AAA surveillance policy
21. Mr W complains in July 2022 the Trust recalled Mr O for an AAA screening scan at six months rather than the three-month interval which is indicated by NICE guidance.
22. We reviewed this issue with the help of our second vascular surgeon adviser using Mr O’s medical records.
23. NICE guidance for AAA screening intervals states:
• no aneurysm found (less than 3.0cm) – no further scans required • small AAA (3.0cm to 4.4cm) – the person is placed under surveillance and a repeat scan offered in 12 months • medium AAA (4.5cm to 5.4cm) – the person is placed under surveillance and a repeat scan offered in 3 months • large AAA (5.5cm or larger) - the person is referred to a vascular surgeon.
24. AAA screening refers to the detection of AAA’s while AAA surveillance refers to the monitoring of growth once the AAA has been detected. Although screening and surveillance serve different purposes, NICE guidance says surveillance should be carried out using the same frequency intervals as the national screening programme.
25. Mr O’s AAA measuring 3.7cm was first identified incidentally in 2017 when he was 61, during a CT scan. Mr O was referred to the Trust’s vascular laboratory, on 5 January 2019 for local surveillance when the aneurysm was still measuring 3.7cm.
26. According to NICE guidance, at 3.7cm an AAA is considered small, and the patient should be recalled for a repeat scan in 12 months. We can see in January 2019 the Trust offered a repeat scan for 12 months’ time. This is in accordance with national guidance.
27. Mr O’s AAA was measured again in January 2020 at 4.2cm. At this size a further scan should be offered in 12 months’ time. We can see Mr O was seen in the vascular clinic again 12 months later on 31 January 2021. This is also in accordance with guidance.
28. At the January 2021 appointment the AAA measured 4.5cm. At 4.5cm an AAA is considered medium in size, and in line with NICE guidelines a scan should be offered for three months’ time. The Trust arranged a further scan for 12 months’ time. This was not in accordance with NICE guidance.
29. The Trust measured Mr O’s AAA again in February 2022, and it was reported to measure 4.7cm. According to NICE guidance, at 4.7cm Mr O should have been recalled for another scan in three months’ time. The Trust arranged a scan for six months’ time on 31 July 2022.
30. At the July appointment Mr O’s AAA measured 4.9cm. Again, at this size, Mr O should have been seen in three months’ time. The Trust offered a screening scan for 6 months’ time, and an appointment was made for 13 January 2023. This was not in accordance with NICE guidance.
31. We asked the Trust why it was not offering surveillance intervals at the same frequency as national screening guidance. The Trust told us it has two available pathways for AAA screening and surveillance. They are the ‘NAAASP’ and ‘surveillance outside the national screening programme’.
32. The Trust told us patients under 65 or with an incidentally identified AAA are surveilled ‘outside the national screening programme’ through vascular laboratories. It confirmed Mr O was being managed under the Trust’s vascular laboratory.
33. The local AAA surveillance policy used by the Trust’s vascular laboratory is:
• 3.0 cm – 4.4 cm – 12 monthly • 4.5 cm – 4.9 cm – 6 monthly • 5.0 cm – 5.5 cm – 3 monthly • larger than 5.5 cm – discharge from the screening programme to the specialist team for further tests and potential treatment.
34. The Trust’s local AAA policy differs from national guidance in the 4.5 – 4.9 cm range. In this range the national screening policy offers three monthly scans, but the Trust’s local policy offers six monthly scans.
35. Additionally, the national screening policy refers the patient for further investigations once the AAA has reached 5.5cm and the Trust’s local policy refers for further investigations once the AAA is larger than 5.5cm.
36. Guidance from gov.uk gives Trusts flexibility to implement local policies, however any changes to the national guidance must be supported by an Equity Impact Assessment (EIA).
37. An EIA is used to evaluate the potential effects of policies, practices or decisions on different groups, particularly those protected from discrimination. The purpose of an EIA is to ensure these actions promote equality and do not disadvantage any specific group. The assessment typically involves gathering evidence and analysing data to understand how proposed changes may impact various communities.
38. We asked the Trust to provide the EIA documentation to show its decision making behind the implementation of its local surveillance policy.
39. The Trust told us it implemented its local AAA surveillance protocol in 2016, agreed by the vascular consultants in post at that time. It told us there is no documentation available detailing the vascular consultant’s decision-making and therefore cannot explain the reasons why it decided to offer less frequent scans.
