Cannula care 16. Mr X says the Trust failed to record and monitor his mother’s cannulas which became infected.
17. The Trust had initially said there was one cannula however later confirmed there were two. It said that they kept monitoring daily and on the day in question (27 July 2021) there were two checks, and the infection was identified in the afternoon check. They identified failings in cannula care monitoring but not specified what those were.
18. We looked at what should have happened. According to the Infection prevention guidelines and NICE QS61 we would expect the Trust to inspect cannula sites at least once every shift and the visual infusion phlebitis (VIP) score to be documented. We also expect them to remove any cannulas if there is no reason for them to be there anymore or if they become infected. Our understanding is there would be at least two shifts each day, therefore we would expect at least two inspections per day.
19. Moreover, the GMC guidelines advise that clinical records must be clear, accurate and legible. Clinicians are expected to record the work at same time as the events or as soon as possible afterwards. There we would expect the Trust to create accurate records as soon as possible after any event.
20. We have looked at the records to see what happened.
21. Mrs Y was admitted to the Trust on 21 July 2021 and had two cannulas inserted, one on each arm. We can see on 22 July 2021; there were one inspection (one for each cannula). As we would expect a minimum of two inspections (one for each shift). On 23 July 2023 there were two inspections for each cannula. On 24 July 2021 there was only one recorded inspection for the left cannula. No recorded inspection for the right cannula was recorded at all that day. On 25 July 2021 there is no documented inspection of either cannula. On 26 July 2021 there is only one recorded inspection of the right arm cannula. This is not what we would expect from the Trust in line with the guidelines, therefore, we consider this to be a failing.
22. On 27 July 2021, we can see there are two inspections (one in the morning and the other in the afternoon shift) which would be in line with what we would expect. However, the records state a cannula infection was identified “Cannula site to right arm appears infected, cannula removed, swab taken, cannula sent to micro and doctor informed” Our nursing adviser explained, it was the cannula site to the left arm that was infected. As this is not accurate it is not in line with the GMC guidelines and therefore, we consider this to be a failing.
23. As mentioned above, two cannulas were inserted on 21 July 2021. According to the nursing advice we received, there was a need for IV fluids to be administered. However, our understanding this will require only one cannula. It is unclear why two cannulas were present, and the documentation does not clarify the need for the second cannula or its use. Based on the guidelines, we would expect the Trust to remove the second cannula as there is no clinical reason for it to be there. We note, given the records do not clarify which cannula was used for IV fluids (left or right arm), we cannot determine if the infected cannula was the one used for IV fluids or the other one. Nevertheless, we find that not removing the second cannula when it was no longer indicated to be a failing as its not in line with the guidelines.
24. We will discuss the impact of these failings in our ‘impact’ section below.
Inadequate treatment and discharge 25. Mrs Y was discharged from the Trust on 11 August 2021 and readmitted on 24 August 2021 in a lot of pain. She was eventually diagnosed with discitis which can be caused by MSSA. She says the treatment initially provided was not adequate.
26. The Trust maintain their approach to antibiotics was appropriate when initiated and was based on advice from microbiology. It also explained as the infection markers were coming down, the patient was getting better and was fit for discharge. It also explained the MRI on 10 August 2021 showed no signs of discitis.
27. We could not identify any guidelines in relation to treatment of MSSA for England. Therefore, we have relied on our physician adviser’s advice to come to our views. Our physician adviser suggested taking direction from Health Improvement Scottland guidelines which reflects standard practice across healthcare in the UK. We have drawn from the Scottish Antimicrobial Prescribing Group (SAPG) - Guidance on the management of Staphylococcus aureus bacteraemia (SAB guidelines) in adults to help us come to our views.
28. According to the SAB guidelines and the advice we received, management of MSSA has two aspects. The first is the clinical management and the second is antibiotic therapy and monitoring.
29. Regarding the clinical management, the Trust needs to assess the patient, consider the source of infection, collect microbiology samples, document the MSSA source and make a clinical plan. The source of infection needs to be removed (once identified). The guidelines also advise for a transthoracic echocardiogram (Echo - a common, non-invasive ultrasound test) of the patient and to discuss the case with an infection specialist (microbiology).
30. Regarding the antibiotic therapy and monitoring. The advice is for IV antibiotics (Flucloxacillin - penicillin antibiotic used to treat infections caused by specific bacteria, primarily those that produce beta-lactamase (like Staphylococcus aureus)) for a minimum of 14 days from bacteraemia clearance.
