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Torbay and South Devon NHS Foundation Trust

P-002804 · Report · Decision date: 17 July 2024 · View Torbay and South Devon NHS Foundation Trust scorecard
Complaint (AI summary)
Mr E and Mrs O complained their father was not adequately monitored or reviewed, and was inappropriately given sedative medication, potentially leading to his unexpected death.
Outcome (AI summary)
Partly upheld. The Trust failed to move Mr R to a daily medication regime and adequately monitor him, causing lasting uncertainty for the family.

Full decision details

The Complaint

8. Mr E and Mrs O complain that when their father, Mr R, was admitted to the Trust between 15 and 17 March 2022:

•he was not adequately monitored or reviewed during his admission, including having cardiac monitoring •he was inappropriately given chlordiazepoxide and lorazepam medication and overly sedated, particularly considering his existing health conditions and his regular medications

9. Mr E and Mrs O say his father may have lived longer if these failings had not happened, and his unexpected death has left the family in shock, with severe anxiety and stress.

10. They say these events and trying to get answers and piece together what has happened has been all consuming, taking time, energy, and money. They say it has caused a complete lack of trust and confidence in the NHS.

11. In bringing this complaint to us, they want the Trust to acknowledge the impact these failings had to their father and them. They also want the Trust to demonstrate it has made effective service changes and to make a financial payment to them for the distress they have experienced.

Background

12. Mr R was taken to the emergency department (ED) at the Trust by ambulance on 15 March 2022. He had poor mobility, felt dizzy and fell getting out of bed. He had hit his head when falling.

13. His previous medical history including Chronic Obstructive Pulmonary Disorder (COPD), high blood pressure, excess alcohol intake and anxiety.

14. In the ED, doctors initially diagnosed Mr R with alcohol dependence syndrome. They discussed alcohol withdrawal with him and he was aware of the risks of this. He agreed to supervision of medical staff, who would manage his alcohol withdrawal with monitoring and medication to control symptoms.

15. The Trust did this using a tool called the Clinical Institute Withdrawal Assessment (CIWA) scale. This tool assesses 10 symptoms to measure the severity of alcohol withdrawal syndrome and to monitor and medicate patients through withdrawal.

16. Staff first checked Mr R’s CIWA scores at 3.45pm on 15 March and then several times until the evening of 16 March. In response to those scores, staff administered chlordiazepoxide to Mr R. This is a medication which treats anxiety and alcohol withdrawal. In the evening of 16 March, staff gave Mr R lorazepam. This is a medication used to treat anxiety and sleeping problems.

17. During his admission, staff checked Mr R’s National Early Warning Score (NEWS). This is a system designed by the Royal College of Physicians in which a score is allocated to physiological measurements - breathing rate, oxygen saturation, blood pressure, pulse, temperature and level of consciousness/new confusion.

18. The total score indicates if a doctor needs to review the patient and within what timeframe. The frequency in which NEWS should be rechecked is determined by the previous score. The aim of NEWS is to standardise the assessment and response to acute illness.

19. Staff last checked Mr R’s NEWS at 9pm on 16 March. Sadly, in the early hours of 17 March 2022, staff found Mr R had died.

Evidence we considered

20. We considered the complaint form and correspondence from Mr E. We have considered the Trust’s complaint file, statements from staff at the Trust, the Trust’s investigation report, and Mr R’s hospital records too.

21. We got advice from a consultant physician with 20 years’ experience (our physician adviser) and a senior nurse with 22 years’ experience (our nurse adviser).

22. Our advisers have suitable knowledge and experience in the matters complained about to give advice. This advice has helped us to understand the clinical issues raised in the complaint. It forms part of the overall evidence we have considered and helps us to reach a view on the issues raised.

23. We use relevant law, policy, guidance and standards to inform our thinking. This allows us to consider what should have happened. We have referred to the following standards:

• National Institute for Health and Care Excellence (NICE) clinical guideline 100: Alcohol-use disorders: diagnosis and management of physical complications, April 2017 (NICE guidance) • British Heart Rhythm Society Standards for continuous monitoring in hospital, 2021 (BHRS guidance) • Trust’s Alcohol Withdrawal Management AWM plan 2011 (the Trust AWM plan) • NICE British National Formulary (the BNF guidance) • Nursing and Midwifery Council (NMC) The Code, professional standards of practice and behaviour for nurses, midwifes and nursing associates, 2015 (The NMC Code) • Royal College of Physicians (RCP) National Early Warning Score (NEWS) 2, Standardising the assessment of acute-illness severity in the NHS, March 2020 (RCP guidance).

