• The design, layout and décor of wards affected the behaviour of patients and the ‘atmosphere’ on wards.
• Wards that resembled a living space, rather than a clinical environment, were considered by the investigation to have a calmer, happier atmosphere.
• Current guidance on ward design and layout did not reflect current clinical thinking in relation to medicine administration areas.
• The number of learning disability nurses recruited by the NHS each year is currently matched by the number of learning disability nurses leaving the NHS each year.
• NHS England and NHS Improvement has found the retention aspect of its All-England plan for learning disability nursing (attract, retain, develop, and celebrate) harder to implement than the other three aspects.
• In the sites visited by the investigation it was common for registered mental health nurses to fill rota gaps for learning disability nurses.
• The competencies and skills of learning disability nurses and mental health nurses differ when considering how patients are engaged in taking medication. This was rarely considered when using mental health nurses to fill learning disability nurse staffing vacancies.
• Electronic prescribing and medicines administration (ePMA) systems observed by the investigation were not interoperable with electronic patient records systems.
• In the observation sites the investigation visited, medicines omissions were not automatically alerted to the prescribing or Responsible Clinician (the clinician with overall responsibility for a patient being treated under the Mental Health Act).
• The number and descriptions of reasons for medicines omissions varied across ePMA systems and between hospitals.

Safety recommendations

• HSIB recommends that NHS England and NHS Improvement reviews and updates all health building guidance relating to learning disability secure units to reflect current clinical guidance on ensuring the design and layout provides a suitable environment for patients and staff.
• HSIB recommends that NHS England and NHS Improvement develops the ongoing work to improve the retention of learning disability nurses, in line with the intent of the All-England plan for learning disability nursing.

Safety observations

• It may be beneficial if electronic prescribing and medicines administration (ePMA) systems were interoperable with electronic patient records (EPR) systems to allow details of medicines omissions to be alerted to staff automatically from the ePMA system to the EPR system.
• It may be beneficial if user menus on electronic prescribing and medicines administration (ePMA) systems provided clear differences and reasoning for the categories used to record medicines omissions.
• It may be beneficial if organisations that use mental health nurses to cover shortages of registered learning disability nurses review their clinical model and conduct a training needs analysis. The aim of this would be to identify skills or training requirements, to make sure mental health nurses have the relevant communication methods and strategies to assist patients with learning disabilities in taking their medication.

The investigation explores:

• Patient flow through hospitals. 
• How delays in discharging patients from hospitals to social and community care impacts on the ability to move patients from an ambulance into an emergency department and on to the right place of care.

Safety recommendations

• 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.

• There is no requirement to report issues nationally relating to incorrectly decontaminated surgical instruments. This means that the size of the issue is unknown and that the healthcare system does not fully understand the risks and issues it is holding.
• Risks and issues are held within individual SSDs and are not integrated within wider trust management systems.
• Trusts frequently focus on clinical risks and not on the risks that arise from non-clinical supporting departments but which present a patient safety risk.
• There is no national requirement for NHS trusts to have a formalised risk management system.
• All SSDs produce a similar product – decontaminated surgical instruments. The legal status of an SSD determines which national body regulates it (the Care Quality Commission (CQC) or the Medicines and Healthcare products Regulatory Agency (MHRA)).
• The CQC does not inspect SSDs for compliance with regulations and standards.
• The MHRA does not inspect SSDs for compliance with regulations and standards, but relies on external assurance bodies (known as Approved Bodies) to do so. It does undertake a small number of witnessed audits of Approved Bodies while that Approved Body audits an SSD to ensure that standards are being maintained.
• MHRA-regulated SSDs have in place quality management systems, managed at a local departmental level. ‘Top management’ are not involved in this quality management system, therefore risks and issues relating to SSD quality are not formally escalated to a trust organisational level.
• Escalation of SSD quality risks and issues relies on the integrity and professional behaviour of managers rather than being required by policy.
• There is a requirement for manufacturers to design reusable surgical equipment in such a way that it can be decontaminated.
• Surgical equipment can be difficult to decontaminate due to its complexity and size.
• Currently the MHRA regulates under the Medical Device Regulations 2002 which incorporate the European Union’s standards and regulations. The MHRA is restricted in developing its own standards due to market forces.
• To overcome design issues with surgical instruments that relate to decontamination, SSDs rely on decontamination processes to ensure equipment is suitable for use in operating theatres.
• It is difficult to change the design of equipment after it has been approved for use, so the success of the decontamination processes relies on trained and competent staff.
• There is no national competency framework for SSD staff to ensure consistency and standardisation.

Safety observations

• It may be beneficial for sterile services departments and operating theatres to report all incidents of incorrectly decontaminated surgical instruments nationally so that the healthcare system can understand the resulting patient safety risks and issues.
• It may be beneficial to consider the adoption of standardised risk management systems across NHS trusts.
• It may be beneficial to define clear lines of accountability for sterile services departments, to include services provided by NHS trusts and contracted services.
• It may be beneficial to review the process that assures that decontamination of surgical instruments is appropriately considered during the design of surgical instruments.
• It may be beneficial to include a process for cleaning internal surfaces of tubes (lumen) by use of an ultrasonic bath and confirmation clear by high pressure air (where this is not specifically excluded by the device manufacturer) in addition to the requirements set in the manufacturer’s instructions for use.