31. If there will be a change from IV to oral antibiotic therapy (IVOST), the guidelines advise this can be considered after two weeks of IV therapy if deep seated or complex (non-endocarditis) infection and demonstrated clinical improvement. If that happens, then the oral therapy, the treatment duration should be monitored and follow up should be agreed with and supervised by an infection specialist.
32. Therefore, we would expect the Trust to assess the patient, identify, remove and document the cause of infection, collect samples to test and make a treatment plan. To treat the patient, we would expect the Trust to prescribe IV antibiotics for a minimum of 14 days after the blood tests show the infection is gone.
33. If there is a need to change from IV to oral antibiotics, this can be done after two weeks of IV antibiotics, given there is no deep-seated infection or complex infection, and the patient has shown clinical improvement.
34. We have looked to see what happened.
35. We can see the infection was identified in the evening of 27 July 2021. We can see the Trust sought advice from microbiology who on 27 July 2021 advised to give Tazocin (a broad-spectrum antibiotic against MSSA) and review the patient for discitis as well as repeat blood tests (cultures). The infected cannula was removed and sent for testing (cultures) which diagnosed MSSA. The following day, on 28 July 2021, microbiology advised to change the antibiotic to IV Flucloxacillin (specific for MSSA) for minimum 14 days. It also advised to do an Echo as well as an MRI of the spine for any deep-seated infection.
36. Mrs Y’s first negative blood test was on 5 August 2021. On 6 August 2021, microbiology advised that if the clinical team is satisfied that the source of MSSA is the cannula and is confident there is no ongoing deep-seated source of infection that requires prolonged duration of therapy they can convert Flucloxacillin to PO Linezolid to complete the 14 days total therapy from 1 August 2021. It highlighted that MSSA is associated with significant complications hence it’s important to be confident no deep seated source of infection.
37. We can see the Trust followed the advice from microbiology and blood tests were done every 48 hours and the antibiotics were changed from Tazocin to Flucloxacillin on 30 July 2021. Echo and MRI tests were done around 10 August 2021 to see if there was any deep-seated infection.
38. The records have clear documentation on a clinical plan to manage and sought advice from microbiology on how to treat and IV antibiotic was initiated. This appears to be in line with the guidelines and the advice we received. We, therefore, do not find a failing in the way the Trust managed the clinical aspect of the infection.
39. We have looked at the antibiotic therapy aspect of the care provided. According to the guidelines advice for IV antibiotics is for a minimum of 14 days from the date of the first negative blood test. Moreover, when switching from IV to oral, this should be done after the 14 days of IV treatment, if there is no deep-seated infection and the patient is improving clinically. Our physician adviser explained these are guidelines and not strict protocol and therefore, there is some room to divert but this depends on the patient’s clinical presentation.
40. Mrs Y’s first negative blood test was on 5 August 2021. Therefore, based on the guidelines, she should be on IV antibiotics until 19 August 2021 (14 days). The records show Flucloxacillin IV was given from 30 July till 11 August 2021. This is 12 days in total and only 7 days after her first negative blood test. The Trust, switched to oral Flucloxacillin for 5 days on 11 August 2021 when she was discharged on advice from microbiology. This means, in total, she received antibiotics until 16 August 2021 instead of 19 August 2021.
41. We do note the records show she was clinically improving as her blood tests were negative, and the MRI and Echo were clear, indicating there was no deep-seated infection. However, we can see she did not complete the minimum 14 day IV treatment before switching to oral. Moreover, she only received oral treatment for five days which was three days less than what she would have had had she remained on the IV treatment.
42. We are satisfied the Trust acted on advice from microbiology when switching to oral antibiotics as the patient’s condition was improving. However, we consider not giving her enough antibiotics (IV or oral) to cover the minimum 14 days post negative test to be a failing. We will discuss the impact of the failings identified in the ‘impact’ section below.
43. Regarding the discharge, as mentioned above, the patient was clinically improving, and all her tests did not show any deep-seated infection. We also note the time of the event is of importance as this was in August 2021 during the height the Covid-19 pandemic. During that time the NHS was struggling as the majority of admissions was Covid-19 patients and the need for beds was essential. This is not to justify any potential failings but to emphasise the risk of contracting Covid-19 in hospital was very high.
44. The records also show documented discussion with the patient’s family advocating for her discharge. Therefore, considering her improving clinical condition (negative tests), the circumstances of the NHS at the time (risk of contracting Covid-19 in hospital) as well as the family’s willingness to take her home, we do not consider the discharge based on her overall clinical presentation to be a failing
Complaint handling
45. Mr X says the Trust failed to adequately carry out complaint handling with inaccurate responses. He also says local resolution took almost three years to complete and required him to keep chasing and pointing out mistakes in the Trust’s responses.
