Consent
21. The GMC’s guidance (decision making and consent) states that doctors should give patients the information they want or need to make a decision. It also states it is acceptable to delegate part of the consent process to a colleague not undertaking the procedure and acknowledges this is routinely done in some teams for specific interventions. The guidance also notes doctors should consider whether the patient already has a trusting relationship with a particular doctor and/or the person the action is delegated to.
22. Our Surgeon Adviser explained UK transplant units operate a 24/7 service 365 days a year to implant organs from deceased donors at short notice. This is because organs must be transplanted quickly, sometimes within as short a time as four hours. Surgeons in these services usually operate on a rota to ensure someone is always able to transplant an organ at short notice.
23. Given the nature of this area of medicine, it is impossible to guarantee who the implanting surgeon may be. It is standard practice that the surgeon undertaking the procedure may be different to the surgeon the patient had built a trusting relationship with. In this context, a specific surgeon cannot reasonably be guaranteed for any patient’s transplant. It is not possible to consider the nature of the relationship between patient and surgeon when deciding on who will undertake the surgery in this time-critical service.
24. Mr K signed a consent form on 5 December 2023. This form stated ‘I understand that you cannot give me a guarantee that a particular person will perform the procedure’. This indicates Mr K was told the surgeon undertaking the procedure could be different than the person he had been seeing at the transplant clinic, and he consented to go ahead with the procedure.
25. Given Mr K signed a consent form that advised him there was no guarantee as to who would complete the surgery, we cannot reasonably conclude he was not aware of this. Furthermore, given the nature of a transplant service and the short notice required to undertake such procedures, it is not possible to guarantee that a specific surgeon will be available.
26. We understand why this was concerning to Dr K given the nature of the trusting relationship his son built with the clinician he saw regularly in the transplant clinic. Unfortunately, this area of medicine is not one which can accommodate choice in the same way other disciplines may be able to. We are satisfied Mr K appears to have been aware of this and consented to go ahead with the surgery with this knowledge. We have seen no indications of service failure in relation to this part of Dr K’s complaint.
Monitoring and response to cardiac arrest 27. Haemoglobin (Hb) is an important protein that helps to carry oxygen around the body. Following surgery or a major bleed these levels can drop significantly.
28. Our Surgeon Adviser explained that Mr K’s post-surgery care would not just rely on monitoring his Hb levels, but his overall clinical picture and symptoms. This would include, but would not be limited to, his Hb levels. Therefore, we have considered not just whether his Hb was sufficiently monitored, but also any additional relevant clinical context.
29. NICE guideline NG24 (Blood Transfusion) notes that the threshold for transfusion is 70g/L unless a patient meets certain, limited clinical criteria. Our Surgeon Adviser explained that in a stable post-transplant patient Hb levels alone do not independently require transfusion, and it is common for post-surgical patients to have lower Hb levels than would usually be expected.
30. Mr K lost an estimated two litres of blood during surgery and received transfusions whilst in theatre because his Hb levels had dropped below 70g/L. Following these transfusions his Hb levels increased to well above this level. He was admitted to the Trust’s Intensive Treatment Unit (ITU) following surgery, which the Trust says is its standard practice in these circumstances. Guidelines from the JPAC (major haemorrhage protocol) outline that clinicians should aim for an Hb level of 80g/L after a major haemorrhage has been controlled.
31. Mr K’s Hb levels were monitored daily following surgery and were as follows:
• 95g/L on 6 December • 90g/L on 7 December • 79g/L on 8 December • 72g/L on 9 December • 59 g/L on 10 December.
32. Mr K’s Hb levels exceeded the threshold recommended by JPAC following his haemorrhage and remained consistently above the threshold for blood transfusion between 6 and 9 December. Our Surgeon Adviser also said that Mr K’s overall clinical condition was stable during this time and not unexpected or unusual for a post-surgical patient.
