Care and treatment
• Mrs O was prescribed ibuprofen despite a history of asthma and hypertension, Mr A is concerned that the dosage and duration of administration was inappropriate.
29. Mr A explains that Mrs O was diagnosed with an Acute Kidney Injury (AKI) on 24 January 2020. He tells us it was determined that the use of ibuprofen as an analgesic contributed to (or caused) her renal failure. Mr A questions if it was appropriate to prescribe ibuprofen to Mrs O given her medical history of asthma, hypertension, and at a risk of sepsis. He also questions if the dosage prescribed, and the duration of administration was appropriate. Mr A considers the AKI had a significant impact on the deterioration of Mrs O’s health and contributed to her death.
30. We do not have a complaints response from the Trust to detail its responses to Mr A’s concerns. However, the Trust has provided us with three statements from clinician’s involved in Mrs O’s care. We have used these statements, alongside the records and Mr A’s account, to help us understand what happened.
31. The Trust explains that Mrs O was started on ibuprofen in the evening of 14 January as she had a fever. She continued to take ibuprofen until 24 January. Blood results from the 24 January showed abnormal kidney function, which had deteriorated from the last blood results on 20 January which were normal. The opinion of the renal physicians was sought, and they explained that this was likely due to a combination of sepsis and a side effect of ibuprofen. For this reason, ibuprofen was stopped on 24 January. The Trust has acknowledged that ibuprofen is well-known to cause renal failure in some cases, particularly when there are other risk factors present.
32. When considering this aspect of the complaint, we sought advice from our renal adviser.
33. The British National Formulary (BNF) and the Summary of Product Characteristics (SmPC) for ibuprofen tell us that the appropriate dosage for pain relief for an adult is 300-400mg three to four times daily. It explains that where symptoms worsen or persist for more than 10 days, the patient should be referred to a doctor.
34. We understand that in Mrs O’s case, both the dosage of ibuprofen (400mg three times a day) and the duration of administration (10 days) were appropriate, based on her medical history and comorbidities. Mrs O had high blood pressure, liver dysfunction, asthma, and a blood clotting disorder. The BNF advises the use of ibuprofen ‘with caution’ in patients who have these comorbidities (it is important to note that her comorbidities are not identified as contraindications to ibuprofen use, either in the BNF or the SmPC).
35. The records show that Mrs O was monitored on a day-to-day basis, with regular checks of her blood pressure and of her liver and kidney function via blood tests. We consider this is in line with the guidance in the BNF, as it demonstrates a cautious approach to the continued use of ibuprofen.
36. Mrs O’s symptoms persisted, and her blood results showed a deterioration in kidney function between 20th and 24th January. The doctors caring for her referred her to the renal physicians who reviewed her promptly and changed her treatment plan (including discontinuation of ibuprofen) accordingly. This action was in line with the guidance in the BNF (explained above), and in line with the GMC’s Good Medical Practice guidance, which explains that doctors should refer patients on to other practitioner’s where this serves the patient’s needs.
37. Although ibuprofen may have contributed to the AKI, Mrs O was seriously unwell and there could have been other contributing causes. The kidney biopsy taken on 30th January showed epithelial injury, which is a non-specific feature of acute kidney damage that is often caused by co-existent severe illness such as sepsis and/or by drug toxicity which may occur with use of medicines such as ibuprofen.
38. It is possible that an unfortunate side effect of ibuprofen, which was prescribed, administered, and subsequently discontinued appropriately for relief of pain and fever, contributed to the AKI diagnosed on 24 January 2020, and Mrs O’s subsequent deterioration.
39. However, it is important to acknowledge that this was not because of a service failure. The prescription, administration, and monitoring of the use of ibuprofen was carried out in line with the relevant guidelines, and Mrs O was appropriately referred onto the renal team when her condition had deteriorated. For this reason, we have not identified a service failure.
• There were delays in the results of a histology report being delivered which were considered critical to Mrs O’s treatment plan. The report took 20 days to deliver and in this time Mrs O’s health had deteriorated, which changed the treatment plan.
