31. Please note that the consideration of Miss S’s concerns below is not presented in chronological order of the events as they took place. This is because we have addressed the concerns about each organisation individually, as Mr N received care at four NHS organisations.
Epsom & St Helier University Hospitals NHS Trust
Investigation of symptoms 32. Miss S complains that in July and August 2019, the Trust treated Mr N symptomatically rather than investigate his full presentation and that he was not seen by a specialist under the two-week cancer urgent referral pathway. We understand her concern is that the Trust looked at Mr N’s symptoms in isolation, rather than looking at the bigger picture of his illness. She believes that, if it had done so, it would have realised sooner that he needed to be referred urgently for exploration of his condition.
33. The two-week cancer referral is a national target that patients who were referred by their GP with suspected cancer should be seen by a specialist, or have a specialist cancer diagnostic procedure, within 14 days of an organisation receiving the GP referral.
34. Paragraph 15 of the GMC Good Medical Practice says that ‘if [doctors] assess, diagnose or treat a patient, [they] must… promptly provide or arrange suitable advice, investigations or treatment where necessary’ and ‘refer a patient to another practitioner when this serves the patient’s needs’.
35. Paragraph 16 goes on to say, ‘[doctors] must provide effective treatments based on the best available evidence’.
36. The Trust undertook the first diagnostic test, which was a gastroscopy, within 10 days of the GP referral. This met the 14-day standard in that Mr N had a specialist cancer diagnostic test within 14 days of the GP referral. That gastroscopy returned normal results.
37. Following the gastroscopy result, the Trust then undertook a thorough work up to investigate Mr N’s symptoms, meaning it conducted a range of tests. Within 21 days of the GP referral, the Trust completed four different diagnostic tests. Additionally, within 29 days of the GP referral, the Trust reviewed all the results at a multidisciplinary team (MDT) meeting in the haematology clinic. An MDT brings together clinicians from a variety of specialisms to discuss the best way forward for patients, based on the evidence available to them.
38. The initial tests did not allow the Trust to reach a clear diagnosis, so further tests were required (a bone marrow biopsy, which we will consider in more detail in the ‘Biopsy and diagnosis’ section below). The Trust therefore admitted Mr N on 21 August to expedite this further exploration.
39. Taking into consideration the evidence available, including our physician adviser’s comments, we consider staff undertook extensive testing in a timely fashion in an attempt to reach a robust diagnosis. Assessing Mr N’s symptoms and arranging appropriate tests is in line with the paragraphs 15 and 16 of the GMC guidance listed above, and in arranging an MDT meeting we can see the Trust did not look at his symptoms in isolation but took a holistic, wider approach to his care with input from specialists in different clinical areas.
Biopsy and diagnosis 40. Miss S complains that in August 2019 the Trust took biopsies, and these were sent for testing at the Royal Marsden, who she believes lost the biopsy, so a second biopsy was needed, which delayed the diagnosis.
41. NICE Guidance 52 on non-Hodgkin’s lymphoma diagnosis and management indicates that an excision biopsy should be the first diagnostic procedure, where this is possible. If this is not feasible, then needle biopsies should be taken. An excision biopsy is when clinicians remove the affected area of tissue and a small amount of the surrounding healthy tissue. A needle biopsy is a less invasive procedure that removes some of the tissue and/or fluid in the affected site.
42. Our oncology adviser says that the most common presenting feature of non-Hodgkin’s lymphoma is a lump in the neck. In this scenario, obtaining a biopsy and gaining histological confirmation of the disease is typically straightforward. By histological, we mean taking a small sample of the tissue, which is then analysed to see if cancerous cells are present. Unfortunately, this was not possible for Mr N as there was no obvious large mass to biopsy.
43. On 14 August, a biopsy was taken from the lymph nodes, but analysis of this sample did not allow the Trust to provide a diagnosis. A bone marrow biopsy was subsequently carried out on 22 August 2019 and sent to the Royal Marsden Hospital for testing on the same day.
44. On 29 August, the records indicate that staff were awaiting the lymph node biopsy results and, from this point, Mr N was reviewed daily, with the Trust chasing up the results on both 30 and 31 August. On 2 September there is an entry recording the diagnosis of Hemophagocytic Lymph Histiocytosis (HLH), which is a rare and life-threatening disorder that occurs when the immune system abnormally overreacts, leading to hyperinflammation, tissue damage and multi-organ failure. Our oncology adviser says that it is important to note that the HLH diagnosis was a consequence of the lymphoma. The lymph node biopsy was inconclusive in diagnosing non-Hodgkin’s lymphoma but neither the HLH nor the biopsy in itself was enough to confirm a definitive diagnosis, and this is only something we can appreciate in hindsight, knowing that he had lymphoma.
