Stroke diagnosis
29. The initial notes taken by the paramedics detail Mrs C had a right sided facial droop, as well as confusion and agitation, therefore identifying that Mrs C was FAST positive. The proposed diagnosis was supported by the notes detailed by the triage nurse at 5:55am, and the ED doctor review at 6:42am.
30. The doctor noted that Mrs C had a low Glasgow Coma Scale (GCS) score of 11/15 and that an intracerebral haemorrhage (ICH – bleeding in the brain) and an acute stroke needed to be ruled out. The GCS is tool used to assess and calculate a patient’s level of consciousness. A score of 11 indicates a moderately reduced level of consciousness.
31. The notes show that the ED doctor contacted the stroke team, however they had not initially accepted the referral, as a scan had not yet been done.
32. Mrs C was sent for a CT scan to determine if she had suffered from a stroke, the notes show that she was transferred for the scan at approximately 7am. The scan was reported on at 7:12am by a radiology registrar (a doctor in training to be a consultant) who suggested there had been a stroke.
33. At 7:30am, the ED team referred Mrs C to the stroke team who advised they would attend to review her, and Mr C was informed of the diagnosis.
34. A consultant neuroradiologist then reviewed the CT head scan at 10:14am and confirmed there was no evidence of Mrs C having suffered a stroke. The stroke team reviewed Mrs C at 11am (two and a half hours after the referral) and referred Mrs C back to the ED team.
35. NICE guideline 128 states for patients who are suspected as having had a stroke:
“1.3.2 Perform brain imaging immediately with a non-enhanced CT for people with suspected acute stroke if any of the following apply
(see additional information):
• indications for thrombolysis or thrombectomy • on anticoagulant treatment • a known bleeding tendency • a depressed level of consciousness (Glasgow Coma Score below 13) • unexplained progressive or fluctuating symptoms • papilloedema, neck stiffness or fever • severe headache at onset of stroke symptoms”
36. As Mrs C had a depressed level of consciousness (GCS11) an immediate CT brain scan was indicated. Mrs C was referred to the stroke team at around 7am, and again at 7:30am based on her presenting symptoms and the results of her CT head scan. This was an hour and a half after her initial presentation to the ED. A CT head scan was carried out to determine the diagnosis, as it was noted that there were possible alternative diagnoses in this case.
37. Overall, we consider it was reasonable for the ED team to initially explore the possible diagnosis of a stroke based on the symptoms Mrs C presented with. The team referred Mrs C to the stroke team and for a CT head scan in line with NICE guidance and kept Mr C informed. Once it became apparent Mrs C had not suffered from a stroke, she was promptly referred to the medical team and Mr C was informed of the outcome of the investigations. For these reasons, our decision is to not uphold this part of the complaint.
Sepsis diagnosis and treatment and conflicting records
38. It is evident that Mrs C was considerably unwell upon her arrival at hospital. Mrs C’s National Early Warning Score (NEWS) was calculated as eight upon admission, and reportedly reduced to two at 7:30am. However, our adviser highlighted this has been calculated wrong, and should be four.
39. NEWS is a tool used to monitor patients in hospital, it is an aggregate scoring system which indicates how unwell a patient is, their level of clinical risk, and what level of response should be given. NEWS can help to identify patients at risk of deterioration, including sepsis, and in escalating them to get appropriate treatment as promptly as possible. A higher score indicates a patient at increased risk of deterioration.
40. We understand Mrs C was likely already septic at this point, the notes show she presented with a low GCS and a lactate level of 6.6mmol/L, she also had a high white cell count (38.7 – which can be a sign of infection/inflammation) and presented with signs of confusion and agitation. Our adviser explained that Mrs C’s increased lactate level indicated a significant risk of death (IDT article 2022).
41. Once a diagnosis of stroke was ruled out, it appears a diagnosis of sepsis was made during the ED registrar’s review. The entry in the records which details this review is untimed, however, on the balance of probabilities, we have concluded this review happened between 11:30am and 12:30pm.
42. This is because the observations recorded as part of the review match those entered in the observation chart at 11:35am. In addition to this, the Trust’s response details that a decision was made to admit Mrs C to the medical team at 12pm. This seems to tie in with this untimed entry in the records, which would suggest Mrs C was reviewed promptly following the stroke team referring her back to the ED team.
43. The review shows that the ED registrar’s impression of Mrs C was that she had sepsis complicated with an acute confused state. A plan was put into place to give Mrs C IV tazocin and IV fluids and refer her to the medical team for further investigations.
