1. HSIB recommends that NHS England and NHS Improvement, as a commissioning body, supports local systems to implement evidence-based interventions, such as standardised information and wheeze management plans, for the parents/ carers of pre-school children. This will be undertaken in conjunction with the British Paediatric Respiratory Society.
2. HSIB recommends that NHS England and NHS Improvement reviews the recommendations arising from the National Review of Asthma Deaths to prioritise and ensure the implementation of recommendations that are outstanding.
3. HSIB recommends that NHS Digital reviews the supporting information for triaging the breathless child up to 16 years of age, to determine whether there are features of life-threatening breathing difficulty.
4. HSIB recommends that NHS England and NHS Improvement supports clinical experts to work with professional bodies to develop training competencies for healthcare professionals with responsibility for caring for children with suspected or confirmed asthma.
5. HSIB recommends that NHS England and NHS Improvement and NHSX identify and integrate data items into information technology systems to develop a greater understanding of the risk factors present in the community
6. HSIB recommends that NHSX, supported by NHS England and NHS Improvement, implements a discovery programme into the roadmap for the digital personal child health record focused on developing support, self-reporting and alerting for asthma self-care.
7. HSIB recommends that Public Health England develops resources for young people and their parents/carers to raise awareness and enable them to self-manage asthma more effectively.

• HSIB recommends that NHS England and NHS Improvement develops standards and an operating framework that describes the assurance required for all outpatient appointment booking processes, including after an inpatient stay. The assurance should include feedback mechanisms which provide safeguards that intended outpatient appointments are booked. Ideally, solutions will use technology and automation to create resilience and efficiency so that there is less reliance on staff vigilance.
• HSIB recommends that NHSX’s What Good Looks Like programme includes a requirement for organisations to be responsive to HSIB reports and recommendations within the ‘Safe Practice’ section of its guidance.

The report identifies that while there are controls in place to prevent wrong tooth extraction, they invariably rely on staff to be effective and should not be regarded as ‘strong systemic protective’ barriers. The investigation went further to examine the differences in how the NHS defines and assures barriers in comparison to other safety-critical industries such as oil, gas, nuclear and aviation. The report sets out that in healthcare, the term ‘barriers’ is used generically to refer to measures put in place to prevent the occurrence of patient safety incidents. In other industries, the term is well-defined and has a specific meaning.

Section Four of the report focused on Barrier Management – the process of ensuring that safety controls are robust enough to protect against serious adverse events and their consequences. One of the investigation’s key findings is that whilst most safety critical industries have invested heavily in systems, often mandated by regulatory bodies, for identifying, analysing and assuring barriers, the NHS has not.

Another key finding in the report is that the description of what constitutes ‘barriers’ is not clearly defined in the NHS Never Events policy and framework and is inconsistent with other literature. As a result, one recommendation has been made to NHS England and NHS Improvement to review and ‘explicitly define’ what can be considered a ‘strong systemic protective’ barrier. This recommendation aligns with the findings and recommendations of the Never Events National Learning Report published in January 2021.

• HSIB recommends that NHS England and NHS Improvement revise the Ambulance Clinical Quality Indicator: Clinical Outcomes for ST-elevation myocardial infarction to reflect each element of the call to balloon response and review this indicator alongside the critical time standards workstream.
• HSIB recommends that the Association of Ambulance Chief Executives, working with the College of Paramedics and cardiology specialists, produces a position statement on the use of pre-hospital thrombolysis by paramedics.
• HSIB recommends that NHS England and NHS Improvement support the Joint Ambulance Improvement Programme to respond to emerging risks and research highlighting factors impacting on effective ambulance response.

