Cancer investigations
21. NHS England sets national waiting time standards for the diagnosis and treatment of cancer. In November 2023 the waiting time standards were:
• maximum of 28 days in 75% of cases from urgent referral for suspected cancer to the point a diagnosis is confirmed or ruled out • maximum of 31 days from decision to treat to first treatment in 96% of cases • maximum of 62 days from receipt of urgent referral to first definitive treatment of cancer in 85% of cases.
22. On 3 November Mrs A’s CT scan resulted in an urgent referral to gastrointestinal colleagues. The radiologist felt the results indicated she had cancer and made an urgent referral to the upper GI MDT on 6 November. This is when the clock started for the NHS cancer wait time standards.
23. The upper GI MDT met on 13 November. It planned to undertake an MRI scan of Mrs A’s liver and an ultrasound guided biopsy. The MRI scan took place on 17 November, and the upper GI MDT discussed her case again on 20 November. The meeting noted the ultrasound-guided biopsy was planned for 28 November and it could not propose a treatment plan until this was completed. This is because the Trust could not be certain of the precise diagnosis without the results of the biopsy.
24. The MDT met again on 4 December. The biopsy results had still not been returned, which meant a treatment plan could not be agreed. In the MDT meeting on 11 December the clinicians noted the results had still not been received but that these were ‘crucial’ for identifying the type of cancer and planning ongoing care.
25. On 18 December the MDT noted that there were significant delays in providing biopsy results at a number of locations. The clinicians decided to repeat the biopsy and send the sample to a different specialist centre. They also documented a need to refer Mrs A to a sarcoma MDT.
26. There are no national standards which outline how quickly the biopsy should have taken place; however, this should have happened within the NHS England wait time standards. The Trust referenced a local policy in its complaint response to Mrs O; however, it has since confirmed this was an error.
27. The evidence shows the Mrs A was urgently referred to the Upper GI MDT on 6 November, meaning that from this point the 62-day target applied. This meant Mrs A’s treatment should have commenced on or before 7 January 2024.
28. We note the MDT was working towards a target date of 14 January; however, this appears to have been an error. The first MDT meeting on 13 November 2023 noted the urgent referral date as being 6 November; however, the following MDTs noted the referral date as the 13 November. It is very unlikely this was the date of the original urgent referral as Mrs A’s care was discussed in the MDT that day.
29. We have found the first biopsy took place within a timeframe that could have enabled the Trust to meet the 62-day referral to treatment standard. Therefore, the time it took to complete this does not amount to service failure.
30. With regards to obtaining the biopsy results, testing samples from sarcomas often takes longer than other cancers. This is because the tissue itself is very complex and often requires special staining to confirm. This takes more time than testing for less complex cancers and tests often need to be undertaken by specialist sarcoma services. The Trust has acknowledged a delay in obtaining the results from the samples taken on 28 November. The records from the upper GI MDT note this was due to ‘challenges’ in interpreting these results both locally and at other specialist sarcoma centres.
31. There is recognition within the 62-day target that 15% of cases will not meet this target. Sarcomas are complex cancers to diagnose, and when the Trust identified the delays in obtaining the sample results it made a plan to attempt to expedite this. It arranged a second biopsy for 3 January 2024, with a plan to send this sample to a different centre for testing.
32. Due to the complexity of diagnosing sarcomas, it is more likely than not Mrs A fell within the 15% of cancers NHS England recognises will not meet the 62-day referral to treatment target. This is because this target also applies to cancers which are simple to diagnose, and accounts for more complex cancers taking longer. We cannot robustly conclude that the delay amounts to service failure in this context; however, we recognise how worrying this must have been for Mrs A and Mrs O.
33. With regards to whether Mrs A should have been referred to a sarcoma MDT, NHS England’s service specification for soft tissue sarcomas says that the provision of care for all patients should be provided by specialist sarcoma centre. This guidance says that when a sarcoma is suspected, a referral to a sarcoma MDT should take place ‘without delay’.