40. Mr A says the family understood the operation was always a part of Mrs O’s treatment plan. However, they also understood the surgeon was waiting for the results of a histology report (from a lung biopsy taken on 21 January) before operating.
41. The family consider the histology report was critical to the further management of Mrs O’s condition. This report took 20 days to be delivered from pathology (report provided on 10 February). The family are concerned about why this report took so long to produce, and whether this would have altered Mrs O’s treatment plan if it had arrived sooner.
42. As explained above, we do not have a complaints response from the Trust to detail its responses to Mr A’s concerns. However, the Trust has provided us with three statements from clinician’s involved in Mrs O’s care.
43. The Trust explains that upon admission on 12 January, it was thought that the causes of the fluid around her right lung were infection or malignancy. A CT scan confirmed the pleural effusion, and a plan was made to sample this fluid for further diagnosis. A sample of the fluid was taken on 15 January which revealed it was an empyema (an infected fluid collection in the chest), which was highly likely to require surgical drainage.
44. The Trust says that on 21 January, Ms O had thoracoscopic drainage of the empyema and a pleural biopsy. 600ml of fluid was drained and sent for laboratory testing. The Trust says that one of the locum consultants in thoracic surgery emailed one of the consultant pathologists to request that the histology report was expedited, as it was felt the report was crucial for the further management of Mrs O’s condition if it showed evidence of malignancy.
45. Mrs O appeared to be making a recovery at this point of her admission. Her chest drain remained in place due to an ongoing air leak, and she continued to receive antibiotic treatment until 3 February when this was stopped upon the advice of the microbiology team. Antibiotics were recommenced on 8 February as Mrs O developed a fever.
46. The results from the pleural biopsy were reported on 10 February, which was 19 days after it had been sent to the laboratory. A further supplementary report was made available on 14 February. The Trust explains that these results were strongly suggestive of infection, but no specific organism was identified. The pleural biopsy also supported the diagnosis of empyema secondary to infection, and there was no evidence of malignancy.
47. The Royal College of Pathologists (RCPath) Key performance indicators guidance says it is expected that 80% of cases are reported within seven calendar days, and 90% within ten calendar days.
48. There was a clear delay in the reporting of the sample results, and in the circumstances of Mrs O’s case, we consider this does amount to a service failure, given the severity of her illness and the potential these results had to change or effect the further clinical management. We can see that there was a request for the results to be expedited, but this does not appear to have been actioned.
49. After discussing this with our consultant cardiothoracic surgeon adviser, we understand that the delay did not have an impact on Mrs O’s treatment plan and therefore did not contribute to her subsequent deterioration. This is because Mrs O had been diagnosed with an empyema prior to receiving the report, and this diagnosis remained the same throughout her admission.
50. Mrs O was receiving treatment for this infection, and her treatment plan was focused on this. We can see from reviewing the records and the subsequent treatment Mrs O received, that the sample results did not change the diagnosis or treatment she received as it continued to be managed in the same way.
51. We also consider that the delay in receiving the report did not delay the decision to operate. This is because the decision to operate was made based on Mrs O’s deterioration on 10 and 11 February 2019, rather than the sample results, as the surgeon aimed to attempt to control the worsening sepsis.
52. Although this did not have an impact on Mrs O’s diagnosis or treatment plan, we recognise that the delay in receiving the results may have caused some concern and distress for the family. We cannot see that this has been acknowledged or remedied by the Trust in any of the correspondence with the family. For this reason, we have made a recommendation to the Trust to put matters right for Mr A.
• Mrs O’s course of antibiotics was stopped on 3 February 2020, and this coincided with a significant decline in her health. He says the reasons for stopping the antibiotics are not clear to the family.
• Mrs O suffered from a Streptococcal bacterial infection and an Acute Kidney Injury (AKI) for five days with no treatment.
53. Mr A tells us that on 3 February 2020, Mrs O’s course of antibiotics was stopped, and this coincided with a significant decline in her health. He says the reasons for stopping the antibiotics were not clear to the family. They understand this was on the advice of microbiology, but this was never explained to them. Further to this, Mr A is concerned that there was no treatment provided to Mrs O following the antibiotics being stopped, other than paracetamol and a chest drain flutter bag.