Safety observations

• It may be beneficial if NHS emergency call handling triage systems consider how intelligent analytics or increased clinical oversight may be enhanced to assist in the early identification of STelevation myocardial infarction calls.
• It may be beneficial if current guidance on the use of thrombolysis as an alternative to primary percutaneous coronary intervention in England is reviewed to consider the challenges posed in safely administering thrombolysis in the pre-hospital setting.
• It may be beneficial if further work was conducted to identify the impact of delays in primary percutaneous coronary intervention on the morbidity of patients, and longer-term mortality of patients, suffering from ST-elevation myocardial infarction. 

• HSIB recommends that the Royal College of Anaesthetists and Centre for Perioperative Care work with relevant stakeholders, such as the Association of Anaesthetists, College of Operating Department Practitioners, and Association for Perioperative Practice, to review, update and integrate new guidance on the surgical safety checklist ‘SignOut’ process. Specifically, the guidance should be updated in relation to the flushing of cannulae and extension lines by strengthening the current administrative barriers, considering the hierarchy of hazard control, and the issues identified by the HSIB investigation.
• HSIB recommends that the Royal College of Anaesthetists reviews its ‘Guidelines for the provision of anaesthetic services’ regarding the planning and oversight of perianaesthetic care in non-theatre settings. This should include: 1 guidance to assist anaesthetic departments to consistently plan for short-notice or emergency cases which take place in the nontheatre setting; 2 planning which considers and mitigates against unexpected changes in conditions.

HSIB makes the following safety observations

• It may be beneficial for healthcare trusts to adopt the programme provided by Health Education England for intravenous (IV) skills, which supports the competency requirements published by the Nursing and Midwifery Council.
• It may be beneficial to increase the use of body maps to record the presence of all indwelling items, such as cannulae, catheter and drains, during an anaesthetic procedure. The body map could be used as part of an enhanced sign-out and to provide instructions for the management of each indwelling item in the postoperative period.
• It may be beneficial for manufacturers to further standardise product specifications to design out the potential for errors. For example, items such as Y-connectors, extension lines and needle-free connectors often look similar but may have differing specifications. 

The review also highlighted that the ‘system factors’ identified in the maternal reviews were seen across the NHS and have been or are being addressed in other HSIB investigations. The seven themes are:

1. Unprecedented demand for telephone health advice caused delays in accessing healthcare.
2. Public messaging and safety netting advice caused delays in presentation.
3. Guidance changed rapidly.
4. Use of early warning scores did not always detect deterioration.
5. Personal protective equipment requirements changed due to COVID-19.
6. Staff described feelings of stress and distress which can affect performance.
7. Difficulties in making a diagnosis and choosing treatment strategies – the difficulties were in the context of clinicians tackling an unknown virus that they had to learn about as it progressed.

HSIB makes the following safety observations:

• It may be beneficial if further work is done to understand the increased risk of maternal death for women from Black, Asian and minority ethnic backgrounds and those with higher socio-economic deprivation.
• It may be beneficial if the NHS England and NHS Improvement communications toolkit for local maternity teams to improve communications with women from Black, Asian and minority ethnic backgrounds is implemented in all healthcare services for pregnant women.
• It may be beneficial if written safety netting advice is developed for pregnant and postpartum women about COVID-19 and other common conditions, incorporating the MBRRACE-UK (Mothers and Babies: Reducing Risk through Audits and Confidential Enquiries across the UK) recommendations.

• Aid their knowledge of systemic patient safety risks.
• Understand the underlying contributing factors.
• Inform decision making to improve patient safety.

HSIB's investigation so far indicates that trusts experiencing issues with oxygen demand have plenty of oxygen reserves [liquid oxygen]. However, the issue lies with a combination of the pipework/system used to deliver the oxygen and where patients needing the most oxygen are cared for along the oxygen supply network.

HSIB therefore suggesting estates, pharmacy services and clinicians work closely together to map out the capabilities of their piped systems. They should consider spreading out patients with the highest need for oxygen more evenly, to help inform decisions about where patients may be safely cared for.

The current pandemic has forced hospitals to reconfigure wards, and in so doing this has unbalanced the oxygen supply.