45. On 4 September, Mr N was taken to St. Georges Hospital. The next day Mr N had a liver biopsy, and the results were provided the same day. Those results confirmed the lymphoma diagnosis, which was shared with him the same day and treatment was started immediately.
46. Our oncology adviser explains that the bone element of the bone marrow biopsy has to be decalcified in the laboratory to enable the histological examination following relevant staining in order to obtain a diagnosis. This cannot be done in 2 to 3 days, so we have not seen any indication of delay here, and the evidence shows the Trust was making clear efforts to obtain the results as soon as it could.
47. The HLH diagnosis was given in an eight-working day turn around, which is within the 10-day overall target range that the research publications noted as ‘the literature’ in our ‘Evidence section’ above suggests.
48. We understand that taking a bone marrow biopsy is not the standard way of obtaining a diagnosis, but this was unavoidable in Mr N’s case in light of the difficulty in getting tissue from other areas of the body to make the diagnosis.
49. After considering the evidence and the oncology adviser’s comments, it is clear that sadly Mr N did not have a disease that allowed a straightforward biopsy, and the diagnosis was eventually made after the unsuccessful lymph node biopsy and subsequent bone marrow biopsy. We understand that the time taken to confirm Mr N’s diagnosis must have been extremely distressing for both Mr N and Miss S.
50. The GMC guidance says clinicians should:
‘prescribe drugs or treatment, including repeat prescriptions, only when you have adequate knowledge of the patient’s health and are satisfied that the drugs or treatment serve the patient’s needs’.
51. Although it was not possible to provide Mr N with a diagnosis as soon as the Trust hoped, for the reasons set out above, there is no evidence to show that this was due to errors on its part or that it caused a delay in him receiving the treatment he needed. Treatment was started on 5 September, based on his clinical observations and symptoms, as this is when it was clear Mr N’s condition was deteriorating. This is before Mr N received his definitive diagnosis on 9 September.
52. We consider that starting treatment before Mr N received a definitive diagnosis it is in line with GMC guidance, as it was given at the earliest opportunity that treatment was clinically indicated. We hope this reassures Miss S that, in our independent view, there was no missed opportunity for Mr N to receive the treatment he needed as soon as the Trust was able to provide it.
St George’s University Hospitals NHS Foundation Trust
Administration of chemotherapy 53. Miss S complains that on 23 September 2019, the Trust did not properly administer Mr N’s dose of chemotherapy. She says Mr N’s chemotherapy was made up of two medications which he was due to receive concurrently, but one of the machines providing the medicines was not turned on.
54. Paragraph 11.5 of NMC standards goes on to say that nurses must ‘undertake accurate checks, including transcription and titration, of any direction to supply or administer a medicinal product’.
55. Mr N started the first cycle of Dose Adjusted EPOCH-R chemotherapy on 23 September 2019. In its complaint response dated 17 June 2021, the Trust acknowledged that on the last day of Mr N’s chemotherapy, a nurse did not unclamp the line administering the drugs and he declined to stay to receive his full dose once the error was identified, so he missed out on 25% of the total Etoposide and Doxorubicin dose in this cycle.
56. We know from the records that and the Trust’s response that Mr N did not receive 25% of the Etoposide and Doxorubicin dose within the last cycle of treatment. Staff advised Mr N he was able to stay and receive the remainder of the dose, but he declined to stay in hospital and wanted to get home.
57. Although the staff did not unclamp the line administering the chemotherapy drugs, we consider their action not so far from what should have happened as set out in the NMC guidance for it to be a failing. This is because nurses identified the error almost immediately and offered to administer the remaining drug in the same treatment, which Mr N declined. This means that, although an error did occur, it was swiftly identified and appropriate steps offered to put right the shortfall in medication, effectively resulting in what would only have been a brief break in the planned treatment.
58. There is no clinical guidance regarding how much of the chemotherapy dose is effective or not, but our oncology adviser informed us of a clinical study, the ‘Impact of R-CHOP dose intensity on survival outcomes in diffuse large B-cell lymphoma: a systematic review’ (the study).
59. The study suggests that taking less than 70-80% of the usual dose of two drugs in the R-CHOP regime (this is a combination treatment of several drugs) can lead to worse outcomes. Our oncology adviser explained that the study notes that the increased risk ratio of death was minimal for the reduced dose group. Mr N received significantly more of the drugs than those patients in the study, only having a 25% reduction in one cycle of six, which the Trust was willing to provide upon identifying the error with the machine. This means that in total, Mr N received 95.8% of the scheduled dose for this regime.