Safety recommendations

1. HSIB recommends that the Care Quality Commission reviews and ensures that the approach used by healthcare providers to assure themselves that in-house or externally contracted sterile services for decontamination are safe and can identify and respond to patient safety concerns.
2. HSIB recommends that the Department of Health and Social Care assesses the benefits of a single regulatory and assurance framework for sterile services departments and implements the findings as required.
3. HSIB recommends that NHS England and NHS Improvement amends Health Technical Memorandum 01-01 to define ‘top management’ and its commitment to quality, and that external independent audits are reported directly to the responsible executive director in a trust who is accountable for the service, not just the certified department.
4. HSIB recommends that NHS England and NHS Improvement develops a competency framework, stating skills, qualifications and professional registration as required, for all sterile services staff and includes it in Health Technical Memorandum 01-01.

• The initial choice of paracetamol and ibuprofen to control Len’s pain following his fall was in line with national guidance.
• Len’s pain was not effectively controlled on paracetamol and ibuprofen, therefore required review by his GP to address this.
• The choice of a morphine liquid was in line with national guidance and a reduced morphine dose was prescribed in line with recommendations for the older person and Len’s degree of kidney dysfunction.
• Len’s dose of morphine was displayed on the dispensing label attached to the outer box that the morphine was provided in. The label was not seen by Len or his Wife.
• Len and his Wife read the manufacturer’s text on the morphine bottle, which showed the strength of the morphine liquid, and understood this to be the required dose.
• When Len was taken to hospital with difficulty with breathing, he was found to have taken an accidental dose of morphine, he had a chest infection and his Charcot-Marie-Tooth disease may have impacted on his breathing.

Safety observations

HSIB made the following safety observations:

• It may be beneficial if manufacturers of morphine oral solution 10mg in 5ml ensure that any dose measurement aid, if supplied with the medication, is able to measure a full range of possible doses.
• It may be beneficial if professional bodies provided guidance and further support to their members to maximise the learning that can be achieved from safety investigations that may improve patient care.

At 17 and a half years old, the Patient was advised by the GIDS that he would not be seen within GIDS before he turned 18 years old. His referral was then transferred to the waiting list of an adult gender dysphoria clinic (GDC), where his previous waiting time with the GIDS was accounted for. However, the Patient was told that this would still incur a further 22 month wait before he could access specialist gender dysphoria services.

The Patient continued to receive care from CAMHS beyond his 18th birthday while he waited to access the GDC, during which time expressed frustration at the waiting time to access specialist gender dysphoria services. The Patient sadly died by suspected suicide before his 19th birthday.

The national investigation

HSIB was notified of a patient safety incident relating to the waiting times and support available for patients accessing specialised gender dysphoria services. The notification was made by the Trust, which was concerned about its capacity and ability to care for patients waiting to access specialised services.

At the time of the investigation there was a 24-month wait to access the GIDS, and longer waits to access adult GDCs.

Safety recommendation

HSIB recommends that NHS England and NHS Improvement incorporates the findings of this investigation into plans to further review and develop the service specifications for specialised gender dysphoria services. This should include further work with relevant stakeholders to:

• Identify the role of relevant voluntary and charitable sector organisations in supporting patients with gender identity concerns and facilitate information sharing between these organisations and regional professional support services.
• Identify work to improve the transfer of care, management, and proactive risk assessment of patients who are moving from the Gender Identity Development Service waiting list to a gender dysphoria clinic waiting list.

Safety observations

These safety observations are made in support of ongoing national work exploring the care of children and young people with gender dysphoria.

• It may be beneficial if professional bodies produced further advice and guidance to assist NHS staff who may need to provide care to patients with gender identity concerns while patients are waiting to access support from specialised gender dysphoria services.
• It may be beneficial if local healthcare commissioners had up-to-date and easily accessible resources to identify all relevant services within a locality that could provide support to patients with gender identity concerns.
• It may be beneficial if further work considered the ability to allow for shared record systems and ways to appropriately share information between NHS and non-NHS services involved in the care of patients with gender identity concerns.
• It may be beneficial if further work considered the availability and accessibility of specialist training to help in the care of children and young people who have gender identity concerns or gender dysphoria.

This national investigation:

• examined clinical decision making in the diagnosis and treatment of pulmonary embolism (PE) and the role of expertise (significant knowledge and skill that supports effective and practical decision making) using an Applied Cognitive Task Analysis (ACTA).
• identified factors in the wider healthcare system that support or inhibit diagnostic decision making when staff are seeing patients with non-specific symptoms and signs that may suggest PE.

Findings

• Recognising that a person may have a PE is challenging, particularly for less experienced staff and when the person’s signs and symptoms are non-specific or atypical.
• Deciding whether to initiate treatment for a suspected PE requires a decision that balances risks, and this decision can benefit from expert knowledge and skill.
• Despite expertise and the available tools to help identify patients who may have a PE, a small number of PEs may always be missed.
• Experts use different thought processes and show different behaviours when making decisions compared to more novice staff.
• Decision-making skills in healthcare are commonly developed through experience, without formal training or opportunities to practise making decisions.
• Simulation-based learning has the potential to help staff acquire decision making skills more quickly.
• Other industry sectors, such as aviation and the fire service, aim to accelerate the development of decision-making skills through structured training and the use of ‘generic decision tools’ for analytical decisions.
• Emergency departments (EDs) do not always provide the conditions which support the development of decision-making skills.
• Decision making in EDs is affected by workload, workforce availability, and performance targets.
• ED staff asked for further guidance to be provided on the use of decision aids to support the diagnosis of PE.
• The design of ED processes influences the decisions staff make. There is no standard model of initial patient assessment in EDs; this contributes to variation in the requesting of tests which can affect later decisions.
• Pathways for the diagnosis and treatment of PE in outpatient settings may create a safety risk where patients are discharged on anticoagulation medicines without a confirmed diagnosis; the capacity of imaging services is a significant contributor to this.
• Loss of clinical information when a patient’s care is handed over was identified as a further safety risk. This can contribute to harm if tests, such as D-dimer (a blood test used as part of the assessment of likelihood of PE), are not followed up.
• Work procedures for the diagnosis and treatment of PE are not routinely designed in line with human factors principles to support their access and use.
• The physical design of environments may also affect decision making.