Many hospitals work on a radial system, so the gas is pumped along the pipe network in one direction. When the system is balanced, anticipated levels of oxygen can be piped to everyone around the hospital. But, with increased and uneven demand on the pipe network - due to a group of COVID-19 patients, for example - oxygen supply levels may be reduced to other patient areas.

NHS England and NHS Improvement

• It is recommended that NHS England and NHS Improvement revises the Never Events list to remove events, such as those presented in this national learning report, that do not have strong and systemic safety barriers.
• It is recommended that NHS England and NHS Improvement develops and commissions programmes of work to find strong and systemic safety barriers for specific incidents where barriers are felt to be possible but are not currently available.

Centre for Perioperative Care

• It is recommended that the Centre for Perioperative Care reviews and revises the National Safety Standards for Invasive Procedures (NatSSIPs) policy to increase standardisation of safety critical steps that are common across all procedures.

Data from national reporting systems shows that there were 14 incidents of misplaced NG tubes from April to September this year. The report acknowledges that measures carried out to tackle COVID-19 have also added to the challenges of inserting and confirming placement of NG tubes.

The report concludes with five safety recommendations focusing on agreeing standards and specifications relating to procurement and design of devices, researching new technologies and standardising competency-based training for national implementation. The report also sets out eight safety observations and three safety actions taken by the Trust following Fabian’s case.

Safety recommendations

• It is recommended that Health Education England coordinates the development and publication of a national standardised competency based training programme for nasogastric tube placement and confirmation by pH testing. The model may include simulation, observed practical assessment and ongoing competency assessment. The competency-based training programme would need to be defined, developed, and tested using a human factors approach prior to any widespread implementation. The competency based training programme will lead to a recognised accreditation which will be transferable across the NHS care providers in England.
• It is recommended that NHS England and NHS Improvement works with the Department of Health and Social Care and others, to identify the process by which the NHS can identify and commission necessary research to support improvements in patient safety. This would include research to confirm nasogastric tube placement.
• It is recommended that NHS Supply Chain and the British Standards Institution work together (engaging other system leaders as appropriate, such as the Medicines and Healthcare products Regulatory Agency and NHS England and NHS Improvement), to develop and publish an agreed standard to minimise the risks relating to human errors in the use of pH strips designed for testing human gastric aspirate at the bedside. The standard should consider product design, regulatory standards, procurement practices and human factors engineering to provide a consistent approach that can be embedded within NHS Supply Chain product specifications.
• It is recommended that NHS Supply Chain develops essential specifications to support the clinicallyled procurement of devices to include devices to confirm nasogastric tube placement, for example, pH testing strips. The essential specifications should set out a range of factors critical to inform the selection by NHS Supply Chain of a product including, but not limited to: clinical output requirements; design and ergonomics; human factors and intended use; and limitations on use and usability. Critically, these specifications should ideally be established in partnership across the healthcare system with clinicians, healthcare professionals and safety leads, while maximising best practice. 
• It is recommended that the British Society of Gastrointestinal and Abdominal Radiologists, working with Health Education England and the Society and College of Radiographers, develops and publishes a national standardised competency-based training programme for X-ray interpretation to confirm nasogastric tube placement. The competency based training programme will include the referral process for X-ray to confirm nasogastric tube position and the subsequent reviewing, recording and communication of the clinical evaluation of the X-ray findings prior to initiation of feed. The standards must meet the Ionising Radiation (Medical Exposure) Regulations IR(ME)R requirements. The competency-based training programme will lead to a recognised accreditation for those qualified to clinically evaluate and record their findings, for example doctors, radiographers and advanced care practitioners. The accreditation certificate will be transferable across NHS care providers in England. 

