Incorrect sepsis management in May 2019
19. Mrs P attended the ED at 7.08pm with lower abdominal pain, signs of sepsis, and a National Early Warning Score (NEWS) of five. NEWS is an observation tool used across the NHS to help clinicians detect and treat patients who are very unwell or deteriorating. A score of five indicates the patient is at medium risk. This should trigger an urgent response from the medical team. Mrs P was not formally diagnosed with sepsis until midnight.
20. The Trust’s sepsis policy says a patient with a NEWS of four or above should follow the sepsis pathway. This would trigger relevant active treatments including fluids and antibiotics to be administered. The policy says treatments must be administered within one hour. In Mrs P’s case, we can see the appropriate sepsis interventions were only administered within six hours. This is not in line with the Trust’s sepsis policy, and we have found this was a failing.
21. Mr P says the failure to correctly follow the sepsis pathway delayed Mrs P’s treatment with antibiotics. He says if she had received the antibiotics sooner, it may have improved her overall condition both during and after surgery. This has led to Mr P and his family worrying the same thing could happen to other patients and have worse consequences.
22. We obtained clinical advice from our surgical adviser to establish the clinical impact of the delay in sepsis treatment. They advised that the impact would have been minimal. This is because Mrs P had been experiencing symptoms for several days before her admission to the ED, therefore a few hours delay would not have made much difference. They also noted Mrs P had a severe infection with pus in her abdomen. Antibiotics given a few hours sooner would have been inadequate to treat her sepsis and would not have prevented her from requiring the surgery for a perforated bowel.
23. We are of the view that although there is no clinical impact for the delay in sepsis treatment, there has still been an emotional impact on Mr P and his family. It is understandable that the issue led to worry and concern for Mr P and his family. They were aware of the delays in treating Mrs P’s sepsis and naturally wondered whether this had a negative impact on her treatment.
24. Our complaints standards say when things have gone wrong, organisations should take responsibility and offer a range of ways to put things right for the individual. This can include apologising, acknowledging failings, taking remedial action such as revising procedures or training staff, or sometimes financial compensation.
25. We can see the Trust has acknowledged this failing in its response to Mr P. It has also apologised and stated that staff will be provided with regularly scheduled sepsis training. We think the Trust has already taken sufficient action to put things right for the emotional impact on Mr P. Therefore, we are not making any additional recommendations in relation to this issue.
Histology delays and delays in starting cancer treatment
26. When Mrs P attended the ED in early May 2019, staff carried out a CT scan and this showed she had a pelvic mass. The Trust took a biopsy the following day during emergency surgery to remove the mass, treat a perforated bowel, and perform a colostomy (an operation to divert one end of the colon through an opening in the stomach called a stoma).
27. Following surgery, Mrs P was unwell and diagnosed with aspiration pneumonia (an infection caused by something other than air entering the lungs), leading to a period in intensive care. We can see from Mrs P’s medical records that the biopsy results were available to the colorectal (bowel) multi-disciplinary team (MDT) meeting in early June, the same day Mrs P was discharged from hospital. She was told of her diagnosis of gastrointestinal neuroendocrine cancer in early July.
28. From then, Mrs P was referred to the oncology team (cancer specialists) for their opinion on further treatment such as chemotherapy. In July, the oncologist deemed Mrs P not fit for chemotherapy at that time. By mid-August, she was in better health and palliative chemotherapy was discussed. Mrs P started chemotherapy in late August.
29. Mr P says there were considerable delays in the reporting of the histology sample. To help us establish whether there were any failings in this area, we have obtained clinical advice from our histopathology adviser.
30. Our histopathology adviser referred to the national pathology standards. These standards say 90% of unknown suspected cancer cases are to be reported within seven calendar days and 90% of all cases are to be reported within ten calendar days.
31. These standards do not give a 100% reporting target as some cases are particularly complex and unusual. In Mrs P’s case, our histopathology adviser told us the sample was both complex and unusual. Therefore, it is not a sign of a failing that the one month time frame was reached in reporting her biopsy.
32. Although Mrs P’s biopsy was a suspected cancer case, as the relevant standards recognise that some samples will take longer than ten days to report, we have found no failings in the length of time it took the Trust to report on Mrs P’s biopsy.