46. The Trust advised there were delays as this was a difficult period (during covid-19) which affected their ability to respond quickly. They also explained they were trying to organise a local resolution meeting in April 2023; however, this was delayed due to the death of a consultant involved. Moreover, they advised that staff changes with the complaints department affected their ability to respond in time. The Trust explained they have apologised for not having the full picture and for the number of significant inaccuracies in their responses.
47. The NHS Complaint Regulations state an expectation that complainants should be given a clear expectation around complaint response times with an outline expectation that a response be given within six months from the date a complaint was raised. This can be extended where there is clear communication about what is happening and when the complainant can then expect the response.
48. The NHS Complaints Standards advice giving fair and accountable responses. Staff should give a clear, balanced account of events based on established facts and compare what happened with what should have happened. In addition, the Complaint Standards advise staff must respond to complaints at the earliest opportunity and consistently meet expected timescales for acknowledging a complaint. They (the staff) give clear timeframes for how long it will take to investigate the issues, taking into account the complexity of the matter.
49. The Complaints Standards also advise staff should explain why things went wrong and identify suitable ways to put things right for people. Staff give meaningful and sincere apologies and explanations that openly reflect the impact on the people concerned.
50. Therefore, we would expect the Trust to respond within six months of getting the complaint or give clear timeframes on how long the investigation would take. The Trust should provide clear, balanced account of events based on established facts and compare what happened with what should have happened. It should also explain why things went wrong and identify suitable ways to put things right for people.
51. We have looked at what happened.
52. Regarding the time it took for local resolution to be completed. We can see Mr X first raised his complaint in November 2021. We appreciate this was during the Covid-19 pandemic and the NHS was under enormous pressure. The Trust first responded in June 2022. Based on NHS Complaints Regulations there should be a response within six months. We can see the first response was sent eight months after it was raised (November 2021 – June 2022). Therefore, in our view a two-month delay here which is not in line with the NHS Complaints Regulations.
53. Mr X was not satisfied as the response contained inaccuracies especially regarding cannula care. He raised several issues regarding the inaccuracies and asked for a local resolution meeting (LRM) with a consultant in July 2022. The NHS complaint regulations do set out an expectation for a meeting to discuss a complaint, albeit this is set out as part of the overall complaint handling ahead of a response. In practice, many organisations agree to meet with complainants to discuss complaints where an initial response does not completely answer things.
54. He chased the Trust about the LRM in November 2022 and was advised one would be organised on 6 December 2022. However, this was cancelled by the Trust on 2 December 2022, due to staff shortages saying they could continue with the written response or arrange the LRM around mid-January 2023. Mr X asked the Trust to arrange it at the earliest opportunity. In March 2023, the Trust offered a LRM for 23 March 2023, but Mr X was unavailable on that date, and a provisional date was set for 24 April 2023.
55. Whilst we appreciate the difficulties the Trust faced during the pandemic, this was an incredibly long time to organise a LRM. We accept this would have cause distress to Mr X.
56. The 24 April 2023 LRM had to be cancelled. Our understanding is this was because of the death of a consultant in April 2023. Whilst we accept this would cause a further delay in the complaints process, this was outside of the Trust’s control. We can see in August 2023 the Trust informed Mr X the LRM was arranged for 7 September 2023 which it took place. We have listened to the LRM recording and the Trust provided explanations and apologies for any failings identified. It explained that a summary of what was discussed during the LRM would be sent to him in a letter.
57. The letter was sent on 31 October 2023, and this was essentially the Trust’s final response as it directs Mr X to PHSO. Therefore, strictly speaking, the overall complaint handling took 24 months (November 2021 – October 2023). However, it is unclear if this was explained to Mr X as during the LRM they said to him they would send him a summary of what was discussed during the LRM and there is no mention about this being the final response. We appreciate this might be confusing to Mr X as we can see he went back in November 2023 asking for further information which was eventually provided in April 2024. However, we do not consider this period to include in the complaint handling period.
58. Whilst the Complaint Handling regulations do not specify expectations around these events, we have seen that 6 months is used as a guide and in this case matters far exceeded that. We would expect responses and LRMs to be done at the earliest opportunity or at least give clear timeframes and updates of when this would be done. The available evidence shows limited discussions about timeframes or explanations about the many delays. Moreover, we can see the complainant constantly chasing updates and challenging the factually incorrect responses for around a two-year period that it took the Trust to complete their investigation. Therefore, although there are mitigating factors, like the pressure of the pandemic and the death of a consultant, we do not consider this meet our expectations in line with the NHS Complaint Standards.
