March, June and September CT scans
19. Mr C said Ms M was told CT scans she had in March, June and September 2022 were clear and that she was free from cancer. He says they were unaware her cancer had returned until the Trust told Ms M, in its response to her complaint in May 2023, that the June and September scans in 2022 actually showed some small cancer nodules in her lungs.
20. The CT scan reports for the scans done in March, June and September 2022 all state there were no metastatic nodules in the lungs and no evidence of cancer.
21. The Trust arranged a review of Ms M’s scans from 2022 as part of its investigation into her complaint. This review said the right middle lung nodule was not present on a scan done on 30 December 2021, but was seen as a 2mm nodule in March 2022, which had grown to 6mm in June and September. The March scan also showed a 3mm right lower lung nodule which had increased to 4.5mm in June and 6mm in September. The June scan showed a new 3mm right lower lung nodule, which increased to 7.5mm in September. All three lung nodules were reported on the November scan at sizes of between 7mm and 8mm.
22. We looked at the CT scan images and asked our radiology adviser to explain what could be seen on them.
23. As the Trust’s radiologist had said the December 2021 CT scans showed no lung nodules or signs of cancer, we asked our radiology adviser to also look at that CT scan for comparison with the other CT scans. The CT scan report for December 2021 states no nodules or cancerous abnormalities were seen.
24. Our radiology adviser says the December 2021 CT scan shows a small 3mm nodule in the left lower lung. They say the usual action with this type and size of nodule would be to monitor the growths and recommend a follow up scan in six to eight weeks. We note Ms M’s next scan took place 12 weeks later.
25. The March 2022 CT scan shows the left lower lung nodule had increased in size to 4mm. The June 2022 CT scan shows two new small 2mm nodules at the lower lung bases, and a new 5mm node in the right middle lung.
26. Our radiology adviser says that in the September 2022 CT scan, all of the nodules seen on the previous scans were clearly visible and had increased in size significantly, measuring between 4-7.7mm.
27. The scans done in March, June and September 2022 were all reported as clear with no signs of cancerous nodules. In considering what should have been reported on the CT scans, we took into account standards and guidance relating to radiology.
28. The Royal College of Radiologists’ guidance on interpretation and reporting of scan images says a radiology report should include the findings in clinical imaging, relate it to the referring clinician’s questions and provide advice for action and potential diagnoses when an abnormality is seen.
29. The British Thoracic Society’s guidelines on lung nodules state lung nodules at a size of 5-6mm should be followed up with an annual CT scan. Nodules larger than 6mm should be scanned every three months, and if there is evidence of growth, further investigations and management should be considered.
30. According to research published by the National Library of Medicine, it is recognised that radiologists may not see smaller lung nodules, even multiple ones, with an average detection rate of 49% of radiologists identifying nodules of 5mm size when checking CT scan images.
31. Our radiology adviser explains small 2-3mm lung nodules of the type they saw on the CT scans are not specific to cancer and can be benign nodules such as lymph nodes or due to inflammation. We have taken into account that not all radiologists would have noted the small nodules seen in the March and June 2022 CT scans, and nodules of this size are commonly missed.
32. With the benefit of hindsight, had the small 3mm nodule been identified in December 2021, then the increase in size to 4mm in March 2022 could have been noted as an unexpected significant finding. Likewise, if the 4mm nodule had first been noticed in March 2022, then its increase to 5mm in June 2022 could then have been noted as an unexpected significant finding. Our radiology adviser says lung nodules of 5mm are less commonly missed by radiologists, and they would expect the 5mm nodule to have been reported and acted on by the radiologist. However, we take into account even nodules of 5mm size are often missed by radiologists.
33. Turning now to the September 2022 CT scan, the Trust said in its response to the complaint that this scan only showed a small view of the area, and the images were not as sharp as the previous scan. Our radiology adviser explains this was not correct as the whole chest was scanned in September, but ‘lung windows’ were not reconstructed which can show lung nodules more clearly.
34. Lung windows are a method used to process CT scan images which provide clearer edges to detect lung nodules. Our adviser explains that it is common knowledge within the radiology community that, in line with the National Library of Medicine’s 2002 review paper, maximum intensity projection (MIP) provides the best method for identifying lung nodules on CT scans. The June CT scan used MIP to reconstruct lung windows, but the September CT scan did not use the same method so the images were not as clear. The visibility of the images taken in September would have been increased with clearer views of the lung nodules, if MIP had been used to reconstruct lung windows. Most radiologists reporting oncology or chest CT scans routinely use MIP to reconstruct lung scan images when preparing their reports.