34. The Trust suspected Mrs A most likely had a sarcoma from 4 December, as outlined in the upper GI MDT documentation. Whilst we acknowledge the upper GI MDT was awaiting the results of her biopsy, it should have referred her directly to this service at this point. This had still not happened when Mrs A, sadly, died on 1 January 2024. This was a delay in referring her to the right service and amounts to service failure. We consider the impact this had later in this report.
Investigations and treatment from 11 December 35. Our consideration of these issues has been hindered in some areas by poor record keeping by the Trust. Where this has occurred, we explain this and how it has impacted on our decision-making.
36. On 11 December the Trust’s records indicate blood tests were undertaken, but it is unclear whether this was by the Trust or another service. There are no notes of any care being provided on this date. These blood test results showed Mrs A’s haemoglobin levels were 85 g/L, with the normal range for an adult female who is not pregnant being above 120g/L. Haemoglobin is a protein which is essential to transporting oxygen around the body.
37. On 13 December, Mrs A presented at the Trust’s SDEC service. She was seen by a nurse practitioner, which is a nurse who has undertaken additional training that enables them to diagnose and treat illnesses. Mrs A reported shortness of breath and feeling exhausted. Her physical observations were in the expected range, and, on examination, she was found to have abdominal distention (a swollen/enlarged abdomen) and pain.
38. The nurse diagnosed Mrs A with symptomatic anaemia, and a unit of blood was transfused to raise her haemoglobin level. She was not seen by a doctor and the nurse discharged Mrs A that day with a plan to be seen again on 28 December.
39. Our Physician Adviser expressed concern that Mrs A was not reviewed by a doctor during this presentation at the SDEC. Her haemoglobin level was 95 g/L on 13 December. NICE guideline NG24 (Blood Transfusion) states that the threshold for blood transfusion, except in limited clinical circumstances, is 70 g/L. Mrs A did not meet these limited circumstances and our Physician Adviser stated they were ‘extremely surprised’ that the blood bank agreed to issue a blood transfusion.
40. Normally, if a medical team wants to transfuse a patient with a haemoglobin level above 70 g/L they would need to seek approval from a haematologist (a doctor specialising in blood and blood-related illness). The exception to this is when a patient is actively, visibly bleeding with a major haemorrhage. This was not the case for Mrs A at this time.
41. Our Physician Adviser explained that a diagnosis of symptomatic anaemia was not clinically justified based on Mrs A’s presentation, and a blood transfusion was not indicated. They added that given her breathlessness was not proportionate to her haemoglobin levels, a senior doctor should have been consulted, and it was not appropriate for the nurse practitioner to discharge Mrs A without this oversight.
42. Our Nurse Adviser also raised similar concerns. They explained that although stable patients can be discharged without a doctor’s review, the problem here was that the diagnosis did not align with national guidelines on anaemia (NICE CKS Anaemia – iron deficiency). They explained the nurse should have explored other reasons for Mrs A’s symptoms, including her existing diagnosis of hypothyroidism and complications that were secondary to her cancer.
43. Mrs A’s type of cancer can cause pain and fluid retention, which can cause shortness of breath and fatigue. The spread of cancer can also cause pulmonary embolism (a blood clot in the lungs), which should have been explored before discharging Mrs A.
44. We have found the Trust failed to seek appropriate clinical oversight and adequately explore the cause(s) of Mrs A’s symptoms before discharging her from the SDEC service on 13 December. We have also found the treatment provided was not in line with national guidelines on blood transfusion.
45. With regards to whether the Trust should have done more to rule out internal bleeding on 13 December, Mrs A’s haemoglobin levels increased by 24 g/L following the blood transfusion. The usual expected increase following a transfusion would be 10g/L, meaning her haemoglobin levels increased more than would normally be expected. This suggests there was no significant ongoing bleeding because, if there had been, her haemoglobin levels would be expected to have dropped, not risen, following the blood transfusion.