59. Regarding the inaccuracies in the responses. The expectation is to be clear and accurate based on established facts. The responses should also explain what happened and why that is a failing or not.
60. Reading the responses, especially the June 2022 response, we do not consider it provided a clear or accurate reflection of what happened. For example, we can see the Trust’s first response explained the infected cannula was in the right arm. This is incorrect, as we identified earlier in this report, the records show it was the left arm cannula which was infected. The Trust response also explained that both cannulas were regularly checked which is also inaccurate.
61. We can see the Trust undertook a post infection review (PIR) and found failings in the cannula care which is the likely source of infection. However, the PIR does not explain what those failings were. Moreover, the local resolution did not identify any failings in record keeping.
62. Whilst we appreciate the Trust apologised for the inaccuracies of their first response with their 31 October 2023 response, we do not consider an apology is sufficient given the effort Mr X had to go through to have his complaint investigated. This is because we have not seen evidence to show the Trust took into account the time it took to complete its investigation and the impact this had on Mr X.
Impact 63. We have seen a failing in monitoring the cannulas, lack of identification and removal of a second unnecessary cannula and inadequate period of antibiotic provision in this case. We have therefore turned to consider the impact of this on Mr X’s mother’s care.
64. We note Mr X says the poor cannula monitoring caused the MSSA infection, and the inadequate treatment resulted in his mother’s readmission on 24 August 2021 (13 days after her first discharge) in absolute agony. The infection was diagnosed as discitis and needed around six weeks of IV antibiotics.
65. Mr X says his mother suffered prolonged and unnecessary pain and had a poor quality of life. He says she had to rely on opioids to manage her pain and could not sit for very long. He also says whilst in hospital she developed a hunchback due to the infection and high blood pressure due to reduced mobility. Additionally, Mr X says she had to be under an infectious disease consultant for two years with a blood test done every six weeks. He says she’s been advised that to correct the damage on her spine, she would need two spinal surgeries, but she could not have it as she suffered from osteoporosis, was week and there was a 10% chance of dying during surgery. Mr X explains this caused the family great distress and lost faith in the Trust.
66. There is no dispute the infection came from the left arm cannula. However, despite the poor record keeping, and poor monitoring, we can see on 27 July 2021, there were four checks (two for each cannula morning and evening) with no signs of infection in the morning check but present in the evening one. Therefore, we are satisfied the poor monitoring had no impact on Mrs Y’s care.
67. Regarding not removing the second cannula as there is no indication of a need for both cannulas. We have considered whether this failing can be linked to the impact. In our view, having two cannulas (when one is not necessary) increased the risk of infection. Due to poor record keeping, we are unable to say if the infected cannula was the one used for IV or not. As she would have always had one cannula and that may have been the source of infection, we are unable to say that earlier removal of the other cannula would have prevented the contraction of infection. Therefore, we cannot say if the infection could have been avoided in this case. We appreciate not knowing if the MSSA infection could have been avoided would cause the family distress.
68. Regarding the treatment, we are satisfied the Trust provided the correct type of antibiotics and relevant tests. However, we find the Trust did not provide the minimum 14-day antibiotics after the first negative blood test. We can see the Trust appropriately tested (blood and MRI, Echo) Mrs Y for any deep-seated infection which would be an indication of development of discitis prior to discharge, and those tests were negative.
69. Therefore, we accept the clinical impression was that of an improving patient which was responding well to the antibiotics. Our orthopaedic adviser explained the antibiotics were given long enough to fight MSSA and there were positive signs of this in her blood tests.
70. However, in our adviser’s view even if the Trust gave the full 14-day treatment, the chances are she would still have developed discitis. This is because it is generally accepted to treat discitis antibiotics for six to eight weeks are required which she would not have been given. Instead, we considered whether there was any basis to suggest signs of discitis were missed. The records show she was improving as all her tests were negative showing no signs of MSSA or deep-seated infection (discitis). This means the Trust did all the necessary tests to reassure themselves before discharging her.
71. Therefore, on the balance of probabilities, even if the Trust provided the 14-day antibiotic treatment, Mrs Y would have still developed discitis. Accordingly, we cannot say there was a missed opportunity for a better clinical outcome. However, we accept not knowing now would cause the family distress.