60. Although we do not consider there to be indications of a failing here, we carefully considered how the Trust responded to this part of the complaint. The Trust explained that it has introduced tighter measures for staff when delivering chemotherapy, such as a daily checklist for nursing staff to complete when monitoring patients receiving (DA) EPOCH-R and information cards for patients to receive at the start of the treatment. Additionally, nursing staff who administer systemic anti-cancer therapy (SATC) within the Trust, such as chemotherapy and immunotherapy, all complete a recognised SATC training course and are recorded on the SATC register. They are also required to complete an annual competency assessment in order to maintain registration. In our view, these are appropriate steps to take.
61. Having looked at all the evidence, including the comments from our oncology adviser and the information provided in the study, we find that it more likely than not that the reduced dose of chemotherapy did not have any effect on the sad outcome, even if Mr N had chosen to receive the amount initially planned.
62. We acknowledge that that Miss S believes the reduced dose the chemotherapy contributed to Mr N’s death has been a cause of upset for her. We can see why she thought it may have been a contributing factor, and we hope this reassures her on this matter.
Availability of equipment 63. On 5 September 2019, staff inserted a chest drain to provide relief from a left pleural effusion. This is when there is an accumulation of excess fluid in the space between the chest wall and the lungs, which can be painful and uncomfortable. On 6 September, the chest drain started leaking. Miss S complains the Trust did not have the correct equipment to fix the drain, meaning it leaked for four days, causing Mr N discomfort.
64. Paragraph 16 of the GMC Good Medical Practice guidance says that, in providing clinical care doctors ‘must take all possible steps to alleviate pain and distress whether or not a cure may be possible’. Paragraph 18 goes on to say that doctors ‘must make good use of the resources available’.
65. Our physician adviser tells us there is no specific guidance on how to manage a fluid leak from a chest drain site. They explain it is common practice to use absorbent dressings to soak up the fluid. If a fluid leak continues once a drain is removed, it is common practice to use absorbent dressings over the insertion site and, if that is not sufficient, a stoma bag is usually applied which allows collection of larger volumes of fluid.
66. On 5 September, the chest drain was inserted, and it is noted in the records it was oozing around the insertion site after the procedure. On 6 September, staff took a sample of the fluid but were unable to reconnect the chest drain bag. Later the same day, and after an escalation to an advanced nurse practitioner (ANP), the chest drain bag was reconnected.
67. The drain continued to ooze from the insertion site until 9 September when it was removed after a chest X-ray, which showed the liquid had reduced. The Trust said the continuous ooze from the insertion site caused Mr N’s discomfort. Staff continued to regularly change the dressings but, despite this, Mr N needed regular changes of clothes.
68. After removal, the site continued to ooze. On 11 September, staff applied a stoma bag to collect fluid and try to minimise the need for regular dressing changes.
69. Taking into consideration the available evidence and our physician adviser’s comments, it is our view that staff managed the fluid leak in line with standard practice and paragraphs 16 and 18 of the GMC guidance. Mr N’s discomfort and fluid leak was not caused by the temporary unavailability of the correct drainage bag or equipment on 6 September, as Miss S feared. Our physician adviser tells us that a fluid leak is a recognised complication of chest drain insertion and, unfortunately, Mr N appears to have been particularly prone to this.
70. We understand that it must have been particularly distressing for Miss S to have witnessed Mr N’s discomfort during this period of his care. We hope we have been able to provide some reassurance that the evidence available to us shows staff acted as they should when managing the fluid leak from the chest drain insertion site and that we have not seen anything to suggest the discomfort he experienced was avoidable.
Fall out of bed 71. Miss S complains that on 28 July 2020, Mr N was over sedated and left unsupervised when in the ICU, meaning he fell out of bed twice, each time banging his head. Miss S believes that Mr N’s falls caused a cerebral oedema, which is brain swelling that causes fluid to develop in the brain, increasing the pressure inside of the skull. She is very concerned this contributed to his death two days later.
72. Paragraph 15 of the GMG guidance says that doctors ‘must refer to another practitioner when this serves the patient’s needs’. As referenced at paragraph REF _Ref193791253 \r \h 64, the GMC guidance also says that in providing clinical care doctors ‘must take all possible steps to alleviate pain and distress whether or not a cure may be possible’.
