The new NHS patient safety strategy brings together a number of initiatives around safety and learning to prevent harm:

• a new safety and learning system to replace the National Reporting and Learning System (NRLS)
• a new system for investigating serious incidents – the Patient Safety Incident Response Framework (PSIRF)
• the work of the Healthcare Safety Investigations Branch (HSIB)
•  implementation of the medical examiners (ME) system to scrutinise deaths
• insight from litigation to prevent harm;
• various improvement programmes (e.g. maternity and neonatal, medicines and mental health)
• sector-specific issues (e.g. older people, learning disabilities).

 At its core is a call from NHS England/Improvement (NHSE/I) to ‘significantly improve the way in which the NHS learns, treats staff and involves patients’. They consider that getting patient safety right could save around 1,000 lives and £100m in care costs each year from 2023, with potential to reduce claims provision by around £750m a year by 2025. NHSE/I intend to publish updates to the strategy annually, every summer.

Strategic aims

The interplay between normal human behaviour and systems is identified as a ‘knowledge gap’ that needs to be plugged.  Future development of both patient safety culture and systems will be supported by the ‘3Is’.

• Insight – improving understanding of safety by extracting intelligence from multiple sources. For example: from the new national safety and learning system, the PSIRF, the work of MEs and sharing insight from claims.
• Involvement– giving patients, staff and partners the skills and opportunities to improve patient safety. For example:
  • Creating Patient Safety Partners (PSPs) as ‘vigilant stakeholders’ in safety, involved in service and pathway design, safety governance and strategy and policy.
  • Devising a system-wide patient safety syllabus and education and training framework for the NHS. Where possible the training (which will include PSPs) will be delivered in multidisciplinary teams across patient pathways.
  • Appointing Patient Safety Specialists to lead on safety in their own organisations

• Improvement – designing and supporting programmes that deliver effective and sustainable change in the most important areas, for example: maternity and neonatal, medicines and mental health.  A National Patient Safety Improvement Programme will build on the National Patient Safety Collaborative Programme with 4 national priorities identified for 2019-20:  preventing deterioration and sepsis; medicines safety; maternal and neonatal safety and adoption and spread of effective evidence-based practice.

A different focus: Safety I and Safety II

Learning from excellence creates a more positive culture. So, instead of focusing on the rare occasions when things go wrong (Safety I) consideration will be given to the occasions when things go right (Safety II). Safety II training will be incorporated in the national patient safety syllabus and in the system replacing NRLS

Foundations for safer care

Culture

The prevalence of fear in relation to NHS patient safety incidents was a consistent message from the consultation.  The report identifies a need for ‘just cultures’ free of fear or blame. The focus should be on systems rather than individuals save for the rare cases where there is a need to protect patients from an individual who is malicious or unfit to practise.

Comment:  Healthcare providers need to embed a safety culture in their organisations in order to comply with the CQC’s well-led framework and Key Lines of Enquiry. NHS Resolution’s 2019 paper ' Being fair' proposes a ‘Just and Learning Culture Charter’ to help individuals and organisations create such a culture for everyone working in and receiving care across health and social care.  Those responsible for managing incidents are encouraged to use the science of human factors to maximise learning to avoid harm.

Systems

All NHS organisations should share information about risk and best practice locally. At regional and sub-regional levels the challenge is to tackle problems that cut across care settings, oversee the safety of care and help scale evidence-based quality improvement initiatives.  National bodies can not only set standards to enhance safety but develop best practice from across the world.  To ensure that the right action is taken by the right organisation, a Guide to Patient Safety in the NHS will be published and kept up to date.

As the roll-out of integrated healthcare gathers pace, the digitisation of clinical processes across healthcare systems will play a critical role, for example electronic records.

The role of regulation in the safety process is acknowledged and a single patient safety syllabus for adoption by all regulators is proposed.

Comment:  Healthcare organisations will need to ensure that their patient safety policies are aligned with the Guide. While digitisation of processes and records reduce patient safety risk, it is likely to introduce risk around data security. As a result, healthcare organisations will also need to ensure that their data security policies are kept under review.

New digital system to replace NRLS and StEIS

In future, there will be a single, simple portal with updated definitions of harm: physical and psychological harm. It is intended that data can be input by patients, carers and the public as well as healthcare professionals.

Learning from complaints

The inter-relationship between complaints and incidents will be explored to ensure that opportunities to learn from complaints are not missed.

Data analysis

Mortality reviews will be included to better understand end of life care and will be linked in with the new ME system. 

Comment: The simpler (and broader) definitions of harm are likely to lead to more incidents being reported and investigated with a potential increase in resource requirements.  In our experience, there is often much to be learnt from complaints investigations and the proposal to consider the inter-relationship between complaints and incidents is to be welcomed. NHSE/I expect the live phase of the new system from Q1 2020/21.