The investigation highlighted the main implementation challenges. This includes:

• National consistency in drug libraries – smart infusion pumps have an inbuilt dose error reduction system (DERS) which requires the use of a drug library. The investigation found that drug libraries were developed ‘locally’ and that there is no agreed national drug library for use in NHS. They also found that there is no national guidelines or standards on how to implement the libraries.
• Significant changes in processes – introducing the technology requires significant changes to prescribing and administration processes in trusts. The investigation found that procedure and guidance documents often needed updating, and variations in medication practice were ‘locally managed’ and were rarely shared within and between hospitals.
• Provision of specialist IT support and infrastructure – substantial IT infrastructure is needed to support the integration of smart pump technology. Software is needed to upload the drug library to smart pumps, download data logs (including any errors detected) and monitor the status of each smart pump. The investigation highlighted that maintaining the required IT infrastructure required specialist staff roles and often a new skill set.

The investigation found that the implementation of smart pump functionality would benefit from the use of risk management practices, as requirements are complex and similar to the introduction of a new IT system. Existing NHS Clinical risk standards could provide a basis for both manufacturers and trusts to work together to manage risks.

Safety recommendation

• It is recommended that the Care Quality Commission, in collaboration with relevant stakeholders, includes assessment of relational aspects such as multidisciplinary teamwork and psychological safety in its regulation of maternity units. 

Questions to consider

• Does your unit have a role, or another means, separate from the labour ward co-ordinator, dedicated to monitoring and anticipation of activity across the maternity service and troubleshooting, such as a roving bleep holder?
• Do you have regular multidisciplinary ward rounds throughout the day?
• Do you have regular safety huddles and multidisciplinary handovers using a structured information tool?
• Do you hold multidisciplinary in situ simulation and facilitated debriefing that includes both technical and non-technical skills? Are scenarios and incidents encountered in your unit included in the training?
• Do you know what your staff’s perceptions of teamwork, psychological safety and communication are within your unit? Are actions taken in response? How are midwifery staff empowered to contact consultants directly if they have concerns?
• Is time and resource dedicated to regular multidisciplinary forums that provide a safe space to openly discuss scenarios where things did not go well? Do these forums also include discussion and reflection on scenarios where things went well despite unexpected events? 
• Are senior midwifery staff assigned to triage and assessment areas? Is there adequate medical presence in these areas?
• In larger units, is the workload on the labour ward separated into elective and emergency work? If so, are there separate labour ward co-ordinators for each?
• How does the physical infrastructure support work? For example, use of DECT telephones, availability of equipment, consultant offices on/near the labour ward, proximity of antenatal ward and neonatal unit to the labour ward.
• How are issues with staffing and workload escalated and responded to? Are senior trust personnel aware and involved?

It is recommended that the Intercollegiate Stroke Working Party with support from the Joint Stroke Medicine Committee and NHS England and NHS Improvement develop a stroke specific venous thromboembolism (VTE) assessment tool and system for ordering the associated treatment for patients who have suffered a stroke. HSIB recommend that the Intercollegiate Stroke Working Party supports development of a tool that ensures that important information is recorded and reviewed at appropriate

intervals. The following points should be considered in the development of this tool:

• The aetiology/type of stroke (ischaemic and haemorrhagic).

• A record of the individual risk factors for VTE that are identified.

• Contraindications for VTE treatment measures.

• The VTE preventative treatment recommendation.

• The record of administration of that treatment.

• The reason that treatment is not administered.

• Patient’s level of mobility and activity (in relation to IPC administration).

• Frequency of IPC devices checking.

• Record of patient’s consent and understanding of risk/benefits of intervention, including patient’s decision.

Safety recommendations

1: It is recommended that the Department of Health and Social Care, working with NHS England and NHS Improvement, Public Health England, and other partners as appropriate, develops a transparent process to co-ordinate the development, dissemination and implementation of national guidance across the healthcare system to minimise the risk of nosocomial transmission of COVID-19.