46. We have found that that whilst Mrs A’s clinical presentation on 13 December did not indicate an active internal bleed at that time, a more senior clinical opinion should have been sought. The nurse practitioner should also have done more to explore the reasons for her symptoms before discharging her from the SDEC service. This amounts to service failure.
47. Mrs A presented at the Trust’s SDEC service for a review on 28 December. Her blood tests that day showed her creatinine levels (a waste product that is removed by the kidneys) had increased from 78 to 107 micromoles per litre (µmol/L). 78 µmol/L is in the upper end of the normal level for adult females, with 107 µmol/L indicating reduced kidney function.
48. Mrs A’s impaired kidney function meant that as of 28 December she had a stage one acute kidney injury (AKI). This suggests early kidney stress or damage, and without treatment, it can progress to further kidney damage. This can lead to fluid overload (where a person has too much fluid in their body), electrolyte imbalance and permanent kidney damage.
49. NICE guideline NG148 (acute kidney injury) states that clinicians should investigate AKIs by comparing creatinine levels to the patient’s baseline. Mrs A’s creatinine levels had risen since her blood tests on 13 December, and considerably risen since her baseline level on 20 November. This showed a deterioration in her kidney function and represented an AKI. The Trust should have investigated the cause of her AKI, which should have included:
• undertaking a urine dipstick test, which should happen for all people as soon as an AKI is detected • reviewing her general condition, especially her hydration status.
50. There are very few notes of the care provided to Mrs A on 28 December, aside from some notes on the actions taken to arrange imaging investigations. There is no evidence any action was taken in relation to her deteriorating kidney function or continued symptom of breathlessness. The Trust did, however, undertake a chest X-ray the following day to investigate her breathlessness.
51. We have found the Trust failed to undertake any investigations into the cause of Mrs A’s AKI. This was not in line with NICE guideline NG148. Our Physician Adviser explained that her discharge on 28 December, in the absence of these investigations, was not clinically justifiable. This amounts to service failure.
52. Mrs A attended the SDEC again on 29 December. Her kidney function had deteriorated further since her blood tests the day prior, and an assessment of her hydration status was essential. She also should have been placed on the Trust’s AKI pathway at this time due to her creatinine levels, in line with NICE guideline NG148.
53. There is very little evidence of any assessment of Mrs A’s deteriorating kidney function or her hydration status, nor did the Trust undertake a urine dipstick as recommended by NICE guideline NG148. There were several opportunities to identify her deterioration in kidney function; however, the records show that multiple clinicians failed to identify this trend of deterioration.
54. We have found the Trust failed to identify Mrs A’s deteriorating kidney function on 28 and 29 December. We have also found that it failed to place her on its AKI pathway and provide essential interventions to treat her deteriorating kidney function. This amounts to service failure.
55. Identifying the cause of an AKI is essential to treating it; however, the Trust failed to take any steps to investigate the potential cause of Mrs A’s AKI on 28 and 29 December.
56. It is difficult to know, with hindsight, what the potential cause of the AKI may have been. This is due to the lack of documented investigations. However, dehydration is a common cause of an AKI and, on balance, it seems Mrs A was more likely than not dehydrated on admission. This is based on documentation on 30 December which stated Mrs A appeared ‘clinically dry’, and her sister’s account of witnessing her sister’s dehydration on these dates.
57. Because it is more likely than not Mrs A was dehydrated when admitted to hospital on 29 December, the Trust should have prescribed IV fluids and commenced a fluid balance chart to monitor her fluid input and output. This did not happen, which amounts to a failing in the care provided to Mrs A.
58. With regards to whether the Trust should have considered and initiated its sepsis pathway, the Trust’s poor record-keeping has hindered our consideration of this. There is no record of any assessment of Mrs A’s risk of infection on 28 December. Her initial clinical assessment on 29 December does not record any physical observations, which are essential to a robust consideration of whether an infection may be present. However, the initial management plan did reference a need for a course of antibiotics. This indicates the clinicians suspected an infection at this time.
