16. Before we decide if we should conduct a detailed investigation of a complaint, we look at whether there are signs the organisation has got something wrong. We do this by comparing what should have happened with what did happen. We have done this and have not found any indications that something has gone wrong. We will explain the reasons for our decision below.
Heart issues:
17. Mr B’s cause of death was leukaemia and ischaemic heart disease. Miss B says clinicians failed to pick up on any heart issues for her father during his admission. The Trust say Mr B remained mostly asymptomatic and clinicians can only investigate symptoms that are there.
18. Paragraph 15 of GMC Good Medical Practice guidance 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’.
19. The notes show Mr B was admitted to hospital on 22 November 2023 with a worsening chest infection that had not responded to oral antibiotics. Our adviser says there were no signs of heart failure on admission.
20. Clinicians performed an echocardiogram (scan of the heart) and lung function tests as a routine assessment of Mr B’s fitness prior to starting the alemtuzumab treatment on 29 November. Our adviser explains it is standard practice to arrange an echocardiogram and electrocardiogram (ECG) prior to starting treatment and there is no requirement to perform other cardiac investigations. Mr B’s echocardiogram showed he had good function (ejection fraction). Our adviser tells us there was no clinical indication to perform any other investigation of Mr B’s heart as he had no signs of heart disease prior to the sudden deterioration in his health on 6 December.
21. We appreciate Miss B is concerned clinicians may have missed an issue with her father’s heart. We can see the treating clinicians arranged appropriate investigations before starting treatment, which we consider is in line with GMC guidance. There was no clinical reason to arrange any further cardiac tests. We cannot see there are indication something went wrong here.
Fluid overload:
22. Miss B says her father had fluid overload and he had put on approximately 12kg of weight during his admission, which shows how overloaded he was. She says the Trust failed to identify and treat this appropriately and in a timely way.
23. The Trust say following review on 2 December, clinicians were concerned Mr B was experiencing fluid overload and his oxygen saturations had dropped so they arranged for ITU to review him.
24. GMC Good Medical Practice says, ‘16 In providing clinical care you must... provide effective treatments based on the best available evidence’.
25. On 2 December, the notes show clinicians were concerned over potential fluid overload. Fluid overload happens when there is too much fluid in the body. It can raise blood pressure, cause swelling, and impact organ function. Blood tests showed Mr B also had a stage two acute kidney injury (AKI). An AKI is where the kidney’s suddenly stop working and one of the treatment options for this is giving fluids.
26. Clinicians prescribed Furosemide on 3 December, and this continued until 6 December. Furosemide is a diuretic medication that helps the body get rid of excess fluid and salt.
27. Our adviser explains management of Mr B’s fluid overload was difficult as clinicians also had to manage treating the deterioration in his kidney function. The notes show the ward team had been in discussion with the critical care team during Mr B’s admission and he was regularly reviewed, had regular observations and had frequent monitoring of his bloods. Our adviser says the medical management of Mr B’s fluid was appropriate.
28. We recognise Miss B’s concerns about how her father’s fluid overload was managed. We can see there was a difficult balance between managing Mr B’s competing needs and we cannot see any indication clinicians failed to act in line with GMC guidance and we cannot see they got something wrong here.
Alemtuzumab:
29. Miss B is concerned her father was too unwell to be given his alemtuzumab treatment on 6 December. Alemtuzumab belongs to a group of targeted therapy drugs called monoclonal antibodies, which can work in different ways to kill cancer cells or stop it from growing. The Trust explain there was a fine balance of risk in offering treatment, but his cancer was acting quite aggressively, so the fully consented decision to push forward was made.
30. GMC Good Medical Practice Guidance says:
‘15 You must provide a good standard of practice and care. If you assess, diagnose or treat patients, you must: a adequately assess the patient’s conditions, taking account of their history (including the symptoms and psychological, spiritual, social and cultural factors), their views and values; where necessary, examine the patient’.
31. The British Journal of Haematology guidelines for the management of mature T- and natural killer-cell lymphoma recommends clinicians ‘offer intravenous alemtuzumab as first-line therapy for T-PLL’
32. The notes show the multidisciplinary (MDT) discussed Mr B’s case on 29 November. They noted his lymphocytes (type of white blood cell) had increased, which indicated a progression on his leukaemia. The MDT’s plan was to start Mr B on alemtuzumab.
