Complaint about tests to look for a blood clot
18. People with AF are at risk of developing blood clots in their heart. Ms U thinks her mother had signs of a blood clot on 3 April (foot pain, leg swelling, breathlessness, chest tightness, and a cough). She says the Trust should have ruled this out by doing a leg ultrasound scan and a blood test to look for D-dimer (a protein which is a byproduct of clotting).
19. The VTE guidelines set out what should happen when someone has signs and symptoms of a blood clot. The guidance differs depending on where the clot is.
20. A deep vein thrombosis (DVT) is a clot in a vein, usually in the leg. It causes leg pain and swelling. People with DVT symptoms should have their medical history considered and a physical examination. If DVT is suspected, they should have a leg ultrasound scan and a D-Dimer blood test. The order in which these are done depends on how likely the DVT is.
21. A pulmonary embolism (PE) is a clot in the lung. It causes chest pain and shortness of breath. People with suspected PE should have their medical history considered, a physical examination and a chest X-ray. If PE is suspected, they should have a CT scan of their chest.
22. The records say doctors found Mrs J had soft calves, that were not tender, with no leg or ankle swelling when examined. Our physician adviser said Mrs J did not have any clinical signs of DVT. Therefore, we found it was appropriate that the Trust did not suspect a DVT or do the tests outlined in the VTE guidelines.
23. Mrs J’s records show she did have shortness of breath and chest tightness. Our physician adviser explained these symptoms could be a sign of a PE but are also caused by other common conditions.
24. In line with the VTE guidelines the Trust considered Mrs J’s medical history, and did a physical examination and chest X-ray. Our physician adviser explained the findings of this support the Trust’s conclusion that Mrs J’s symptoms were being caused by her AF and other medical conditions, and not a blood clot. This meant a PE was not suspected as it could be ruled out, and there was no need to do a CT scan.
25. We understand why Ms U was suspicious about blood clots given her mother’s medical history. We consider the Trust acted in line with the VTE guidelines, and there is no evidence it should have suspected a DVT or PE or done further tests.
Complaint about prescription of amiodarone
26. Amiodarone is a medication used to restore normal heart rhythm and pace. The AF guidelines say treatment for people with this condition should focus on controlling the heart rate (how fast the heart beats) with amiodarone if the onset of AF is more than 48 hours ago or uncertain. For people with long term AF, a different type of medication called beta blockers is recommended.
27. The BNF, which provides advice on medicines, says amiodarone can be used to treat an abnormal heart rhythm, particularly when other medications will not work or are unsuitable.
28. The records show Mrs J arrived at hospital with a new case of AF, the onset of which was uncertain, but estimated to be nine days earlier. Doctors established she had been unable to tolerate beta blockers in the past. Based on this, and after seeking the views of an out of hours cardiologist at another NHS trust, the Trust prescribed amiodarone to Mrs J.
29. We think the Trust’s use of amiodarone was in line with the NICE and BNF guidance. It was the appropriate medication for Mrs J’s condition and other medication was not suitable. We hope this is provides Ms U with some reassurance. We can also offer further reassurance that amiodarone did not contribute to Mrs J’s stroke.
30. The Trust accepted there was a risk of stroke when it prescribed amiodarone. It made a note of this in Mrs J’s records and discussed this with her. Our physician adviser explained this medication, as well as others that control the heart rate or rhythm, can lead to a stroke in rare cases because of how it changes the heartbeat.
31. This is because when the medication is successful, and the heart starts beating normally again, there is a rare chance this change can trigger any clots in the heart to become dislodged and travel to the brain.
32. In Mrs J’s case, although she had a stroke due to a blood clot, we can be confident this was not due to amiodarone correcting the heart rhythm. This is because her heart rate and rhythm remained abnormal, and her AF was still present throughout the admission.
Complaint about the delayed stroke diagnosis on 5 April
33. Ms U has concerns about the doctor’s assessment at 3.30pm, and the nursing care after this. We consider these in turn.
The doctor’s assessment
34. The NHS.uk website says the most common symptoms of stroke are weakness on one side of the face or body, and speech problems. A stroke can cause other symptoms like confusion and loss of consciousness, but these symptoms can be caused by other conditions.