59. In addition, Mrs A’s CRP (an indicator of inflammation) and white cell count were both rising. Whilst these can be elevated in patients with cancer, this would usually be relatively stable and not actively rising. If clinicians suspect the rise is due to reasons other than infection, this should be robustly documented. Therefore, in the absence of a documented rationale for an alternative explanation as to why Mrs A’s CRP and white cell count were rising, this more likely than not this was a result of infection rather than her cancer.
60. NICE guideline NG51 (suspected sepsis) states that clinicians should consider sepsis whenever a person presents with symptoms or signs of a possible infection. This should include an assessment of physical observations, stratification of clinical risk using the National Early Warning Score (NEWS2), and a thorough clinical examination.
61. There is no documentation of any physical observations when Mrs A presented at the hospital on 28 and 29 December. The Trust’s response to Mrs O’s complaint says it ruled out sepsis because Mrs A did not have a high temperature; however, this is not in line with NICE guideline NG51 (section 1.4.1), which says: ‘do not rely on fever or hypothermia alone to rule sepsis either in or out’.
62. The GMC’s Good Medical Practice guidelines say that doctors must: • adequately assess patients’ conditions, taking account of their history (including any symptoms) and, where necessary, examine them • promptly provide or arrange suitable advice, investigations or treatment when necessary.
63. The Trust’s failure to document any physical observations falls far short of the GMC’s Good Medical Practice guidelines in the context of Mrs A’s clinical presentation. It is well-known that an AKI in the context of sepsis is associated with a worse prognosis, and patients require more significant attention. As per section 1.10.11 of NICE guideline NG51, patients with an AKI should be treated as meeting one or more high risk criterion for sepsis.
64. Patients who are high risk for sepsis and have indicators of an infection should be immediately assessed by a senior clinical decision maker (an emergency care qualified doctor at grade ST4 or above). A broad-spectrum antibiotic should be administered at the maximum dose within one hour. Blood cultures should also be taken, and the patient’s case should be discussed with a consultant.
65. Mrs A was admitted to hospital at 5.25pm and assessed by a Senior House Officer (SHO) at 6.07pm. An SHO is a doctor in the first two years of speciality training, which does not meet the required level of seniority for assessing patients at high risk of sepsis.
66. Mrs A’s prescription chart indicates her antibiotics were administered at 8pm, which was not in line with NICE guideline NG51. The antibiotics should have been administered within one hour, which did not happen. There is also no indication that her risk of sepsis was discussed with a consultant, nor were blood cultures taken. This also does not align with NICE guideline NG51.
67. We have found the Trust did not consider Mrs A’s risk of sepsis despite clear indications of infection on admission on 29 December. It did not document her physical observations, which indicates a failing in and of itself, and she was not reviewed by a clinician with the required seniority for her presentation. This amounts to service failure.
68. Furthermore, the Trust’s account of why it did not consider sepsis does not align with NICE guideline NG51, which specifically says clinicians should not rely on temperature alone to rule sepsis in or out.
69. In addition, the Trust delayed in administering antibiotics, failed to take blood cultures, and her case was not discussed with a consultant. This fell so far short of NICE guideline NG51 that it amounts to service failure.
70. We cannot know if these actions should have taken place on 28 December due to the Trust’s poor record keeping.
71. With regards to Mrs O’s concern about a delay in undertaking a CT scan, there are no national guidelines to tell us how soon this should have happened from 29 December. However, the GMC’s Good Medical Practice guidelines state that doctors must promptly provide or arrange investigations when necessary.
72. Our Physician Adviser said that based on Mrs A’s clinical presentation, there was no unreasonable delay in undertaking the CT scan. This is because it was appropriate to manage her AKI without imaging whilst it was at stage one and two. A CT scan became necessary when this deteriorated to an AKI stage three on 31 December.
73. Regarding whether the Trust acted on Mrs A’s deteriorating kidney function, between 29 and 30 December her blood tests showed her AKI had progressed to stage two. By 31 December her kidney function had deteriorated to an AKI stage three. Mrs A’s blood tests showed significant deterioration in her kidney function over the course of three days, and we have considered whether the Trust took appropriate action.
