During the investigation, HSIB became aware of changes the UK Health Security Agency made to processes in a number of areas. These ‘safety actions’ are noted below.

• The UK Health Security Agency has taken steps to ensure governance arrangements are in place to assure themselves that contracted services are monitored and delivered as intended.
• The UK Health Security Agency has taken steps to assure itself of the safe and effective delivery of telephone triage for future healthcare emergencies. These have been tested through the delivery of services for Monkey Pox and Avian Flu.
• The UK Health Security Agency has taken steps to review contractual arrangements to ensure flexibility and the opportunity to implement the most appropriate contract for future public health issue.

Findings

• There are currently no proven treatments available to reduce the risk of preterm labour for twin pregnancies.
• There are gaps in scientific knowledge and challenges to completing research in the field of preterm labour and birth. This creates a challenge for the development of detailed guidelines to support clinical decision making.
• Guidelines and equipment recommended for managing and monitoring singleton (one baby) and full-term pregnancies are used to assist with clinical decision making about preterm twin pregnancies; some interventions within the guidelines are unproven for use in preterm twin pregnancies.
• Research and national improvement initiatives, such as the British Association of Perinatal Medicine perinatal optimisation care pathway and NHS England and NHS Improvement ‘Saving babies’ lives care bundle version two’ and the Maternity and Neonatal Safety Improvement Programme are improving the standardisation and implementation of evidence-based interventions.
• Intelligence from national data gathered by maternity units can support the learning on preterm labour and birth in twin pregnancies.

Safety observations

• It may be beneficial if further research aimed to generate additional knowledge to predict and prevent preterm labour for twin pregnancies among different groups of women/pregnant people.
• It may be beneficial to increase awareness among the public and healthcare professionals of the limitations of interventions for the prevention of preterm labour of multiple births.
• It may be beneficial to regularly analyse data on multiple births so the interpretation of this data can inform learning and research.

Safety actions

Following stakeholder feedback received during an update of the guideline for preterm labour and birth, the National Institute for Health and Care Excellence decided to delete the recommendation relating to milking the cord and amend the subsequent recommendation on clamping of the cord to wait at least 60 seconds before clamping the cord of preterm babies unless there are specific maternal or fetal conditions that need earlier clamping.

There is a known patient safety risk in connection with this where glucose solutions being inadvertently and incorrectly used to flush arterial lines. This has led to inaccuracies in blood glucose measurements, which resulted in unnecessary administration of insulin and subsequent cases of hypoglycaemia, some of which have been fatal.

Findings

The key findings from the investigation include:

• The physical layout and design of the clinical and storage areas will influence how reliably staff are able to select and collect similar-looking equipment and medication.
• The labelling of bags of fluids, similar looking medications and manufacturers’ packaging reduce the reliability of selecting the correct flush fluid in the context of a critical care unit with time pressures and high workloads.
• The procurement and design of arterial transducer line equipment, the pressure infusion bags and transducer, do not assist in the identification of the incorrect flush fluid or prevent contamination from the flush fluid of a blood sample taken from the arterial line. Alternative equipment, for example transparent pressure infusion bags and closed arterial transducer lines, are currently available to the NHS. These may reduce the risk but are not routinely in use.
• Challenges in the provision of a consistent suitable workforce and high workloads have a detrimental effect on the safety controls currently relied upon to avoid or identify the risk of using the wrong flush fluid. Safety checks and training lack resilience to organisational pressures regularly experienced within critical care units.
• There can be a delay in identifying the contamination with glucose of an arterial line blood sample due to a normalisation and acceptance that critically ill patients may have altered blood glucose levels and require insulin treatment, and a perceived low risk associated with the use of a flush fluid.
• The design of systems to record and monitor information relevant to the arterial transducer line system and blood glucose levels do not easily alert staff to the potential use of the wrong flush fluid.
• Recommendations issued over the last 14 years by national safety bodies and professional healthcare organisations to address the safety of blood sampling associated with arterial lines have not been effectively implemented.

Safety recommendations

The report makes the following safety recommendations:

• HSIB recommends that the Medicines and Healthcare products Regulatory Agency [Head of Metabolic Disorders and Renal Systems] engages with other national regulators and relevant stakeholders to develop design guidance on labelling and packaging specific to fluids to reduce selection errors.
• HSIB recommends that the Medicines and Healthcare products Regulatory Agency [Head of Metabolic Disorders and Renal Systems] reviews and acts on the available evidence to regulate for the use of pressure infusion bags that allow fluid labels to be read when inflated.
• HSIB recommends that the Medicines and Healthcare products Regulatory Agency [Head of Metabolic Disorders and Renal Systems] communicates to all relevant stakeholders and acts on the available evidence concerning the management of the risks associated with arterial transducer line sets.
• HSIB recommends that the Department of Health and Social Care [Director of Medical Technology], once post-market surveillance data is available, involves relevant stakeholders including the Association of Anaesthetists’ review and determine appropriate actions that could be taken to further mitigate the risk of blood sample contamination by the flush fluid when using arterial transducer line systems.
• HSIB recommends that the Association of Anaesthetists [President] works with relevant professional organisations to revise existing national guidance to manage the risks of contamination by the flush fluid when using an arterial line to take a blood sample.
• HSIB recommends that the Care Quality Commission [Chief Executive] reviews the recommendations from the Association of Anaesthetists on how to manage the risks of contamination by the flush fluid when using an arterial transducer line and determines any appropriate actions for the oversight of governance and assurance arrangements within NHS providers following.

