Generally, radiology incidents fall into the near miss, or no/low harm categories, as radiation exposure may increase the risk of deterministic or stochastic effects occurring but not specifically actual harm at the time of the incident. There are some occurrences for example, where a missed pathology, or failure to escalate a report may impact on the patient causing harm due to the delayed diagnosis. However, unlike the previous Serious Incident (SI) framework, PSIRF does not respond to the level of harm, so investigations may be triggered for other reasons. Investigations such as these, have in the past taken a lot of resources, but rarely added any new insight to inform improvement.

In 2019, a new coding taxonomy for diagnostic services was published (6), with the aim to align with the radiotherapy coding which had been used since 2008 (7).  This is a voluntary process, but its use is encouraged by the regulatory boards (Care Quality Commission in England, Healthcare Improvement Scotland, Healthcare Inspectorate Wales and the Regulation and Quality Improvement Authority in Northern Ireland). The primary aim of the incident coding taxonomy is to help clinical imaging staff minimise future potential ionising radiation exposure incidents and near miss events, while enhancing ongoing patient safety. 

This original diagnostic radiology document focused on the root cause of the event along the lines of the Serious Incident pathway. It has been reviewed by the UK Health & Safety Authority (HSA) and a multidisciplinary working party and was published in Spring 2024. The updated version aligns with the PSIRF philosophy of investigating the process. The new incident coding taxonomy version will also include Magnetic Resonance Imaging (MRI), and nuclear medicine therapies alongside the other clinical imaging modalities. The wording of the document has changed from that root cause of linear blame, to a more open process by breaking down incidents into the following pathway codes: referral process, justification and authorisation process, and practical aspects. It is no longer linked to duty holder roles as found in the previous 2019 version. By using a trigger code at the start of the taxonomy code, this will ensure when the incident is uploaded through the Learn From Patient Safety Events (LFPSE) website, Once for Wales, or direct submission to UK HSA, it can be easily identified. The submitted data will be analysed by the Medical Exposures Group (MEG) within UK HSA.  As the system becomes more established, results and learning will be published in the form of a regular report, allowing local departments to compare themselves against the national trends, and learning from incidents can be shared on a much wider platform.

Within radiotherapy this process is already well established, and the UK HSA Radiotherapy team, in conjunction with the Patient Safety in Radiotherapy Steering Group (PSRT) provide regular analysis and learning from radiotherapy errors and near miss events. These include a safety e-bulletin, a triannual report and a biennial report. The plan is to have a similar process set up for the clinical imaging modalities also.

The Ionising Radiation (Medical Exposure) Regulations 2017 (8), and the Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2018 (9), have the primary objective to ensure individuals are protected when exposed to ionising radiation from medical equipment for imaging and treatment purposes. However, things do go wrong, so it is about having the knowledge of what is a proportionate response based on the event and how learning can be best obtained. 

By utilising the tools developed by NHS England the maximum learning from the incident can be obtained. Examples available to use are: 

• SWARM huddles/debrief – useful immediately after a particular traumatic event (e.g. trauma patient, cardiac arrest)
• After Action Review (AAR) – a more planned briefing session to allow the group involved in the incident to talk about it to agree on some learning points. These are more likely to be arranged by the ward, or other department, and may not be specific to a radiology department, these are more relevant if the radiographer was involved as part of the wider multidisciplinary team. 
• Thematic reviews – these are probably the most useful tool within a specific radiology department, as they are about reviewing multiple incidents to see the common themes. So even the near miss incidents or the no/low harm, may be able to pull some learning, to minimise the risk of the incident occurring again. 
• Patient Safety Reviews – There are generally two different levels of review, one is a quick fact-finding exercise to see what the initial cause of the incident was etc, the second review then takes this further by obtaining a clinical opinion and review, and identifying any learning and actions. 
• Patient Safety Incident Investigation (PSII) – these are an in-depth three to six-month review, normally undertaken by your local Patient Safety Team or specialist staff who are trained to do these investigations.  

Contact your own local Patient Safety or Governance Teams, who will be able to advise on the PSIRF process local to your hospital and department. They may also offer training around PSIRF, incident reporting, incident investigations, AAR conductor training, human factors training etc. 