Safety observations

1. It may be beneficial for healthcare to learn from other industries and develop its own evidence base on strategies to accelerate the development of expert decision-making skills. These strategies may include: development of a generic decision tool for implementation in healthcare, training and clinical practice to support analytical decision making; incorporation into education programmes of theory around how people make decisions and influences on decision making; the use of simulation as a regular intervention to support practice and development of decision-making skills across scenarios with different levels of complexity; and consideration of the role of simulation in competency assessments for key skills.
2. It may be beneficial if the findings of this investigation are used to support the development of staff expertise in decision making through: building understanding of how experts think and make decisions; supporting reflection on the outcomes of simple and complex decisions; development of clinical supervision skills of senior staff; and regular multidisciplinary case review.
3. It may be beneficial for individual organisations to understand the extent to which national guidance on the diagnosis and management of pulmonary embolism is implemented across their organisations. This would help to identify local barriers to implementation to address. In particular it may be helpful to consider, in line with the findings of this investigation, local engagement with the scoring systems available to help predict the likelihood of a pulmonary embolism.
4. It may be beneficial for emergency departments and same-day emergency care units to have rapid access to recommended imaging for patients who require it for the diagnosis of pulmonary embolism.
5. It may be beneficial for the positivity standard for computerised tomography pulmonary angiography (CTPA) (that at least 15% of CTPAs should show a pulmonary embolism) to be evaluated to understand its effects on emergency department decision making.
6. It may be beneficial for healthcare work procedures to be written in line with the principles for effectiveness and usability provided by the Chartered Institute of Ergonomics and Human Factors.

Before they set off with the patient, one of the paramedics contacted the emergency department (ED) at the first hospital (Trust A) to ‘pre-alert’ them of his arrival. The ED advised that they could not accept the patient as their stroke service was closed between 11pm and 8am, and that the paramedics should contact a neighbouring hospital (Trust B). 

Trust B advised that they could not take the patient as he was outside of the window for immediate stroke treatment and should be taken to Trust A.

Trust A then reiterated that they could not accept the patient. The paramedic phoned Trust B again and they agreed to accept the patient. Once at Trust B, the patient had to wait 40 minutes in an ambulance as the ED was very busy.

It was then confirmed by CT scan that he had suffered an ischaemic stroke (a stroke caused by a blood clot in the brain), and he was taken to the intensive care unit.

Findings

The investigation found that: 

• There was no cross-trust policy in place that clearly defined which FAST-positive patients (patients who show symptoms outlined by the Face, Arms, Speech, Time acronym) should be taken to Trust B overnight. This resulted in different local interpretation of the overnight stroke arrangement.
• The different local interpretation resulted in the patient being “double bounced” between the two hospitals. Staff stated that this was “not uncommon” but would likely resolve once a centralised regional stroke treatment unit (a hyper-acute stroke unit) is in place.
• The electronic search tools accessible to ambulance crews provided inconsistent information about the availability of local stroke services. This was particularly confusing for the paramedics in the safety event, who did not routinely work in the local area.
• When the patient arrived at the hospital, his care was not handed over within the recommended 15 minutes.

Recommendations

The report makes the following local safety recommendations: 

• HSIB recommends that Trust A and Trust B update the information provided to the Directory of Service on the availability of stroke services once they have created a harmonised cross-trust stroke policy.
• HSIB recommends that the Ambulance Trust works with Trust A and Trust B to ensure that their local stroke policies are aligned and direct ambulance crews to the most appropriate service.
• HSIB recommends that Trust B works collaboratively with Trust A to develop a harmonised, cross-trust stroke policy with a clearly defined joint emergency department overnight stroke protocol for FAST-positive patients.

Findings of this investigation included:

• The administration of a blood transfusion as part of resuscitation requires a number of preparatory steps, including collecting the blood and undertaking various checks before using it. Inclusion in resuscitation training of a prompt for clinicians to consider the need for a transfusion, and to prepare for it if appropriate, may help reduce any delay.
• Involving members of neonatal teams (staff who specialise in the care of newborn babies) in multidisciplinary training in maternity units is not routine. Standardising their inclusion in such training would promote a shared understanding of relevant clinical information and ways of working.

Recommendations

The report makes the following safety recommendations: 

• HSIB recommends that NHS Resolution, working with relevant specialities through the clinical advisory group, amends the maternity incentive scheme guidance for year five to include the neonatal team as one of the professions required to attend multi-professional training.
• HSIB recommends that the Resuscitation Council (UK)’s Newborn Life Support training course highlights that neonatal resuscitation teams should consider fetal blood loss in the event of neonatal resuscitation that includes chest compressions. In addition, this consideration should be included in the guidance to support the newborn life support algorithm.

• Oral paracetamol is a widely used medication that has few side effects for most people.
• There is limited data on how oral paracetamol affects adults with low bodyweight.
• Although liver toxicity is a recognised risk with oral paracetamol, evidence regarding the relationship between low bodyweight and the risk of liver toxicity is unclear.
• Two independent bodies are contracted to provide oral paracetamol prescribing guidance for clinicians. The information provided is not consistent.
• There is potential for electronic prescribing and medication administration systems to prompt healthcare providers to record a patient’s weight and consider liver toxicity in those who weigh less than 50kg.
• Environmental and other factors create challenges to the timely weighing of patients on a ward.