35. According to the RCP guidelines, stroke is a medical emergency, and to get the best outcome, it needs to be diagnosed and treated (where possible) quickly. Patients with stroke symptoms need to be urgently assessed to see if a stroke, or something else, is the cause.
36. The GMC guidelines say when doctors are assessing a patient, they should adequately assess their condition, take account of their history, examine them, and arrange suitable investigations. Their clinical records should include the relevant clinical findings.
37. The records show that in the lead up this incident Mrs J was alert and orientated, had no communication issues, and was able to carry out activities with minimal assistance.
38. At around 3.20pm another patient noticed Mrs J had become unresponsive when sat up in bed. They called for the nurse, who then alerted the medical team. A doctor assessed Mrs J at 3.30pm. They listened to her chest, examined her abdomen, and checked her vital signs (such as blood pressure and heart rate).
39. The doctor also considered her Glasgow Coma Scale (GCS) score, which is the measure of consciousness levels. Normal is 15/15. Mrs J’s was 9/15 and went up to 12/15 during the review. The doctor wrote ‘patient is conscious but choosing to sleep. Not making any conversation’.
40. The doctor documented three possible causes of the episode. They said it was either: • a paroxysm of AF that resolved quickly (which means a spontaneous episode of AF that quickly gets better) • a vasovagal event (which is another term for fainting caused by a drop in blood pressure in response to some sort of strain or stress) • or functional (which could refer to a condition with no physiological cause or where the symptoms cannot be explained).
41. They said no action was needed, the nurses should continue to observe Mrs J, and they would return if there were any issues.
42. Based on the evidence we have considered, we think the doctor failed to adequately assess Mrs J and failed to suspect or rule out a stroke.
43. Our physician adviser explained Mrs J had a sudden onset neurological episode and her symptoms of being unresponsive, drowsy, and not speaking (when she was previously alert and communicating) were suggestive of a stroke. The doctor’s suspected diagnoses did not adequately explain her symptoms.
44. We consider the doctor should have suspected a stroke and investigated further. In line with the RCP and GMC guidance, the doctor needed to perform a neurological examination under these circumstances. This would include looking for signs of leg, arm or face weakness and checking reflexes, eye movements, and pupil size.
45. We cannot see any evidence the doctor considered stroke as a potential cause of Mrs J’s symptoms or did a neurological examination to rule this out. These are things we would have expected to see.
46. When it investigated the complaint, the Trust felt its assessment was adequate. It said the doctor was aware of the stroke risk, but Mrs J had no signs of a stroke when examined. It said she had no facial droop or obvious limb weakness.
47. The medical records do not support the Trust’s account and there is no record the doctor considered or examined these things. The doctor’s record is detailed and include notes of the chest and abdomen examination alongside theories about why Mrs J was sleepy and not speaking. Therefore, because consideration of stroke or a neurological exam are not documented, we think they did not happen.
48. We find the Trust failed to act in line with the GMC and RCP guidelines when Mrs J became unresponsive, and it did not suspect a stroke when it should have. This was a failing.
The nursing care
49. Ms U says after her mother’s unresponsive episode the nurses did limited checks that were not often enough. She also thinks the nurses took too long to escalate things to the medical team when Mrs J’s symptoms persisted.
50. The Trust did not identify any issues with the frequency or quality of nursing checks, but agreed escalation should have happened sooner.
51. The NMC code says nurses must effectively deliver the fundamentals of care without delay. This includes things like ‘nutrition, hydration, bladder and bowel care, physical handling and making sure that those receiving care are kept in clinically safe environment’. Our nurse adviser explained these are considered during regular rounding checks, which usually take place every one to two hours.
52. The NMC code also says nurses must ‘accurately identify, observe, and assess signs of normal or worsening physical and mental health in the person receiving care’ and ‘make a timely referral to another practitioner when any action, care or treatment is required’.
53. In addition to regular rounding checks, nurses are also responsible for monitoring people’s vital signs by measuring their early warning score (EWS). This is a measure of observations like blood pressure and heart rate to detect clinical deterioration. A score is given based on the results, and that determines how often the EWS should be recalculated.