73. Mr N was admitted to the Trust, following a fall down the stairs at home due to the deterioration in his condition. His agitation at that time was so severe that he required sedation to undertake a CT scan of his head and following the removal of his endotracheal tube, and records show that his confusion and agitation continued. The agitation was explained to the family on 26 July as being due to a relapsed central nervous system lymphoma, and the MRI showed meningeal involvement which was causing the agitation. Agitation with meningeal involvement suggests brain irritation from meningitis or haemorrhage (i.e. bleeding).
74. There are documented assessments and records of monitoring of Mr N’s agitation and delirium completed by the nursing, medical and pharmacy teams to try and manage his physical distress, alongside the administration of sedatives to keep him safe and to enable his treatment. Staff also sought advice from the psychiatry team regarding the sedative medication.
75. This is in line with paragraph 15 of the GMC guidance as staff referred the decision to use sedatives to the psychiatry team as the appropriately qualified and experienced clinical colleagues to ensure that this was the best way to manage Mr N’s presentation.
76. The GPICS version 2.0 guidance, which is the applicable guidance that was in place in July 2020, gives an overview on the level of care required by critically ill patients in hospital, according to their clinical needs. Care levels are categorised from level 0, for patients whose needs can be met through normal ward care in acute hospital, to level 3, who are patients requiring advanced respiratory support alone, or basic respiratory support together with support of at least two organ systems. This level includes all complex patients requiring support for multi-organ failure.
77. The care classification within the guidance acknowledges ‘there is ongoing work into the development of enhanced care in the UK and this work may lead to the modification of levels of care in the future’. It also acknowledges that levels of care classification, particularly for level 2 and above, include wider clinical factors than only the presence or absence of organ failure.
78. There is an updated version of the care classification levels in the later version 2.1 of the guidance, published 2022, after Mr N was in the ICU. Our nursing adviser says that it is appropriate to refer to version 2.1 in addition to version 2.0, even though it was published after the events complained about, as guidelines are usually in progress for years leading to being published. Based on both versions of the guidance and the comments from the nursing adviser, we understand they broadly reflect the clinical practice that should have been followed at the time.
79. Version 2.1 describes ‘patients who experience delirium and agitation in addition to requiring Level 2 care would be categorised as level 3 and require 1:1 nursing’. As such, Mr N was appropriately categorised as a Level 3 patient, based on the guidance outlined in version 2.1 of the GPICS guidance, as he was in receipt of 1:1 nursing. This means that the evidence available shows the Trust acted in line with both versions of the guidance in providing Mr N with 1:1 nursing.
80. We have also considered the measures the Trust put in place to reduce the risk of falls. The Trust says that Mr N was at a high risk of falls, and so it was in his best interests to have the bed rails up at all times and for him to wear non-slip footwear.
81. On 28 July, we understand staffing levels on the ICU and for Mr N allowed one nurse to care for each patient, in line with the 1:1 nursing put in place for Mr N set out in the above guidance. The records show Mr N remained agitated throughout his admission, but the bed rails were used at all times. Despite their use, he was able to bypass them in a swift motion and, despite nursing staff coming swiftly to his aid, they were not in time to prevent his fall.
82. We know Miss S was very worried and upset about Mr N sustaining a fall. We recognise that, even where organisations act in line with applicable guidance, some falls do still occur, and so we do not criticise organisations where they have taken all appropriate steps to mitigate the risks of that outcome. As we have seen that the Trust took those steps, as explained above, we have not identified any failings here.
83. Miss S explained to us she was very concerned that falls led to Mr N developing an oedema. The MRI scan from 26 July 2020 showed evidence of oedema on Mr N’s brain due to significant lymphomatous disease. As the disease was present prior to the fall on the 28 July, we have not seen anything to indicate that the falls led to the oedema or to Mr N’s death. We hope this provides some comfort to Miss S.
Moorfields Eye Hospital
84. In April 2020, Mr N was referred to Moorfields due to ongoing vision problems, headaches and confusion. Miss S complains staff only prescribed eye drops instead of investigating his symptoms further. She believes that if Moorfields had done more investigations, it would have identified sooner that the lymphoma had spread to Mr N’s central nervous system.
85. Moorfields explained in its response dated 11 May 2021 that the oncology referral from Royal Marsden NHS Foundation Trust had not asked it to consider whether Mr N had developed central nervous system (CNS) lymphoma. It had only asked Moorfields staff to examine his eyes to help explain the perceived visual blurring. Moorfields explained that its role was to simply advise on what it thought was the cause of the blurred vision, and it had no role in Mr N’s care and treatment beyond that matter.