35. Our radiology adviser explains as lung windows were not reconstructed on the September 2022 scan, the images were not as sharp as on previous scans. Nevertheless, the lung nodules on this scan had grown significantly in size with one measuring 7.5mm and were clearly visible, and these nodules should have been identified and noted by the radiologist. This should have resulted in the Trust’s unexpected significant finding pathway being triggered, with an email sent to Consultant A to alert them of the presence of new lung nodules. This did not happen. We take a closer look at the process for unexpected significant findings later in this report.
36. We turn now to address communication of the CT scan findings with Ms M in her oncology clinic appointments. Mr C complained that Ms M was wrongly told her CT scans taken in March, June and September 2022 were clear and showed no return of cancer.
37. GMC’s Good Medical Practice says doctors must share with patients the information they will need to make decisions about their care, including their condition. Our oncology adviser 1 says oncologists are not required to check radiology images when they have access to written radiology reports, and while some may choose to do so, oncologists are not trained to interpret those images.
38. Consultant A’s team shared with Ms M the outcome of the CT scan reports for March, June and September, in line with Good Medical Practice. We have previously noted those scan reports stated there was no evidence of lung nodules or a return of cancer. It was appropriate for the oncology team to pass on the information they had about this to Ms M at the time.
39. We cannot be critical about Consultant A’s team telling Ms M her scans were clear, as no signs of potential cancer were reported on the CT scans until November 2022. However, we have seen evidence that lung nodules were present on CT scans as early as December 2021, and by September 2022 had increased to a size which should have been noted by the radiologist. This should have resulted in a significant finding alert, and Consultant A should have been alerted at this point.
40. There was a missed opportunity to identify a return of Ms M’s cancer, and to inform her of this, earlier. This could potentially have been identified following the June 2022 CT scan, and definitely following the September 2022 CT scan. We discuss the impact of this later in this report.
Significant findings from November scan and change in consultant
41. Mr C says Ms M had to wait almost three months to find out the results from the November 2022 CT scan. She was expecting a clinic appointment in December 2022. He says he had to chase this up with the Trust in order to secure an appointment in February 2023. It was not until this appointment that Ms M found out her cancer had returned and spread to her lungs. At that appointment, Ms M also found out her responsible consultant had changed from Consultant A to Consultant B.
42. Ms M’s consultant was changed in September 2022, but this should not have caused any delays in providing her with clinic appointments or changed when her next clinic reviews were due. The Trust says a follow up appointment in February was made following her outpatient appointment in October 2022. The clinic letter for Ms M’s appointment on 14 October 2022 states the oncologist had requested a repeat CT scan three months later, with follow up in clinic with the results afterwards. We could not see specifically that any appointment was made to follow Ms M up after this or after the CT scan results in November.
43. The November 2022 CT scan report said there was a progression of lung metastases (spread of cancer to the lungs) with larger nodules, including three middle lung nodules measuring between 6mm and 8mm, four lower lung nodules measuring between 4mm and 8mm, and a new nodule in one of the ovaries. Our radiology adviser says this CT scan report accurately reflects what they could see on the November 2022 CT scan.
44. The November scan report states ‘RED ALERT: This report contains a significant finding requiring the attention of the referring clinician.’ Our radiology adviser explains red alert scan protocols, also known as ‘unexpected significant finding’ protocols, are in place across the NHS as part of the Royal College of Radiologists’ recommendations. There are three levels of significant findings, and the required action depends on which level applies to the finding.
45. The Royal College of Radiologists recommends radiologists follow the guidance on unexpected significant alert findings set out by the Academy of Medical Royal Colleges (AMRC). This says red alert scan protocols must be in place in all NHS Trusts as set out in its recommendations. There are three levels of significant finding: • critical – to be reported to the requesting clinician immediately, or the on-call team if they are not available, and the patient brought in for treatment as soon as possible • serious – the patient needs to be seen urgently (over the next few days) for treatment • unexpected – findings that may change a patient’s management, but do not require immediate action.
46. Ms M’s red alert would have been considered an ‘unexpected’ significant finding, as this showed a new metastatic disease which would require a change in her management, but did not require urgent or immediate action. This information would need to be shared with the referring clinician as soon as possible, but not necessarily on the same day.
47. The Trust has its own procedure in place for unexpected significant findings in its radiology department. The Trust uses Everlight, a radiology service that provides teleradiology reporting to NHS trusts, to share significant findings and notifications between its radiologists and referring clinicians. The Trust’s procedure states the radiologist will contact the referring clinician and their secretary by email to notify them that the report contains significant findings.