33. We have investigated all potential periods of delay between Mrs P’s biopsy in early May and starting chemotherapy in late August. Following the biopsy results being discussed at the colorectal MDT meeting in early June, there was a period of four weeks before Mrs P was told of her diagnosis.
34. We asked our surgical adviser to help us establish whether this period may have contributed to the length of time it took for Mrs P to begin chemotherapy. They informed us the GMC good medical practice was relevant in Mrs P’s case.
35. The guidance (section 48) says doctors “must work in partnership with patients, sharing with them the information they will need to make decisions about their care, including: • their condition, its likely progression and the options for treatment, including associated risks and uncertainties • the progress of their care, and your role and responsibilities in the team.”
36. Our surgical adviser noted it is usually better practice to deliver bad news to patients and relatives in an environment where there is time and space available, as well as appropriate support staff such as Macmillan nurses to provide further information. This is usually better in the outpatient setting rather than a busy ward which is why Mrs P was not given her results before discharge.
37. The Trust said Mrs P’s original outpatient appointment in late June was rearranged so a specialist nurse could be present. At this stage, we consider this would reflect the good practice our surgical adviser explained. However, our surgical adviser noted the need for a specialist nurse to be present must be balanced with the distress that extra waiting can cause patients and relatives.
38. Given the serious nature of the information and prognosis, we find the four week delay in telling Mrs P her diagnosis was not reasonable. It is not clear why it took the Trust so long to schedule Mrs P’s appointment, given the impact of this information on Mrs P.
39. After learning of her diagnosis, Mrs P saw an oncologist in mid-July. They did not consider Mrs P was well enough to start chemotherapy but noted she was improving following her long recovery post-surgery.
40. To help us establish whether this was the correct decision, we sought advice from our oncology adviser. They explained that deciding when somebody is ‘fit enough’ for chemotherapy is entirely a matter of clinical judgement. They said there is risk with providing chemotherapy when people have a poor performance status (they cannot perform activities of daily living and have poor physical strength). They also said patients can get seriously ill and even die from chemotherapy if they are not fit enough.
41. Having reviewed Mrs P’s notes, our oncology adviser said the decision to delay chemotherapy in mid-July was appropriate based on the oncologist’s clinical judgement. They noted the oncologist clearly documented Mrs P’s fitness and poor performance status. They also explained that the notes from the colorectal MDT meeting in early June document that all members of the team felt Mrs P needed time after surgery to recover before starting chemotherapy given the prolonged hospitalisation, antibiotics, and intensive care admission she experienced.
42. Mr P says the delay starting Mrs P’s cancer treatment reduced her chance of survival or living for longer. He also says the poor care affected the quality of Mrs P’s life. Mr P says these issues caused significant worry and distress for the entire family.
43. We have considered all potential periods of delay between the biopsy and Mrs P starting chemotherapy in late August. We have found that although there was a delay in informing Mrs P of her diagnosis, which understandably would have caused distress, there were no failings by the Trust in the time taken to report the histology results, or begin chemotherapy.
44. We have seen evidence that the Trust has apologised to Mr P for poor communication surrounding the length of time before Mrs P had her results and started chemotherapy. Although we have found that there were no delays in either the histology reporting or chemotherapy starting, it is encouraging that the Trust has recognised this could have been better communicated to Mrs P and her family. Therefore, we are not making any additional recommendations in relation to this issue.
Delays in providing a histology sample to another hospital
45. During a consultation in mid-August 2019, Mr P requested Mrs P be referred to a large specialist neuroendocrine centre. By this point, Mrs P’s most recent CT scan had shown widespread intra-abdominal disease (cancer throughout her abdomen). We have seen evidence in Mrs P’s medical notes that this referral was made the following day.
46. The specialist neuroendocrine centre sent a sample request via email to the histology department at the Trust the day after the referral was made. The Trust say the sample was sent around 3.5 weeks later as the request had been missed. It says this was due to the request being misfiled as a result of staff holidays.
47. The Trust did not have a policy in place in 2019 for how it would deal with email requests to the pathology department. However, the Trust does now have a policy in place which would cover such scenarios.
48. To establish whether the 3.5 week delay between the request being received and the sample being sent was reasonable or not, we received advice from our histopathology adviser. They confirmed that although there is no specific national guidance on dealing with email requests from other Trusts, it is a very common occurrence and should be actioned without delay.