2: It is recommended that NHS England and NHS Improvement

• supports additional capacity for testing for NHS patients and staff (Pillar 1 testing)
• facilitates the accessibility of rapid testing for NHS trusts, as soon as an increase in rapid testing supplies becomes available.

3: It is recommended that NHS England and NHS Improvement:

• develops a national intensive infection prevention and control (IPC) safety support programme for COVID-19 which focuses on leadership, IPC technical support, education, practice, guidance and assurance
• develops a national IPC strategy which focuses on developing IPC capacity, capability and sustainability across the NHS in England.

4: It is recommended that NHS England and NHS Improvement reviews the principles of the hierarchy of controls in its health building notes (HBN) and health technical memoranda (HTM) for the design of the built environment in existing and new hospital estate to reduce the risk of nosocomial transmission.

5: It is recommended that NHS England and NHS Improvement responds to emerging scientific evidence and shared learning when reviewing guidance for NHS trusts on the role of hospital ventilation systems in nosocomial transmission.

6: It is recommended that NHS England and NHS Improvement investigates and evaluates the risks associated with the potential impact of staff fatigue and emotional distress on nosocomial transmission of COVID-19.

7: It is recommended that the Department of Health and Social Care reviews and identifies the mechanisms which enabled regional and local organisations to adapt and respond with agility during the pandemic. This should inform the development of a strategic approach to national leadership models at times of crisis and under normal conditions.

8: It is recommended that NHSX considers how technology can assist in mitigating nosocomial transmission in the ward environment with regard to:

• the use of digital communication technologies in assisting with the deployment of staff and the dissemination and circulation of key information
• the increased use and availability of personal computing devices and electronic health record systems.

• It is recommended that the British Association of Urological Surgeons, in collaboration with other relevant specialties (such as the Royal College of Radiologists and British Transplant Society), develops national standards which support electronic and paperbased systems for stent logging/ tracking. These standards should include guidance on monitoring and human oversight.
• It is recommended that the British Association of Urological Surgeons works with the Patient Information Forum to review its stent patient information leaflet. This should include accessibility and clinical considerations, especially with regards to side effects and complications, and advice on the action to take should concerns arise.
• It is recommended that the British Association of Urological Surgeons provides guidance for staff working within the stone care pathway to promote consistent advice to patients as part of discharge planning.
• It is recommended that the British Association of Urological Surgeons encourages members to include information in discharge letters and other communication sent to GPs and patients regarding patients’ stent status, potential complications and the possibility of a retained stent. 

Safety observations

• The NHS Summary Care Records (SCR) system is being developed to allow for specific patient groups to be flagged. It may be beneficial for the British Association of Urological Surgeons to liaise with NHSX should opportunities arise in the future to use SCR to flag patients with ureteric stents to aid communication with primary/urgent care services.
• The National Institute for Health and Care Excellence (NICE) guidance for the management of urinary tract infections does not include ureteric stents as a cause of urinary symptoms which could mimic a urinary tract infection. It may be beneficial for this potential complication to be considered in the next review of this and other clinical practice guidance.

As a result of the national investigation, HSIB has made three safety recommendations to facilitate better understanding of the role of the ward-based pharmacist, and to encourage best practice and resilience when identifying and developing models of pharmacy provision.

1. It is recommended that NHS England and NHS Improvement carry out work to understand and further define the work of hospital clinical pharmacy teams, including the period between initial medicine reconciliation and discharge, in consultation with relevant stakeholders.
2. It is recommended that the Royal Pharmaceutical Society, supported by NHS England and NHS Improvement, should provide guidance on models of hospital clinical pharmacy provision. The guidance should provide information on the models’ ability to enhance safety and healthcare resilience and include consideration of the appropriate skill mix and experience within the clinical pharmacy team.
3. It is recommended that the NHS Specialist Pharmacy Service should update its resource on the prioritisation of hospital clinical pharmacy services to facilitate the dissemination of developments in good practice and policy with respect to pharmacy prioritisation and the issues highlighted in this report.