48. The November CT scan was taken on 21 November 2022 and the written report was produced on 25 November. The radiologist emailed Consultant A’s secretary on 28 November with a copy of the CT scan report, alerting Consultant A of the significant findings. This action was in line with the Trust’s process and the Royal College of Radiology’s guidance.
49. The AMRC says in its recommendations for imaging alerts and notifications that it is the referring clinician’s responsibility to acknowledge and act on the report or re-direct the report accordingly, and to record this in the patient’s records. It says when multiple clinical teams are involved in the care of a patient, the receiver of the alert should act or re-direct the alert accordingly if they are no longer part of the team looking after the patient. The responsible clinician should acknowledge and document the report and action taken including communication with the patient. It adds organisations must have a fail-safe system to follow up on reports that have not been acknowledged.
50. This means the referring clinician should have acknowledged the alert and confirmed when the appointment was next due, and if the appointment was not within the next two to four weeks, it should have been brought forward. The patient should have been informed of the scan results in a timely manner and treatment planned accordingly.
51. In this case, as Consultant A was informed of the alert but was no longer involved with the patient’s care, this alert should have been passed on to Consultant B to take action on. This did not happen. No actions were taken to ensure Ms M had an appointment to share this information with her and discuss treatment options in a timely manner. We have seen no evidence that the significant finding alert was viewed by an oncologist until Ms M attended her appointment with Consultant B in February 2023. This is not in line with AMRC recommendations on responding to significant alerts from imaging reports.
52. During this period of care, Ms M also received care and treatment from a consultant urologist to treat disease in her kidney and urinary tract linked to her illness. From the complaints file, we can see both Consultant A and the consultant urologist were asked by the Trust to give reasons for the three month delay in acting on the results of this scan. Their responses to the Trust complaint team are set out in paragraphs 53-54 below.
53. The consultant urologist noted the CT scan performed on 21 November 2022 incorrectly had them listed as the ordering clinician. The urologist said they had not ordered the scan, and they were concerned the report listed them as the ordering clinician when this was not the case. The urologist confirmed they had not received a significant finding alert email on 28 November 2022 in relation to the CT scan done that month. The urologist added they completed an incident report on 29 March 2023, when they became aware they had been incorrectly listed as the referring clinician for the November 2022 scan.
54. Consultant A said Ms M’s care was handed over to Consultant B in September 2022. They said the oncology team is always receiving emails relating to significant scan findings, and it is not uncommon for scan results to show recurrent or progressive disease. They said the oncology team’s practice for many years on receiving significant findings responses was simply to review patients in clinic with results of follow up scans. They said the follow up appointment is requested on the outcome sheet from the previous appointment and the significant finding reported on Ms M’s CT scan would automatically have been followed up at the next clinic appointment. As Ms M’s care had been transferred to Consultant B they said a follow up appointment would have been booked for Consultant B’s clinic at the previous appointment.
55. Oncology adviser 1 said it would have been best practice to arrange a follow up appointment for two to four weeks after the November CT scan. This means best practice would have been to arrange Ms M’s next clinic appointment for her to be seen by 21 December 2022. We could not see any evidence in Ms M’s clinical records that a follow up appointment was booked following her October 2022 clinic appointment. While it would have been good practice for this to have been arranged at the time, or brought forward after the November CT scan reported unexpected significant findings, there are no specific standards setting out timeframes for providing patients with follow up appointments in these circumstances.
56. Oncology adviser 2 says in general, CT scans are routinely done for cancer patients with a planned follow up to discuss the results. They say it is common within oncology for significant finding alerts to be reported, but in many cases these are not unexpected findings and as patients have planned follow up appointments, often no action is taken until the patient is reviewed in clinic.
57. However, we note that no follow up appointment appeared to have been arranged for Ms M at the time that the unexpected significant finding alert was raised in November 2022. We should also take into account that, as Ms M’s previous CT scan reports had all said she had no signs of cancer, in this case the significant finding was unexpected, and so action should have been taken on this.
58. No action was taken in response to the unexpected significant finding alert, which should have been passed on to Consultant B by Consultant A. The CT scan results should have been shared with Ms M sooner, and plans for managing the unexpected findings made earlier. This is not in line with the guidance set out above and we find this a failing. We consider the impact of this and other failings we have found below.
Impact of failings identified
59. Mr C says missed findings from the March, June and September scans and a delay in acting on the findings from the November scan meant Ms M was unaware that her cancer had returned for twelve months. He says Ms M was unaware the scans done in November 2022 showed a recurrence and spread of disease until she attended her appointment in February 2023. And she only found out the June and September scans showed a recurrence of disease after she had complained to the Trust.