49. They explained there is no specific timescale for requests as it would depend on the reason for it. For example, if the request was for research purposes, then further work from the laboratory would be required to confirm consent for the tissues to be used, which would in turn delay the request.
50. However, in Mrs P’s case, the request clearly stated the sample was needed urgently for an MDT meeting. The national pathology standards say ‘timeliness in pathology ensures an appropriate level of patient care’. Our histopathology adviser said a delay of 3.5 weeks as in this case, was not reasonable and not an example of good practice.
51. We consider that as Mrs P had a terminal diagnosis, a 3.5 week delay was particularly significant given her greatly reduced life expectancy. We have found the Trust did not act in a timely manner in responding to the sample request.
52. Mr P told us that the sample cannot have been sent in early September, otherwise it would have arrived in time for the specialist neuroendocrine centre’s MDT meeting eight days later. Mrs P’s case was not discussed for another eight days. We have seen evidence from the Trust that the sample was sent to the post room in early September. The Trust cannot provide evidence of the sample actually being dispatched as the logbook was unfortunately lost during a departmental move at the end of 2019.
53. As we do not have any further evidence to analyse, we cannot make a finding on whether the sample was actually dispatched on the day the Trust says it was. We acknowledge this will continue to leave Mr P and his family with uncertainty over what happened but hope the further explanations below on the impact of the delay between mid-August and early September provides some answers.
54. Mr P says the delay responding to the histology sample request reduced Mrs P’s chance of survival or living for longer. He also says the poor care affected the quality of Mrs P’s life. Mr P says these issues caused significant worry and distress for the entire family. As the claimed impact for this issue is the same as for the next, we will consider our findings on the impact in paragraphs 61 to 69.
Misdiagnosis of tumour
55. Mrs P was originally diagnosed with a gastrointestinal neuroendocrine tumour (a type of cancer that has formed within in the gastrointestinal system). This was diagnosed from the biopsy taken during emergency surgery in early May 2019. After being referred to the specialist neuroendocrine centre and a review of the biopsy sample, Mrs P received a new diagnosis of carcinosarcoma of gynaecological origin.
56. The Trust has acknowledged that Mrs P was wrongly diagnosed in the first instance. We have focused our investigation on the impact this misdiagnosis had.
57. To help us establish the impact of the misdiagnosis and delayed histology sample, we sought further advice from our oncology adviser. When Mrs P started chemotherapy in August 2019, she received a combination of two chemotherapy drugs, carboplatin and etoposide. Following her new diagnosis, she continued this same chemotherapy regime.
Mr P was unsure whether this was the correct decision and whether this had an impact on Mrs P’s prognosis or quality of life.
58. Our oncology adviser told us the first line chemotherapy treatment for carcinosarcoma of gynaecological origin is carboplatin and paclitaxel. However, they also advised that the decision to keep Mrs P on her original chemotherapy combination of carboplatin and etoposide was appropriate. We can see Mrs P’s consultant requested further advice from specialists at a specialist cancer hospital in October 2019 as to whether keeping Mrs P on her current course of chemotherapy was appropriate.
59. Mrs P’s case was discussed at a multidisciplinary team meeting at the specialist cancer hospital and both they and Mrs P’s consultant agreed it was appropriate to continue the original chemotherapy regime, despite it not being the first line choice for Mrs P’s new diagnosis. Our oncology adviser confirmed this was because there had been improvements in the PET-CT (specialist type of scan, particularly used in cancer cases) and Mrs P had been tolerating the chemotherapy well so far.
60. We have found the Trust acted in line with GMC good medical practice section 57 when deciding to keep Mrs P on the same, original chemotherapy treatment. This says ‘the investigations or treatment you provide or arrange must be based on … your clinical judgement about the likely effectiveness of the treatment options’. We can see the clinicians considered whether to change Mrs P’s treatment, and after careful consideration of the benefits and risks, decided to continue with the current course of chemotherapy.
61. We asked our oncology adviser what the impact would have been, had Mrs P received the correct diagnosis earlier. They confirmed that if Mrs P been diagnosed correctly in the first instance, she would likely have received carboplatin and paclitaxel when she first started chemotherapy on 30 August.