• The maternity investigation programme has completed 706 reports during 2021/22.
• There has been a 9 percentage point reduction in the number of babies with an abnormal MRI or evidence of neurological damage, from babies referred in 2020/21 compared to 2019/20 (where consent to access medical records was given).
• Over the last year HSIB has made more than 1,740 safety recommendations to trusts addressing a wide range of issues.
• HSIB contacted all families who agreed to do so. However, in 7% of all cases that met HSIB criteria during 2021/22, the families did not agree to any contact being made by HSIB. Therefore HSIB were unable to speak to these families. A further 7% when contacted declined an investigation.
• HSIB has translated information into 31 languages to support families to make an informed choice about being part of the investigations.
• HSIB has implemented a race equality group to develop a considered approach to the use of our demographic data and to help learn how race impacts on people’s lives, experiences and outcomes.
• HSIB has developed an approach to maximise the inclusion of families in investigations. HSIB engages with them at the beginning of an investigation and at significant points during the process to try and understand any needs they may have with regards to communication, health and wellbeing, or day-to-day life.
• HSIB has developed the information it share with trusts to ensure that immediate concerns and emerging themes are shared with them. Trusts receive regular updates on investigations being undertaken and quarterly information to share with their executive boards and frontline staff.
• Quarterly review meetings with trusts continue to see improved attendance from perinatal teams, with maternity board-level safety champions increasingly being in attendance and supporting the frontline teams.
• HSIB has introduced a newsletter to support trusts to share the improvements they have made in response to safety recommendations. This is providing learning opportunities across England and beyond.
• HSIB has piloted work with trusts to develop a Maternity Quality Matrix to provide each trust with insight into their HSIB maternity investigations over time. HSIB plan to roll this out during 2022/23.
• HSIB received feedback from trusts about our investigations and have developed a Maternity Quality Improvement Team to make sure it continues to learn and improve investigations and the processes that support them.
• During investigations HSIB gathers ‘soft intelligence’ relating directly or indirectly to an investigation. This is captured in the maternity observational diary. The diary supports feeding back areas of good practice to trusts and further information relating to the ongoing challenges trusts are experiencing.
• HSIB teams are working with system-level leaders to provide feedback and thematic learning from our investigations.
• During the COVID-19 pandemic, HSIB has continued to work with families and trusts to make sure all communication has been adapted to support families’ wishes.
• HSIB has responded to trusts’ requests to reduce the burden of work required and work collaboratively to ensure investigations are completed.
• The maternity team was part of two live webinars: a joint webinar with the national investigation team in collaboration with ambulance trusts, and a maternity-led webinar entitled ‘Who, what and why?’ which provided information and support for doctors in training.

On being admitted to hospital (for a reason unrelated to her diabetes) a nurse administered her insulin as measured by an insulin syringe, rather than the pen device. However, the syringe was intended for use with standard strength insulin and as a result Kathleen was given five times the dose of insulin that she had been prescribed. She received two overdoses of insulin in this way, on both occasions becoming hypoglycaemic (a condition where a person’s blood glucose level becomes too low, which can be dangerous if not treated quickly) and requiring medical treatment.

Findings

• Trusts vary in their use of high-strength insulin and the number of patients on these medications.
• Healthcare staff in any speciality may be required to care for hospital patients prescribed high-strength insulin.
• Restrictions on promoting the use of an unlicensed medication have made it difficult to communicate the risks associated with the ‘semi-routine’ use of Humulin R U-500 insulin.
• Nursing staff were not always familiar with the range of different high-strength insulins and associated pen devices.
• Variation was seen in the training and competency assessment of healthcare professionals with respect to the administration of insulin.
• National safeguards are inadequate to support the safe use of high-strength insulin by healthcare professionals.
• There is a lack of standardisation in the role and training of diabetes specialist nurses.
• Inconsistent numbers of diabetes specialist nurses are employed across trusts to support the upskilling of ward staff in relation to diabetes management, including on the use of high-strength insulin.
• Administering insulin via a pen device is a complex task that requires coordination across and between different departments to ensure that the insulin and associated equipment required are readily available in the clinical area when they are needed.
• The consequences of not using the insulin pen administration device as intended can be significant, particularly with high-strength insulins.
• Contract changes meant that a safety needle in widespread use across England disappeared from the catalogue.

Safety observations

HSIB made the following safety observations:

• It may be beneficial for insulin training to be competency based and specific to the healthcare practitioner’s role, in line with the ‘Diabetes: getting it right first time’ national specialty report.
• It may be beneficial if national work was undertaken to review the robustness of the strategies to prevent administration errors with high-strength insulin and update accordingly.
• It may be beneficial for systems to support regulators in identifying when large volumes of unlicensed medication are regularly being prescribed to patients.
• Regulators can then engage in dialogue with the manufacturer about applying for a UK product licence.
• It may be beneficial to conduct work to standardise the role, qualifications, training and competency of diabetes nurse specialists, as recommended in the Diabetes UK Position Statement.