33. Our adviser tells us this treatment was clearly indicated for Mr B due to progression of his leukaemia and the notes show he agreed to it. We consider this was in line with GMC guidance and the British Journal of Haematology guidelines. Clinicians administered the first dose of alemtuzumab to Mr B on 29 November. An hour after administration of alemtuzumab, the notes say Mr B appeared pale and shivering. Clinicians stopped the treatment and gave Mr B steroids and oxygen. Clinicians then realised the medication was infused over one hour period instead of two hours, in error.
34. The following day, clinicians decided to give Mr B the next dose of alemtuzumab infused over two hours. Mr B developed the same symptoms, so clinicians stopped the infusion and gave steroids and an antihistamine.
35. On 2 December, the plan was to resume Mr B’s alemtuzumab infusion, but clinicians were concerned over potential fluid overload. On 4 December, Mr B’s blood and stool tests were positive for clostridium difficile (c-diff). C. diff is a type of bacteria that can cause diarrhoea, and it often affects people who have been taking antibiotics.
36. During the ward round on the morning of 6 December, the clinician noted Mr B was concerned he may miss another dose of the alemtuzumab, and he was keen to procced. The clinician noted there was a risk in restarting the treatment given his recent C-diff, so they were discussing this with the microbiology team. Following this discussion, the clinical team decided to restart Mr B’s alemtuzumab infusion at 12:40pm.
37. Our adviser explains making decisions about giving treatment for leukaemia can be extremely challenging in patients who are unwell. Haematology patients frequently have infection due to their poor immune systems. It is clear Mr B’s leukaemia was behaving aggressively, and the haematologists felt reasonably that further treatment was needed to control it. Our adviser tells us T-PLL is an aggressive leukaemia with a poor prognosis and without achieving control of Mr B’s leukaemia, it would have likely caused his death.
38. We are very sorry to hear about Miss B’s concerns over the alemtuzumab being restarted on 6 December, given her father’s clinical condition at that point. We understand this was a finely balanced decision based on clinical judgement. There were risks in withholding the treatment given the aggressive nature of Mr B’s leukaemia. The notes show clinicians explained the risks to Mr B and took his views into account in line with GMC guidance. We cannot see any indications the Trust acted inappropriately.
Critical care:
39. Miss B says clinicians failed to consider transferring her father to a critical care unit when his condition deteriorated on 6 December. The Trust say clinicians consulted with the ITU on 2 December and they advised Mr B did not need to be transferred at that point as he did not require organ support. It says Mr B’s deterioration on 6 December was sudden and unexpected and it was confirmed ITU admission would not be appropriate.
40. The UK Intensive Care Society guidelines set out criteria patients should meet to be considered for escalated levels of care. The levels of care are:
• Ward care (needs can be met through normal ward care- can be managed on a ward but remain at risk of clinical deterioration) • Level one- enhanced care (requiring more detailed observations/ requiring ongoing interventions from critical care outreach teams- requiring more detailed observations or interventions) • Level two- critical care (increased levels of observations/ requiring interventions to prevent deterioration beyond that of level one including basic support for two or more organ systems) • Level three- critical care (needing advanced respiratory monitoring and support- needing two or more basic organ system monitoring and support)
41. There is a focus in the guidance on whether a patient's needs meet criteria for admission to critical care, and whether critical care would offer benefit to the patient at that point in their illness. Every decision is individualised.
42. At around 5:50pm on 6 December, Mr B reported feeling breathless and he had a fast heart rate. Clinicians requested a chest X-ray and blood gases. His rapid and shallow breathing was noted at 8:50pm.
43. Our adviser explains most of the time while Mr B was an inpatient, ward-based care was appropriate as he did not need organ support, in line with the intensive care guidelines above. This also included most of the day of 6 December. ITU is reserved generally for patients who have a high likelihood of requiring a ventilator to support breathing, support of their blood pressure or dialysis.