33. Blood transfusion itself can be risky for post-transplant patients. It can cause significant harm due to its impact on the immune system, and it can present a major barrier to any future transplants. This is an important consideration in the care of a relatively young post-transplant patient, meaning the Trust needed to balance this risk carefully against Mr K’s overall clinical presentation.
34. In the morning of 10 December, Mr K’s Hb levels dropped suddenly and significantly to 59g/L. This was coupled with the symptom of vomiting ‘coffee ground mixed with blood’. At this point the Trust should have requested a transfusion and taken steps to investigate the source of the bleed. This appears to have happened quickly and with appropriate monitoring of Mr K’s condition.
35. Following this transfusion, our Surgeon Adviser explained it would have been good practice to transfer Mr K to a high dependency unit (HDU). This is because an urgent upper-gastrointestinal (upper GI) endoscopy and ongoing resuscitation was ‘almost certainly necessary’ and logistically ‘far more difficult’ to co-ordinate in a standard ward environment. An upper GI endoscopy is a procedure which helps doctors look at the upper part of the digestive tract.
36. The Trust requested an urgent upper GI endoscopy at 11.58am on 10 December. This appears to be in line with NICE guideline CG141 (acute management of upper GI bleeding in over 16s), which states this should happen within 24 hours.
37. Mr K received a second blood transfusion later that day. Sadly, he appears to have had a reaction to this transfusion that caused his blood oxygen levels to drop significantly. This recovered once the transfusion was discontinued. The Trust attempted to restart the transfusion, but Mr K began to react again. He experienced a cardiac arrest soon afterwards, and a crash call was initiated. A crash call is a hospital’s emergency alert for patients with a life-threatening condition. When a crash call is initiated, a specialist resuscitation team attends.
38. There were two doctors present when Mr K went into cardiac arrest, and they immediately commenced cardiopulmonary resuscitation (CPR). The crash team also attended as quickly as possible. Mr K was experiencing pulseless electrical activity (PEA), meaning his heart was functioning as expected, but there was no cardiac output. The team spent 30 minutes resuscitating Mr K. He was then transferred to the ITU when his cardiac function had been restored.
39. PEA is one of the most challenging types of cardiac arrest to resolve and, even in hospital and with the best care, it has a very poor prognosis.
40. The evidence indicates Mr K’s Hb levels were appropriately monitored and did not require further action until his Hb levels dropped below 70g/L. He was given a blood transfusion promptly when this happened, which increased his Hb levels to 64g/L. A second transfusion was also initiated to attempt to raise these levels to above the 70g/L threshold. Mr K experienced a reaction to the second transfusion which meant this could not be completed. This appears to be in line with NICE guideline NG24.
41. The Trust also requested an urgent upper GI endoscopy to take place within 24 hours because the clinicians suspected an upper GI bleed. This appears to be in line with NICE guideline CG141.
42. One area where, with hindsight, the Trust may have fallen short is that it did not transfer Mr K to the HDU where it would have been logistically easier to co-ordinate resuscitation. That said, there is no indication there was any undue delay in initiating resuscitation when Mr K experienced the cardiac arrest. The records indicate two doctors were immediately in attendance, commenced CPR, and acted promptly to raise the alarm. This indicates that whilst, with hindsight, the Trust should have considered transferring Mr K to a different environment as a precaution, this appears to have had no impact on the timeliness of his resuscitation.
43. The evidence indicates Mr K’s Hb levels were monitored appropriately, and the Trust’s actions were, overall, in line with national guidelines. We have seen no indications of service failure and, where a different approach may have been appropriate, this does not appear to have any impact on the timeliness of the resuscitation efforts.
Communication 44. The GMC’s Good Medical Practice guidelines say doctors should be considerate to those close to the patient and be sensitive and responsive in giving them information and support.
45. There are no national guidelines on how quickly a patient’s family should be advised of any clinical deterioration. In such circumstances, the priority would, understandably, be to respond to this deterioration and communicate with the patient in the first instance, where possible.