Findings

24. As the issues Mr E complains about are interlinked, we have addressed his concerns in chronological order rather than under separate headings.

Cardiac monitoring

25. BHRS guidance gives suggestions for patients who would benefit from cardiac monitoring while in hospital. It includes certain circumstances in which patients have ischaemic or structural heart disease (blockage in the arteries or a defect/abnormality in the heart), and arrhythmia (irregular heart rhythm). During his admission Mr R did not meet any of the criteria to require cardiac monitoring.

26. Our adviser said there was nothing within Mr R’s history or presentation to indicate he needed cardiac monitoring. His family history of death from cardiac causes would not be reason to provide this.

27. The records show Mr R had not previously been diagnosed with a heart condition. Tests conducted in 2021 showed he did not have heart failure. Although he took statins, these are to prevent heart conditions and lower cholesterol, rather than being prescribed for a heart condition.

28. Our adviser said this, and the blood pressure tablets Mr R took, would not indicate the need for cardiac monitoring. We can also see the use of statins and blood pressure tablets were not a suggested reason for cardiac monitoring set out in the BHRS guidance.

29. The records show that on admission, Mr R had tachycardia (a fast heartbeat). This peaked at 121 and then came down to 110 and below. A simple high heart rate was not a reason to provide cardiac monitoring.

30. Our adviser said it is quite common when experiencing agitation for someone to have a higher heart rate. Mr R’s heart rate came down to expected levels for someone experiencing agitation.

31. Considering the guidance and the view of our adviser, Mr R did not require cardiac monitoring during his admission, and we have seen no failing here.

Suitability of medication

32. NICE guidance details how to manage acute alcohol withdrawal and treat alcohol-related conditions. It says people in acute alcohol withdrawal should be assessed immediately on admission to hospital.

33. It says to consider offering a benzodiazepine (a type of sedative medication) and to follow a ‘symptom triggered regimen’ for drug treatment for people in acute withdrawal. This is where treatment is tailored to the person’s individual needs, which are determined by the severity of withdrawal signs and symptoms.

34. The patient is regularly assessed and monitored, either using clinical experience and questioning alone or with the help of a tool such as CIWA. Drug treatment is provided if the patient needs it, and treatment is withheld if there are no symptoms of withdrawal.

35. The records show staff assessed Mr R on admission and doctors commenced the Trust’s AWM plan. Doctors prescribed chlordiazepoxide and lorazepam to him to ease his symptoms from alcohol withdrawal. These medications are both benzodiazepines.

36. Mr E is concerned his father’s family history of heart issues and the medications he was taking meant staff should not have been prescribed his father these medications.

37. Our adviser said there is nothing within Mr R’s history to indicate these were not suitable medications for him. The BNF guidance lists the conditions or circumstances that indicate these drugs should not be given to a patient. None of the exclusions for this drug applied to Mr R.

38. We have seen no failing in the prescription of these drugs. We hope this reassures Mr E that these drugs were suitable for his father.

Administration of medication

39. Turning to the administering of these drugs, the Trust’s AWM plan sets out the dose staff should give a patient depending on the severity of the symptoms of alcohol withdrawal. It says within the first 24 hours staff should recheck CIWA scores every one to two hours.

40. When the Trust began using the tool at 3.45pm on 15 March, Mr R’s CIWA score was 27. Nurses administered 20mg chlordiazepoxide to him, which was in line with the Trust AWM plan. Nurses continued to check his CIWA scores and administered chlordiazepoxide to him at the appropriate dose set out in the AWM plan.

41. However, the records show staff had not checked the CIWA scores every one to two hours as they should have done. The longest gap between checks was more than six hours, on 16 March between 5.15am and 11.32am. There are also other times when the checks took place between three and four hours. This was not in line with its own AWM plan.

42. The Trust AWM plan explains that after 24 hours, staff should calculate the total dose administered in that period. This is then used to identify the dosing regimen for the following days - high, medium, or low.

43. Staff should have done this at around 3.45pm on 16 March. They did not do so. We have seen no evidence to indicate this was a conscious and considered decision, rather it seems to be an oversight.

44. We can see that if they had done this, Mr R would have been placed on the high dose reducing regime. This would have meant he received four doses of chlordiazepoxide throughout the day, at 8am, 12pm, 6pm and 10pm.