62. Our oncology adviser could not say for sure what the outcome would have been for Mrs P, had she received the first-choice chemotherapy drugs for her type of cancer as early as 30 August. They said there is a possibility she may have responded better and an equal possibility that she may not have responded at all. They said that on the balance of probabilities, it is unlikely that carboplatin and paclitaxel would have prolonged Mrs P’s life or improved her quality of life in any significant way.
63. Our oncology adviser explained that the type of cancer Mrs P had was unfortunately highly aggressive. They cited a uterine carcinosarcoma clinical study which concluded that persistent/progressive disease (which Mrs P had) is usually fatal.
64. We have found that on the balance of probabilities, unfortunately it is unlikely Mrs P’s would have survived or lived for longer had she received the correct diagnosis and first choice chemotherapy drugs from August 2019.
65. Although we have found there was a delay in the Trust responding to the sample request by the specialist neuroendocrine centre, we cannot say this delay reduced Mrs P’s chance of survival or living for longer. This is because we are of the view that it is unlikely receiving the first choice chemotherapy without delay would have had any significant impact on Mrs P.
66. Mr P also says the poor care surrounding both the delay in sending the sample and the misdiagnosis affected the quality of Mrs P’s life. He says these issues caused significant worry and distress for Mrs P and her family.
67. We have found failings in the Trust’s delayed sample request and the Trust has already acknowledged failings in regards to the misdiagnosis. Although we cannot link these failings with a physical impact on Mrs P, we have found that the experience as a whole and the multiple failings had a significant emotional impact both on Mrs P and her family wondering if she would have suffered less if she had received better care. We are also of the opinion that the failings would have caused uncertainty and a lack of confidence between Mrs P’s family and the Trust.
68. We can see the Trust has given a written apology for the delayed sample request but not for the misdiagnosis. We can also see the clinician who made the original diagnosis completed a thorough reflection of their work following the event.
69. We do not consider the written apology provided is enough to put things right for the level of distress Mr P and his family experienced, in particular the lack of confidence in the Trust. We acknowledge some progress has been made by the Trust with regards to preventing other misdiagnoses in the future, however will be recommending further action as we have only seen evidence of a single clinician reflecting on the incident rather than the Trust as a whole. Our recommendations are set out in paragraphs 109 to 115.
Inappropriate discharge in late January 2020
70. Mrs P had an oncology appointment in mid-January 2020 where it was noted the recent PET-CT scan showed definite progression of her cancer. It was also noted she had increased symptoms such as abdominal bloating and a high stoma output. She was offered community palliative care at this point and also attended hospital three days later for a magnesium transfusion as a result of her high stoma output.
71. Two days later, Mrs P attended the ED to see the surgeons, on advice from her GP as she had increased stoma output and associated symptoms. She was diagnosed with gastroenteritis and a member of the surgical team discharged her home at 5am the following morning. She was then readmitted 13 hours later and sadly died two days later.
72. Mr P says that Mrs P’s discharge was inappropriate. He says she should not have gone home given she was so unwell that she was readmitted later that day and died less than 48 hours after.
73. The Trust’s complaint response says that the notes state Mrs P was keen to go home. Mr P told us this was unsurprising given it was the early hours and Mrs P was elderly, frail, and tired. He said even if she was keen to go home, it does not mean it was the right decision to discharge her. We can see from the medical notes that when discharge was discussed, Mrs P was content to go home, however we also note that her daughter raised concerns surrounding this.
74. Our surgical adviser told us Mrs P had required at least three litres of intravenous fluid (fluid given through a vein) indicating that she was dehydrated because of her high stoma output. She also had episodes of atrial fibrillation (an irregular heart rate) and had attended hospital earlier in the week requiring a magnesium infusion because of high stoma losses.
75. Our surgical adviser said Mrs P’s high stoma output was not adequately addressed by prescribing loperamide (medication for diarrhoea) and discharging her. This was because there was no monitoring to see if loperamide had the desired effect. As a consequence, Mrs P’s discharge was not safe, and she should have remained in hospital for a period of observation.
76. Our surgical adviser referred to a gastroenterology journal article which explains how to manage a high-output stoma. The ‘monitoring’ section outlines specific tests and measurements which should be taken. It says accurate daily measurements of body weight, fluid balance (especially stoma output) and blood pressure are important. It also says tests of blood creatinine, potassium, and magnesium levels and urinary sodium estimation may be done every one to three days initially.