60. Mr C says he had noticed changes in Ms M’s health during 2022, but she was falsely reassured in July and October there was nothing to worry about. He says he now knows her leg and back pain and discomfort, and kidney and urinary tract issues, were symptoms of a recurrence of her disease. He says if the cancer had been identified earlier, she could have received treatment to relieve her symptoms sooner.
61. Mr C says he is concerned Ms M could have had more palliative treatment options available, if she had been informed earlier of the recurrence and spread of her cancer. He says by the time treatment was started in March 2023 it was too late to make any difference. He says if they had been aware earlier in 2022 that the cancer had returned, they could have brought their plans forward and enjoyed the time they had left together.
62. Our oncology adviser 2 says they would not expect small lung nodules of around 2mm in size to be reported or to require any actions, other than a repeat CT scan three months later to monitor any changes to such growths. They said if the September CT scan had been accurately reported, as set out in paragraph 35, this would have resulted in a diagnosis of metastatic cancer at that point.
63. Ms M should then have been seen by the oncology team and palliative chemotherapy discussed. Treatment would have been palliative only, to relieve symptoms, as the type of cancer Ms M had was not curable.
64. Oncology adviser 2 says, from the clinical records, Ms M did not have symptoms and had low volume disease. They say it is possible no treatment would have been advised at that point, with further imaging planned three months later and palliative chemotherapy considered again as the disease progressed or as Ms M experienced significant symptoms. There were no other treatment options for Ms M other than the treatment that was provided from March 2023. Even if the lung nodules had been identified earlier, the return of her primary cancer could not have been prevented.
65. However, we take into account Mr C’s statement that Ms M was unwell throughout 2022 with symptoms that, in hindsight, could have been due to the returning cancer. The clinical records do show Ms M had symptoms of ill health, with a short admission to the Trust in September to investigate leg and back pain. Mr C says in addition to back and leg pains and discomfort, Ms M also experienced symptoms of kidney and urinary tract issues, which had in the past been linked to her previous cancer. The oncologist who saw Ms M in October wrote to the consultant urologist, noting she continued to experience back pain and radiology imaging showed she had hydronephrosis (swelling in the kidneys) which needed a urologist’s advice.
66. We cannot say whether or not Ms M’s symptoms during 2022 were linked to the developing cancer. This is because at the time, she had not been diagnosed with a return of her cancer with spread to her lungs. However, if the CT scans had been accurately reported, Ms M could have been diagnosed with cancer as early as the June 2022 scan and certainly following the September 2022 CT scan. This means any symptoms of ill health she was having could then have been explored to identify if they were linked to the cancer, and if so, appropriate palliative treatment could have been considered at that point.
67. Cancer is defined in four number stages, according to how large the cancer is, and this determines the treatment options available. These stages are: • Stage 1 – the cancer is small and contained within the organ it started in • Stage 2 – the cancer is larger than stage 1 but has not started to spread • Stage 3 – the cancer is larger and may have started to spread • Stage 4 – the cancer has spread from where it started to another organ in the body, such as the liver or lung.
68. In 2018, Ms M was diagnosed with a very rare type of cancer, adenocarcinoma of the jejunum (cancer in the small bowel). She was diagnosed with this cancer at Stage 4, with metastases to her ovary. When the cancer returned in 2021, metastases were found in her ureter (part of the urinary tract). This type of cancer, unfortunately, has a poor prognosis, particularly with metastases. The World Journal of Surgical Oncology published a research paper showing average survival time in patients with Stage 4 cancer with metastases, is three months without chemotherapy, and eight months with chemotherapy. Research published by Science Direct suggests patients with this type of cancer have less than 30% chance of surviving five years from diagnosis.
69. On balance, the delay in diagnosis did not change Ms M’s treatment options, and she was well enough in March 2023 to start the treatment that was the best option for her. This treatment would have been palliative only, as her cancer was sadly incurable. The same treatment options could have been considered earlier, if Ms M’s cancer had been diagnosed earlier. We consider the delay in diagnosis led to a missed opportunity to consider palliative treatment to provide symptom relief and make Ms M more comfortable earlier.
70. We find failings in the reporting of CT scans and the actions taken on a significant finding alert. We do not think earlier treatment would have led to a different outcome in terms of the progress of Ms M’s disease, or that her death could have been prevented. However, these failings led to a missed opportunity to provide Ms M with a diagnosis earlier and potentially consider providing her with palliative treatment to relieve her symptoms sooner. They also led to a missed opportunity for Mr C and Ms M to be made aware of the diagnosis earlier, come to terms with it and make plans for the time they had left together.
71. We partly uphold Mr C’s complaint. We set out below a number of recommendations to the Trust to put things right for Mr C and to improve its services to prevent the failings from happening again.