X-rays are the most common radiological examination. 22.9 million were carried out in the NHS in 2016/17. Failures in communication or follow-up of unexpected significant radiological findings is a nationally recognised patient safety risk.
The lack of follow-up or communication of unexpected significant findings can have a serious or life-threatening impact on patients.
In the investigation reference event, a 76-year old woman had a chest X-ray showing a possible lung cancer which was not followed up and resulted in a delayed diagnosis. The patient died just over two months after her diagnosis.
This healthcare safety investigation reviews the processes for communication and follow-up of unexpected significant radiological findings to understand why such findings are not always received or acted upon.
The factors that influence the communication of results are explored and opportunities to reduce the risk of this happening in future are identified.
The investigation pays particular attention to unexpected significant radiological findings from chest X-rays performed during a patient’s time in an emergency department.
X-rays are the most common radiological examination and large volumes are requested from emergency departments. However, the conclusions of this investigation apply to the communication of radiological findings from other areas, and other types of diagnostic test results.
We made safety recommendations to The Royal College of Radiologists, NHS England and NHS Improvement, NHSX and the Care Quality Commission as a result of this healthcare safety investigation.
All organisations responded to their safety recommendations within 90 days of publication of the investigation report.
The Royal College of Radiologists
It is recommended that the Royal College of Radiologists, working with the Society and College of Radiographers and other relevant specialties through the Academy of Royal Medical Colleges, develops:
- principles upon which findings should be reported as ‘unexpected significant’, ‘critical’ and ‘urgent’
- a simplified national framework for the coding of alerts on radiology reports
- a list of conditions for which an alert should always be triggered, where appropriate and feasible to do so.
We extend our sympathy to the family of the patient at the heart of these systemic failings and welcome the thorough investigation of the wider issues raised in the reference case to this investigation.
As the report points out, there have been a number of attempts to resolve the challenges of alerts and acknowledgments of unexpected findings over the years, especially since in 2007 the National Patient Safety Agency (NPSA) Safer Practice Notice highlighted the risk of harm to patients if radiology reports are not acted upon.
Ownership of alerts and acknowledgements extends between teams.
After very positive initial discussions with the College of Radiographers and the Academy of Medical Royal Colleges, we are committed to gathering data and evidence to inform conditions which should always be notified by the end of December 2019. Through the Academy we will consult widely across specialties to establish consensus on those conditions and identify the key partners with whom we will work to develop principles for classification and national model for coding. We intend to publish substantive guidelines in Autumn/Winter 2020.
Whilst convergence in terminology and methodology on significant unexpected findings will make considerable progress toward avoiding these critical diagnoses falling between the gaps, the value of this safeguarding is limited without digital systems and infrastructure capable of adapting to an agreed national framework. This is particularly important as we move toward an increasingly networked approach to delivery of our diagnostic services, which will challenge systems and the integration between teams and organisations. We have invited NHSX to join us to ensure that the collaborative framework we develop can be practically implemented across the country at the earliest opportunity. This is the key lever to ensure that both patients and services can have confidence that serious unexpected findings will be acted upon.
This response was received on 10 October 2019.
NHS England and NHS Improvement
It is recommended that NHS England and NHS Improvement’s patient safety team takes steps to ensure providers are aware of the safety recommendations in this report and act to implement the key findings regarding risk controls such as a monitored acknowledgement system for critical, urgent and unexpected significant findings.
Once the Royal College of Radiologists, and partner organisations, have developed and published their proposals and definitions (as outlined in Recommendation 2019/039) the national patient safety team will utilise avenues at its disposal, including a national patient safety alert (if the nationally agreed criteria are met), to promote systematic implementation of the safety recommendations related to unexpected significant radiological findings.
This response was received on 14 October 2019.
It is recommended that NHSX develops a method of digitally notifying patients of results. This should be used to inform patients of unexpected significant radiological findings after an agreed timeframe. It should be developed in conjunction with the Royal College of Radiologists. The notification system should be tested and evaluated.
We acknowledge and agree with the report’s recommendation 2019/041 - that a method should be developed to digitally notify patient of unexpected significant radiological findings after an agreed timeframe. We are happy to work with the Royal College of Radiology and other key stakeholders such as the Royal College of General Practice on this issue.
We are already aware of local areas using patient facing portals to provide results to patients and our national work with the GP Connect programme is looking specifically at capabilities to support tasking and alerting to GPs. In response to this recommendation, we are planning to conduct some discovery work over the coming months to look at requirements, potential solutions and guidance that NHSX can provide to improve digital practice and ultimately patient safety..
There will be information governance and integration issues to overcome which we will, of course, work through in partnership with provider organisations.
This response was received on 17 October 2019.
Care Quality Commission
It is recommended that the Care Quality Commission amends all appropriate core service frameworks to include risk controls identified in this report, to mitigate the risk of significant abnormal findings not being followed up.
CQC agree that effective fail-safe processes such as those identified in the report are important in helping protect the safety of patients, but that it is, of course, not possible or appropriate for CQC inspectors to review all aspects of every service in detail on every inspection, and we therefore need to be selective as to what we include in our assessment frameworks.
However in light of the report we would consider what changes we could make to our core service frameworks to include aspects of fail-safe processes where appropriate and where we will be able to collect sufficient evidence to drive improvement. This would be taken forward as part of the wider work CQC is currently undertaking in relation to lightening the load work and review of frameworks.
However, the IR(ME)R Team and the Hospitals Policy Team regularly review the diagnostic imaging frameworks to make sure they are kept up to date and include any relevant new standards or appropriate guidance such as this HSIB recommendation.
This response was received on 26 November 2019.
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