Staff should not have prescribed spironolactone to Ms O during her hospital admissions in May and June 2018
18. Mrs A questions whether it was appropriate for the Trust to prescribe spironolactone to Ms O, given she ended up with acute kidney injury (AKI). We note the Trust has already accepted failings, in relation to the dosage and monitoring of spironolactone, which we are not considering as part of our investigation.
19. The Trust completed a Root Cause Analysis (RCA) which identified Ms O’s admission notes incorrectly stated she was on spironolactone, 100mg daily. Spironolactone was not on her repeat prescription from her GP.
20. However, the Trust explained spironolactone is an accepted treatment for patients with ascites (when too much fluid builds up in your abdomen), in cirrhosis of the liver (scarring of the liver caused by long term liver damage).
21. We got clinical advice to help us decide whether it was appropriate for the Trust to prescribe spironolactone to Ms O.
22. Our gastroenterology adviser said spironolactone is an appropriate drug to prescribe for patients like Ms O with decompensated liver disease (when cirrhosis has progressed to the point it affects the liver functioning) with ascites. It is recommended by the British Society of Gastroenterology which states, ‘Spironolactone is the drug of choice in the initial treatment of ascites due to cirrhosis.’
23. As prescribing spironolactone was in line with the British Society of Gastroenterology guidance, we consider it was appropriate for the Trust to prescribe it to Ms O for her liver disease. Therefore, we do not uphold this part of the complaint. We hope this provides some reassurance to Mrs A.
The Trust has not acknowledged the full impact spironolactone had on Ms O
24. Mrs A believes spironolactone caused Ms O’s AKI, and therefore could have contributed to her rapid decline and death.
25. The Trust’s RCA found it increased the dose of spironolactone more quickly than recommended, and this may have contributed to the development of AKI and hepatorenal syndrome (a form of impaired kidney function). It concluded this did not affect the outcome, as the main cause of Ms O’s death was the existing liver disease. The RCA also found there was inadequate monitoring of Ms O’s blood, but this did not change the outcome. It said this was because Ms O was very unwell before the first admission and was expected to have a short life expectancy due to the decompensated liver disease.
26. We got clinical advice to help us understand the impact of the failings regarding the dosage and monitoring of spironolactone.
27. Our gastroenterology adviser explained Ms O had severe alcoholic liver disease. The Model for End Stage Liver Disease (MELD) score is used to predict the risk of death for patients with severe liver disease. At the point of Ms O’s admission on 5 June 2018, her MELD score was 35, which is associated with a 52% risk of death within three months.
28. Our gastroenterology adviser explained it is more likely than not the high dose of spironolactone contributed to a deterioration in Ms O’s kidney function, which led to her admission on 5 June. However, the high dose of spironolactone was stopped at the point of admission, and there is evidence in the medical records that Ms O’s condition began to improve as her liver and kidney function improved. It seems Ms O’s condition began to deteriorate again, along with a deterioration in kidney function. This was around 18 and 19 June, following some rectal bleeding. Our gastroenterology adviser said this second deterioration was not linked to spironolactone and was more likely linked to the blood loss.
29. Our gastroenterology adviser explained Ms O was treated with blood products to replace the lost blood, and intravenous fluids to boost her kidney function. She did not respond to the blood products and intravenous fluids, which built up in her system due to the poor kidney function. It was the build-up of these fluids which caused Ms O to become breathless and led to her sudden deterioration on 21 and 22 June.
30. Having considered the evidence, including the clinical advice, we consider it is likely the high dose of spironolactone did initially contribute to a deterioration in Ms O’s kidney function. However, Ms O improved after spironolactone was stopped, so we do not consider this contributed to her death. It is likely the main reason for her death was the underlying severity of her liver disease, which meant she was unable to recover from an episode of rectal bleeding.
31. We consider the Trust has already acknowledged the full impact spironolactone had on Ms O. This is in line with the Ombudsman’s Principles of Good Complaint Handling, which say good complaint handling means, ‘Taking account of any injustice or hardship that results from…the original dispute.’ Therefore, we do not uphold this part of the complaint. While it must be difficult for Mrs A to know the failings had any impact on Ms O, we hope she is reassured there was not a more serious impact.