54. The RCP guidance says people with an EWS of 1-4 should have it checked again every four to six hours.
55. We looked at whether the nursing checks were appropriate and often enough, and if escalation to the medical team was timely. We considered the period between Mrs J’s unresponsive episode, and the stroke being suspected by nurses at 9pm.
56. The records show Mrs J’s EWS was 2 or 3 when staff measured it at 3.22pm, 5.43pm and 8.57pm. We are satisfied checks were repeated well within the minimum four hour timescale in line with the NEWS guidance.
57. Rounding checks were done at 3.58pm, 5.44pm, 6.02pm and 8.30pm. The gap between checks ranged from 20 minutes – 2.5 hours. Our nurse adviser says these timeframes were acceptable. We therefore think the frequency of checks was in line with the NMC code.
58. The Trust’s electronic rounding charts give prompts to staff to check the following things: pain, personal care, position, possessions, hydration, falls, and skin integrity. We think these were appropriate things for staff to be checking, as they were in line with what the NMC code says about the fundamentals of care.
59. Unfortunately, the Trust’s charts do not include detail about the outcomes of these checks. They just say ‘yes’ or ‘no’ against the various measures. There is no way for us to say if anything different should have been done, such as more detailed or more frequent checks.
60. The only exception is at 6pm when a nurse wrote a more detailed entry in the main notes about Mrs J’s presentation. They said Mrs J was sleepy, and when offered food and drink would not speak and just stared.
61. Our nursing adviser says these were concerning symptoms that could be a sign of worsening health. In line with the NMC code the nurse should have asked the medical team to review Mrs J, but this did not happen. This was a failing. We recognise the Trust does not dispute that something went wrong here.
62. Later in the report we set out our views on the impact of the Trust’s failure to suspect a stroke at 3.30pm and to escalate to the medical team at 6pm. This is because we need to first examine Mrs J’s bowel care.
Complaint about bowel care
63. Ms U says the Trust took too long to realise her mother had not been opening her bowels after her stroke. The Trust accepts its monitoring was inadequate.
64. She also says her mother had a bowel obstruction that should have been diagnosed sooner. This is a blockage that prevents food or liquid moving through the bowel. The Trust said Mrs J’s bowel issues were caused by a blood clot travelling to her bowel and had no concerns with the timing of this being diagnosed.
65. As set out in paragraph 51, the NMC code says bowel monitoring is one of the fundamental aspects of nursing care. Our nursing adviser explained, in practice, nurses should make a note of any bowel movements, or that there had been none, at least once a day, if not more. They do this on a stool chart.
66. As stated in paragraph 52, nurses must be able to spot signs of worsening health and refer patients to other practitioners, doctors in this case, when needed.
67. Our physician adviser explained doctors do not routinely monitor a person’s bowels, but they will review a patient in this context if nurses or the patient raise concerns. In line with the GMC guidance the doctor would need to adequately assess the patient’s symptoms, taking account of their history and where necessary, examine the patient.
68. When we looked at Mrs J’s records, we saw the Trust’s bowel monitoring was inadequate but escalation, once a potential problem was identified, and further assessment to examine it was appropriate.
69. Nurses did not regularly complete the stool chart or document anything about Mrs J’s bowels. There were more days than not where no monitoring occurred at all. This was despite the dieticians regularly documenting that bowel monitoring was needed. This was not in line with the NMC code and represents a failing.
70. The nurses first acknowledged Mrs J was not opening her bowels on 11 April and arranged with the doctors for laxatives to be given. Then, on 13 April nurses noticed her bowels had not opened, and she had a distended abdomen (swollen tummy).
71. This was a sign of worsening health, and in line with the NMC code they asked the doctors to review this. Our nursing adviser did not identify any occasions before 13 April where escalation was needed.
72. When the doctors saw Mrs J, they examined her abdomen and arranged scans to look at her bowel. Our physician adviser said this plan was in line with GMC guidance.
73. A scan showed Mrs J had ischaemic colitis (inflamed bowel due to a blood clot in the blood vessel supplying the bowel). Our physician adviser said Mrs J did not have a bowel obstruction, and there were no warning signs of ischaemic colitis before 13 April.