Safety observations

1. It may be beneficial for electronic prescribing and medication administration systems to include an alert for oral paracetamol that prompts documentation of a patient’s weight and consideration of the risk of liver toxicity when their weight is less than 50kg.
2. It may be beneficial for the evidence on oral paracetamol and low bodyweight to be reviewed by the relevant national bodies to reach a consensus and agree standardised prescribing guidance.
3. It may be beneficial for available technological solutions, such as beds with built-in scales, to be used to weigh patients. However, the cost of such equipment makes its widespread adoption within the NHS challenging.

Amy’s case formed one part of an initial investigation carried out by the HSIB maternity investigation programme. This investigation identified a potential patient safety risk regarding the pre-arrival instructions given to women/pregnant people by 999 call handlers while they wait for an ambulance. Aspects of the pre-arrival instructions did not align with UK evidence-based maternity guidance (for clinicians in a clinical setting). This was considered to present a risk of harm to women or pregnant people and/or babies.

Similar concerns relating to maternity pre-arrival instructions given by 999 call handlers were identified in 15 HSIB maternity investigations. These were referred to HSIB’s national investigation programme for consideration for a national investigation.

Findings

Findings of this investigation included:

• There are two triage clinical decision support systems in use in England, which provide different pre-arrival instructions for the same maternity clinical scenario for women/pregnant people who are waiting for an ambulance to arrive.
• The different pre-arrival instructions across triage clinical decision support systems, for the same reported symptoms, have different clinical implications/risks, creating a ‘postcode lottery’ of care.
• Stakeholders acknowledged a gap in maternity emergency guidance relating to the non-visual, non-clinician-attended environment.
• The investigation found no evidence of a regulatory mechanism for 999 call handler pre-arrival instructions.

Recommendations

The report makes the following safety recommendations:

• HSIB recommends that the Department of Health and Social Care commissions the National Institute for Health and Care Excellence to work with relevant stakeholders to develop guidance for maternity emergencies in the non-visual, non-clinician-attended environment.
• HSIB recommends that the Department of Health and Social Care identifies a suitable regulatory mechanism to provide formal oversight of 999 maternity pre-arrival instructions across NHS-funded care in England.
• HSIB recommends that NHS England and NHS Improvement develops the content of the patient safety incident investigation (PSII) standards to further support cross-boundary investigations.

Findings of this investigation included:

• There is limited standardisation of handovers, ward rounds (visits to each patient in a ward to review and discuss their care) and huddles (short, focused staff briefings), in terms of which members of the multidisciplinary team are involved, and how they are conducted for maximum effectiveness.
• Processes for the checking of medicines varied without evidence of what constituted the most effective process.
• The environments within which staff prepared and checked medicines influenced their performance.
• There are no standards for what safety-critical functionality should be available in ePMA systems configured for use in paediatrics (for example, the use of weightbased dose bands, where individually calculated doses are rounded to a set of predefined doses).
• Local configuration of ePMA systems potentially introduces variability and risks if not undertaken with clear understanding of the potential hazards and their mitigations.

Recommendations

The report makes the following safety recommendations:

• HSIB recommends that the Royal College of Paediatrics and Child Health identifies the best practice principles for effective paediatric ward rounds in relation to medicines, and disseminates them to its members.
• HSIB recommends that NHS Digital and NHSX promote the organisational requirements for digital clinical safety, including organisations’ responsibilities in terms of safety cases and clinical safety officers, to encompass system functionality and processes.
• HSIB recommends that the Care Quality Commission (CQC) reviews whether a provider’s assurance of its compliance with the Clinical Risk Management standard specific to electronic prescribing and medicines administration systems in healthcare, can form part of the CQC’s developing regulatory model.
• HSIB recommends that the National Institute for Health Research assesses the priority, feasibility and impact of future research on processes for second checking medication, and considers the most appropriate way of building up the evidence base on this topic.
• HSIB recommends that the Medicines and Healthcare products Regulatory Agency works with the manufacturers of electronic prescribing and medicines administration systems to provide guidance on their obligations under the Medical Devices Regulations 2002 (as amended).

• The correct identification of patients relies on staff checking patient details and therefore will not always occur effectively. There may be opportunities for further engineered or technological barriers to help mitigate the risk of incorrect identification.
• The investigation recognises that a single hospital trust may receive patients from multiple ambulance trusts, and ambulances from a single ambulance trust may attend several hospital trusts. Pathways and procedures potentially vary across different trusts and a consistently agreed approach may not exist.
• There may be variation across the country in how NHS numbers are used by trusts for identification of patients. The investigation found that the NHS number may not be being used as per national expectations.

Recommendations:

The report makes the following local safety recommendations:

• HSIB recommends that the nursing home implements a mechanism to use care records with the lowest risk of having incorrect personal identification data during interactions with the wider healthcare system.
• HSIB recommends that the Ambulance Trust carries out additional personal identification data verification when a successful Patient Demographic Service search via NHS Spine has not been achieved.
• HSIB recommends that the Acute Trust, in collaboration with the Ambulance Trust, develops and implements a formal emergency department booking-in policy.
• HSIB recommends that the Acute Trust carries out additional personal identification data verification when an NHS number is not available.
• HSIB recommends that the Acute Trust tests its positive patient identification procedure for patients with dementia in order to identify risks and support the development of effective mitigating controls.

The report made the following local safety observations:

•  It may be beneficial if the Acute Trust reviews the infrastructure and layout of the emergency department majors area in order to support the flow co-ordinator to reliably carry out their full responsibilities.
• It may be beneficial if the Acute Trust considers the results of current research to understand whether a way of visually identifying patients with dementia would be appropriate to help positive patient identification.