A note on Duty of Candour

The Duty of Candour legislation (10) is to ensure an open, honest and transparent service. As soon as the incident has occurred then the duty of candour regulations apply. It currently applies to moderate and severe harm, or where the patient has died due to the incident rather than natural causes. As previously stated, radiation exposures do not tend to reach the statutory threshold of harm for duty of candour to occur, however, IR(ME)R schedule 2(l) states ‘the referrer, the practitioner, and the individual exposed or their representative are informed of the occurrence of any relevant clinically significant unintended or accidental exposure, and the outcome of the analysis of this exposure’, so check your local employer’s procedures.

The Practice Plus Group (PPG) Experience

A full review of patient safety data (encompassing incidents, feedback, risks, litigation cases, ongoing improvement work was undertaken to understand our patient safety profile, and to identify the patient safety priorities, which will develop the Patient Safety Incident Response Plan (PSIRP) for 2023/24.

Failure or breakdown in the diagnostic treatment pathway is one of the key patient safety priorities identified. This directly involves diagnostic imaging as delays in imaging results can be a cause for pathway failure. PPG uses external providers for some imaging modalities and for the majority of diagnostic imaging reporting, and therefore the main risk lies with managing incoming results from many different external sources using different communication methods.

Once we had identified our priorities, a working group met to decide the appropriate level of PSIRF response that would be required. The learning response (diagram A) algorithm identifies the agreed responses to each incident. 

A clinical harm review for incidents where the causation factors are easily understood, such as error in uploading results, allows us to use a standardised approach to identify the level of potential harm that may have been caused by pathway delays. We can then identify patients that require duty of candour to be undertaken. Clinical harm reviews can also be used as a basis for a thematic review to identify common causation factors that might be missed if incidents are investigated as “one offs” with an individual Root Cause Analysis (RCA) process.

Where causation factors are more complex, multifactorial or not understood at the time of the incident, then undertaking a Patient Safety Incident Investigation (PSII) provides the opportunity to fully explore actions taken and decision made as related to the incident. Although we have not had to undertake many PSIIs in diagnostic imaging since the introduction of PSIRF (thankfully) staff undertaking the investigations find the approach taken by the PSII framework much more open than the Serious Incident Framework as there is not the pressure to try to find a root cause but instead the flexibility to explore actions and consequences.

Challenges 

Accessing appropriate investigation training for investigators/learning response leads

DATIX readiness for LFPSE and PSIRF

The InHealth Group Experience

An open incident reporting culture that does not apportion blame and seeks to investigate and address learning, is fundamental to ensuring a patient focused safety culture exists within InHealth.

SWARM huddles/debrief - After an incident, staff ‘swarm’ to analyse what happened, how it happened and decide what can be done to reduce risk (diagram B). They are an excellent way to get things moving quickly, enabling insights, reflection, and learning, whilst ensuring the burden does not fall on one person (unlike an RCA). We find these very constructive, and actions are added to InPhase, creating Gantt chart to monitor timeframes and responsibilities.

An example swarm huddle: an administrative incident where approximately 30 patients were missed from being added to our booking system by the patient referral centre. The agreed action included putting a referral tracker in place to ensure referrals are followed through. A weekly check was also agreed to ensure checks are carried out at the point of vetting and input by the patient referral centre to avoid any lost referrals.

After Action Review (AAR) - The AAR templates include four key questions followed by agreed actions taken by InHealth staff: 

• What was supposed to happen?
• What did happen?
• Why was there a difference?
• What can we learn from this?

An example AAR: two patients received unintended Computed Tomography (CT) Pelvis exposures due to operator errors. The first patient was due a CT chest and abdomen with contrast and head, but the pelvis was also included. The second patient was due a CT chest and abdomen scan, but received a chest, abdomen and pelvis scan.  The importance of pause and check was identified as a critical finding. 

We have found AARs and thematic reviews are simpler to complete than the previous RCA template. AARs really concentrate on the important factors – what should have happened vs what actually happened, and then why the difference and what can we learn from this. Thematic reviews are really useful for radiation incidents, allowing us to look at the different elements of the service. Problems/weaknesses and also strengths can be analysed and acknowledged, learning identified and action plans created. 

Patient Safety Incident Investigation (PSII) - Recently at InHealth, a decision to undertake a PSII has been identified due to the potential for learning. It involves the management of anaphylaxis post intravenous contrast administration. The scope for this investigation includes the following:

• Review of the medical emergency pathway that was used to manage the anaphylaxis incident following a CT contrast scan. 
• To establish the sequence of events that led to the event
• To understand process failings which contributed to the event 
• To identify learning opportunities and establish a robust method for disseminating lessons learned.

