Failures in communication or follow-up of unexpected significant radiological findings

HSIB legacy content

This investigation was carried out by the Healthcare Safety Investigation Branch (HSIB). Find out more about HSIB legacy.

Background

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.

Reference event

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.

The national investigation

Failures in communication or follow-up of unexpected significant radiological findings is a nationally recognised patient safety risk.

HSIB contacted the hospital where the reference event occurred after it was reported as an incident on the national serious incident reporting database.

The investigation reviewed 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 were explored and opportunities to reduce the risk of this happening in future were identified.

The investigation paid particular attention to unexpected significant radiological findings from chest X-rays performed during a patient’s stay in an emergency department (ED).

X-rays are the most common radiological examination and large volumes are requested from EDs. However, the conclusions of this investigation are applicable to the communication of radiological findings from other areas, and other types of diagnostic test results.

Findings

There is wide variation in practice in how unexpected significant radiological findings are communicated to clinicians. There is also considerable variation in how findings are acknowledged by clinicians, if they are at all. There is very little assurance that the actions indicated by the findings have been taken.
Unexpected significant radiological findings may be communicated by telephone, electronic or paper-based systems, and involve a variety of policies and procedures. It is often a multi-step process, involving a number of individuals and information systems; this increases the risk of errors.
Monitored acknowledgement of radiological findings is an important component of a reliable system and requires dedicated time and resource. Monitored acknowledgement is not in place in many trusts.
Opening a report and generating a read receipt is an unreliable form of acknowledgement. A more robust risk control is for acknowledgement to be a separate, distinct action. That said, acknowledgement does not guarantee action has been, or will be, taken. A system that provided assurance that necessary actions had been completed would best mitigate risk. Current IT infrastructure in many trusts means this is not feasible in the short term.
There are often many steps before a patient is informed of an unexpected significant radiological finding. These steps provide opportunities for error. Inspection of trusts by the Care Quality Commission is limited in scope in relation to the communication and follow-up of radiological findings. Inspections do not look at whether a monitored acknowledgement system and other risk controls necessary for a reliable system are in place.
There is no nationally agreed list of what constitutes an unexpected significant finding that should trigger an alert. Some trusts have developed lists to standardise when alerts should be triggered by radiologists and to create a common expectation for clinicians.

Impact

During our investigation we collaborated closely with the Royal College of Radiologists and the Academy of Medical Royal Colleges. They were integral to the development of our safety recommendations, which you can read in full below.

As a result of our safety recommendations, the Academy of Medical Royal Colleges published Recommendations on alerts and notification of imaging reports guidance in October 2022. The main objective of this guidance is to ensure prompt and effective imaging result notification and its subsequent action to protect patient safety.

This guidance reflects the evidence found in our investigation and fulfils our safety recommendation.

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Safety recommendations

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.

Response 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.

Response received on 14 October 2019.

NHSX

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.

Response 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.

Response received on 26 November 2019.

Safety observations

There is an established model of radiology departments requesting a CT scan for chest X-rays referred from GPs that show possible lung cancer. Two trusts are extending this to chest X-rays referred from the emergency department.

It would be beneficial for this practice to be evaluated.

Observation to the Royal College of Radiologists:

Given the likely wider use of artificial intelligence in the future, some standardisation of radiology reports may be required. It would be beneficial for this to be evaluated.

Safety actions

The Academy of Medical Royal Colleges has written a statement endorsing the need to ensure clinicians act on alerted radiological findings and that a monitored acknowledgement system is in place in all local organisations.

Whether this is a single centralised system or specialty-specific process is for local decision depending on the available infrastructure.

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