19. Mrs N raised a complaint about what happened. The Trust carried out a review of the clinical care it provided using its serious incident process.
20. This process identified some of the things that had gone wrong and described changes it had made to prevent a recurrence. We have considered the chronology of what happened in this section of the report, to see where it fell below what should be expected. We have considered the impact of this, and the actions the Trust has taken, in the impact and actions section of our report.
21. The Trust received an MRI report from the second trust with the details of the clinically significant unexpected finding (mentioned in paragraph nine) on 7 February.
22. The guidance at the time was Royal College of Radiologists (RCR) - Standards for the communication of radiological reports and fail-safe alert notification, 2016.
23. This says:
‘It is the responsibility of the requesting doctor and/or their clinical team to read and act upon the report findings and fail-safe alerts as quickly and efficiently as possible.’
‘Fail-safe systems should be IT based to reduce error and increase efficiency, but if facilities are not available, alternative manual processes should be in place.’
24. We can see this did not happen. The cardiologist’s letter of 10 February noted they had ordered a renal USS to rule out significant pathologies. This should have happened urgently to be in line with the guidance outlined in paragraph 23.
25. The lack of urgent referral was also not in line with General Medical Council: Good Medical Practice, the professional standards for all doctors in the UK, 2013. This says:
‘You must provide a good standard of practice and care. If you assess, diagnose or treat patients, you must: […] promptly provide or arrange suitable advice, investigations or treatment where necessary.’
26. The Trust did not do this and this was a failing. The Trust acknowledged this in its investigation. It identified the USS should have been ordered urgently. This was the first missed opportunity for a timely intervention for Mr N.
27. The Trust investigation also identified a further failing. The referral for the USS should have been made using a fail-safe system as outlined in paragraph 23.
28. There was no such system, nor a reliable alternative manual system in place, as evidenced by the fact this referral was lost. We do not know how this happened, and there was no safety net to prevent this situation. This was the second missed opportunity.
29. On 8 March Mr N contacted the Trust to ask about a date for the scan. The Trust created another routine, rather than urgent, referral. There is no evidence this referral reached its destination. It again relied on a manual system with no fail-safe. This was the third missed opportunity.
30. On 15 March Mr N contacted the Trust again to chase the imaging. A further routine referral was then manually delivered on 18 March. This was a fourth missed opportunity for the imaging to be expedited.
31. On 21 March the GP sent an urgent two week wait referral. It appears this was the point at which the Trust was prompted to take urgent action in line with the expectations of the two week wait system. The Trust arranged an appointment with a urology specialist for 24 March. This was in line with the NHS constitution which says a patient should be seen by a cancer specialist within a maximum of two weeks from GP referral, for urgent referrals where cancer is suspected
32. Unfortunately this appointment, and the rearranged appointment for 30 March were cancelled. The renal USS was carried out on 2 April and Mr N was seen by a urology specialist on 7 April.
33. From 21 March onwards, we recognise these cancellations were missed opportunities for a slightly early specialist urology appointment. We carefully considered whether we would consider these missed opportunities to be failings.
34. Our urology adviser explained there is no guidance or process for cancellations of patient appointments on the two week wait pathway. They said this does happen occasionally, for reasons such as sickness. The context at this time is that there was a high level of COVID-19 infection.
35. Our urology adviser pointed out the Trust was pursuing other options within this two week period while the appointment was awaited. These were the renal USS on 2 April and a referral to the urology MDT by the cardiac consultant on 4 April.
36. Taking into account our adviser’s view that such cancellations can be unavoidable, that the appointment took place within three days of the target date, we did not consider this fell so far below the standard as to constitute a service failing. Our adviser told us the three day delay did not make any difference, as investigative actions were already ongoing.
37. Mrs N told us the urology consultant who saw her husband didn't examine him or take a history. She told us if the consultant had examined him they may have found the fluid on the lungs, might have given him treatment, and he might have then been fit enough immunotherapy.
38. Our urology adviser told us that it would not be usual for a urology consultant to carry out a physical examination. The EAU Guidelines on Renal Cell Carcinoma (RCC) say ‘many renal masses remain asymptomatic until the late disease stages. The majority of RCCs are detected incidentally by non-invasive imaging investigating’ and ‘Physical examination has a limited role in RCC diagnosis’.
39. The urology consultant arranged a CT scan, which our adviser said was the right action to take, and was in line with the EAU guidelines which say: ‘Most renal tumours are diagnosed by abdominal US or CT performed for other medical reasons’.
40. Taking into account the guidelines and the advice of our urology adviser we did not see any failings in the action of the urology consultant. They arranged the relevant investigation in a timely way.
41. To summarise this section, we can see there were service failings because the Trust should have requested an urgent USS on 7 February. The renal USS was eventually carried out on 2 April.
42. The actions of the Trust were in line with guidance from 21 March onwards.
Impact and actions the Trust has taken 43. Mrs N says the consequences of the delay in diagnosis was a delay in considering starting immunotherapy treatment. She says if treatment started eight weeks earlier, when her husband had no more symptoms than a cough and was fit, he would have lived longer than he did. She said he would have had longer to be able to plan the end of his life and put his affairs in order.
44. We carefully considered whether we could say the impact is as Mrs N has claimed. We did not think we could reach this conclusion. Our urology adviser told us Mr N had rapidly progressive renal cancer, which has a poor prognosis. They said the delay is highly unlikely to have affected the outcome.
45. We know this will be difficult for Mrs N to read. We do not seek to minimise the distress the delays caused and the feelings of anxiety Mr and Mrs N will have felt knowing about the delay, and then getting the sad diagnosis of a rapidly progressing cancer.
46. Our adviser explained the report of the CT, carried out on 12 April, showed a ‘large enhancing lesion in the left kidney highly suspicious for an RCC, a borderline left para-aortic lymph node and multiple small lung nodules bilaterally suspicious for metastatic disease’. This means there were signs the cancer had spread. A specialist MDT at a third trust recommended a biopsy and oncology opinion.
47. Our urology adviser said at this time Mr N had unfavourable risk category disease according to the International Metastatic RCC Database Consortium (IMDC) criteria (a clinical tool to predict prognosis in patients with cancer), with a median overall survival of 7.8 months. This means that of the people who were fit enough, and received treatment, 7.8 months was the middle value of how long people lived with the type of cancer Mr N had.
48. Our urology adviser said Mr N’s declining condition meant that he was borderline fit for treatment at that time. However, we cannot say what the outcome of any assessment for immunotherapy would have been, as he had unfavourable risk category disease.
49. We have reached the conclusion that we would never be able to say, even on the balance of probabilities, that Mr N could have lived longer because there are too many variables. These include whether he would have been suitable for immunotherapy, whether he would have been fit enough if considered sooner, and whether immunotherapy would have lengthened his life.
50. The conclusion we can reach is there was a missed opportunity for immunotherapy to be considered sooner. He was unfit when it was eventually considered, and we must recognise he may have been deemed unfit earlier, even if there had been no delays and he had been assessed at the earliest opportunity.
51. We recognise Mr and Mrs N may have had the information they needed to fully understand his prognosis sooner. We cannot say Mr N would have had longer to live or more opportunity to prepare for the end of his life because of the rapid progression of the disease.