One of the issues that we frequently encounter when looking at claims involving a delay in diagnosis of cancer is the system in place for reviewing and reporting on radiology. While the issue in some of the radiology and delayed diagnosis clinical negligence claims is one of performance, interpretation and/or reporting by an individual radiologist, in others it is more about the system that the hospital or trust uses to review and communicate results. Where there are gaps in that system, in can mean crucial information is never acted upon.
One of the roles of a coroner investigating an unexpected death is to consider whether the death arose due to circumstances which could happen again resulting in further deaths and what steps could be taken to avoid or reduce that risk. A coroner has the power to make a Prevention of Further Deaths (PFD) report in such circumstances and this is sent to a person or organisation whom the coroner believes has the power to take the action needed.
The assistant coroner for Cumbria recently made such a report and submitted it to North Cumbria Integrated Care NHS Foundation Trust and to the EMIS Group following the completion of an inquest investigation that he had carried out. Rather unusually, the facts about which he was concerned were not thought in this particular instance to have caused or contributed to the death of the individual concerned but he was sufficiently concerned about the potential for future effects to make the report.
In this instance, the deceased had been suffering from headaches for which he was referred for an MRI scan. The MRI was done but the imaging was never reviewed by a clinician. This later came to light and, as a result, North Cumbria Integrated Care NHS Foundation Trust - which managed the hospital where the deceased had had his MRI scan - began an investigation.
The investigation looked carefully at the system in place for reviewing and reporting imaging and noted that the trust used a system provided by EMIS to create an electronic patient record but a separate system called ICE to gather the results of tests and scans. ICE is capable of linking to EMIS to input results into the EMIS system. Once a test result has been linked to a patient in EMIS, the result enters the EMIS record as a provisional result pending review and is placed on a work list. The consultant or a deputy then reviews the result, files it with or without comment and records any actions taken. EMIS provides two options: 'file no comment' and 'file and comment'.
Certain tests results which are inputted into the EMIS system are reported in a way that flags up any abnormalities (for example, in blood results). Where an abnormality is flagged, EMIS will automatically default to the ‘file and comment’ dialogue box even if ‘file no comment’ is selected. This acts as a safeguard against missing a significant finding.
However, the investigation noted that, as there is no flag attached in the ICE system for abnormal radiology results, there is no failsafe for defaulting to a 'file and comment' if a significant positive or negative finding is reported.
In the course of investigating what happened to the deceased’s MRI scan, it was determined that clicking more than once on the 'file no comment' button will result in the displayed result being filed but will also result in filing the next result in the list if that result has no flag indicating the result is abnormal.
So, if a radiology result lies below a normal blood result and a clinician inadvertently double clicks to file the first result, the radiology result is also filed without comment and without the result being displayed. Furthermore, multiple clicks (up to six and perhaps more) will lead to multiple filings. It is therefore possible that a clinician inadvertently clicking 'file no comment' more than once on one result would cause results which require urgent follow up being marked as ‘file no comment’ and filed without a clinician being involved.
Having heard evidence on this, the assistant coroner expressed concern that this might lead to lost opportunities to treat patients whose scans reveal early malignancies. It might also mean that scans which reveal the need for urgent action will be overlooked and that future deaths could occur as a result of a system where an abnormality is not flagged and a clinician inadvertently marks the results as ‘no comment’ without actually reviewing them.
The investigation carried out by the trust had identified this issue before the inquest was concluded and had already taken steps to address the issue. It was identified that a proper fix required action by the publishers of EMIS to prevent accidental filing of results.
However, in the interim, the trust was working to try to flag all radiology results, where the greatest risks lie, within the ICE system as abnormal so that any attempt to file a radiology result would be flagged up in the file and comment dialogue box. But as this could not ensure a distinction between results which were actually abnormal and those that were not, the risk remained of results being assumed to be normal and that they had just been flagged as abnormal due to the system and would still not be acted upon.
As a resolution via the EMIS system had still not been found by the time the inquest concluded, the assistant coroner directed that the trust and EMIS between them needed to continue to look at this issue, find a solution and report back. He was clear that the trust needed to identify and put in place a system that ensured that any radiology results which were noted or reported as abnormal would be flagged and would undergo clinical review and could not simply be filed without review or action.
This is a good example of a coroner fulfilling their role – looking not just at the death of an individual but at system failures which may lead to further or future deaths. In this instance, the trust was already aware of the issue and taking steps to manage the situation but, as the coroner clearly felt that more needed to be done, he also directed his report to the developers of the EMIS system.
Philippa Luscombe, partner in the clinical negligence team and lead of our oncology specialist group comments: “From our experience it is likely that similar issues are present in some other trusts where there is no failsafe system to ensure that abnormal radiology results are reviewed and actioned.
“We have dealt with a number of cases (particularly those involving ultrasound imaging and chest imaging) where an abnormality has been identified by the radiologist and noted correctly in the report but that report has then filed in the notes and no action taken. Sometimes it is not reviewed at all and sometimes the imaging has been logged as normal when, in fact, the report is clear that it is not normal.
“The whole point of this sort of imaging is to identify any potentially sinister cause for symptoms and to take early action. A system that does not have a mechanism in place to ensure that any abnormal results are flagged and reviewed obviously presents the risk that a patient’s diagnosis may be delayed by many months or even years – and, ultimately, adversely affects their prognosis.
“This recommendation by the assistant North Cumbria coroner will hopefully be the start of a nationwide review of these reporting systems and a reduction in the number of such incidents, resulting in prompt diagnosis for more patients.
“For patients to discover that a diagnosis could have been made much earlier and the information was available but not actioned can be devastating when already coming to terms with their diagnosis and implications. Any steps to ensure abnormalities are not just identified but acted on promptly must be a welcome step forward.”