72. We do appreciate Mr X has described a significant impact on his mother’s life as a result. He said his mother’s quality of life became poor and could not sit for very long. He also says she suffered prolonged pain and whilst in hospital she developed a hunchback due to the infection and high blood pressure due to reduced mobility. We also appreciate that his mother experienced kyphosis (spinal damage). We have thought about this further.
73. We have been unable to say that discitis could have been avoided and as such we cannot say that anything because of the discitis could have been avoided. According to the orthopaedic advice we received, whilst discitis can cause kyphosis, Mrs Y also had several pre-existing issues including osteoporosis, and rheumatoid arthritis. We also note the records show she had endplate fractures (fractures on the spine), as early as 2 August 2021. Moreover, the records show she had a scan (CT TAP) on 22 July 2021 which found her spine had an abnormal structure. Therefore, it is difficult to attribute the kyphosis to discitis or if it was a contributory factor to establish the degree it contributed. Furthermore, as noted, we have been unable to say the discitis itself could have been avoided. Similarly, we are unable to say her readmission to hospital with discitis could have been avoided.
74. Regarding the pain, according to our orthopaedic adviser, discitis can be a painful infection. However, having looked at the records, our adviser explained this was appropriately managed with pain relief.
75. Mr X says his mother had to be under an infectious disease consult for two years with a blood test done every six weeks. we could not identify any specific guidelines for this. Our orthopaedic adviser explained the BASS Management update for Pyogenic spinal infections (2019) advise close monitoring. This is because discitis can often stay hidden in the spine and therefore, there is a high chance of returning. As we have explained we cannot say the discitis could have been avoided and as such cannot link this impact.
76. However, in the interests of sharing information it is important to note that they need to closely monitor the patient for long periods of time to make sure any possible recurrence is identified at the earliest opportunity. We also looked at supporting material like ‘The diagnosis and management of discitis and spinal infection’ (ScienceDirect), which advise for close monitoring for up to a year. Our understanding as these are not guidelines; it is up to the clinician to decide the appropriate monitoring period. Therefore, whilst we appreciate the monitoring period was extensive, we can see this was done to ensure Mrs Y did not have a relapse.
77. Regarding the impact of the poor complaint handling. We identified delays in responding to the complaint, as well as inaccurate responses with the overall local resolution time taking over two years. Mr X raised his complaint in November 2021, and the first response was sent to him eight months later in June 2022. This was two months over the basic expectation. We also took into consideration the timing as this was during the Covid 19 pandemic which caused backlog on the entire NHS. Therefore, whilst we can see there was a delay, we accept there were valid reasons for it. We, therefore, do not consider the initial two-month delay to have caused a significant distress to Mr X at the time.
78. What caused his distress and loss of faith were the inaccuracies in the Trust’s initial response, especially regarding the main issue about the cannulas. Consequently, Mr X went back to the Trust in July 2022, challenged the findings and requested a LRM. We have seen delays in the LRM being arranged from July 2022 till April 2023. This included a last-minute cancellation in December 2022 by the Trust and rearranging the LRM for April 2024. We have seen some updates (mostly informing of cancellations or attempts to organise the LRM in March 2023). Whilst we appreciate the practical difficulties in arranging meetings with a number of clinical attendees who have clinical responsibilities, we also note this is an exceptionally long time. We would not expect the LRM to happen in July 2022 (when it was requested as organising would take time. However, we accept this 9-month delay (August 2022 – April 2023) would cause distress to Mr X.
79. Regarding the delay from April 2023 till September 2023 (5 months) we accept this was caused by reason’s outside of the Trust’s control as there was a death of a person who was supposed to be attending. Whilst we appreciate this delay would be distressing to Mr X, we cannot link this to a failing on the Trust.
80. Therefore, in our view the overall delay we can link is around 9 months from the complaint handling. The LRM was took place in September 2023, and a final response was issued a month later on 31 October 2023. We note the 31 October 2023 letter refers Mr X to PHSO, we also note from the LRM recording he was advised the letter would be a summary of what was discussed during the LRM and not that it would be their final response. We appreciate this might have been confusing to him, however, we also note Mr X was aware of PHSO from previous complaints and could have approached us at the time.
81. Overall, we have seen a delay of around 10 months in in the way the Trust handled this complaint. We can see the Trust apologised for the delay, the inaccurate response as well as the failings in cannula care. Whilst we agree an apology is appropriate, we recognise that Mr X is also looking for a financial remedy. We are persuaded, given the link between the failings identified and the impact described, Mr X be offered financial remedy in line with our Severity of Injustice (SOI) scale. We explain our thinking below.