77. Our surgical adviser also referred to GMC good medical practice. Section 15 says doctors must provide a good standard of practice and care. It says when assessing, diagnosing, and treating patients, they must adequately assess the patient’s conditions, taking account of their history, views, and values. It also says doctors must promptly provide or arrange suitable advice, investigations, or treatment where necessary.
78. In Mrs P’s case, our surgical adviser told us that the medical notes suggest the doctors who discharged her focused on her high output stoma and dehydration, and did not appreciate the bigger picture that her disease had progressed and she needed palliative care.
79. We find that the decision to discharge Mrs P in late January was not in the spirit of GMC good medical practice. This is because the Trust did not take full account of Mrs P’s history and current condition. In addition, the tests and monitoring as advised in the journal which reflects good practice could not have been done at home, and there is no evidence in Mrs P’s records to suggest these were arranged as an outpatient.
80. We have therefore found that Mrs P should not have been discharged at this time.
81. Mr P says discharging Mrs P caused significant upheaval, distress, and confusion amongst the family. He also says this led to Mrs P suffering unnecessarily.
82. Our surgical adviser confirmed that when Mrs P was discharged it was not clear from the notes if she was on an end of life care pathway or what palliative care and anticipatory medicines (care and medicine at the end of life) were available to her at home.
83. Our surgical adviser said Mrs P was not fit to go home unless she was doing so to fulfil a wish to die at home. However, the notes do not suggest a decision of this nature had been decided or even discussed. The fact Mrs P returned to hospital a few hours later adds weight to the view she had not been discharged with a plan to die at home.
84. We find Mrs P suffered unnecessarily from the significant upheaval, disruption, and travel in the last few days of her life when she could have been cared for more compassionately in hospital. We also appreciate how confusing and upsetting this must have been for both Mrs P and her family. They were aware Mrs P was acutely unwell however she was being sent home from hospital in her final days with no support in place.
85. Mr P told us how traumatised he and his sister have been following the death of Mrs P, due to the poor care she received throughout. This final instance of failures in her care brought together everything the family had experienced in the prior eight months. He told us the whole experience was a catalyst for his sister relapsing with her struggles with alcohol. He also told us how he has been unable to return to Mrs P’s home since her death, as he feels as though he let her down when he was unable to prevent these failures in care from the Trust.
86. We have found that Mrs P was inappropriately discharged from hospital and both she and her family suffered significant unnecessary distress as a result. We have found this trauma sadly affected many members of Mrs P’s family and the impact has been considerable for a lengthy period of time.
87. The Trust has not taken any action to put this right. We have set out our recommendations to the Trust in paragraphs 109 to 115.
Poor complaint handling
88. Mr P says the Trust delayed responding to his complaint and did not provide adequate communication surrounding the delays.
89. Mr P made his original complaint to the Trust in late February 2020, one month after the death of Mrs P. We can see he made it clear in his letter this was a formal complaint, which is also affirmed in an email from the Trust staff member he handed it to. In the complaint, he raised several points and asked for a full timeline review of Mrs P’s care as this had been previously promised (as acknowledged by the Trust).
90. We can also see the complaints department had a conversation with Mr P in early March where it was documented it had been agreed the Trust would investigate why he had never received the promised timeline, but Mr P would make his full complaint after requesting Mrs P’s medical records. This was confirmed via email in early March and the Trust gave a 40 day timescale for this to be investigated.
91. There is evidence in the Trust’s complaint file of communication between the complaints department and Mr P during the investigation. We can see the reasons given by the Trust for the delays in providing the report include not being able to source Mrs P’s medical notes immediately, and then the COVID-19 pandemic putting additional strain on the staff writing the timeline.
92. In March 2020 NHS England announced that NHS organisations could temporarily pause the NHS complaints process to allow healthcare providers to prioritise their response to the pandemic. This optional pause lasted until June 2020. This means we cannot criticise the Trust for not progressing Mr P’s complaint from March to June 2020.
93. The report was sent to Mr P in mid-August 2020. Although this is significantly past the 40 day target set by the Trust, we consider the reasons behind this delay were reasonable and there was a reasonable level of communication with Mr P during this time.