54. Mr A says on 8 February Mrs O was diagnosed with Streptococcus based on a fluid sample which had been sent to the lab on 30 January 2020. The family understand that antibiotics were started again because of this diagnosis. The family are concerned that Mrs O suffered from a Streptococcal bacterial infection, as well as an AKI, for five days with no treatment. They believe that before this period the antibiotics were keeping the infection/risk of sepsis under control.
55. Mrs O was started on antibiotics upon her admission on 12 January to treat her infection. On 21 January when Mrs O underwent a thoracoscopic drainage of the empyema, her treatment plan was for IV antibiotics to be continued for at least two weeks. The Trust explains that Mrs O made a good initial recovery from her operation, and she continued to receive antibiotic treatment.
56. The Trust explains that on 3 February, Mrs O was reviewed with the microbiologists and a decision was made to stop her antibiotics as all cultures were negative 13 days post procedure. A repeat CT scan was planned to assess any further collection within the chest, and when performed on 4 February, showed a moderate sized pneumothorax (collapsed lung). Her chest drain was left in place to treat this.
57. The Trust tells us that there were no major changes in Mrs O’s condition that week, however her temperature did spike on 6, 8, and 9 February. It explains that molecular testing from the right pleural fluid became available on 8 February which had been sent to the laboratory on 30 January. This had detected a bacterium, namely a Streptococcus infection. The Trust says antibiotics were restarted on 8 February as Mrs O had developed a fever, and a plan was made for further surgery in the next few days considering this change in her presentation.
58. In the interim period Mrs O continued to receive regular reviews from the renal team, and the nursing team took care of observations, monitoring, fluids, and pain relief. As well as the chest drain remaining in situ.
59. The daily nursing notes from this period suggest that Mrs O was stable, was not experiencing pain, and was able to communicate her needs. It is recorded that she remained alert and oriented and appeared well and comfortable. The antibiotics appear to have been restarted in response to the results from the right pleural fluid, which indicated a further infection.
60. The nursing notes from 8 and 9 February record similar observations, with notes being made that Mrs O looked well and was communicating well, although it is noted her National Early Warning Score (NEWS) had increased from one to four. Mrs O’s NEWS reduced to two in the early hours of 10 February, and it is noted that she was able to communicate but looked confused. The NEWS is a guide used by clinicians to determine the degree of illness of a patient.
61. However, we can see that within the course of the day on 10 February Mrs O’s clinical presentation had deteriorated and she was suffering from worsening sepsis. The GMC’s Good Medical Practice guidance explains that doctors must provide a good standard of practice and care. When treating patients, they should promptly provide or arrange suitable advice, investigations, or treatment. They should also refer a patient to another practitioner when this serves the patient’s needs. Further to this, when providing clinical care, doctors must provide effective treatments based on the best available evidence, consult colleagues where appropriate, and work collaboratively with colleagues.
62. After discussing this part of the complaint with our consultant cardiothoracic surgeon adviser, we understand that the clinicians treating Mrs O approached the decision making in this case in line with the GMC’s Good Medical Practice guidance. They sought advice from the microbiology team, and the recommendations were based on the evidence from Mrs O’s negative cultures. There are no indications that Mrs O was severely septic at that time, and a reasonable period had passed since her operation. It was thought that Mrs O was recovering well, and as such it was reasonable, and in line with the GMC’s guidance on working collaboratively, to make this decision informed by the microbiology advice.
63. We also acknowledge that Mrs O’s infection was severe and was deep seated within her chest cavity, despite antibiotic treatment. Because of this, we are unable to say if continuing to receive antibiotics within this four-day period would have prevented Mrs O’s deterioration due to the severity of her infection. However, as we have detailed above, Mrs O was reviewed and monitored regularly, and the clinicians responded to her deterioration in a timely and appropriate manner in line with the GMC’s Good Medical Practice. The decision was made based on all culture results being negative 13 days post procedure, this suggests there was no clinical reason for her to be on antibiotics at that time. For these reasons, we have not identified a service failure relating to this part of the complaint.