The Trust has not taken enough action in relation to the failings identified with the dosage and monitoring of spironolactone
32. Mrs A is not satisfied with the action the Trust has taken, in relation to the failings with the dosage and monitoring of spironolactone.
33. Based on the evidence available, the Trust completed a detailed review of the dosage and monitoring of spironolactone, in Ms O’s case. Following the RCA, the Trust completed an action plan setting out its intention to complete the following actions:
· share the RCA at the Acute Medical Unit (AMU) governance meeting, gastroenterology governance meeting, and pharmacy and diagnostics meeting · to investigate if a learning package can be developed for doctors on the gastroenterology ward regarding the use of medications in liver disease · to investigate the possibility of presenting an education session on AKI and those ‘at risk’ medicines to the nursing staff on the ward · to investigate the possibility of ensuring all pharmacists are confident in making entries into medical notes, and how best to make the entries.
34. The Trust has confirmed the actions were completed, and provided an action report which summarises the following steps have been taken:
· the RCA has been discussed at a pharmacy meeting, including the need to document interventions · the RCA has been shared with medics on AMU · learning was scheduled to be provided by the pharmacy department to clinicians on the gastroenterology ward · a presentation was given to senior doctors at a directorate meeting · the pharmacy department completed an education session for nursing staff · a commitment was made to provide relevant training for each new intake of doctors on the gastroenterology ward.
35. We consider the Trust has taken enough action to prevent a similar incident happening again in the future. The Trust has acted in line with the Ombudsman’s Principles for Remedy, which explains good practice means, ‘Using the lessons learned from complaints to ensure that maladministration or poor service is not repeated.’ We have not identified anything further the Trust should do, so we do not uphold this part of the complaint. Despite this, we acknowledge nothing can be done to change the experience Ms O had.
Staff transferred Ms O to a side ward on 22 June 2018, after she asked not to be moved, and they asked the family to leave the ward even though she was dying
36. Mrs A complains on 22 June, Ms O was transferred to a side ward after she asked not to be moved, and staff asked the family to leave during the transfer.
37. Mrs A says family members were sat around Ms O’s bed when a nurse attended and said they were going to move her into the side ward to give her some privacy. The nurse asked if the family could move out of the way for a few minutes, so they left the ward. Mrs A says Ms O’s son returned to collect something and heard his mother tell the nurse she did not want to move.
38. We got clinical advice to help us decide whether it was appropriate to transfer Ms O to a side ward.
39. Our nurse adviser said there are circumstances when it is appropriate to move a patient to a side ward for privacy and dignity reasons. This includes patients receiving end of life care. Our nurse adviser said the timing of a decision to move a patient at the end of their life must be appropriate, to prevent distress to the patient or family.
40. Our nurse adviser considered the decision to move Ms O to a side ward was taken quite late in the day from when she was first identified as being critically unwell. They also noted Ms O was assessed as being breathless, very anxious, and distressed.
41. The medical records indicate Ms O was unwell and deteriorating early in the morning of 22 June. Throughout the day she was being reviewed, and a consultant spoke with Mrs A about her deteriorating condition that afternoon.
42. A nurse made a retrospective entry in the medical records at 3.45pm noting Ms O had been moved to the side ward. A doctor then made a retrospective entry at 4.58pm. The doctor noted, at around 3pm, they were asked by a nurse to see Ms O as she was taking her last breaths. The doctor also noted she had been taken to a side ward before this, due to her deterioration. The evidence in the medical records suggests Ms O was taken to a side ward before 3pm, but the time of the transfer is not documented.
43. Our nurse adviser said nursing staff should get consent before transferring a patient to a side ward. This should involve clearly explaining why a side ward is being offered. If the patient does not wish to be moved, this should be respected.
44. Mrs A’s account is that the nurse explained they were moving Ms O to give her some privacy. However, there is no documented evidence in the medical records of a discussion with Ms O, or her family, to confirm she had agreed to the transfer.
45. Mrs A also shared Ms O’s son’s account that he heard his mother say to the nurse, ‘No, no, don’t move me, I don’t want to move’, or words to that effect. In response to the complaint, the Trust said staff were not aware of Ms O’s request not to be moved. This means there is conflicting evidence about whether staff knew Ms O did not want to move. It is unfortunate we are unable to make a finding on this point as there is no independent evidence to help us reach a robust view on whether staff knew she did not want to move.