74. Although the bowel monitoring was inadequate, we do not think it had a clinical impact on Mrs J or led to a delay in the ischaemic colitis being diagnosed. While we hope this reassures Ms U, we recognise the lack of monitoring added to her worries about her mother’s death. The next section of our report will consider Mrs J’s death in more detail.
Our view on the impact of the stroke failing
75. We have found the Trust failed to consider, assess for, or rule out a stroke at 3.30pm. There was then a further missed opportunity at 6pm.
76. The stroke was not suspected until 9.15pm when a new nurse that came on shift was worried about Mrs J’s presentation. They escalated this to the medical team and within an hour she had a CT scan and the stroke was diagnosed.
77. Because of the timing of the diagnosis and Mrs J’s history (which we explain in more detail next) she could not have any treatment for the stroke. Ms U considers her mother’s stroke may have been treatable and less disabling if diagnosed sooner, and she wonders if her mother may not have died.
78. We looked at what would have been different if the Trust had considered the possibility of a stroke at 3.30pm, as this would make the most significant difference.
Was treatment possible?
79. Our stroke adviser said the neurological examination that should have been done would have supported the diagnosis of stroke and, in line with the local stroke pathway, Mrs J would have likely been able to have treatment.
80. Treatment for an ischaemic stroke is either thrombolysis (breaking down the offending blood clot) or thrombectomy (manually removing the blood clot from the blood vessel using specialised equipment). The criteria for these are set out in the local stroke pathway.
81. Mrs J did not meet the criteria for thrombolysis as she was taking blood thinning medication, which meant there was a high risk of bleeding. Even if the failing did not occur, she would never have had thrombolysis. However, she appears to have met the criteria for thrombectomy.
82. In April 2021 thrombectomy was only available during the day, up to 6pm, and it was done at another hospital approximately 15 miles away by road. Patients at Mrs J’s hospital had to be referred before a 4.30pm cut off time. We think the Trust could have made the thrombectomy referral before this cut off time if not for the failing at 3.30pm.
83. We note there could be unforeseen challenges in transporting Mrs J to this other hospital for thrombectomy (such as transport issues or delays at the other hospital) making it more difficult to treat her by 6pm. However, we also recognise the cut off time in the policy accounts for this, and we have seen no reason to think transfer within this time would not have been possible.
84. We therefore think it is likely Mrs J could have been referred for thrombectomy and received it in time, if not for the failing.
85. The other thrombectomy eligibility criteria relate to the person’s age and usual function, the severity of stroke, and time since of symptom onset. Our stroke adviser says Mrs J met these criteria. She was fit enough for the procedure, and her stroke was serious enough to warrant it.
86. According to the local stroke pathway, if someone meets all the thrombectomy criteria the next step would be immediate CT head and CT angiogram scans (these are advanced X-ray scans that look inside the brain and examine the blood vessels and soft tissues). This is what should have happened in Mrs J’s case after the 3.30pm review.
87. Mrs J had a CT head later that evening. This found she had a blood clot in a large blood vessel (also called a large vessel occlusion). Our stroke adviser said had the CT head and CT angiogram scan been done from 3.30pm onwards when required, the findings would have likely been the same, and would have probably shown there was a clot suitable for thrombectomy.
88. On the balance of probabilities, when we weigh up all the factors outlined above, we consider it is more likely than not that Mrs J would have been eligible for, and would have had, a thrombectomy if not for the failing to diagnose the stroke at 3.30pm.
Would treatment have reduced Mrs J’s disability?
89. Before these events, Mrs J was active and independent. She lived alone, drove, and did her own shopping. At the time, her grandson described her as being sharp and good with technology.
90. Mrs J’s stroke left her unable to speak, express her needs, or understand information. She was drowsy and unable to participate in her care and had to be fed through a tube. She had considerable weakness on one side of her body and was unable to move by herself. She needed full assistance with all her care needs including personal hygiene and toileting.