44. We appreciate Miss B’s strength of feeling about this and understand why she feels her father should have been for ITU as he was very unwell during the evening of 6 December. His clinical deterioration leading to his cardiac arrest was extremely rapid over a period of a few hours. Our adviser tells us there was no point earlier during that day, when it would have been appropriate for him to be transferred to ITU. Mr B’s rapid deterioration and cardiac arrest was not predictable or anticipated. We are therefore not critical that Mr B was not moved to ITU on 6 December, and we cannot see there is an indication of a failing.
Monitoring:
45. Miss B says a qualified medical professional should have been monitoring her father on 6 December given how unwell he was, not a HCA. She says her father should have been on continuous monitoring. The Trust say it is normal and acceptable practice for a HCA to obtain observations and they are trained to recognise concerning results and escalate to nursing staff.
46. Guidelines on the management and admission to intensive care of critically ill adult patients with haematological malignancy says ‘hospitalised patients with haematological malignancy are at risk of developing critical illness. Sub-optimal ward care is associated with adverse outcomes, and it is important to maintain adequate staffing and skill mix outside routine working hours. An aggregate track and trigger system such as the National Early Warning Score (NEWS) should be in place to monitor patients’. NEWS determines the degree of illness of a patient using six physiological findings and one observation.
47. Our adviser tells us it was appropriate for a HCA to look after Mr B on 6 December, along with other staff. It is rarely possible or indicated to give more senior one to one nursing outside of ITU. From the notes we can see the HCA recorded observations on the NEWS chart for Mr B on the evening of 6 December. A nurse also entered Mr B’s observations in the notes taken at around 9:20pm.
48. We can see Mr B’s NEWS was consistently high from around 6:24pm on 6 December. A nurse noted they gave Mr B oxygen and escalated this to the acute response team for critical care review. The response team advised a further dose of intravenous (IV) furosemide for suspected overload, increased monitoring continued at ward level with senior review of care, additional blood gases and blood cultures. A doctor reviewed Mr B at approximatively 8:50pm.
49. We are sorry to hear about Miss B’s concerns that her father wasn’t being monitored by medically qualified staff when he was so unwell. We can see from the notes, Mr B was regularly monitored, and his observations were recorded in line with guidelines. Whilst the HCA was recording observations, we can see medical staff also reviewed Mr B during this time and his high NEWS score was escalated. Both medical and more senior nursing staff were aware of Mr B’s acute deterioration and attended him as well as the HCA. We therefore do not consider there is an indication of a failing here.
Pain relief/ breathing support:
50. Miss B says her father was in pain and struggling to breathe during the final hours of his life and the Trust failed to administer appropriate pain relief or provide breathing support.
51. On the NEWS chart, Mr B’s pain score is recorded as zero (no pain) throughout the day/ evening on 6 December. From the medication chart, we can see his regular paracetamol was administered at 6:26pm. There is no mention in the notes of Mr B reporting pain when clinicians reviewed him at 7:18pm or 8:50pm.
52. The notes show Mr B complained of shortness of breath at 5:50pm and he was given oxygen. Mr B’s family called staff in for help at around 9:20pm as he was deteriorating rapidly. Clinicians gave him oxygen to manage his dropping stats. Mr B then became unresponsive. The clinicians note from 9:30pm says Mr B ‘looked unwell’ and he had ‘significant tachypnea’ (rapid and shallow breathing). He sadly went into cardiac arrest and CPR was commenced immediately.
53. In a retrospective note, the nurse recorded Mr B went into cardiac arrest before they were able to give him a dose of oxycodone (an opioid pain killer). They noted a registrar directed them to prepare this and ‘no pain [was] expressed, however appeared agitated’.
54. We appreciate it would have been incredibly distressing and traumatic for Mr B’s family to see his rapid deterioration and his difficulty breathing and we are truly sorry to hear about this. Our adviser explains this would have been extremely challenging to manage. Mr B sadly became acutely unwell with a rapid deterioration. Up to that point our adviser says there was no indication he required ITU care or organ support. The notes also do not indicate Mr B was in pain and therefore it is not possible for us to say additional pain relief should have been given. As noted above, Mr B’s sudden deterioration and cardiac arrest were not predictable and his ‘rapid and shallow breathing’ was noted shortly before he went into cardiac arrest. We cannot see any indication the Trust got something wrong here.
55. We recognise how important this complaint is to Miss B and thank her for bringing it to us. We hope she is reassured by our decision.