46. Prior to the crash call, Mr K was noted to be conscious and lucid. He was counselled on the events surrounding his deterioration on 10 December. His mother was listed as his next of kin, and she was updated about Mr K’s deterioration via telephone. This happened prior to her son’s cardiac arrest. They contacted her again when the Trust suspected an upper GI bleed and suggested she come into the hospital in light of her son’s deterioration. The Trust documented his mother said ‘her husband was en route’ and that ‘immediately after this call’ Dr K arrived. His son then experienced a cardiac arrest.
47. There was no reason to update Dr K prior to the arrest. This is because Mr K’s mother was regularly receiving updates, as Mr K’s next of kin, and she was updated on his deterioration via telephone on 10 December, prior to her son’s cardiac arrest. She was also advised to attend the hospital prior to the arrest in light of his deterioration. This indicates the doctors were being sensitive and considerate to Mr K’s next of kin and had promptly updated her about his deterioration, in line with the GMC’s guidelines.
48. Whilst we understand why Dr K would like to have been informed of this sooner, it is not proportionate for doctors to contact and update several family members when a patient deteriorates. It is appropriate that they update the patient’s next of kin who can them communicate this to other members of the family.
Investigation 49. The Trust initiated an internal review of the events leading up to Mr K’s cardiac arrest and notified the family of this in February 2024.
50. Whilst there are no national guidelines on how an internal investigation should be carried out or how often families should be updated, our Principles of Good Administration (our Principles) say the public bodies, including NHS services, should treat people sensitively and deal with matters in a reasonable timeframe. They should also give people an estimation of how long a process may take and let them know if things may take longer.
51. We recognise the internal review was a complex undertaking due to the nature of the events which took place. It was important the Trust took the time to look into all aspects of Mr K’s care and take learning from these where it identified its service could be improved. This would understandably take some months to do.
52. We also recognise how anxious Mr K’s family were to receive this report, especially given how devastating and unexpected their loss was.
53. When the Trust wrote to Dr K to advise of the investigation, it did not explain that this may be a complex process. It also did not give any indication of how long this would likely take. We recognise the Trust would be unlikely to know precisely how long this process would take, but it could have given Dr K a broad timeframe or explained this would likely be a lengthy process due to the complexity of the matter at hand. This appears to fall short of our Principles.
54. We have seen no evidence the Trust contacted Dr K between February and August. On 27 July Dr K wrote to the Trust but received no response. He then wrote to the Trust’s complaints team on 20 August. The complaints team replied to this letter on 23 August and apologised that the family had needed to chase the Trust for an update. It advised Dr K a member of the review team had written to the family to update them and request additional evidence. This evidence was consent to request Mr K’s autopsy report from the coroner’s office.
55. On 3 September, Dr K sent a response to the Trust that included consent for the Trust to obtain his son’s autopsy report. He chased the Trust for an update on 7 and 8 October. The Trust responded on 10 October and apologised again for the delay in updating the family. The Trust explained that because of the complexity of the review the outcome would take some time. It apologised for the impact this was having and advised once the surgeon had more information, they would have a timeframe to share with Dr K.
56. On 15 October Dr K wrote to the Trust explaining he had sent several letters to the surgeon and had not received responses. He also advised he would be raising a complaint. On 16 October, Dr K raised a complaint. At this point, the Trust should have followed national regulations relating to complaints, and our NHS Complaint Standards (our Standards).
57. The Local Authority Social Services and National Health Service Complaints (England) Regulations 2009 (the Complaint Regulations) say the Trust should have told Dr K how long the complaint would take to investigate and sent a written response as soon as possible.
58. Our Standards say the Trust should have given an open and honest response as quickly as possible, in the context of the complexity of the issues. It should also have looked into the complaint in a fair and objective way, based on facts, and kept Dr K updated during this process.
