15. Mr R attended the Trust’s emergency department on 14 August 2022 with vomiting and was admitted on 15 August. The doctor who carried out the initial assessment on admission noted a suspected infection with unknown cause.
16. The assessing doctor took a detailed history, gave Mr R a physical examination, arranged investigations including X-rays and blood tests, and began treatment for the infection with antibiotics.
17. The assessment was in line with GMC Good Medical Practice guidance, which says:
‘You must provide a good standard of practice and care. If you assess, diagnose, or treat patients, you must work in partnership with them to assess their needs and priorities. The investigation or treatment you propose, provide or arrange must be based on this assessment, and on your clinical judgement about the likely effectiveness of the treatment options.
In providing clinical care you must:
- adequately assess a patient’s condition(s), taking account of their history, including: symptoms, relevant psychological, spiritual, social, economic, and cultural factors, the patient’s views, needs, and values - carry out a physical examination where necessary - promptly provide (or arrange) suitable advice, investigation or treatment where necessary - propose, provide or 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 will meet their needs’
18. Mr R had a NEWS (National Early Warning Score) of 2. NEWS is a tool used for the detection and response to clinical deterioration in patients. The NICE sepsis guidance NG51 says this low NEWS meant he was at low risk of severe illness or death from sepsis (a life-threatening condition triggered by infection, when the body’s response injures its own tissues and organs).
19. NG51 recommends doctors should give low risk patients broad spectrum antibiotic treatment ‘for up to 6 hours after calculating the person's first NEWS2 score on initial assessment in the emergency department or on ward deterioration’. Our physician adviser told us this is what happened and so we find this was in line with guidance. Mr R was given co-amoxiclav which is broad spectrum. The Trust carried out prompt blood tests which was also in line with NG51 which says ‘gather information for a more specific diagnosis’.
20. Later on 15 August Mr R’s blood test results showed the presence of staphylococcus aureus (S. aureus) in his bloodstream. S. aureus is a bacterium that can cause illnesses which range from mild to life-threatening. These include infections of the heart valves (endocarditis).
21. On 16 August the Trust’s microbiology team contacted the treating team to advise that if they suspected prosthetic valve endocarditis (a serious infection occurring on artificial heart valves), then they should change Mr R’s antibiotics to gentamicin and vancomycin. We can see this happened, which is in line with the BNF (guidance on the selection, prescribing and use of medicines) which says ‘if methicillin-resistant Staphylococcus aureus suspected […] use vancomycin + low-dose gentamicin’.
22. This was also in line with the BASC Guidelines which say ‘Blood cultures remain a cornerstone of the diagnosis of IE [infective endocarditis] cases and should be taken prior to starting treatment in all cases’.
23. It is after this point that we find the care and treatment deviated from what we would expect to see.
24. Mr R’s white cell count (a marker for infection) was high and our cardiology adviser explained this, and the presence of S. aureus in the blood in a patient with a prosthetic heart valve, should have triggered urgent action. This is because the first concern in a patient with these factors is ruling out, or seeking urgent treatment for, endocarditis. Endocarditis is a rare and potentially fatal infection of the inner lining of the heart (the endocardium).
25. Our adviser said the first step for exploring this is an echocardiogram. It is our view that this did not happen with sufficient urgency.
26. The Trust ordered an echocardiogram that day citing the reasons as ‘staph aureus positive blood cultures, patient unwell ?prosthetic valve ??Infective Endocarditis’. This shows the medical team were aware of the presence of S. aureus and suspected infective endocarditis (IE, as outlined in paragraph 20). There are numerous mentions in the records of possible IE, from the morning of 15 August onwards.
27. We think it was right the Trust ordered an echocardiogram at this earliest opportunity. However, we do not think the decision making in relation to the urgency of this echocardiogram was in line with the BSE guidance. This says for suspected IE the timeframe should depend on clinical need.
28. Our cardiology adviser gave their view on this clinical need. They said Mr R’s valve replacement in 2020, the clear signs of infection without an infection site and his low diastolic blood pressure measurements should have increased the suspicion of an urgent clinical need.