44. Based on this information, it appears Mrs C was reviewed promptly once a stroke had been ruled out. A diagnosis of sepsis was made, and further investigations were ordered. Mrs C was then referred to the medical team for further review and care.
45. We consider this is in line with the GMC’s Good Medical Practice guidance, point 15 which states:
“You must provide a good standard of practice and care. If you assess, diagnose, or treat patients, you must:
• 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.
• Promptly provide or arrange suitable advice, investigations, or treatment where necessary.
• Refer a patient to another practitioner when this serves the patient’s needs”
46. However, whilst a diagnosis was made and treatment plan was put into place promptly, we find there was a lack of monitoring of, and treatment provided to, Mrs C.
47. Due to a lack of information recorded in the medical records, it has been difficult to determine what happened next in this case.
48. NICE guideline 51 says a person’s history and physical examination results should be used to grade risk of severe illness or death from sepsis, using criteria based on age (1.4.1).
49. Based on this criteria, Mrs C was at a moderate to high risk of severe illness or death from sepsis as she had a history of new onset change in mental state as well as signs of potential infection indicated through her blood results (1.4.3 - 2016).
50. The guidance states that for adults who have suspected sepsis and one or more high risk criteria including a lactate over 4mmol/litre, a broad-spectrum antibiotic and IV fluid bolus should be given at the maximum recommended dose without delay, and within one hour of identifying they meet any high-risk criteria. The patient should also be referred to critical care for review of management (1.6.1, 1.6.2 -2016).
51. Within Mrs C’s notes, there is a Trust ‘sepsis six’ care pathway document which confirms the team identified Mrs C met at least one high risk criteria due to her reduced consciousness. The document is incomplete, and unsigned, but suggests IV tazocin was given at 12:30pm.
52. The sepsis six care pathway is part of the UK Sepsis Trust’s recommended approach to diagnosing and treating sepsis. It allows clinical staff to record and track symptoms, identify red flag symptoms, track treatment given, and monitor the patient’s response.
53. The prescription chart within the records is signed to say the dosage due around 2pm had been given. However, as there is no corresponding written entry in the records, we cannot determine if this was given at the time of the ED registrar’s review (between 11:30am and 12:30pm), or at 2pm. The Trust’s response says Mrs C was reviewed at 2:20pm and IV antibiotics were started at 2:40pm, but there is no corresponding entry within the medical records to confirm this. Therefore, in the best-case scenario, antibiotics were given at 12:30pm, and in the worst-case scenario they were given at 2:40pm.
54. On the balance of probabilities, we consider antibiotics were not given within one hour of identifying Mrs C met high-risk criteria and we consider this was a delay in providing antibiotic treatment. We will consider the impact of this in the next section of our report.
55. With regards to the provision of IV fluids, the records suggest they were given at 6:40am, and again at 3:35pm. We have considered whether the fluid regime was sufficient based on Mrs C’s presentation.
56. IV fluids were given upon admission (6:40am), and at this time the clinical impression was a suspected stroke. Our adviser confirmed that there would have been no reason to give any more fluids until it was suspected Mrs C had a diagnosis of sepsis. Further to this, our adviser explained that the provision of fluids in elderly patients is a difficult balance when managing sepsis. A careful approach is often taken, as 1 litre of fluids given via a drip can overload the heart if given too quickly.
57. The fluids given at 3:35pm were to be given over six hours, which should have finished around 9:30pm. There is no evidence within the records that Mrs C was given any more IV fluids after this time.
58. NICE guideline 51 (2016 version) says to “Reassess the patient after completion of the IV fluid bolus, and if no improvement give a second bolus” (1.8.4).
59. We understand that Mrs C’s blood pressure had returned to a normal range when observations were taken at 7:40pm and 8:10pm, however her pulse rate was still high, and her NEWS remained at six. We consider that, given her diagnosis and presentation, a second bolus of IV fluids should have been given. This was a further missed opportunity to provide treatment in line with NICE guidance, based on Mrs C’s presentation. We will address the impact of this later in the report.
60. We have also considered the level of monitoring provided to Mrs C.
61. The RCP NEWS2 guidance says that those who score one to four should be monitored every four to six hours unless more/less frequent monitoring is considered appropriate (point 38).
62. Observations taken at 11:35am and 12:30pm show Mrs C’s NEWS to be three, which suggests some initial improvement since the point of admission. A score of three would warrant monitoring every four to six hours, as outlined above. Therefore, we consider it was in line with the RCP guidance that the next set of recorded observations were taken at 3:45pm.