• Mrs O’s surgery went ahead, despite tests beforehand indicating her blood clotting function was deemed abnormal, and no action was taken to delay the operation or improve blood clotting function. Mr A questions whether the choice to proceed with surgery was appropriate given the risk factors involved.
64. Mr A says that during the final operation, Mrs O bled significantly into her chest cavity and lost a lot of blood because her clotting system was not functioning normally. The family are concerned that it was known Mrs O’s blood was not clotting normally before the operation took place, and that the operation went ahead despite these risks. Mr A tells us they cannot understand why the operation to help control the source of Mrs O’s infection became a ‘salvage operation’ and was not performed sooner when she was in better health.
65. The Trust explains that Mrs O deteriorated on 10 February and required admission to the ICU for further support. She continued to be unwell into the morning of 11 February and required support for her blood pressure and worsening kidney function. Mrs O was reviewed by one of the thoracic surgeons who decided to take Mrs O to theatre for urgent surgery to try and control the source of the infection.
66. We can see from the daily notes in the medical records that Mrs O had deteriorated rapidly and significantly by the time the decision was made to proceed with surgery. Her care had been escalated to the ICU, and she required drugs to support her blood pressure. Her kidney function was also worsening.
67. We have discussed this aspect of the complaint with our consultant cardiothoracic surgeon adviser, and we understand it is likely Mrs O’s worsening kidney function and abnormal blood clotting was being driven by the continuing infection in her chest. For this reason, it would have been crucial to clean the infection out through surgery, to give Mrs O the best possible chance of recovery. For this reason, although it was known that the surgery was high risk due to Mrs O’s presentation, it was also felt to be necessary.
68. The medical records leading up to this operation confirm that this was a salvage operation, and this was communicated to the family at the time of events. Our adviser has explained that it is likely if Mrs O had not had surgery, the outcome of this case would have been the same due to the sad circumstances of her deterioration.
69. It appears that the level of risk involved had been considered by the clinicians involved in Mrs O’s care and discussed with Mrs O’s family. This is in line with the GMC’s Good Medical Practice guidance, which explains that clinicians should promptly provide or arrange treatment where necessary, take all possible steps to alleviate pain and distress whether a cure may be possible, and be considerate to those close to the patient by being sensitive and responsive in giving them information and support. For these reasons, we have not identified a service failure relating to this part of the complaint.
Complaint handling
70. Mr A complains about the way his complaint has been handled. He says the Trust will not investigate the concerns he has raised due to its involvement in the Coronial process.
71. There is an entry in the medical records from 5 March 2020. This tells us that a meeting took place between Mrs O’s family and members of the cardiothoracic team. The notes explain that during the meeting they talked through the events that took place and went through the questions that Mr A had. It is noted that the family was happy with the discussion and its outcome. The conclusions of the meeting suggest that a further meeting was to be arranged once the family had received the post-mortem results, and that PALS were to liaise with pathology regarding the timing of the histology results. There are no indications that a further meeting took place.
72. The post-mortem report is dated 9 April 2020 (completed 27 February 2020), and an inquest was opened on 21 April 2020 with the hearing for the inquest being held on 29 October 2020. Mr A wrote to the Trust on 20 November 2020 asking further questions about Mrs O’s care and treatment which stemmed from the information they had been given at the inquest. The family asked that an independent clinician reviewed Mrs O’s care and provided the answers to their questions.
73. The Trust responded to this letter on 23 December 2020 explaining that in its view, the questions they were asking had been raised and responded to as part of the coronial process. For this reason, it felt it had no further information to provide beyond the answers given during this process.
74. The Local Authority Social Services and National Health Service Complaints (England) Regulations 2009 explains that there is a duty upon the NHS to handle complaints about the exercise of its functions. It states that a responsible body to which a complaint is made must investigate the complaint in a manner appropriate and this also requires a complaint to be responded to in writing.