 The report also notes the following specific national safety risk:

•  The NHS number is a unique identifier for people living in England (and Wales). There is a risk to the accurate identification of patients when the NHS number is not used as the primary patient identifier.

Response from Patient Safety Learning

Patient Safety Learning welcomes the publication of this report by HSIB.

The local investigation highlighted a number of patient safety issues regarding patient identification, many of which relate to a lack of standardisation.

Standardisation can play an important role in improving patient safety, forming a core component of systems that reduce the opportunity for error and avoidable harm. This is not a new concept, many safety-critical industries adopt such an approach very successfully and the importance of this to healthcare is cited in the World Health Organization Global Patient Safety Action Plan.

The findings of HSIB’s report highlight several areas where the failure to adopt a standardised approach can contribute to errors in patient identification:

• Lack of a standardised and consistent patient ‘booking-in’ procedure in the emergency department.
• Variation in how NHS numbers are used by trusts for identification of patients. The findings in this report suggest that in some cases the NHS number may not be being used as per national expectations.
• Differing pathways and procedures between acute trusts and ambulance trusts.

The scope of this HSIB report is concerned with making recommendations at a local level. Patient Safety Learning believes that the issues highlighted above are likely to have wider applications beyond this local context and require a system-wide review and response from NHS England and NHS Improvement.

Findings of this investigation included:

• The existing systems for triage do not always take into account the colour of a patient’s skin. This may influence a healthcare professional’s assessment of an infant’s/child’s physical signs.
• Staffing standards that relate to the treatment of children in emergency departments cannot always be met due to workforce challenges, particularly in hospitals without a dedicated paediatric emergency department.
• Sometimes parents describe feeling powerless when trying to articulate their concerns for their child. Some healthcare professionals do not always consider or listen to what parents are telling them.
• The Association of Ambulance Chief Executives are not currently involved in the ongoing national work to develop early warning scores for infants and children.
• Undergraduate training for paramedics on the identification of sick infants/children is variable across England.
• There is inconsistency across English ambulance services in training for ambulance personnel, including paramedics and non-registered clinicians, on the identification of sick infants/children.

Recommendations

The report makes the following safety recommendations:

• HSIB recommends that the Chair of the NHS System-wide Paediatric Observations Tracking (SPOT) Programme ensures that the Association of Ambulance Chief Executives, community NHS 111 providers and primary care services are integral members of the NHS SPOT Programme.
• HSIB recommends that NHSX develops national standards describing the electronic deployment of the NHS System-wide Paediatric Observations Tracking (SPOT) e-PEWS (the digital version of the Paediatric Early Warning Score tool), in collaboration with the NHS England and NHS Improvement SPOT Programme. This should include specifications for data capture, calculation of the score and escalation status, and also the display of the information and connectivity with other digital systems.
• HSIB recommends that the Chair of the NHS System-wide Paediatric Observations Tracking (SPOT) Programme ensures that any resources produced include examples of children and young people with non-white skin showing signs of serious illness.
• HSIB recommends that the Association of Ambulance Chief Executives works together with the ambulance services to share best practice in relation to paediatric training, education resources, frequency and types of training, and that it collates and shares areas of best practice.
• HSIB recommends that the College of Paramedics works with partners and higher education providers to develop, agree and implement standards for paediatric education for the future ambulance service workforce.

Response from Patient Safety Learning

Patient Safety Learning welcomes the publication of this new report by HSIB looking at ways to improve patient safety in relation to recognition of the acutely ill infant and child. Our reflections on this report are as follows:

Increased collaboration within the NHS SPOT Programme

We welcome HSIB’s recommendation that the NHS SPOT Programme should ensure it includes involvement from the Association of Ambulance Chief Executives, community NHS 111 providers and primary care services. The tragic circumstances of Mohammad’s death clearly emphasise the important role that each of these different services can play in the process of recognising life-threatening bacterial infections in very young patients.

Health inequalities

This investigation specifically draws attention to how existing systems for triage in primary and secondary care are not always considering the colour of a young patient’s skin, noting the impact this may have on a healthcare professionals’ assessment of physical signs. The report indicates that the importance of considering how symptoms and signs can present differently on dark skin has been highlighted in Mind the Gap: A handbook of clinical signs in Black and Brown skin. They also refer to the ongoing work of the Skin Deep Project, which aims to develop a free, open-access bank of high-quality photographs of medical conditions in a range of skin tones for use by both healthcare professionals and the public.

We welcome HSIB’s specific recommendation that the SPOT programme should seek to ensure its resources include examples of children and young people with non-white skin showing signs of serious illness. We know however that safety issues faced by patients due to the colour of their skin are not limited to these specific cases.

In line with the ambition set out in the NHS Long Term Plan to take a more concerted and systematic approach to “reducing health inequalities and addressing unwarranted variation in care”, we believe this should be a priority issue for the NHS National Patient Safety Team. We would like to see them working together with the Dr Bola Owolabi, Director – Health Inequalities at NHS England and NHS Improvement, to scope a potential programme of work in this area.

Listening to parents

The report highlights communication concerns from Mohammad’s parents, noting “the family’s perception is that they trusted what staff were telling them but that they were ultimately not listened to”. This remains a recurring problem in healthcare and emerges time and again in patient safety failings. Too often concerns raised by patients and family members are not acted on and, when harm occurs, they are left out of the investigation process.

In our report, A Blueprint for Action, we set out what we believe is needed to progress towards a patient-safe future, identifying six foundations of safe care. Patient engagement is one of those six foundations. In this, we outline how patients should be engaged for safety at the point of care, if things go wrong, in improving services, advocating for changes and in holding the system to account.