74. On 29 and 30 December doctors documented Mrs A’s blood test results but did not note any interpretation of these as signifying an AKI. At this stage she had an AKI two and a management plan should have been documented as part of the ward round. This did not happen. There was also no consideration of her deteriorating kidney function in the ward round that took place at 12.30pm on 31 December.
75. At 3pm on 31 December a doctor noted the AKI and documented a management plan to prescribe IV diuretics (medication to remove fluid from the body) and IV fluids. Mrs O told us this review took place remotely and the doctor had not seen Mrs A in person.
76. Our Physician Adviser explained this plan made no logical sense because the actions contradicted each other. Mrs A was either dehydrated, in which case the diuretics should not have been prescribed, or she was overloaded with fluid and should not have been given IV fluids. A pleural tap (a type of drain) was proposed for removing the fluid from Mrs A’s lung.
77. We have found the Trust delayed in recognising and treating Mrs A’s AKI and, when it did recognise her AKI in the afternoon of 31 December, the proposed management plan was not clinically appropriate. This amounts to service failure.
78. Mrs O is concerned there was a delay in obtaining and acting on repeat blood tests that showed a life-threatening rise in Mrs A’s potassium levels. Due to the Trust’s poor record keeping, we cannot know whether there was a delay in actioning these. The Trust’s response acknowledges a delay arising from a mislabelling of the bloods taken earlier that day; however, because the Trust provided incorrect information in its complaint responses, which is explored later in this report, and the lack of documentation relating to this, we cannot know, even on the balance of probabilities, whether there was a delay in undertaking and interpreting these blood tests.
79. From 8.55pm on 31 December, the Trust recognised Mrs A’s acute deterioration and referred her to critical care colleagues. Mrs O says this was done at her insistence due to her sister’s deteriorating condition. A CT scan was undertaken promptly at 10.42pm, which identified an acute haemorrhage from her liver. She was transferred to the Critical Care Unit at 3.20am on 1 January.
80. The decisions to refer Mrs A to Critical Care and in requesting a CT scan from this point were prompt and appropriate and there were no delays in providing appropriate treatment from this point. We acknowledge Mrs O’s account that this happened promptly due to her insistence, rather than the Trust being proactive. This was in line with the GMC’s Good Medical Practice guidelines.
81. In summary, we have found the Trust failed to:
• appropriately investigate Mrs A’s symptom of breathlessness on 13 December; whilst actions to rule out bleeding were not indicated, the nurse practitioner should have done more to explore the reasons for symptoms and sought a more senior clinical opinion before discharging her from the SDEC • document the care provided to Mrs A to an acceptable standard on 28 and 29 December • undertake any investigations into Mrs A’s deteriorating kidney function on 28 and 29 December, and her discharge from the SDEC on 28 December was not clinically justifiable • recognise Mrs A’s deteriorating kidney function on 29 and 30 December, place her on its AKI pathway, and provide essential interventions to treat her deteriorating kidney function • consider Mrs A’s risk of sepsis in line with national guidance, ensure she was reviewed by a suitably experienced clinician, and it delayed in administering antibiotic treatment • provide appropriate treatment for Mrs A’s worsening AKI and, instead, prescribed an illogical and contradictory management plan on 31 December.
82. These failings fell so far short of national guidelines that the amount to service failure.
Complaint handling 83. Our NHS Complaint Standards (our Standards) set out how NHS services should handle complaints. In line with our Standards, the Trust should have:
• given a clear, balanced account of what happened based on established facts and clearly referencing any relevant legislation, policies or standards • been open and honest when things have gone wrong.
84. The Trust issued its complaint response on 4 April 2024. Its response contained a reference to target times for undertaking biopsies; however, the Trust has since confirmed that no local policy exists, and this was an error. This related to an area where we have found no failings. We can see this was an attempt to be open and honest about something that may have gone wrong; however, the information provided was incorrect.