63. The observations carried out at 3:45pm show Mrs C’s NEWS to be six. NICE guidance indicates a person is at moderate risk of severe illness or death from sepsis if they have a suspected or confirmed infection and a NEWS2 score of five or six (1.13.8 - 2024).
64. The RCP NEWS2 guidance recommends that the frequency of monitoring should be increased to a minimum of hourly for those with a NEWS of five or six, or if the patient has a red score in any single parameter, until they are reviewed, and a plan of care is documented (point 39).
65. Therefore, from this point on, in line with the RCP guidance, we consider Mrs C should have been monitored hourly.
66. The next entry we have in the records is a review at 5:30pm, carried out by one of the ED registrars who had been asked to see Mrs C. It is noted Mrs C had a raised white cell count, CRP, and lactate level, and that IV fluids and tazocin had been provided. The registrar stated Mrs C had been handed over to the medical team, and that they had updated the family.
67. No observations were recorded at the time this review. By this time, Mrs C should have been reviewed at around 4:45pm, and would have been due for a further set of observations after this review.
68. The Trust’s response says the medical team reviewed Mrs C at 7:22pm, but this review is not detailed in the records and so we do not know what actions were taken, if any. This was approximately seven hours after the referral was made to them. Given the severity of Mrs C’s presentation, we consider the medical team should have taken responsibility for Mrs C and reviewed her care much sooner than they did. We also consider this should have been complemented by more frequent monitoring of Mrs C by ED nursing staff.
69. By this time, it is evident from Mrs C’s observations/NEWS that she was deteriorating. Observations carried out at 7:40pm show Mrs C’s NEWS to be six, reducing to five at 8:10pm.
70. The records show that Mrs C’s observations were not monitored between 3:45pm and 7:40pm. We consider this to be a service failure as the team did not respond to Mrs C’s presentation in line with NICE and RCP guidance. We will consider the impact of this in the next section of our report.
71. The increase in NEWS to six marks a clear change in Mrs C’s presentation, and we cannot see that any action was taken in response to this. The last set of observations were taken at 8:10pm and there are no further written entries in the records until those made in retrospect after staff had found Mrs C to be unresponsive at around 3am.
72. This shows that Mrs C’s observations were not monitored between 8:10pm and 3am, which is a period of seven hours. During this period, they should have been monitored hourly as a minimum, given the severity of her illness. It is also of note the medication chart does not confirm that the planned dose of IV tazocin was given at 10pm.
73. We consider this to be a service failure, as the team did not respond to Mrs C’s presentation and deterioration or provide her next dose of antibiotics. We will consider the impact of this in the next section of our report.
74. Mr C also raised concerns about the record keeping in this case.
75. The GMC’s Good Medical Practice guidance says clinical records should be clear, accurate, and legible. Doctors should make records at the same time as the events they are recording, or as soon as possible afterwards. The records should include relevant clinical findings, decisions made, and actions agreed, information given to patients, any drugs prescribed or other investigations or treatment and detail who is making the record and when (Points 19 and 21).
76. The NMC’s Code says nurses should keep clear and accurate patient records. They must complete records at the time or as soon as possible after an event, identify any risks or problems that have arisen and the steps taken to deal with them, complete records accurately, and ensure entries are dated and timed (Points 10 – 10.6).
77. Within Mrs C’s records, the sepsis six pathway document is incomplete and unsigned, meaning we cannot be certain when screening took place, and what other actions were taken in response to Mrs C’s presentation, nor if these actions were taken in a timely manner. Further to this, the review undertaken by the ED registrar around midday is untimed, meaning we cannot know what time Mrs C was diagnosed with sepsis.
78. There is contradictory evidence as to when IV antibiotics were started. The sepsis six pathway document suggests IV tazocin was given at 12:30pm, whereas the Trust’s response says IV antibiotics were started at 2:20pm. This means we cannot be certain on the length of the delay of Mrs C receiving treatment.
79. The Trust’s response also details two reviews undertaken by ED doctors at 2:20pm and 7:22pm. There are no corresponding entries within the medical records which confirm these reviews took place. The Trust has confirmed it does not hold any documentation of these reviews.
80. For these reasons we consider there to be a service failure in the record keeping in this case.
Communication
81. We have identified a service failure in the level of communication with Mr C.
82. Mr C says he spoke with a doctor at approximately 7pm on 11 October. He discussed his concerns about Mrs C’s presentation with the doctor and felt reassured from this discussion that she would improve with the correct care and treatment.
83. In response to the complaint, the Trust says the doctor was attempting to convey that sepsis takes time to respond to treatment, and this can vary from patient to patient. The doctor was hoping for a good response to the antibiotics, but unfortunately this did not happen.