The value of early warning scores

The report highlights that research shows that existing early warning scores are not sensitive or specific enough to help health professionals to distinguish between a seriously unwell infant/child and one with a mild viral illness. It states that “changes in vital signs (for example temperature, heart rate and respiratory rate) may be predictors of deterioration in an infant or child but they may also simply reflect that a child is unwell but not at significant risk”.

We find it surprising therefore that there is not a reflection or recommendation on the need to support clinicians in their assessment of deteriorating patients, such as the further development of early warning scores.

Review of ambulance service training

The report notes the following safety observation:

“It may be beneficial if the 10 English ambulance services review and assess their paediatric training provision and report this assessment to their trust board.”

HSIB explains this observation is intended to “identify all clinical staff working in the ambulance service that have accessed ‘Spotting the sick child’ or equivalent training as an education resource and find out how often it has been accessed, and to highlight any gaps in training needs for recognition of the acutely ill infant/child”.

It is our view that it would be preferable for this to be a specifically cited safety recommendation for implementation and response.

Findings

The investigation identified the following learning points for potential national benefit:

• The correct identification of patients relies on staff checking patient details, and therefore will not always occur effectively. There may be opportunities for further engineered or technological barriers to decrease the chance of incorrect identification.
• The design of the digital systems considered in this investigation did not always account for variations in how people identify themselves (for example, by different names). Those systems also did not make it clear to staff where patient demographics (that is, details such as the patient’s name, date of birth, address and NHS number) might be incorrect.
• The investigation recognises that a single hospital trust may receive patients from multiple ambulance trusts, and ambulances from a single trust may go to several hospital trusts. Pathways and processes potentially vary across different trusts and a consistently agreed approach may not exist.
• The use of NHS numbers to identify patients may vary across the country. The investigation found that the NHS number may not be being used according to national expectations.

Recommendations

The report makes the following local safety recommendations:

• HSIB recommends that the Ambulance Trust develops and implements a standardised approach to patient identification in the emergency operations centre.
• HSIB recommends that the Acute Trust develops and implements a standardised approach to patient identification in the emergency department.
• HSIB recommends that the Acute Trust explores the barriers to checking three identifiers when confirming a patient’s identification for their wristband, and takes appropriate action.

The report also made the following regional safety recommendation:

• HSIB recommends the Acute Trust work with the Ambulance Trust to develop and implement a standardised approach to verifying and confirming a patient’s identification during the handover process.

Response from Patient Safety Learning

Patient Safety Learning welcomes the publication of this report and HSIB exploring new approaches to their patient safety investigations through this pilot programme. Our reflections on this report are as follows:

Wider value of these findings

In their report HSIB make four recommendations relating to the Acute Trust and Ambulance Trust in this case. It may be that there are similar issues occurring in other trusts across the country and that there would be value in NHS England and NHS Improvement reviewing patient identification processes more broadly in line with these findings. We would also suggest it would be helpful if NHS England and NHS Improvement could identify examples of patient identification good practice that could be shared more widely.

Role of patient and family engagement

HSIB states in its report that the patient, when offered the incorrect medication, declined this, but for unclear reasons. It also notes the role played by the patient’s Granddaughter in identifying this error on two separate occasions:

• On the first day she alerted staff to incorrect information on the patient’s wristband, but no record was made of this.
• On the fifth day she alerted staff to an error regarding her grandmother’s details on medical records.

It is notable however that the error was not formally addressed until the pharmacist noticed a discrepancy and confirmed this was an error when speaking to the patient’s Granddaughter. We believe this serves to underline the importance of engaging and listening to patients and their family members. This patient safety issue may have been identified and addressed much more swiftly if the patients Granddaughter’s concerns about incorrect patient information had been followed up on appropriately.

CPAP is often used to support a patient’s breathing in critical care or high dependency units, where there are high numbers of staff to patients. Staff in these units are trained and familiar with the use of non-invasive respiratory support.

During the first and second waves of the COVID-19 pandemic, however, many more patients needed CPAP than there were beds in critical care and high-dependency units. Thus, hospitals had to create alternative areas and arrangements for delivering and caring for patients who needed CPAP.

This investigation looked at the use of CPAP outside of critical care and high dependency units during the COVID-19 pandemic, specifically focusing on care for acutely unwell patients require CPAP in the side rooms at general wards.

Findings

Key findings of in the investigation included:

• The treatment of patients with COVID-19 with CPAP in side rooms on general wards poses a patient safety risk without central monitoring, with staff not able to clearly see the patient and often unable to hear the equipment alarms designed to alert them to a problem.
• The impact of the COVID-19 pandemic on staffing levels, through illness and self-isolation requirements, created a challenge to caring for acutely unwell patients requiring non-invasive respiratory support outside of critical care of high-dependency units.
• Staff caring for patients with COVID-19 requiring CPAP on general wards need training and competency assessment to feel confident in delivering care.

Recommendations

This HSIB report makes no specific recommendations. It notes that documents have been published by the Intensive Care Society, the British Thoracic Society, Getting It Right First Time and others during the course of its investigation that have made recommendations that have address the safety risks it has identified.