40. The Trust says it recognises this does not meet expected standards and has initiated a Trust-wide review of all clinical documents held across all divisions and storage systems. These documents will be aligned with current national guidance, and a strengthened governance and document management process will be implemented urgently.
41. The Trust concluded by saying it recognises its surveillance policy is outdated and not in line with NAAASP, although national guidance does allow some leeway for local risk-assessed interpretation. It also acknowledged, had it followed the NAAASP guidance, Mr O would have had his repeat scan three months earlier than the booked January date.
42. We have seen the Trusts local surveillance policy was not created with the correct supporting documentation outlining its decision-making. We consider this is a failing and will address the impact of this later in our report.
ED triage
43. Mr W says a doctor in the ED did not examine Mr O within the correct timeframe. He says had Mr O been examined sooner, staff would have known he needed urgent medical attention. Mr W believes there was a chance Mr O could have been transferred to a specialist vascular centre, and his outcome may have been different.
44. We reviewed this issue with the help of our ED adviser using Mr O’s relevant medical records.
45. On 10 January at 6.45pm paramedics attended to Mr O at his home. Mr O complained of intense pain in his right side. The paramedics took a medical history from Mr O, documenting his chronic lung condition, recent Covid-19 and pneumonia infections, atrial fibrillation (irregular heartbeat), thyroiditis (inflammation of the thyroid gland), hypokinesia (reduced movement of muscles) and high cholesterol. It is not clear why Mr O did not report he had an AAA to the paramedics.
46. The paramedics took Mr O to the ED, and he was admitted at 8.15pm. ED staff took Mr O’s physiological observations, noting he was awake and coherent. Mr O’s heart rate was 139bpm and his blood pressure was 132 over 103. Mr O described his pain as level two (the pain score is on a scale of one to three) telling staff he had taken paracetamol at 7.23pm. ED staff categorised Mr O as a priority three patient.
47. At 1.40am ED nursing staff noticed Mr O looked pale and was having difficulty breathing. They informed a doctor about Mr O’s condition, and the doctor examined Mr O.
48. At 1.50am, Mr O was transferred to the resuscitation department. At 1.55am, Mr O was not breathing and staff started CPR. Staff realised during resuscitation Mr O had a DNAR and CPR was stopped after eight attempts. At 2.30am, Mr O sadly died.
49. Guidance set out by the Royal College of Emergency Medicine says all patients attending the ED should be assessed by a triage nurse within 15 minutes of their arrival. The triage process then assigns a priority to the patient according to the Manchester Triage System.
50. The Manchester Triage System uses a series of algorithms based on a patient’s presentation and initial observations to determine the priority to be seen. Depending on the priority, a recommended waiting time to be seen by a clinician is assigned to the patient; from priority one to be seen immediately to priority five to be seen within four hours.
51. Mr O was triaged as priority three, to be seen within one hour. This was not correct as Mr O had a very high heart rate of 139bpm, and this meant he should have been assigned a priority two, to be seen by a doctor within ten minutes.
52. Mr O was seen by a doctor for the first time at 1.40am, five and a half hours after being admitted to the ED.
53. A rapid review carried out by the Trust stated there was a lack of communication from the ambulance crew handover with regards to Mr O’s AAA diagnosis which did not flag his urgent issue to staff in the ED.
54. Mr O’s records show the paramedics were not aware of Mr O’s AAA diagnosis therefore this information could not have been passed on to ED staff.
55. We asked our ED adviser whose responsibility it is to ensure the correct information is known about the patient once they are handed over to ED staff by paramedics. Our ED adviser told us once a patient has been handed over to the care of ED staff, it is the ED staff’s responsibility to take a history from the patient. It would normally be expected in a patient who is alert and oriented that the patient could provide the information themselves.
56. We know Mr O was alert and able to communicate his pain level to nursing staff. It is unclear why he did not make ED staff aware of his AAA diagnosis. In any case, despite not knowing about Mr O’s AAA diagnosis, his very high heart rate should have alerted staff Mr O needed to be seen more urgently.
57. We take note these events happened on an unusually challenging evening in the ED. The Trust told us it had 38 patients waiting to be seen by seven doctors with several mental health patients also requiring security, nursing and doctor presence. This was also the evening (from midnight) of an ambulance strike with paramedics initiating immediate handovers.
58. We have seen ED staff did not correctly triage Mr O, and he was not seen by a doctor within ten minutes of arrival to the ED in accordance with the Manchester Triage System guidelines. We go on to discuss the impact of this failing further in the report.
