Patient Safety Spotlight interview with Judy Walker, Senior Business Consultant, iTS Leadership

Disaster recovery: restoring hope after things go wrong (Judy Walker, 5 January 2023)

Together, they have co-designed new guidance to make investigations more human and meaningful for those involved, and support better organisational learning.

The project has created investigation resources to support you if you are involved in a Patient Safety Incident Investigation either as a patient, family member, healthcare staff member or investigator, including:

• Patient safety incident investigation information booklets for patients/families and for staff
• Investigator guidance
• Investigation record

. You can download the relevant co-designed guidance or support booklets from the link below, which contain helpful information to guide and support your involvement in an investigation.

PSII contributory and mitigation factors classification
A taxonomy of key factors (including ergonomic and human factors), which underlie patient safety incidents.

PSII contributory, causal and mitigating factors analysis worksheet
A tool designed for use in conjunction with the contributory factors framework above, to guide and organise the analysis of interconnected, contributory, causal and mitigating factors

PSII change analysis tool
A template to identify and document variations to policy, protocol or expected practice (work as imagined). It is important to note that variations are common and are most often the result of efficiency-thoroughness trade-offs.

PSII nominal group technique tool
A template to prioritise problems and their further analysis.

PSII options appraisal and impact analysis tool
A tool to assess and compare the relative efficacy, value and cost of a range of solutions. This can be used either at the improvement development stage, or after the solutions/improvements have already been implemented.

Risk assessment tool
A tool to assess the likelihood and severity of identified hazards in order that risks can be determined, prioritised, and sensible control measures applied (eg clinical, safety, business risks).

The purpose of this document is to ensure that efforts undertaken in performing RCA2 will result in the identification and implementation of sustainable systems-based improvements that make patient care safer in settings across the continuum of care. The approach is two-pronged:

1. Identify methodologies and techniques that will lead to more effective and efficient RCA2.
2. Provide tools to evaluate individual RCA2 reviews so that significant flaws can be identified and remediated to achieve the ultimate objective of improving patient safety.

The purpose of an RCA2 review is to identify system vulnerabilities so that they can be eliminated or mitigated; the review is not to be used to focus on or address individual performance, since individual performance is a symptom of larger systems-based issues.

Root cause analysis (RCA) is a structured method used to analyse serious adverse events. Initially developed to analyse industrial accidents, RCA is now widely deployed as an error analysis tool in healthcare.

The RCA approach is the current methodology to investigate why and how serious incidents have happened in healthcare and to assure the Trust, Clinical Commissioning Group (CCG) and the patient/family that lessons have been learned and that the incident will not happen again.  This methodology is soon to change next year as set out in the new Patient Safety Incident Response Framework.

What happens to the report?

Once written, the RCA report will be sent to the CCG, other outside bodies and the patient/family, alongside an action plan on how practices will change. 

What type of incident is RCA used for?

Many Trusts will perform an RCA on incidents which are deemed to have greater learning for the Trust despite the degree of harm, moderate harm and above, and never events.  Most Trusts use a modified RCA for ‘local’ investigations – these incidents may include pressure damage, falls and medication errors.

What is the process?

The current process of undertaking and processing a serious incident is laid out below.  This is taken from the NHS Serious Incident Framework.  Many Trusts will provide RCA training to anyone undertaking the lead role in an investigation – this could be a patient safety lead or a clinician.

How long does it take to complete an RCA?

This can depend on the experience of the investigator, the capacity of the department involved to collect statements, a timeline and information.  If the incident has been declared to the CCG, the report will need to be completed within 60 days. A local RCA should take no longer than 4 weeks.

How many RCAs are completed each year in the UK?

During 2018 there were nearly 62,500 incidents that were reported as moderate harm or above. The majority of these would require an RCA. This figure does not include incidents that were not reported on to the Strategic Executive Information System (StEIS) but were investigated using the root cause analysis locally. 

Currently, patient safety teams up and down the country are drowning in writing RCA reports.