HSIB lists the following recommendations in these other reports that it also endorses in response to its findings:

• Hospitals should establish respiratory support units that are staffed in line with existing national recommendations. This includes a minimum nurse-to patient ratio of 1:4, with nurses trained in administering CPAP and high-flow nasal oxygen.
• Patients requiring non-invasive respiratory support such as CPAP should be centrally monitored. Central monitoring allows patients to be observed and equipment alarms to be heard at the central nurses’ station.
• Hospitals should have protocols that define the frequency of nursing review (that is, how often a nurse checks on a patient), especially for acutely unwell patients located in side rooms.
• Hospitals should have checklists for the safe use of CPAP/NIV outside of critical care and high-dependency units. For example, the British Thoracic Society and Intensive Care Society (2021a) guidance on establishing respiratory support units includes a checklist for the safe use of CPAP/NIV outside of critical care and high-dependency units.
• Minimum safe staffing levels should be followed when caring for patients who require non-invasive respiratory support.
• Where possible, organisations should procure CPAP devices that allow remote monitoring.
• Staff caring for patients requiring non-invasive respiratory support outside of critical care settings should meet training and competency requirements.

• Safety issues associated with the establishment of surgical services in independent hospitals to support the NHS and in particular the specialist services that are in place to deliver patient care.
• The assessment of patients prior to surgery to identify their risk and suitability for an operation and where it was to be undertaken; this included identification of patients with frail physical states.

Key findings included:

• National and local NHS organisations had limited understanding of independent hospitals’ capabilities. This resulted in variation in how independent hospitals were used during Covid-19.
• Some independent hospitals saw patients with increasingly complex conditions and undertook more complex operations during Covid-19. The increasing complexity was well managed where capability of the independent hospitals had been evaluated and addressed prior to implementation of new services.
• Where pathways between NHS and independent hospitals were effective, it was often found that relationships between the hospitals had been longstanding and direct.
• There was variation in how preoperative assessments were undertaken across NHS and independent hospitals. This included what tests were ordered and risk assessments undertaken.
• Preoperative nutrition screening was inconsistent across NHS and independent hospitals. Examples were identified where it was not undertaken, or undertaken too late to allow any preoperative optimisation – that is, to make sure the patient was in the best possible nutritional state before their operation.
• Remote preoperative assessment became the norm during Covid-19, but created risks when staff were not able to see the patient. Lack of video call facilities and staff preference meant assessments were commonly done by telephone.

Safety recommendations

• HSIB recommends that NHS England and NHS Improvement ensures that effective processes have been implemented in integrated care systems to identify local capability and capacity of their independent acute hospitals.
• HSIB recommends that NHSX expands its work programme addressing the challenges associated with interoperability of information systems used in healthcare to include transfer of information between the NHS and independent sector in support of safe care delivery.
• HSIB recommends that the Care Quality Commission reviews and appropriately develops its methodology for regulatory assurance of arrangements between NHS and independent providers for the provision of care across care pathways. This is to include any screening and risk management processes used to ensure the safe transfer of care between providers.
• HSIB recommends that NHS England and NHS Improvement reviews models of perioperative care for their value and impact. This should inform future work to support implementation of a standardised approach, based on evidence, across all healthcare providers that deliver surgical services.
• HSIB recommends that NHS England and NHS Improvement establishes a process to ensure that findings of the National Institute for Health Research’s policy research programme into frailty in younger patient groups are reviewed and acted upon.

• sought to understand the context and contributory factors influencing a delay in lung cancer diagnosis in a patient repeatedly attending primary care with non-specific symptoms.
• identified the systemic factors that help or hinder the detection of lung cancer on chest X-rays.
• considered the utility of chest X-ray to assess for lung cancer in symptomatic patients being seen in primary care.
• identified the implications of the findings for mitigating the risk of delayed diagnosis of lung cancer.

Safety recommendations

1. HSIB recommends that NHS England and NHS Improvement work with research partners to explore options for commissioning research to address whether low-dose computed tomography (CT) is clinically- and cost-effective for the diagnosis of lung cancer in symptomatic patients seen in primary care compared to chest X-ray.
2. HSIB recommends that the National Institute for Health and Care Excellence (NICE) reviews its current safety netting advice to healthcare professionals with respect to the investigation of possible lung cancer. The wording of the advice should be amended as required to make it clearer what should be offered to patients with ongoing, unexplained symptoms who have had a negative chest X-ray.
3. HSIB recommends that NHSX, in collaboration with relevant stakeholders such as The Royal College of Radiologists and The Society and College of Radiographers, develops guidance to support independent benchmarking and validation of artificial intelligence algorithms for the identification of lung diseases such as cancer.

HSIB made eight safety recommendations as a result of this investigation, five to NHS England and NHS Improvement, one to the Royal College of Obstetricians and Gynaecologists, one to NHSX, and one to DHSC.

1. HSIB recommends that future iterations of the Royal College of Obstetricians and Gynaecologists’ guidance clarify the management of a reported change in fetal movements during the third trimester of pregnancy with due regard to national policy.
2. HSIB recommends that NHS England and NHS Improvement leads work to develop a process to ensure consistency and clarity across national maternity clinical guidance.
3. HSIB recommends that NHS England and NHS Improvement leads work to collate and act on the evidence on the risks and benefits associated with the use of remote consultations at critical points in the maternity care pathway.
4. HSIB recommends that the Department of Health and Social Care commission a review to improve the reliability of existing assessment tools for fetal growth and fetal heart rate to minimise the risk for babies.
5. HSIB recommends that NHSX develops specifications for electronic patient record (EPR) systems that require adherence to national interconnectivity standards for the exchange of core maternity healthcare information. The specifications should include functionality to enable both women and pregnant people and professionals to add to the record, and also support alerting functionality.
6. HSIB recommends that NHS England and NHS Improvement develop minimum operating standards for interpretation services in maternity care which will include a communication risk assessment.
7. HSIB recommends that NHS England and NHS Improvement leads the development of minimum operating standards for pre assessment maternity telephone triage services to support safe and consistent telephone triage to ensure reliable identification of risks.
8. HSIB recommends that NHS England and NHS Improvement develop a framework to support Trusts to anticipate operational risk in maternity services when delivering neonatal resuscitation.