Pain relief
59. Mr W says ED staff gave Mr O inadequate pain relief. He says Mr O was in severe pain and the nurse only gave him paracetamol and codeine.
60. We reviewed this issue with the help of our ED physician adviser using Mr O’s medical records.
61. The Trust told us it uses the World Health Organisation (WHO) analgesic ladder as its pain assessment tool in the ED. The WHO analgesic ladder works on a scale of one to three.
• 1 – pain • 2 – mild to moderate pain • 3 – moderate to severe pain
62. If pain occurs there should be prompt administration of drugs in the following order:
• non-opioids (paracetamol) • as necessary, mild opioids (codeine) • then, strong opioids (morphine)
63. The British National Formulary states paracetamol should be given every four to six hours for mild to moderate pain. The NHS website states paracetamol, and codeine can be given in conjunction with each other.
64. Guidance from the Royal College of Emergency Medicine recommends all patients should have their pain assessed at triage and then pain relief administered within 15 minutes.
65. This guidance also states the effect of the pain relief should be re-evaluated within 30 minutes of its administration.
66. ED staff triaged Mr O at 8.15pm. Mr O was awake, coherent and able to communicate his level of pain. Mr O described his pain as a two which is moderate pain according to the WHO pain ladder.
67. Mr O told ED staff he had taken paracetamol at 7.23pm. According to the BNF, ED staff could have safely administered codeine at 8.15pm when Mr O reported moderate pain as codeine can be taken in conjunction with paracetamol.
68. At 10pm Mr O was still complaining of pain, and ED staff gave him codeine.
69. We asked our ED physician adviser if the pain relief given to Mr O was sufficient. They told us, administration of pain relief in the ED is based on the assessment of pain scores rather than the potential diagnosis. In this case Mr O graded his pain as moderate and appropriate pain relief (codeine) was given for this level of pain.
70. Our ED physician adviser said Mr O was assessed as having moderate pain at 8.15pm but was not given codeine until 10pm. This represents a one hour and 45-minute delay in providing pain relief.
71. We saw no evidence to suggest ED staff re-evaluated the effects of the codeine until midnight when paracetamol was administered.
72. We consider the type of pain relief given to Mr O was correct according to the WHO analgesic ladder and the BNF.
73. We consider ED staff delayed providing codeine by one hour and 45 minutes and did not re-evaluate the effects of the codeine after 30 minutes. We discuss the impact of this failing later in our report.
Impact of failings identified
AAA surveillance policy
74. We sought advice from our vascular surgeon adviser to consider the impact of the Trust’s surveillance policy not being created in line with guidance. We considered whether an earlier scan (at three months) would have provided a different outcome for Mr O.
75. A study by the European Journal of Vascular and Endovascular Surgery into the growth rates of AAA’s states the average growth ranges from 1.3mm to 4.75mm per year.
76. Mr O’s AAA measurements:
• January 2019 - 3.7cm (first measured) • January 2020 - 4.2cm (5mm growth in 12 months) • January 2021 - 4.5cm (3mm growth in 12months) • February 2022 - 4.7cm(2mm growth in 12 months) • July 2022 - 4.9cm (2mm growth in 6 months)
77. We can see on the whole Mr O’s AAA had been growing within the average rate with no rapid growth.
78. For Mr O’s AAA to meet the threshold for repair in October 2022 it would need to have grown by another 6mm in three months from July – October 2022. A growth of 6mm in three months is equal to a rate of 24mm a year. This is much higher than the average growth rate and not in keeping with the previous recorded growth rate of Mr O’s AAA.
79. We saw evidence the Trust carried out a CTPA scan (a scan which looks at the pulmonary arteries) during Mr O’s admission to hospital in December 2021. The CTPA report indicated although the AAA was not fully visualised, there was no significant change from the previous CT scan.
80. We consider even if Mr O had been recalled at three months, based on the preceding growth rate and information from the CTPA scan, it is more likely than not the AAA would still have been below the threshold for repair. In this scenario Mr O would only have been offered further surveillance and not treatment.
81. Based on the Trust’s surveillance policy, Mr O could potentially have been recalled in three months’ time. This would have been 31 January 2022 at the earliest. As Mr O’s AAA ruptured on 11 January 2022, we therefore consider the outcome would have been no different.