46. There are no specific guidelines on when it is appropriate to transfer a patient to a side ward. However, the NMC guidance says:
‘2.6 recognise when people are anxious or in distress and respond compassionately and politely’ ‘3.2. recognise and respond compassionately to the needs of those who are in the last few days and hours of life’ ‘4.2 make sure that you get properly informed consent and document it before carrying out any action.’
47. After considering the clinical advice and the NMC guidance, it was not appropriate to transfer Ms O to a side ward. This happened too late following her deterioration, she was anxious and distressed, and she did not consent to the transfer. We consider this was a failing.
48. We also got clinical advice to help us decide whether it was appropriate to ask the family to move while Ms O was being transferred.
49. Mrs A’s account is that the nurse asked if the family could move out of the way for a few minutes while they transferred Ms O to the side ward. The family decided to leave the ward.
50. Our nurse adviser explained there were different options the nurse could have considered. For instance, the nurse could have directed the family to the side ward so they could wait for Ms O to arrive. As Ms O was anxious, the nurse could have allowed a family member to walk alongside her during the transfer. Alternatively, the nurse could have asked the family to wait in the family room on the ward.
51. After considering the clinical advice, our view is that the nurse could have handled the situation better to minimise any distress to Ms O and her family. We do not consider the nurse’s actions were so far below the standard that they were a failing. Despite this, we acknowledge any shortcoming in communication must have been upsetting for Mrs A.
52. We considered the impact of the Trust transferring Ms O to the side ward. Mrs A believes Ms O’s wishes at the end of her life were not respected. She says the family arrived in the side ward after around five to seven minutes and found Ms O had died and was alone.
53. The entry in the medical records, completed by a doctor at 4.58pm, says at around 3pm a nurse asked doctors to see Ms O as she was taking her last breaths. She had been taken to a side ward before this due to her deterioration. On attendance, the family were present and were concerned Ms O had stopped breathing. On approaching Ms O, no signs of life were found.
54. We have also seen a statement from the nurse on duty at the time. The nurse says they were called into the side ward twice after Ms O was transferred. They said during their second visit the family alerted them to the oxygen being disconnected and they immediately reconnected it. The nurse says when Ms O was taking her last breaths, they went to the doctor’s office and asked a doctor to see her. They said, ‘The patient died with myself and the family present.’
55. Mrs A strongly believes the nurse is incorrect when they state they were present with the family when Ms O was taking her last breaths. Mrs A recalls, when she and her daughter arrived in the side ward, Ms O had blue lips and her chest was not moving. They believed she had died, so Mrs A’s daughter asked a nurse to call a doctor.
56. Based on all the evidence available, we agree Ms O’s wishes were not respected as the nurse did not get her consent before transferring her to the side ward. The transfer meant the time Mrs A spent by Ms O’s side during the end of her life was disrupted. We also acknowledge Mrs A found this distressing.
57. Our role is to come to an independent view based on all the evidence available. It is unfortunate there is not enough evidence for us to say whether Ms O died on her own before the family arrived in the side ward. Mrs A and the nurse have very different recollections of what happened, and we are unable to resolve this. The only relevant entry in the medical records refers to a nurse telling a doctor that Ms O was taking her last breaths, after she was transferred. However, there is no direct entry from the nurse to support this and when doctors attended, Ms O had died. We acknowledge Mrs A is left with the thought that Ms O died on her own and this must be very upsetting.
58. We considered whether we need to make any recommendations to the Trust. Before the complaint was made to the Ombudsman, the Trust acknowledged Ms O’s wishes should have been listened to and respected. However, the Trust did not acknowledge the reasons it was inappropriate to transfer Ms O, or the full impact of this. This is not in line with the Ombudsman’s Principles of Good Complaint Handling, which say good complaint handling means ‘Acknowledging mistakes’ and ‘Taking account of any injustice or hardship that results from…the original dispute.’ We are making recommendations to the Trust to acknowledge what went wrong and the impact this had and take action to prevent this happening again.