The guidance available at the time found that Public Health England’s (PHE) primary COVID-19 guidance for home care provision, published on 6 April, did not reference the PPE needed when caring for those within the most vulnerable groups. On 2 April, separate Official UK Guidance on PPE had been published for those working in outpatient, community and social care settings but was not linked to the PHE primary guidance and not easily accessible. Public Health England then issued newer guidance on 27 April (how to work safely in domiciliary care in England) which did include PPE provisions for the ‘clinically extremely vulnerable’ group. However, the original (6 April) guidance was still live and available and did not reference the new update.

After HSIB highlighted the case and the associated safety concerns to Public Health England, they withdrew the link to the primary guidance and provided a link to the newer guidance.

Medical Director, Dr Kevin Stewart said: “Guidance that protects frontline workers and vulnerable patients needs to be as clear and accessible as possible and this is even more important in times of crisis. However, there are multiple guidelines for different care sectors and it is easy to see where confusion can occur as new updates overlap with older versions. Our report recognises the challenges in implementing national guidance and that further work is needed to understand the most effective systems that would enable better version control.

Whilst our analysis focused on PPE guidance for carers working in homes, the risk to patient safety because of poorly communicated guidance is applicable across all healthcare settings. Our aim is to identify specific safety risks for COVID-19 and share that insight as widely as possible to aid the decision-making process and ensure consistent care for all.”

• Working with the Office for Product Safety and Standards and the British Standards Institute to produce a guide to best practice for manufacturers and retailers of button and coin cell batteries.
• Instigating the Royal College of Paediatrics and Child Health and the Royal College of Emergency Medicine to produce a comprehensive guide on button battery ingestion in children covering common signs, symptoms and critical care situations.
• Recognising the importance of digital technology in healthcare by making multiple safety recommendations, nine to NHSX, across a number of our investigations. In our investigations with a digital impact, we discovered there were no standards for system interoperability for medication messaging; that a standardised digital care passport should be developed with a particular focus on supporting patients with autism; and, that there should be better electronic record sharing between the prison health electronic record system and the custodial services system.
• In the report ‘Design and safe use of portable oxygen systems’ one manufacturer decided to act quickly on HSIB's report’s safety recommendations and developed a new component to improve safe delivery of oxygen to patients.
• 88% of families engaging with maternity investigations.
• HSIB's maternity programme highlighting eight areas of learning from our initial investigations which will be developed into thematic national learning reports and published during 2020/21 (‘Severe brain injury, early neonatal death and intrapartum stillbirth associated with group B’ report already published).
• Strengthening our collaborative working relationships with trusts and maternity stakeholders including, the Royal Colleges, Maternity Transformation Board, NHS Resolution and others. The relationship ensures that trusts are immediately informed when there are safety concerns, and actions implemented so similar incidents can be prevented from happening again.

This report, Severe brain injury, early neonatal death and intrapartum stillbirth associated with group B streptococcus infection, highlights a number of patient safety concerns and recommends that maternity care providers should consider the findings and make necessary changes to their local systems to ensure that mothers and babies receive care in line with national guidance. The Healthcare Safety Investigation Branch will keep the theme of group B streptococcus under review and consider a future national investigation to explore this subject further.

• the referrals caseload under the maternity investigations programme for East Kent Hospitals University NHS Foundation Trust
• the themes which were identified as indicative of patient safety risk to mothers and babies
• the engagement and escalation process that HSIB undertook with the trust and the wider system in response.

The purpose is to for HSIB to share their family engagement process with other healthcare organisations involved in patient safety investigations and raise awareness of the value of an effective family engagement process in such investigations.

The report will:

• Describe HSIB’s approach to family engagement in our investigations and what has informed our practice.
• Describe what has worked well in our approach to family engagement.
• Summarise what families and staff tell us about our approach.
• Explain what we have learned and plans for future work.