84. NICE guideline 51 states a care team member should be nominated to give information to families and carers, this should include an explanation that the person has sepsis and what this means, an explanation of any investigations and the management plan, and regular and timely updates on treatment, care, and progress (1.11.1 – 2016).
85. We were not present at the time of this discussion, and there is no corresponding entry within the medical records which details what was said. However, we can draw from Mr C’s account and the statement from the doctor that they discussed the fact Mrs C had sepsis, and that Mr C was told of the treatment plan.
86. At the time of this discussion, and from the point of admission to the hospital, the records show us Mrs C was significantly unwell. There is no evidence within the records that Mr C was told of the seriousness of Mrs C’s illness, and based on Mrs C’s presentation at the time, we consider he should have been told. Had he been told; he would not have left the hospital. We consider not making Mr C aware of the severity of Mrs C’s presentation is a failure in communication. We will address the impact of this below.
Impact
87. As we have identified failures in Mrs C’s care, we have considered what would have happened if Mrs C had been treated, monitored, and reviewed in line with the guidance we have referenced in this report.
88. Whilst there was a delay in the diagnosis of sepsis, we consider this was justifiable as the team were ruling out a possible stroke diagnosis. This led to her receiving antibiotics around nine hours after her admission (when considering the worst-case scenario of administration at 2:40pm).
89. We explored with our adviser the impact of this potential delay in giving antibiotics. As we have detailed earlier in this report, Mrs C was a 78-year-old lady who was already seriously unwell at the point of her admission. She was presenting with signs that she was at a significant risk of death. Taking this into consideration, we consider there is no clear evidence that, in the worst-case scenario, the delay of approximately one hour (from the point of diagnosis) would have made a difference to Mrs C’s outcome when considering the severity of her illness.
90. With regards to the provision of IV fluids, we understand it is unlikely the omission, in isolation, would have made a significant difference to Mrs C’s outcome, as it is one component of the overall lack of monitoring and intervention that forms part of this case.
91. It is likely that by the point Mrs C received antibiotics and IV fluids, she already had severe sepsis. It is of note that even after initial antibiotic and fluid administration, Mrs C’s condition deteriorated.
92. Despite this, she should have had more frequent observations, as none took place between 3:45pm and 7:40pm, and from 8:10pm to the time she was found unconscious at 3am.
93. We consider there was a missed opportunity to provide further IV fluids after the dosage finished at 9:30pm and a second dose of antibiotic at 10pm which may have prevented her sudden deterioration at 3am. We have considered with our adviser whether Mrs C would have survived longer had this occurred.
94. We have considered Mrs C’s presentation to the ED, and her presentation throughout the day. As detailed throughout this report, Mrs C was significantly unwell at the point of presentation and was likely already severely septic.
95. There is a possibility that if Mrs C had been monitored and treated in accordance with the guidance referenced in this report, she would have lived slightly longer than she did. Our adviser explained this may have been a few more days, or up to a week, but sadly it is more likely than not that Mrs C would have succumbed to her illness during this admission.
96. The lack of monitoring and intervention represents a missed opportunity for a more dignified death. Had the team been monitoring and responding to Mrs C’s deterioration, it would have allowed the family the chance to have been present when she deteriorated further and died.
97. If the deterioration could not have been avoided, effective monitoring would have meant her deterioration would have become apparent to the team sooner than 3am.
98. At this point, we would expect Mr C to have been contacted and updated in line with the NICE guidance quoted above. This demonstrates a missed opportunity for Mr C to have been informed that Mrs C was deteriorating so that he could come back to the hospital to be with his wife when she died. This opportunity was taken away from him due to the lack of monitoring of Mrs C’s deterioration.
99. Overall, we have identified that there was a small possibility Mrs C could have lived up to a week longer than she did. The Trust’s failings meant that there was a missed opportunity for a more dignified death in both scenarios we have outlined in this section of our report.
100. Whilst we cannot conclude that Mrs C would have recovered from her illness, the failings in care in this case are particularly serious. We should not underestimate the significant distress this has caused to Mr C, or that this is likely to be exacerbated by the findings of our report. We are sincerely sorry for any additional distress our report causes.
101. We consider this is likely to have a lasting impact on Mr C as he comes to terms with the care Mrs C received, and the missed opportunities we have identified in this report.
102. For these reasons, we will be making recommendations to the Trust to put things right for Mr C and to address the failings in service we have identified. We hope these recommendations reassure Mr C that his concerns have been taken seriously, and that improvements will be made so that other families do not have the experience he did.