The King’s College Hospital (KCH) Experience

King’s College Hospital updated its Risk Management system in April 2023, which included the capturing of incidents in line with the Learn from Patient Safety Events (LFPSE) service. The organisation has also implemented process flows to support the effective roll out of PSIRF. 

Radiology at this trust covers multiple modalities and over different sites. Ensuring everyone understands what PSIRF specifically means to them is a challenge, but every opportunity is used both at the trust level and within radiology at the different operational and staff meetings. 

To inform our PSIRP we undertook data analysis and stakeholder feedback to understand our patient safety profile - 18 patient safety themes were identified. Thematic reviews were carried out into each to triangulate insight from a range of internal and external sources, including qualitative sources. Through a more robust understanding of system factors which contribute to these themes, improvement groups for each could be established to drive ongoing improvement. This supports decision making around proportionate responses to specific patient safety incidents, allowing more resource to be used for improvement than learning responses/investigations.

The KCH Radiology Care Group has limited experience as we begin in earnest in September as a pilot group for PSIRF within the trust. This started by setting up regular PSIRF panel meetings. The group consists of three consultant radiologists and a quality radiographer, supported by a Trust Patient Safety Manager. It was agreed Leads for specific areas may be proactively invited to attend to help in fully understanding specific incidents, as and when needed.  The PSIRF Panel is held twice a week and reviews all patient safety incidents reported since the previous meeting. Incidents are very quickly assessed by those attending in identifying which response is required for each event. For some incidents further information is needed before an agreed response is reached, and by meeting regularly any updates can be discussed at the next PSIRF panel, so in a timely manner. Each meeting varies in length, depending on number and complexity of incidents being discussed.

So far, we have completed two after action reviews (AAR) in response to two radiation incidents. It has been really important in giving the staff, attending the discussion, the assurance of ‘no blame’. They have attended with a certain amount of trepidation, but at the end of the process have shared how positive the experience was for them. They felt their ideas and suggestions had been heard, and definitely without blaming them as individuals. Working through the different parts of the AAR, as described above, helps keep those participating to remain focused on what information is required. Further improvement work within radiology is being carried out to identify the themes for improvement work, such as reporting discrepancies, imaging the wrong side, etc.

References

1. www.england.nhs.uk. (n.d.). NHS England» Patient Safety Incident Response Framework and supporting guidance. [Online] Available at: https://www.england.nhs.uk/publication/patient-safety-incident-response-framework-and-supporting-guidance/.

2. NHS England (2019). The NHS Patient Safety Strategy Safer culture, safer systems, safer patients NHS England and NHS Improvement. [Online] Available at: https://www.england.nhs.uk/wp-content/uploads/2020/08/190708_Patient_Safety_Strategy_for_website_v4.pdf.

3. Patient Safety Learning - the hub. (2023). A simple guide to the Patient Safety Incident Response Framework (PSIRF). [Online] Available at: https://www.pslhub.org/learn/investigations-risk-management-and-legal-issues/investigations-and-complaints/methodology-and-guidance-how-to-do-an-investigation/patient-safety-incident-response-framework-psirf/a-simple-guide-to-the-patient-safety-incident-response-framework-psirf-r10538/.

4. Patient Safety Incident Response Framework Preparation guide. (2022). Available at: https://www.england.nhs.uk/wp-content/uploads/2022/08/B1465-6.-PSIRF-Prep-Guide-v1-FINAL.pdf#:~:text=We%20have%20developed%20this%20preparation%20guide

5. www.england.nhs.uk. (n.d.). NHS England» Patient safety learning response toolkit. [Online] Available at: https://www.england.nhs.uk/publication/patient-safety-learning-response-toolkit/.

6. Learning from ionising radiation dose errors, adverse events and near misses in UK clinical imaging department’s Working party report to clinical imaging board Contents. (2019). Available at: https://www.rcr.ac.uk/media/zdhdlbpt/rc5491-1.pdf.

7. Development of learning from radiotherapy errors Supplementary guidance series. (n.d.). Available at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/579541/DL_guidance_finalNB211216.pdf.

8. HEALTH AND SAFETY The Ionising Radiation (Medical Exposure) Regulations 2017. (2017). Available at: https://www.legislation.gov.uk/uksi/2017/1322/data.pdf

9. Legislation.gov.uk. (2018). The Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2018. [Online] Available at: https://www.legislation.gov.uk/nisr/2018/17

10. Public Health England (2020). Duty of candour. [Online] GOV.UK. Available at: https://www.gov.uk/government/publications/nhs-screening-programmes-duty-of-candour/duty-of-candour.