1. access to care and transitions of care (when patients move between care providers or care settings)
2. communication and decision making
3. checking at the point of care.

These three themes represent the most significant threats to patient safety that HSIB has found, based on its investigations, so far.

This analysis also looked at the 85 safety recommendations made in the 22 investigations. These safety recommendations were grouped into one or more of six categories. The categories were chosen as they represent the fundamental safety management activities used across safety-critical industries:

• identification of patient safety hazards
• improving the management of known patient safety risks
• monitoring of patient safety performance
• evaluation of patient safety interventions
• training and education for patient safety
• promotion of patient safety.

Safety management systems seek to proactively mitigate threats to safety before they result in undesirable outcomes. Through the implementation of safety management systems, all those involved in safety can integrate their activities. This enables a prioritisation of actions to address safety issues and effectively manage resources.

HSIB’s work so far suggests that it may be beneficial for the NHS to explore how the application of safety management principles could build on the foundations developed by the NHS Patient Safety Strategy. The complexity of the NHS means that it is unlikely that having one single safety management system would be feasible and that a more integrated approach of multiple systems, as seen in other high-risk industries, may be necessary. A greater adoption of the principles of a safety management system in the NHS may support more effective responses to HSIB’s safety recommendations which can be a challenge in this complex environment.

• Assessing the resilience, consistency and reliability of the pathway(s) for patients experiencing potential red flags for CES.
• Seeking to understand the context and contributory factors influencing the pathway for patients with CES from their first presentation.
• Reviewing the national context surrounding the timely detection and treatment of spinal nerve compression (CES) in patients with back pain.

Safety recommendations

1. HSIB recommends that the British Association of Spine Surgeons, supported by the Royal College of Surgeons of England and the Royal College of Emergency Medicine, develops a decision-making tool to support the identification of patients who need an immediate MRI for suspected CES (which may result in the patient being transferred for MRI if this is not immediately available at the assessing site).
2. HSIB recommends that guidance is developed by the Royal College of Radiologists, supported by the Society and College of Radiographers, stating that all hospitals should reserve the first MRI slot of the day for patients with suspected CES who do not meet the criteria for an ‘emergency’/immediate scan overnight.
3. HSIB recommends that the British Association of Spine Surgeons oversees the development of national guidance to identify how ‘urgent’ and ‘emergency’ requests for scans for suspected CES are defined and prioritised.
4. HSIB recommends that the National Institute for Health and Care Excellence updates its current low back pain guideline to include the symptoms and initial management of CES. This update should include a review of the role of supplementary investigations, such as bladder scanning, in patients with suspected CES.
5. HSIB recommends that NHS England and NHS Improvement develops a national CES pathway. This should define the safety-critical elements of the pathway and highlight areas that can be adapted locally.

Over 2020/21, HSIB maternity investigation reports have contained 1500 safety recommendations to trusts, addressing an array of issues and the most frequent emerging themes. This includes:

• effective escalation of safety concerns about mothers and babies
• clinical oversight
• clinical assessment and monitoring
• use of clinical guidelines influence the care provided
• impact of pathways of care crossing healthcare boundaries.

• HSIB recommends that NHS England and NHS Improvement amends the ‘Saving Babies’ Lives care bundle version 2’ to enhance the role of the ‘fetal monitoring lead’ to include, training and competency checks of all maternity staff on the use and functionality of cardiotocograph (CTG) equipment.
• HSIB recommends that NHS England and NHS Improvement amends the ‘Saving Babies’ Lives care bundle version 2’ to remove specific references to DawesRedman and instead use a generic term such as ‘computerised cardiotocograph (CTG) analysis’.
• HSIB recommends that the National Institute for Health and Care Excellence considers reviewing its telemetry recommendation as part of the current update of clinical guideline CG190, taking into account the existing evidence and the findings of this report.

Safety observations

• It may be beneficial for trusts to ensure that when procuring new equipment, they form a multidisciplinary team, which incorporates staff with the requisite skills in procurement and the clinical environment in which the new equipment will be used. If the new equipment has additional functionality, then stakeholders from these areas should be included – for example, if the equipment is to be networked the IT department should be included.
• It may be beneficial if a single procurement guidance document were produced for trusts to use when purchasing clinical equipment, with all relevant information included.
• It may be beneficial for trusts to use a change management system when implementing new systems or introducing new equipment.

Safety recommendation

• HSIB recommends that NHS England and NHS Improvement leads a review of risks relating to patient identification in outpatient settings, working with partners to engage clinical and human factors expertise. This should assess the feasibility to enhance or implement layers of systemic controls to manage these risks. It should also consider existing challenges relating to the usability and practice of including the NHS unique identifier in patient identification processes, and consider technological solutions to support its use.

Safety observations

• It would be beneficial if scheduling, resources, and organisational performance targets were considered relative to the associated demand for care and interventions, as staff workload may influence the integrity and sustainability of safety checks in an outpatient setting.
• It would be beneficial if it was easier for trusts to find clear national guidance on what a good patient identification check looks like to assist the quality and consistency of trust guidance.
• It would be beneficial if the risks associated with patient identification in an outpatient department are considered within staff education and in the procurement and implementation of technical systems.
• It would be beneficial if there was national guidance on the principles for good design of tools to support the critical task of patient identification. Safety observation O/2021/114: It would be beneficial if trusts trained or employed suitably qualified and competent patient safety specialists to align with the national Patient Safety Syllabus currently under development.