The new PSIRF

The new framework has been designed to ‘support insight generation at the point of care’.   Key changes include:

• Broader scope – moving away from a focus on current thresholds for serious incidents.
• Setting expectations for transparency and support for those affected
• A risk-based approach to incidents – based on ‘proportionate and effective learning responses’ with selection criteria for investigation based on opportunity for learning.
• Preventing ‘scope creep’ – so that safety investigations do not judge ‘avoidability, predictability, liability, fitness to practise or cause of death’
• Terminology to reflect the systems approach i.e. references should be to systems-based patient safety investigation rather than root cause analysis
• Timeframes – to be agreed with those affected rather than within pre-ordained time limits.

Comment: Serious Incident Investigations should never consider liability, attribute blame or be used as part of the disciplinary process.  The focus should be on establishing the facts to devise an action plan to prevent recurrence. Although the current 60 day time limit for completing of the SII can be tight, healthcare organisations will need to take care to manage the expectations of all those affected and set a realistic time limit for an effective investigation to take place. The timeline for implementation includes resources for boards being incorporated into existing board development programmes by Q4 2019/20, delivery of training from the end of Q2 2020/21, with full implementation by July 2021.

Medical examiners

Examining end of life care can provide crucial safety insight. Annual learning from deaths data will be published again this summer within Trust quality accounts. Learning from deaths guidance is being extended to ambulance Trusts and there is ongoing work to improve systems for learning from the deaths of children and people with learning disabilities.  A non-statutory scheme for MEs to scrutinise and oversee deaths in hospital not subject to an inquest was introduced on 1 April 2019.  Acute trusts are expected to establish ME offices to scrutinise deaths occurring in their trusts by 31 March 2020. In 2020/21 the service will be expanded to include all deaths including those in the community and in the care of independent providers. Reports from both regional and national ME teams will identify key themes relating to cause of death and causes for concern. These will be triangulated with mortality indices and local intelligence to identify trends that merit further investigation.

Comment: Trusts have a further 5 months to set up and embed an ME service.  As the introduction of the scheme may lead to more inquests, the time also provides an opportunity for SII procedures be reviewed. The intention to triangulate reports from the ME teams could lead to further investigation.  For those cases subject to an inquest, ensuring that the SII action plan is not only adequate but effective in preventing future harm is central to minimising the risk of a Prevention of Future Deaths Report. In future, this is also likely to be critical for non-inquest cases should there be a post-ME investigation. The government intends putting the ME system on a statutory footing in due course. 

Insight from clinical negligence claims

NHS Resolution maternity safety and learning initiatives support the national ambition to halve maternal and neonatal deaths by 2025. Initiatives include the early notification of incidents, CNST rebates for Trusts delivering 10 key maternity safety actions and in-house research into causes of maternity incidents which is shared to enable safety improvement.  Claims scorecards for members, work with the Getting It Right First Time programme and thematic reviews of claims, all involve sharing insight and focusing on improvement.  Data is key to identifying future priorities and extracting insight.  NHS Resolution aims to align its data on incidents, complaints and claims with the replacement for NRLS to support development of a shared taxonomy enabling cross-database analysis.

Comment:  The GIRFT programme’s best practice guidance for hip arthroplasty and knee arthroplasty, seeks to support safe clinical practice including the importance of documenting key information should review or revision be needed. Common themes on surgical technique and documentation were collated from claims notified to NHS Resolution and guidance issued with the aim of reducing the frequency of incidents

Safety in primary care

A 2019 study by the University of Nottingham has found that the vast majority of patients receive safe primary care.   The most common problems were identified as: difficulties making the right diagnosis; delays in referring patients to hospitals; prescribing errors.

The development of Integrated Care Pathways between primary, community and secondary care will be an opportunity for local systems to develop clinical governance procedures with clear lines of accountability leading to safer care.  The new Primary Care Networks also present an opportunity to promote a safety culture and for continuous quality improvement, with the role of PCN Clinical Director being key.

Comment: While frequency of serious incidents tends to be low in primary care, there is the potential for serious harm, for example failure to refer to hospital for suspected meningitis or cauda equine syndrome, where life changing injury can occur. As at-scale delivery of primary care gathers pace, organisations will need to review their governance arrangements around for example, sharing of patient information, reporting and investigation of incidents and integration of multidisciplinary working. 

Independent sector

Alignment of patient safety standards between the NHS and the independent sector has sometimes been ineffective, not least because of the different reporting requirements for NHS and private patients.  The Acute Data Alignment Programme (ADAPt) will integrate data on privately-funded healthcare into NHS systems and standards.  This should assist in providing a ‘whole systems approach’ to safety focused on continuous improvement and strong clinical governance in both sectors.

Comment: Publication of the report into safety and learning following the conviction of breast surgeon Ian Paterson is due at the end of 2019.  Mr Paterson worked in both the NHS and private sector. The report will be a key piece of learning for providers in both sectors. Terms of reference include sector comparisons on accountability for safety and quality of care, multidisciplinary working and responsibility for adverse incidents and clinical recall, plus perhaps most significantly - cross sector information sharing to prevent recurrence.

Conclusions

The new strategy will require healthcare organisations to adopt a different focus for patient safety based on culture and systems (rather than individuals).  Incident investigation will require an approach based on risk and opportunities for ‘proportionate and effective learning’ including analysis of human factors. They will need to prepare for the new regime by reviewing governance procedures and policies and ensuring that staff are trained for their new role.