59. The Trust acknowledged the complaint on 18 October and advised that the estimated timeframe for a response was 25 working days. The Trust’s internal emails indicate this complaint was taken seriously, with a draft response commencing within days, and a consideration of what could be shared before the final investigation report was completed. The Trust also organised a meeting to discuss the complexity of the information to be contained within the response. This appears to align with the Complaint Regulations and our Standards.
60. On 23 October, a transplant surgeon approved the contents of the complaint response. A different surgeon reviewed the response on 24 October and suggested some minor amendments. A nursing matron and the director of nursing also reviewed the draft response and approved it on 25 October. Finally, the operating surgeon approved the response on 28 October.
61. The complaint response was issued on 29 October. This was well within the timeframe given by the Trust, and we can see the Trust was actively working on the complaint response during this time. Given how many members of staff were working on this complaint within a relatively short timeframe, it appears evident that Dr K’s complaint was being treated as a priority.
62. The complaint response of 29 October acknowledged and apologised for the delay in providing the family with the investigation report. It explained this was due to the complexity of his case and the need for multidisciplinary input into the report. It reassured Dr K that once the report was complete, it would be shared in full.
63. The Trust issued its report on 3 December. It also included a complaint response that explained it had not found Mr K’s cardiac arrest arose from an intraoperative bleed (a bleed occurring during surgery); rather it had happened due to an upper GI bleed that was delayed, by several days, following surgery. The investigation report indicates this arose from where the small bowel had been grafted to the duodenum (the first section of the small intestine). The response also noted Mr K’s history of cardiomyopathy made resuscitation more challenging.
64. The Trust did not say that blood loss was not the cause Mr K’s cardiac arrest and brain injury. What it did say was that it disagreed with the coroner that the bleed which happened during surgery was the cause. Instead, its investigation had found that Mr K experienced a delayed post-operative bleed and that this was the cause of his cardiac arrest and brain injury. The disagreement was about where and when the bleed occurred, not whether or not a bleed caused this sad outcome.
65. It is not uncommon for there to be professional disagreements between diagnoses based on clinical data and post-mortem observations. The Trust appears to have robustly outlined the rationale for its conclusion, which has been reviewed by our Surgeon Adviser. Our adviser has not raised any concerns about the report’s accuracy or the conclusion reached by the Trust.
66. The Trust also appears to have been correct to say Mr K had a history of cardiomyopathy. This was consistently documented in his clinic letters from 2020 to 2024. In November 2020, his clinic letter detailed that a scan of his heart had identified a dilated ventricle (heart chamber) with a low ejection fraction (ability to pump blood). This meant the heart’s main pumping chamber had become enlarged and was struggling to effectively pump blood around Mr K’s body.
67. Mr K was reviewed by cardiology colleagues at the Trust on an ongoing basis. His clinic letter dated 19 March 2021 noted a diagnosis of dilated cardiomyopathy and that this was likely caused by fluid overload (a build-up of fluid in the body). Mr K required ongoing cardiology investigations and approval from the Trust’s cardiology team before he could be actively listed for transplant. This eventually happened when his heart function was found to have improved.
68. The evidence indicates that the Trust’s investigation report was accurate, in line with our Principles. It appears, however, to have fallen short in communicating with Dr K during this process.
69. The Trust has already acknowledged its poor communication during this period and apologised to Dr K for the impact this had. This is the outcome Dr K is looking for, and there is nothing further we can reasonably ask the Trust to do to put things right.
70. The time it took the Trust to complete the investigation also appears to have been reasonable given the complexity of the matters at hand and the number of different disciplines and teams involved in the review. The evidence does not indicate the report was unreasonably delayed; rather, the Trust’s lack of communication with the family likely gave the impression that this was the case.
71. We recognise how devastating it was for Mr K’s family when he unexpectedly died following his surgery. We do not underestimate the impact this has had on them. We hope this statement helps to reassure Dr K we have seen no indications of service failure in the clinical care his son received. We also hope the family are reassured that an independent clinician has reviewed the Trust’s investigation report and has not found any cause of concern or clinical errors contained within this.