We are caught up in a process of investigating harm that has already happened. Hours, days, months are spent having meetings mulling over the RCA. Looking at timelines, thinking of why the incident happened and whether there was any way for it to have been prevented.

The cost of undertaking an RCA must be in the thousands of pounds. The team often includes the patient’s consultant, head of nursing, governance leads, patient safety managers and clinical staff.  This group may meet up at several different occasions to make sure that all facts are correct and that the RCA is written well and meet a standard that the CCG will accept.  Multiple drafts are written before submitting the final report.

Action plans are found at the bottom of the RCA – once the root causes have been found, that is when the actions can be formulated. These actions will need to be carried out in the department/area where the incident took place or across the Trust if it was a system failure.

Once written and signed off by the Trust and the CCG – the RCA is complete.

What happens next?

The end of the RCA should be the beginning of either a quality improvement initiative, a new policy, a change in practice or change in process. This part of the process is often poor – ‘reminding staff’, ‘education’ and ‘reflection’, assuming it must be human error and must be ‘fixed’ by telling people how to do it better. There is little training in setting appropriate actions or a centralised place to evidence that the action is now imbedded. 

The Care Quality Commission (CQC) can call on these actions and the evidence of these actions at any time.

At present there is not a robust, standardised approach across the NHS to gather evidence that actions have been put in place post incident.

One of the reasons for this is a lack of capacity and capability due to the industry we have made of writing the RCA and lack of quality improvement training or time provided to all staff throughout the NHS.

 Final words

Have we forgotten the purpose of our role within patient safety?

Figuring out what went wrong systemically is only one part of our role; however, assuring the family and patient that we have put new systems in place and that we are striving for this incident to never happen again is equally, if not more, important – so why is there not a standard process/industry for this? If we focussed more on the prevention we could get off the hamster wheel of investigating recurrent harm.

It is hoped that the new serious incident framework will address this issue and allow us the time and the capability to put in measures to stop recurrent harm happening to patients and the public. 

 What are your solutions to action plans and gathering the evidence for these plans?

Have you a system that is easy to keep track of RCA reports and follow up?

I would also be interested in the patient/public view of investigation reports and whether this type of approach is what they want? 

Employers, supervisors, SHE champions, union and safety representatives will benefit. Attending the course will enable you to:

• Independently investigate simple incidents.
• Gather evidence including conducting witness interviews.
• Produce an action plan to prevent a recurrence of an incident.
• Contribute to team investigations for large scale incidents
• Positively impact the safety culture in your organisation.

One particular limitation of investigation was that many investigations stop the analysis at the level of “preventable causes”, the level where remedies that were currently practical to implement could be found. This could potentially limit the usefulness of using investigations to get a view on the “big picture” of causes of accidents as a basis for further remedial actions.

Based on this research, a team of practicing clinicians with human factors experts has adapted the evidence to a two page framework. The YCFF includes all sixteen domains of the evidence-based domains. 

The document suggests questions that you might want to ask of those involved in the incident. The underlying aim of this tool is not to ignore individual accountability for unsafe care, but to try to develop a more sophisticated understanding of the factors that cause incidents. 

• Serious incidents that require full investigation should be prioritised and alternative methods for managing and learning from other types of incident should be developed.
• Patients and families should be routinely involved in investigations.
• Staff involved in the incident and investigation process should be engaged and supported.
• Using skilled analysis to move the focus of investigation from the acts or omissions of staff, to identifying the underlying causes of the incident.
• Using human factors principles to develop solutions that reduce the risk of the same incidents happening again.

The phases of care are:

• admission and initial care – first 24 hours
• ongoing care 
• care during a procedure 
• perioperative/procedure care
• end-of-life care (or discharge care) 
• assessment of care overall.

While the principle phase descriptors are noted above, dependent on the type of care or service the patient received not all phase descriptors may be relevant or utilised in a review.

• An understanding of Just Culture as a framework to employ root cause analysis at your own sites
• An understanding on root cause analysis as a tool for evaluation of clinical and administrative quality issues
• When you should do a root cause analysis
• How to engage leadership