59. We partly uphold the complaint that Ms O was transferred to the side ward, as we consider there was a failing, but we cannot say this led to Ms O dying alone. We do not uphold the complaint that staff asked the family to leave the ward, although we acknowledge this could have been handled better.
When the family returned on 22 June 2018, after Ms O had been transferred, her oxygen was not connected
60. Mrs A complains when they went to the side ward, she and her daughter realised Ms O’s oxygen mask was not on her face or plugged into the wall.
61. We considered the evidence available and got clinical advice to help us decide whether anything went wrong here.
62. We have seen a statement from the nurse on duty who says they saw two health care assistants transferring Ms O to a side ward. The nurse says they went to the side ward to check on Ms O and her family and ‘…the oxygen was on and so it had been put back on following transfer.’ The nurse also says, ‘On my next visit the oxygen was disconnected at the tube near the mask and the relatives first alerted me to this…I immediately reconnected it.’
63. In response to the complaint, the Trust said the health care assistant who transferred Ms O recalls using a portable oxygen cylinder and reconnecting to the wall oxygen. We have not seen a statement from the health care assistant to support this.
64. There is nothing documented in the medical records to indicate what happened with Ms O’s oxygen when she was transferred. This is not in line with the NMC Guidance, which says, ‘10 Keep clear and accurate records relevant to your practice.’ We consider there was a failing with record keeping, as staff should have documented what they say happened in relation to the oxygen therapy.
65. After considering all the evidence available, it is more likely than not the oxygen was disconnected at some point, as Mrs A and the nurse recall this. However, they have different recollections of when and where the oxygen was disconnected. Given the different recollections, and the lack of any other evidence, we are unable to say whether the oxygen was reconnected after Ms O was transferred, or what may have caused the oxygen to become disconnected.
66. We consider the failing with record keeping has added to the uncertainty of what happened. The impact on Mrs A is that we are not able to provide a full independent view on what happened, which is disappointing.
67. In response to the complaint, the Trust apologised for not being able to provide any further information, due to poor documentation. It acknowledged a more detailed record should have been made. The Trust explained the senior nursing team is working on the quality of documentation, by completing weekly audits and spot checks. It said documentation has improved since Ms O’s admission, but there is room for improvement.
68. We acknowledge the Trust has taken some appropriate steps towards addressing the impact of the failing with record keeping. However, there seems to be a gap as there is no evidence it provided feedback to nursing staff that a more detailed record should have been made. The Ombudsman’s Principles for Remedy say good practice means ‘Using the lessons learned from complaints to ensure that maladministration or poor service is not repeated.’ In line with this we are making a recommendation for the Trust to take further action to prevent this happening again. Therefore, we partly uphold this part of the complaint.
Staff did not inform Mrs A that Ms O was at the end of her life during her hospital admission in June 2018
69. Mrs A says Ms O went from being told she could go home for the weekend to dying suddenly on the ward. She says she knew the situation was serious, but her understanding was that Ms O was stable.
70. We considered when it became apparent Ms O was at the end of her life, and whether staff communicated this to Mrs A in a timely manner. It was also relevant for us to consider what staff communicated to Ms O, as she had mental capacity. We got clinical advice to help us make a decision.
71. Our gastroenterology adviser says Ms O was seriously ill when she was admitted to hospital on 5 June, with less than a 50% chance of survival. The medical records show a doctor told Ms O she had a life-threatening illness and may not survive.
72. Our gastroenterology adviser says Ms O’s condition stabilised after admission and her blood tests showed signs of improvement, although they remained significantly abnormal. It is documented in the medical records that the clinical team were considering a liver transplant and planned to refer her to the next level of care on the High Dependency Unit (HDU). Although the clinical team recognised the serious nature of Ms O’s condition early on, they were still pursuing active treatment for her. There is also an entry in the medical records on 14 June showing the clinical team were considering possible discharge.
73. Our gastroenterology adviser says the medical records show there was a sudden deterioration in Ms O’s condition. On 19 June it is documented her kidney function was deteriorating again. This prompted the clinical team to give her intravenous (IV) fluids and start a drug called terlipressin. Unfortunately, IV fluids can cause problems with fluid overload if the kidneys are failing. This is because they are unable to handle the excess fluids, which then accumulate in other organs, particularly the lungs. The medical records show a deterioration in Ms O’s breathing early in the morning of 22 June.