29. The history and symptoms should have also made aortic valve failure a diagnostic consideration. The BSE guidance says in these circumstances, ‘where the history and examination findings suggest that the clinical picture and/or organ failure may be due to critical or acute valve dysfunction’ an echocardiogram should be carried out within 24 hours.
30. The BSAC guidance also says ‘Echocardiography must be performed as soon as possible (ideally within 24 h) in all patients with suspected IE’.
31. The ESC guidance says ‘Echocardiography must be performed as soon as IE is suspected… In patients with S. aureus bacteraemia, echocardiography is justified in view of the frequency of IE in this setting, the virulence of this organism and its devastating effects once intracardiac infection is established.’
32. The Trust requested the echocardiogram urgently but did not carry it out for a further nine days. There is no indication the Trust followed up the request with sufficient urgency. We consider this was a failing and was not in line with the any of the guidance quoted above.
33. The Trust’s complaint response acknowledged the echocardiogram did not take place as quickly as it should. The first complaint response said:
‘[Principal Cardiac Physiologist] would like to assure you that there were no shortages of machines, but there are high numbers of requests for echocardiograms to be undertaken. There can therefore, be a delay for these to be undertaken. There is a Cardiology senior doctor on call 24/7, if it is decided that an urgent investigation is required by the referring team’.
34. This is not a reasonable response. We consider Mr R met the criteria for an urgent echocardiogram, within 24 hours. Despite the availability of a cardiology senior doctor on call, there is no evidence of any attempt to expedite the request.
35. The second complaint response said: ‘I am sorry that there was a delay that occurred in undertaking your father's echocardiogram. Unfortunately, there is a national shortage of Cardiac Physiologists which has led to vacancies within the Cardiology team for a number of years.’
36. This is not a reasonable response. We recognise it will not always be possible to achieve the aim of the guidance outlined in paragraph REF _Ref177568452 \r \h 30 ‘ideally within 24 hours’. Our physician adviser explained that eight days was too long for a patient to wait for an echocardiogram, and they would have expected this to be escalated or the request followed up.
37. The Trust may have expedited the echocardiogram if it had involved a cardiologist and taken a multi-disciplinary approach, as outlined in the BASC guidance above. We look further at the missed opportunities to expedite the request in paragraphs 45 to 51.
38. We have looked at whether the Trust has taken sufficient action to remedy this failing in paragraphs 61 to 68.
39. When considering whether the Trust explored appropriate treatment options for Mr R’s symptoms, we considered whether the correct specialists had provided treatment. Mrs D told us she thought her father should have been on a cardiac ward so he could be treated by cardiac specialists.
40. The BASC guidance says ‘A cardiologist and infection specialist should be closely involved in the diagnosis, treatment and follow-up of patients with IE’ and ‘Specialist teams managing patients with IE should have rapid access to cardiac surgical services’.
41. The Trust involved the infectious diseases team on 17 August. This was in line with the guidance, but there is no record of the Trust involving a cardiologist, or cardiac surgical services.
42. We consider this was a failing. The Trust’s complaint responses are not reasonable and give an unclear picture of what processes the Trust was following. The Trust wrote:
‘A large vegetation is a potential indication to discuss surgical intervention and this is done through the endocarditis team. It is not something that would be an emergency indication for surgery, as a lot of clinical workup (investigation, multi-disciplinary team discussions) are required before surgery is ever undertaken. The surgeons are informed in cases where this is necessary, but this is usually through the endocarditis team.’
‘It is common practice within the Trust that any patients with suspected infective endocarditis are managed between the Medical and Infectious Disease teams jointly. This is until infective endocarditis is confirmed, and then a Cardiology referral is made for the transfer of the patients' care to them. The Infectious Diseases team will often have Cardiologist and Endocarditis specialist team members sit in on their multidisciplinary team meetings. This is so they can advise on the ongoing management of any patients with suspected endocarditis. As your father was already on treatment for infective endocarditis and his clinical condition was stable during his hospital admission, the plan was to await the echocardiogram results and refer your father to Cardiology team following the results becoming available.’