91. Ms U considers her mother’s stroke would have been ‘less disabling’ if diagnosed sooner. We thought about whether any of the disability described in the previous paragraph could have been avoided, or minimised, if thrombectomy had gone ahead.
92. The thrombectomy research says thrombectomy can restore 70-80% of the blood flow in the blocked blood vessel (therefore reducing level of brain damage and disability caused by the clot). People who have the procedure might not benefit from it, or may be left with some degree of disability. Around 43% of people who have the procedure will have their disability prevented (meaning a return to their pre-stroke level of function).
93. Its possible Mrs J could have been left with the same level of disability after a thrombectomy. Or, thrombectomy could have been successful and she could have suffered less.
94. We cannot say Mrs J would have definitely avoided any disability if the thrombectomy had gone ahead, as the data shows it only prevents this in less than 50% cases. However, our stroke adviser tells us it is possible she could have at least been less disabled (i.e. left with only mild stroke symptoms) if the procedure was partly successful.
95. This means Mrs J’s disability after the stroke was potentially avoidable or worse as a result of the failure to diagnose and treat it. This may have meant that for the 19 days Mrs J lived after her stroke, she was left more disabled, and therefore suffered more, as a result of the failing. We will never be able to say any more than this.
96. We recognise that knowing whether her mother may have suffered more will be a significant concern for Ms U. She tells us her mother’s suffering was a deeply upsetting experience and witnessing it had an emotional impact on the whole family. Ms U tells us it has affected her confidence in the NHS and exacerbated her anxiety issues.
Was the failing, and lack of treatment, linked with the bowel complication that caused Mrs J’s death?
97. Mrs J sadly died as a result of a further blood clot that travelled to her bowel and could not be operated on. As we go on to explain below, this clot could have been unrelated to how her stroke was handled and not a consequence of any failings in care. However, we have also explored whether the bowel clot could have been linked to the failings.
98. After a stroke, people with a blood clot are at risk of further damage from secondary bleeding due to tissue death. Because of this, the Trust stopped Mrs J’s blood thinners. This meant she was less protected from developing blood clots.
99. Our stroke adviser explained that, had Mrs J had a successful thrombectomy to remove the clot, she could have possibly been left with less brain damage. If this was the case, she would have likely been able to restart blood thinners within a couple of days. Although we will never know for sure, if things had developed this way, it could have possibly affected the overall outcome for Mrs J.
100. The stroke research shows people with AF are at risk of having more strokes after their first one, but fewer people have recurrent strokes when blood thinners are re-started early on. Therefore, having a thrombectomy and restarting blood thinners may have lowered Mrs J’s risk of developing a new clot. There is a possibility the bowel ischaemia may not have occurred, and she may have survived.
101. However, the clot that led to Mrs J’s death may not have been a newly formed one. It may have formed with the clot that caused her stroke and taken longer to leave her heart and travel around her body to the bowel. If this clot was already present, she likely would have still died even if she had the thrombectomy and blood thinners were restarted.
102. Our stroke adviser says there is no way of knowing if the clot was new or already present, and both scenarios are equally likely. Even on the balance of probabilities, we cannot say which is the case.
103. Considering everything set out in this section of our report so far, we are in a position where we can see multiple points along the way where things could have possibly been better for Mrs J had she not missed out on prompt stroke treatment and diagnosis. There is a possible best case scenario that could have resulted in her survival. However, there are also other scenarios where she could have still died despite receiving the correct care.
104. There is no way for us to ever know how things could have developed if the failings did not occur. Unfortunately, we will never be able to say if Mrs J would have survived, or sadly still died.
105. We recognise this unknowable scenario will be difficult for Ms U to hear and she is now left with uncertainty about her mother’s death that can never be resolved. We do not take this lightly, and acknowledge this uncertainty, caused by the Trust’s initial failing to diagnose the stroke and the possible series of events that followed, is a lifelong injustice.
106. Ms U told us she has struggled to come to terms with her mother’s death because of her concerns about her care. The knowledge that there could have been a possible series of events where her mother may have survived will likely compound the upset and distress Ms U is experiencing. We consider it is also likely to further damage her confidence in the NHS.
107. We think the Trust should take action to put things right, and we address this in the next section of our report.