Posted by Sarah White, Solicitor
How serious incidents in healthcare are investigated using root cause analysis. Are lessons learned?
Ahead of World Patient Safety Day on 17 September, Sarah White reviews the root cause analysis process for patient safety learning. Is it working as it should?
Currently, when serious incidents occur within NHS funded healthcare services, they should be investigated as set out in NHS England’s Serious Incident Framework 2015.
The framework describes the circumstances in which a serious incident investigation is required and the process and procedures to follow to ensure that the incident has been correctly identified, investigated thoroughly and, most importantly, learned from, to prevent similar incidents happening again. According to the framework, patients and their families / carers must be involved in the investigation and be supported through the process.
Root cause analysis
Currently the recognised systems-based approach for conducting investigations is called ‘root cause analysis’ and there are seven key principles in this type of investigation.
Each investigation must be:
- open and transparent – this includes the NHS contractual Duty of Candour requirement, which applies to staff and patients and involves giving a formal apology and an acknowledgement of what has gone wrong.
- preventative – investigators should aim to identify and analyse weaknesses in systems and processes that allowed the incident to occur, and to fully understand what went wrong in order to prevent similar incidents occurring.
- objective – investigators must not be involved in the direct care of patients affected or work directly with staff involved in the incident. This ensures confidence that findings and subsequent action plans will be robust and meaningful.
- timely and responsive – serious incidents must be reported to NHSE and commissioners within two working days of being identified. This ensures that any immediate action can be taken as required and the investigation can begin. The investigation is usually required to be completed within 60 working days, although there are some instances where different timescales may be applied.
- systems based – root cause analysis methodology seeks to identify problems, contributory factors and fundamental issues and root causes, to ensure that a SMART action plan can be developed and implemented.
- proportionate – the scale and scope of the investigation should be proportionate to the incident with effective use of resources.
- collaborative – some serious incidents involve multiple organisations. If this is the case, partnership working must take place to investigate the incident.
Is this framework working?
Despite this framework being in place, unfortunately there are many recurring incidents in certain areas of healthcare.
Arguably the biggest and most catastrophic issues involving patient safety in recent times have been in relation to maternity services. Our team has previously blogged on the Shrewsbury and Telford Hospitals Trust scandal which is now considered one of the largest maternity scandals in NHS history with almost 1,900 cases being investigated and the Trust also facing a criminal investigation. Donna Ockenden, the Chair of the Independent review has recently commented that she hopes to have initial, emerging recommendations for maternity services published at the end of the year.
Unfortunately, the situation at the Shrewsbury and Telford NHS Trust is not unique. In recent years there have also been investigations into other scandalous incidents regarding maternity services at East Kent Hospitals and the University Hospitals of Morecambe Bay NHS Trust. It is deeply concerning that despite these substantial investigations, maternity incidents continue to happen, seemingly showing that the failings have not been appropriately addressed and lessons have not been learned.
Maternity care in midwifery-led settings is also not immune to issues. We have recently commented on the Enhancing the safety of Midwifery Led Births Enquiry (ESMiE). This involved investigating the care received when babies had died following a planned birth in a midwifery led setting. In total, 64 deaths were reviewed and in 48 cases (75%), the panel identified improvements in care which may have saved the baby’s life.
In March of this year, the Care Quality Commission warned that maternity units across the country posed safety risks to mothers and babies. It said: “Maternity services stand out as one of the core services we inspect that is not making improvements in safety fast enough.”
Is progress on the horizon?
In July of this year The Health and Social Care Select Committee, chaired by former health secretary Jeremy Hunt, announced that it will hold an inquiry, namely ‘The Safety of Maternity Services in England Inquiry’ to build on findings at Shrewsbury and Telford Hospital Trust, East Kent Hospitals University Trust and the inquiry into University Hospitals of Morecambe Bay in 2015. It will look into why maternity incidents keep re-occurring and what needs to be done to improve safety, showing that the safety of maternity services continues to be a matter of concern.
Launching the inquiry, Mr Hunt was quoted in the Independent newspaper as saying:
“If we had the same neonatal death rate as Sweden, a thousand fewer babies would die every year. What’s happened at Shrewsbury and Telford, perhaps East Kent, is an indication that high standards have not been spread to every corner of the NHS.
“This maternity safety inquiry we’re launching today is going to look root-and-branch at how effective and safe our maternity services are, what we do well and what we need to improve to be the safest and highest quality maternity care in the world.”
The inquiry is planned to look into recurrent failings in maternity services in order to understand what action is needed to improve safety for mothers and babies UK-wide.
The launch of this inquiry has been widely welcomed. We hope that it will establish a way to identify problems at the earliest possible stage so that tragedies are avoided and mistakes can be learned from.
NHS England has now issued its NHS Patient Safety Strategy and as part of this work the current ‘Serious Incident Framework 2015’ is to be replaced by the ‘Patient Safety Incident Response Framework’ (PSIRF). This is currently being trialled with some early adopter organisations prior to wider roll out and implementation by all NHS funded healthcare providers in Autumn 2021. The impact of this remains to be seen.
For further information on any of the above and to view the documents mentioned please go to www.England.nhs.uk/seriousincidentframework
If you have any questions for our Medical Negligence team about any of the issues raised here, please contact us today.
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