43. The Trust gave a further explanation to PHSO about its processes:
'Dr A acknowledges that Mr R's echocardiogram was not undertaken in a timely manner, with a 9-day delay from referral. If undertaken earlier Mr R’s case would likely have been discussed in the Endocarditis Multi-disciplinary Team (MDT) meeting with assessment for possible surgical treatment options as well as the ongoing medical management plan. There was no referral to the Endocarditis MDT during R's admission as this is completed once a confirmation of a diagnosis is made on echocardiogram.’
44. The Trust responses and explanations present an unreasonable situation. The Trust has an expert endocarditis MDT but will not refer a patient who clearly has IE to this team until an echocardiogram confirms it. This means that any delays in carrying out an echocardiogram would lead to the Trust not providing the specialist input that is needed, available and required by the guidance outlined in paragraph REF _Ref177569807 \r \h 40.
45. Our cardiology adviser agreed that an echocardiogram was required to make a definite diagnosis. However, it was their view that Mr R should have been referred to cardiology to get the urgent echocardiogram at the point infective endocarditis was suspected (15 August). Urgent discussion with the cardiac surgeons was required, as potentially Mr R could have had surgery before the endocarditis MDT was arranged.
46. The treatment should have been to counter the speed of the disease, not to fit in with the Trust’s processes. This would have been in line with the BASC guidance which says: ‘A cardiologist and infection specialist should be closely involved in the diagnosis, treatment and follow-up of patients with IE’ and ‘Specialist teams managing patients with IE should have rapid access to cardiac surgical services’.
47. The 2015 ESC guidelines for the management of infective endocarditis state ‘Echocardiography must be performed as soon as IE is suspected… In patients with S. aureus bacteraemia, echocardiography is justified in view of the frequency of IE in this setting, the virulence of this organism and its devastating effects once intracardiac infection is established’.
48. We think the failure to involve cardiology sooner was a failing. It was not reasonable for Mr R to wait for the Trust’s processes and timetable when he had such a time sensitive condition.
49. Our cardiology adviser gave a view on Mrs D’s concern that Mr R was not looked after on a cardiology ward. They explained this would have been the most appropriate setting for Mr R’s care. The GIRFT report recognises the benefits of this early recognition of acute cardiac patients. It considers it essential there is:
• Coronary care unit (CCU) or equivalent high dependency unit (HDU) • Dedicated (ring-fenced) inpatient beds • 24/7 consultant on-call • 7/7 cardiology consultant ward review for all cardiology inpatients • 24/7 emergency echocardiogram provision and review (including virtual review) and 7/7 elective/urgent echocardiography
50. Our cardiology adviser said this can lead to cardiologists conducting therapeutic interventions, as well as providing imaging and care on the wards.
51. Mr R was not given the opportunity for cardiology input for the reasons already stated, and there was also a missed opportunity for him to be looked after in the most appropriate ward. We consider it a failing that these opportunities were not available to Mr R.
52. The complaint response also addressed the Trust’s failure to carry out an urgent cardiac review on 24 August, after it had the results of the echocardiogram. At this point Mr R had confirmed IE and moderate to severe aortic regurgitation (a condition where the aortic valve in the heart does not close properly, causing blood to leak back into the heart).
53. The second complaint response said: ‘[The doctor] has acknowledged that he was dealing with other urgent clinical cases as a priority, at the time of the referral. Your father appeared to be on the correct antibiotics and he was clinically stable. Based on the clinical information that [the doctor] had to hand, his plan was to ask the Cardiology Consultant on 25 August 2022, to review your father on the post take ward round’.