85. The Trust’s response provided an incomplete account of its management of Mrs A’s haemoglobin levels and its consideration of her AKI. We have already considered whether the care and treatment itself was appropriate in this report, and we will not repeat this consideration here. What we can say is that the Trust could have done more to outline the actions it took and include relevant policies and guidance within the complaint response to support its conclusions.
86. In addition, the Trust said none of the medication Mrs A was taking was toxic to kidneys; however, our Physician Adviser commented that she had been prescribed naproxen whilst her renal function was impaired. Naproxen is a drug that should be avoided when a patient has an AKI because it can further reduce kidney function. The response to this aspect of Mrs O’s complaint contained information that was incorrect.
87. Additionally, the response said Mrs A had a CT scan on 29 December 2023. This was incorrect. She had a chest X-ray and abdominal ultrasound on 29 December; the CT scan took place on 31 December.
88. The Trust issued a second complaint response on 30 July 2024. It reiterated the incorrect information that a CT scan took place on 29 December 2023.
89. The responses also failed to include any guidelines or standards to support the conclusions reached. If it had done this, it may have assisted the Trust in providing more accurate responses.
90. We have found the Trust’s complaint responses contained inaccurate information and failed to sufficiently reference relevant guidelines or standards to support the conclusions it reached. This fell so far short of our Standards that it amounts to service failure.
91. With regards to whether this reflects a lack of candour on the part of the Trust, this is difficult to reach a view on. This is because it is difficult to know whether the incorrect information arose from genuine error or not. What we can say, however, is that it is understandable that Mrs O would be concerned about the Trust’s candour due to the poor quality of the complaint responses.
Impact 92. Mrs O says these failings caused her sister to die sooner than she should have. This has been devastating for her family and has caused her to feel a lot of guilt and distress. She adds her sister died experiencing a lot of pain, and her passing could have been more comfortable had these failings not occurred.
93. Our Physician Adviser explained that, sadly, Mrs A had an aggressive cancer that progressed significantly on the scans performed. This included the cancer damaging and destroying the liver capsule, which is a protective barrier around the liver, leading to an intra-abdominal bleed. They explained this condition was so serious that no treatment options would be able to address this. They added that when the cancer damaged the liver capsule, Mrs A was actively dying and, had her care been in line with national guidelines, the devastating outcome would more likely than not have been the same.
94. With regards to whether Mrs A could have been more comfortable, this is difficult to take a view on due to poor record keeping by the Trust in the final days of her life. Given very little could be done to treat the intra-abdominal bleed, we cannot reasonably conclude any suffering arising from this could have been avoided.
95. However, had the Trust had appropriately assessed Mrs A’s deterioration and recognised she was actively dying sooner, there is a tangible possibility that doctors could have considered palliative care rather than an admission to the Critical Care Unit.
96. Our Physician Adviser explained that the decision to treat Mrs A on the Critical Care Unit would have entailed a significant amount of avoidable pain and distress with a negligible chance of a meaningful clinical outcome. That said, the poor recording-keeping by the Trust in relation to this decision means we cannot say this more likely than not would or would not have happened. This uncertainty is an injustice to Mrs O.
97. We can understand why Mrs O felt such distress and a sense of guilt when witnessing her sister’s care. Mrs O is an experienced nurse and was aware of the shortcomings in her sister’s care as they happened. She had to witness care that she knew did not align with national guidance, and the impact this had on her sister’s experience in the final days of her life.
98. We can also understand why, despite these events being entirely beyond Mrs O’s control, what happened led to a sense of guilt and feeling that, with her clinical experience, she should have done more to advocate for better care. We have no doubt this caused Mrs O a significant amount of distress.
99. Regarding the Trust’s complaint handling, we understand why this caused further distress to Mrs O. We also recognise how this caused her to lose faith in the Trust’s ability to learn from its mistakes and improve its services.
100. The Trust has not acknowledged the failings we have provisionally identified, nor has it taken appropriate steps to put this right. Therefore, we have outlined recommendations below.