86. Paragraph 16 of the GMC guidelines says that doctors must provide treatments based on the best available evidence.
87. Moorfields completed an examination and identified Superficial Punctate Keratitis (SPK), a breakdown in the pre-corneal tear film, as a likely cause of his blurred vision and headache. Our ophthalmology adviser says SPK is frequently seen in patients undergoing chemotherapy. They say this diagnosis adequately explains the symptoms of blurred vision and headaches and that topical treatments, such as eye drops, are appropriate.
88. Taking into consideration the comments from our ophthalmology adviser, we consider the Moorfields acted in line with paragraph 16 GMC guidance when investigating Mr N’s reported symptoms, reaching its diagnosis based on the evidence available to it, and prescribing eye drops.
89. Because staff were concerned that Mr N’s cancer was affecting his central nervous system, they also completed a standard neuro-ophthalmological assessment. This involves the testing of visual acuity, visual fields, colour vision, stereopsis (perception of depth), the appearance of the eyes, lids, and the pupils, ophthalmoscopic examination of the optic disc and retina, and testing of the eye movements. The neuro-ophthalmological assessment found normal vision, colour vision and visual field and did not find any abnormality of pupil reactions to light. We understand from our ophthalmology adviser that the results of the neuro-ophthalmological assessment were normal, so there was nothing to indicate to Moorfields that any further action was needed.
90. In addition to Mr N’s blurred vision and headaches, one pupil was larger than the other and, on this basis, staff diagnosed physiological anisocoria. Physiological anisocoria is when human pupils differ in size and is usually a harmless condition. Our ophthalmology adviser confirms this is the most common cause of unequal pupil sizes, affecting one in five people.
91. This diagnosis was made by eliminating other potential causes of unequal pupil sizes, such as Horner’s syndrome or Adies Pupil, which our ophthalmology advisor explains are rare conditions but need to be considered as per the Neuro-Ophthalmic Manifestations of Intracranial Malignancies publication. In ruling out these possibilities, and in making its decisions based on the evidence available to it, including to take no further action, the Trust acted in line with the GMC guidance.
Royal Marsden NHS Foundation Trust
Mental capacity awareness 92. Miss S complains that in June 2020 the Trust failed to identify the deterioration in Mr N’s mental capacity, which she believes resulted in a delay in identifying the lymphoma had spread to his central nervous system.
93. The Mental Capacity Act says staff should ‘assume a person has the capacity to make a decision themselves, unless it's proved otherwise’.
94. Our geriatric adviser explained that Mental Capacity Act is decision-specific, and so capacity only needs to be assessed if there is a concern an individual does not have capacity to make decisions in relation to their care. A mental capacity assessment is a process used to evaluate whether an individual can make a particular decision at a particular time. It involves examining the person’s ability to understand, retain, weigh up and communicate information related to the decision. An assessment is indicated it there is concern if an individual is showing signs of not being able to do the above.
95. During June and July 2020, Miss S says that Mr N was agitated, delusional and confused; he missed MRI scans, and she did not know what he understood of the situation. Miss S has not referred to specific decisions she had concerns Mr N did not understand, only that Mr N was experiencing general deterioration and confusion outside of his usual behaviour.
96. Although Miss S clearly had concerns about Mr N’s mental state, there is nothing to suggest in the records that staff had concerns about his mental capacity.
97. On 7 July, staff suspected that his symptoms were suspicious of CNS disease so requested an MRI scan on 9 July. This scan did not take place due to cannulation issues. Mr N did not attend the second MRI appointment on 16 July, which Miss S says he missed due to a decrease in capacity. The Trust says that in June and July Mr N was attending his radiotherapy appointments, where staff reported no concern as he was demonstrating full capacity.
98. The Trust says that, as soon as staff noted symptoms of confusion in early July, a scan was organised for the following day. Sadly, even with earlier diagnosis of the cerebral infiltration, we understand there would have been no material difference in Mr N’s prognosis as by this time he was extremely unwell.
99. Taking into consideration the evidence and our clinicians’ comments, Mr N was not making any new decisions about his care, and staff did not have any concerns about his capacity that should have prompted a capacity assessment. We understand why Miss S is worried that the development of Mr N’s disease may have been missed, and we hope she is reassured that have not seen any evidence of failings here, nor a delay in identifying that his lymphoma had spread to his central nervous system.
100. Having very carefully considered the concerns Miss S raised about the care provided to Mr N by the organisations above, we have not seen any indications of service failure. As such, we do not uphold this complaint but hope that the work we have done and the information we have shared with Miss S is helpful to her, as we know the loss of Mr N is very painful to her and this continues to be a difficult time for her and her family.