75. We have reviewed the Regulations and NHS England’s complaints policy and we cannot see that there is any direction that a complaints investigation cannot take place following an inquest.
76. We contacted the Trust to explore the reasons for not carrying out an investigation. We understand the Trust’s position is that the questions posed were raised and responded to as part of the inquest, and as the Trust cooperated fully with this request it feels it has no further information to add. However, the purpose of a complaints investigation and an inquest is significantly different.
77. An inquest is an investigation into a death which appears to be due to unknown causes. It is designed to find out how the death occurred. The coroner’s officer carries out this investigation and this is how the medical cause of death is determined. We understand that the family may have been able to ask questions at the inquest, however we also note that this would have been limited to those relevant to the inquest and its scope.
78. A complaints investigation would have addressed the family’s concerns about the care provided, rather than ascertaining the cause of death. We can see that the family had further questions based on the information provided at the inquest.
79. Providing a formal complaint response would have allowed the Trust to reflect on its actions and if appropriate, provide a proportionate remedy and use the complaint to inform service improvements based on what happened in this case. This would have been in line with the Ombudsman’s Principles of Good Complaint Handling, as well as the NHS Regulations. However, this was not done.
80. We also think it is pertinent to consider that had the Trust responded to Mr A’s complaint it may have resolved his concerns at the local resolution stage and this could have reduced the effort Mr A has had to make in pursuing his complaint and submitting it to the Ombudsman.
81. The Trust advised us previously that witness statements were sent to the coroner for the inquest, but they were more of an overview of the care. We have had sight of these statements and consider that they are an overview of the care provided, rather than a direct response to the questions raised. The statements themselves have been written for the inquest, and whilst informative, are medical in their nature.
82. We consider that providing a complaints response would have given the Trust an opportunity to put this information into a more reader friendly format and would have allowed them to explain what had happened in plain language. This may have further helped the family to understand the answers to their questions and would have allowed the Trust to expand on the information provided.
83. Furthermore, the Trust explained there was no written documentation in response to the questions posed by Mr A. This makes it difficult from our perspective to determine if it has responded to Mr A’s questions in line with the Ombudsman’s Principles of Good Complaint Handling. We do not have the evidence to support the view that it did so, and in the absence of this evidence, and considering Mr A’s approach to our Office, it is our view that the Trust has not adequately responded to the complaint.
84. It is also of note that within the Trust, there had been no independent review of the care provided, as the witnesses who provided statements to the coroner were involved in Mrs O’s care. It is a requirement outlined in the complaints handling regulations and guidance referenced above, as well as our Principles of Good Complaint Handling, that a member of staff who was not involved in the events leading to the complaint should review the case.
85. In conclusion, we do not consider the Trust has adopted a customer focused approach to responding to Mr A’s concerns. Whilst the information provided to the family has explained what happened, the Trust has not explained or explored why such decisions were made or actions were taken. These were the outstanding queries the family had, and we do not have the evidence to support the view that these questions were answered. For this reason, we do not consider the Trust acted fairly and proportionately when handling this case and we have identified a service failure in the complaint handling.
86. Understandably, Mr A tells us that Mrs O’s death was unexpected and a shock to the family. Mr A also tells us that the Trust’s lack of response to his complaint has exacerbated the distress faced by the family at an already difficult time.
87. We consider the way the Trust has handled Mr A’s concerns is likely to have compounded the distress faced by the family at what was an already challenging time. The family had unanswered questions and concerns about Mrs O’s care and treatment, which the Trust does not appear to have responded to. This meant Mr A had no option but to approach the Ombudsman to escalate the concerns he had. The emotional toll of making a complaint in these circumstances should not be underestimated.
88. The notes from the first meeting with the family also suggest that the Trust was initially open to having a second meeting, and this approach was fair, open, and accountable. However, when Mr A raised further concerns, the Trust advised it would not reply any further, and it is likely this caused further concern and frustration as it did not do what it said it was going to do. For this reason, we have made a recommendation to the Trust to put matters right for Mr A.