74. During the morning ward round on 22 June, the consultant reviewed Ms O and continued to request referral to HDU for further treatment. The HDU consultant reviewed Ms O that afternoon and documented admission to HDU was not in her best interests. The HDU consultant considered Ms O did not have a good chance of recovering from her illness. This evidence suggests it was not until 22 June that staff felt Ms O was at the end of her life.
75. At 1.40pm the consultant on the ward documented a discussion with Mrs A. According to this, Mrs A asked if Ms O was dying, and the consultant explained she may be and said she was critically unwell. The consultant explained it was not suitable to refer Ms O to HDU for further treatment. This was because her body would not cope with invasive treatments, her liver function was likely to deteriorate further, and she would not be able to have a liver transplant.
76. The consultant had a further discussion with Mrs A and Ms O’s brother at 2.15pm at Ms O’s bedside. According to this, the consultant explained Ms O was critically unwell, as her liver failure had led to kidney failure and a build-up of fluid on her lungs. The consultant explained they were actively treating this, but referral to HDU for further treatment was not appropriate. They explained Ms O may die despite her current treatment.
77. Based on the evidence in the medical records and the clinical advice, we consider the Trust’s communication in relation to Ms O’s deteriorating clinical condition was appropriate. We consider the Trust followed GMC Guidance which says doctors must ‘…give patients the information they want or need to know in a way they can understand…’ and ‘…be considerate to those close to the patient and be sensitive and responsive in giving them information and support.’
78. In summary, there is evidence Ms O was told at the time of her admission on 5 June her clinical condition was serious and life threatening. Ms O’s deterioration happened quite suddenly. It was not until 1.15pm on 22 June that the Trust decided critical care admission would not be in Ms O’s best interests. The consultant had a discussion with Mrs A promptly at 1.40pm and explained Ms O may be dying.
79. We acknowledge there is no evidence of any discussions with Mrs A about Ms O’s clinical condition before 22 June. There are no specific standards in terms of how often doctors should have discussions with patients and relatives. We have not identified any failings here, as the consultant was still considering referral to HDU for further treatment. We also note Ms O had mental capacity to understand the information given to her. This meant she could decide what information to share with those close to her.
80. Mrs A is concerned it was not until around 1pm that she received a call from a nurse who told her she should come to the hospital right away. She says after Ms O died, she had a meeting with the consultant who told her they asked staff to call the family at 9.30am, as Ms O asked to see them.
81. In one of the complaint responses, the Trust says it spoke with the staff nurse on duty, who said they had not been asked by anyone, other than Ms O, to contact the family. The nurse said they phoned Mrs A almost immediately. In a further response, the Trust suggests someone should have called the family much earlier.
82. We have seen brief handwritten notes of a meeting Mrs A attended with the Trust. The notes appear to document the consultant saying they asked staff to contact Mrs A around 9.30 to 10am. This may be why the Trust suggests someone should have called the family sooner.
83. There is conflicting evidence about whether Ms O or the consultant asked staff to contact the family during the morning of 22 June. There is no evidence in the medical records that Ms O asked to see her family, or that the consultant asked staff to call them, during the morning. It is unfortunate we are unable to make a finding on this point due to a lack of independent evidence. Despite this, we consider staff communicated with Mrs A promptly after the decision was made not to refer Ms O for further treatment.
84. We do not uphold Mrs A’s complaint that staff did not inform her when Ms O was at the end of her life. We do not intend to minimise how difficult it must have been for Mrs A to come to terms with how quickly Ms O deteriorated.
Conclusion
85. We consider there was a failing by the Trust in transferring Ms O to a side ward. This was not appropriate as it happened too late following her deterioration. She was anxious and distressed and she did not consent to the transfer. We consider the impact of this is that Ms O’s wishes were not respected, the time Mrs A spent by her side at the end of her life was disrupted, and this caused distress to Mrs A.
86. We are not able to provide a full independent view on what happened in relation to Ms O’s oxygen. However, we consider there was a failing with record keeping which has added to the uncertainty of what happened.
87. We have not identified any failings in relation to the other complaints raised by Mrs A. We hope our explanations have provided some reassurance about the care and treatment Ms O received.