82. We do however consider this matter has caused uncertainty for Mr W and his family. This is because they will understandably wonder what Mr O’s care and treatment might have been had he been recalled at three months.
83. We have seen the Trust has acknowledged its local surveillance policy was not in line with national guidance and was not able to explain its decision-making. We have seen the Trust has committed to implementing an action plan to remedy this.
84. We have made recommendations to remedy this at the end of the report.
ED Triage
85. We sought advice from both of our vascular surgeon advisers to consider the impact of the incorrect ED triage.
86. When Mr O presented to the ED he had new onset back pain and tachycardia (when the patient’s heart rate is over 100 beats per minute). These symptoms indicated he may have already had a small tear in his aorta. Initially this is plugged by the adjacent tissue giving time to transfer to a vascular unit for assessment and repair.
87. Had it been identified Mr O had AAA the next investigation would have been an urgent CT angiogram to see if there were signs of rupture or impending rupture. If this had been done shortly following admission to the ED, it would have been possible to transfer Mr O since he did not collapse and arrest until several hours after first presenting to the ED.
88. Providing Mr O was assessed promptly and the diagnosis made following a CT angiogram he could have been transferred urgently to one of the two local vascular units. As long as the transfer took place while he was still complaining of pain and before he collapsed Mr O had a good chance of being assessed by the vascular unit and considered for treatment.
89. The two treatment options are endovascular aneurysm repair (EVAR) and open surgery repair. EVAR is the less invasive option requiring small incisions in the groin area for placement of a stent graft (a fabric tube supported by a metal mesh frame).
90. EVAR is typically recommended for patients who may not be suitable candidates for open surgery due to age or other health conditions.
91. Mr O had several co-morbidities including hypertension and severe COPD. He had recently had a Covid-19 infection so severe it had required hospital admission. Additionally, he had a DNACPR/Respect order in place. The surgical and anaesthetic team would have considered these factors including the anatomy of the aneurysm and its suitability for open repair or EVAR.
92. Mr O would most likely not have been a candidate for repair at all due to his significant co-morbidities. With the addition of the DNACPR/Respect order being in place many vascular surgeons would decline to carry out repair due to there being no benefit.
93. Mr O would still have faced a significant risk of dying even if he was offered a repair. The National Vascular Registry data for 2020 – 2022 indicates the in-hospital mortality rate for patients having an EVAR was 21.7% and open repair was 47.3%.
94. We should also consider the ambulance strike which was in effect from midnight that evening. It is possible the ambulance strike may have affected how efficiently Mr O could have been transferred to a vascular unit.
95. Given all the above, we consider had Mr O been triaged correctly there was a chance he could have been transferred to a vascular unit and considered for repair. We think this represents a missed opportunity for a potentially different outcome.
96. Even on the balance of probabilities, it is not possible to say with certainty Mr O would have been considered a candidate for open repair or EVAR and then survived the operation. This is due to his significant co-morbidities, recent ill health and DNACPR/Respect order.
97. We consider this has led to an impact of uncertainty for Mr O’s family who will never know if Mr O could have had a different outcome had ED staff correctly triaged him. We also think the knowledge Mr O received a poor standard of care prior to his death has exacerbated their grief.
98. In response to this issue, the Trust carried out an audit to review the quality of triage and drew up an action plan to remedy the issues identified. It also implemented a system of ‘safety rounds’ to be carried out by the ED doctor and nurse in charge when the wait time to see a doctor exceeds two hours.
99. The Trust has already acknowledged this matter, provided an apology and committed to putting service improvements in place. Mr W has requested financial compensation and we make recommendations for this later in our report.
Pain relief
100. We sought advice from our ED physician adviser to understand the impact of the delay in providing pain relief and re-evaluating Mr O.
101. We found the pain relief given to Mr O was appropriate for the level of pain (moderate) he was reporting. We have seen no evidence to suggest Mr O reported severe pain.
102. We consider the one hour and 45-minute delay in administering codeine meant Mr O was experiencing moderate pain for longer than necessary.
103. We think the one hour and thirty-minute delay in re-evaluating the effects of the codeine meant a missed opportunity to administer paracetamol earlier than midnight. Mr O had reported taking paracetamol at 7.23pm therefore he could be safely given paracetamol again at 11.23pm. Again, we consider this meant Mr O was experiencing moderate pain for longer than necessary.
104. We have not seen the Trust has acknowledged or apologised for the impact of this issue. We have therefore made recommendations to remedy this.