54. Our adviser said it is difficult to imagine what cases could have been prioritised over Mr R’s in the 13 hours between the outcome of the echocardiogram and Mr R’s sad death. It is our view that it was a failing that the Trust did not carry out an urgent cardiac review once the echocardiogram was reported on 24 August. It was not in line with the seriousness of his condition, or the GMC guidance which says a doctor must ‘promptly provide (or arrange) suitable advice, investigation or treatment where necessary’ and ‘consult colleagues or seek advice from your supervising clinician, where appropriate’
Impact
55. We asked our cardiology adviser about Mrs D’s concern that her father was denied earlier treatment that would have prevented his death. Taking into account their views we could not reach this view. We cannot know what would have happened if Mr R had seen a cardiologist sooner, and whether this would have led to treatment that would have prevented his death.
56. Our cardiology adviser explained IE is a serious disease that carries a high risk of death and serious illness. Prosthetic valve endocarditis (PVE, which is what Mr R had) has a high mortality. The ESC guidance says ‘Staphylococcus aureus PVE carries a very high risk of mortality (>45%)’. This means there is a more than 45% chance that patients with this disease die.
57. The finding of severe aortic regurgitation meant Mr R’s prosthetic valve had failed. The only treatment option available for Mr R was surgery. We cannot know if his medical history and wellness would have led surgeons to take the risk of operating. The Trust’s failure to evaluate him for surgery means we will now never know if this would have been a treatment option.
58. In patients with staphylococcus aureus septicaemia on natural valves (not prosthetic) urgent surgery is associated with lower mortality. There is no data about the outcomes for patients with PVE, as prosthetic valves were excluded from the randomised trial.
59. To summarise, we cannot know whether Mr R would have been a suitable candidate for surgery, or whether surgery would have been successful. Even on the balance of probabilities after weighing these points we cannot find this was an avoidable death. We think it reasonable to conclude this was a missed opportunity to consider clinical and surgical treatment that may have given Mr R the best opportunity of survival.
60. We understand the impact on Mrs D. She told us the battle to understand events leading up to her father’s death means she has unable to fully grieve, causing further distress and upset. She said the situation has impacted on her work commitments, and has affected her health, causing sleeplessness, irritability and stress.
Improvements the Trust has made
61. We have considered what steps the Trust has already taken and whether these actions go far enough to put things right for Mrs D and prevent a recurrence.
62. As outlined throughout this report, the complaint responses to Mrs D do not give information to provide reassurance there would not be a recurrence. The responses do not acknowledge the care and treatment was not in line with guidance.
63. The Trust has taken some positive steps. These have been shared with us, but regrettably not with Mrs D when the Trust answered the complaint. The Trust told us:
‘Since Mr R’s admission [the Trust network of hospitals] now has an electronic patient record system (HIVE) with online referrals to specialties and investigation requests. This ensures timely request and transfer of accurate information, together with remote access to clinical records and results. Specifically for echocardiograms within HIVE the referral proforma now has clear indications of what is required for endocarditis based referrals.
It has been acknowledged by all the leads that there are key learning points that have arisen from Mr R's case, especially with regards to the urgency of communication between specialist teams in the context of a patient with a Staphylococcus bacteraemia and a prosthetic valve. The case will be presented at the departmental teaching in medicine, cardiology, and ID and at Advancing Clinical Excellence Days across all relevant divisions for dissemination of this learning.’
64. This response does not provide full reassurance that the Trust has identified what led to the failings. It states that ‘the referral proforma now has clear indications of what is required for endocarditis based referrals’. As outlined in this report, at the time of the care and treatment there was clear guidance of what is required for IE referrals, which was not followed. We have not seen an analysis of why this happened or details of whether the proforma is aligned to the guidance. We are not assured this would prevent a recurrence.
65. The Trust has not recognised a failing in the fact that despite there being ‘a Cardiology senior doctor on call 24/7, if it is decided that an urgent investigation is required by the referring team’ this case was not recognised as being urgent.
66. The Trust has not recognised a failing in the fact it did not carry out an urgent cardiac review on 24 August. At this point Mr R had confirmed IE and moderate to severe aortic regurgitation. The response said the doctor ‘was dealing with other urgent clinical cases as a priority, at the time of the referral’.
67. For these reasons we do not think the Trust has carried out sufficient analysis of what led to the failings. This means we cannot be assured it has taken sufficient action to prevent a recurrence.