94. Having reviewed Mrs P’s medical records, Mr P made a further formal complaint to the Trust in mid-October 2020 outlining the entirety of his concerns. We can see evidence of the Trust agreeing in writing to update Mr P every four weeks during the investigation, but also acknowledging it is complex and may take some time. There is no evidence of a formal timescale being set and shared with Mr P.
95. Mr P received a formal written response from the Trust in mid- May 2022, having approached both us and his MP for assistance in chasing this. We are of the opinion that due to us being of the view that the original complaint delays were reasonable, the start date for Mr P’s complaint is mid-October 2020. Mr P received a formal response one year and seven months after making this complaint.
96. Mr P also complains the Trust did not provide adequate communication surrounding the delays. To come to a decision on how the Trust handled Mr P’s complaint, we have reviewed the Trust’s complaint file and all correspondence with him.
97. There is no evidence of a timescale being set and shared with Mr P after his formal complaint was raised in October 2020. The national complaint regulations say the organisation must tell the complainant how long the investigation is likely to take. We have not found any evidence the Trust did this.
98. The complaint regulations also say the investigation should be completed speedily and efficiently, and the complaint should be kept informed as far as reasonably practicable. It says if a response has not been provided within six months, the organisation must write to the complainant to explain why and send the response as soon as possible after that.
99. We can see that the original co-ordinator for Mr P’s complaint began collating information from various specialities as early as November 2020, however it was eight weeks before Mr P received an update and this seemingly was only as a result of him emailing several times, asking for information. There was then another eight weeks before the next update and as before, appears to only be as a direct result of Mr P chasing for answers. This is not in line with what the Trust agreed in writing with Mr P.
100. The Trust sent formal extension letters to Mr P in July and November 2021, apologising for the delays caused by staff sickness and the continued pressures of COVID-19. We have found this was not in line with the complaint regulations as it was nine months before the Trust sent Mr P an extension letter and the response to his complaint took a further 10 months after this.
101. This course of action does not reflect the complaint regulations as Mr P was not updated sufficiently and the investigation does not appear to have been speedy nor efficient.
102. We recognise that this was a very difficult time for the NHS and matters were clearly compounded by staff sickness. However, we have seen evidence to strongly suggest that following the long term absence of the previous co-ordinator, Mr P’s complaint was only properly picked up again and new lines of enquiry into his complaint started in September 2021, 11 months after he made the formal complaint.
103. Between September 2021 and the complaint response in May 2022, we can see that although the Trust responded to enquiries made by us and Mr P’s MP, Mr P himself was not regularly updated and the Trust did not always provide full and honest reasons for the delays.
104. Our complaint standards say organisations should respond to complaints at the earliest opportunity and give clear timeframes for how long it will take to look into the issues, taking into account the complexity of the matter. They also say organisations should agree with people how they will be kept informed and involved, and give regular updates as agreed with the parties.
105. It is evident from the complaint file that the complaint was complex, involving multiple specialities who were busy dealing with the ongoing effects of COVID-19. We also acknowledge that from the first written response in May 2021 onwards, the Trust’s complaint handling improved. However, we have found that the Trust did not act in line with our complaint standards when dealing with Mr P and did not provide regular enough communication surrounding the delays and reasons for them.
106. Mr P says the complaint handling has caused significant distress for Mrs P’s family and prolonged their grief. Mr P does not feel like he can fully process things before the complaint has concluded satisfactorily, and improvements have been made and evidenced for the benefit of future patients. He says he has committed a disproportionate amount of time and energy into trying to make things right for both their family and others, fighting for answers from the Trust.
107. We have found that the failings in the complaint handling process by the Trust has resulted in prolonged emotional distress for Mr P and his wider family. They have waited a long time for answers to their concerns about Mrs P’s care. Mr P has evidenced to us the time and effort he has put into the complaints process through the very detailed timeline of Mrs P’s care following review of all her medical records and the numerous pieces of correspondence he has had with the Trust, his MP and us. This time and effort required has understandably had an impact on his own wider family.
108. We recognise the Trust has apologised in writing for the poor complaint handling however we do not consider this is enough to put things right for Mr P so we have made recommendations as documented in paragraphs 109 to 115.