45. The records show that instead, staff continued to use the CIWA chart and gave him doses of chlordiazepoxide at 7pm and 8.30pm. This was not in line with its AWM plan.

46. The Trust AWM plan says the maximum dose of chlordiazepoxide to give a patient is 200mg in 24 hours. It says 1mg lorazepam is equivalent to 30mg chlordiazepoxide.

47. Between 10.30pm on 15 March and 9.30pm on 16 March, Mr R received a total of 220mg chlordiazepoxide, due to receiving eight 20mg doses of chlordiazepoxide and 2mg lorazepam. The Trust AWM plan differs from national guidance as the BNF guidance says for alcohol withdrawal in severe dependence, a maximum of 250mg per day should be given.

48. It is unclear why the Trust specified in its AWM plan a maximum dose which is lower than the BNF guidance. It may have deliberately taken a more cautious approach.

49. Ideally, if the Trust had decided that 200mg was the limit, it should have given the medication in line with that limit. However, the 24-hour dose staff gave to Mr R was below the maximum dose set out in the BNF guidance. Therefore, we have not found a failing in the Trust’s actions.

Monitoring and reviews

50. Although we have seen the Trust did not give Mr R excessive doses of benzodiazepines, we have considered if there was evidence of over sedation.

51. Even when administered under the maximum dose, there is a risk of a person being over sedated. The BNF guidance explains that some of the common or very common side effects include low blood pressure and respiratory depression (reduced breathing).

52. Our physician adviser said a patient could be over sedated due to different sensitivity to non-toxic levels of sedative drugs. This can lead to the breathing rate slowing to dangerous levels which then causes the heart to stop. Over sedation would therefore be seen in a patient’s physiological measurements.

53. The records and the Trust investigation report show staff checked Mr R’s NEWS during his admission. Although one was a little late, the NEWS was initially done overall in line with the timeframes set out in the RCP guidance.

54. Mr R’s final NEWS score, which was at about 9pm on 16 March, was 2. According to the RCP guidance, this meant his next set of observations was due between 1am and 3am on 17 March.

55. The records of the evening of 16 March and early hours of 17 March are very poor, and the staff statements are not entirely consistent. This means it is difficult to comprehensively set out the timeline of events and to say what happened. However, they do show there were events which altered when the NEWS should have been done.

56. There is evidence that around 9.30pm, Mr R was experiencing significant symptoms from alcohol withdrawal, despite staff giving chlordiazepoxide to him. Due to this, nursing staff contacted the on call doctors and the critical care outreach team (CCOT). This is a team of highly experienced senior nurses who have advanced skills in the care of acutely unwell patients.

57. Staff statements say that as nursing staff did not consider Mr R was unsafe, it would be a routine review by a doctor as they were seeing other patients at the time. On advice of the CCOT nurse, staff administered 2mg lorazepam to Mr R at around 9.30pm.

58. The dose of lorazepam was equivalent to 60mg chlordiazepoxide, much higher than Mr R had received in a single dose previously. Staff had given him a high level of sedation in a short period, and it was the first time lorazepam had been administered to him.

59. The NMC Code says nurses should accurately identify, observe and assess signs of normal or worsening physical and mental health in the person receiving care.

60. Our nursing adviser said to meet this guidance, after giving this dose of medication staff should have checked Mr R’s NEWS within one to two hours. This is to specifically check for signs of over sedation.

61. There is some evidence in the staff statements that Mr R was still agitated around 30 to 40 minutes after taking lorazepam. Notes on the prescription chart say doses of other routine medications were missed as Mr R was ‘not safe to swallow’ around that time.

62. There is an added note to this chart which says this was ‘as patient was fast asleep’. However, this appears to have been added at some point after the initial entry was made. Based on our consideration of the records and the statements from staff, we have concerns that this added note is not credible or reliable.

63. Further, our physician adviser explained that being unsafe to swallow is a different scenario requiring a different response to a patient who is asleep when medications are due. Being unsafe to swallow is usually due to drowsiness or confusion. They said this condition should have prompted staff to check his NEWS.

64. Although staff did not check Mr R’s NEWS it appears from the statements that nursing staff did contact the CCOT again. This was in line with the NMC guidance which says staff should:

• work with colleagues to preserve the safety of those receiving care • share information to identify and reduce risk • make a timely referral to another practitioner when any action, care or treatment is required.

65. There is evidence from the staff statements that at some point after this the CCOT nurse visited the ward and was told Mr R had settled. The statement says they advised staff to await the doctor’s review and to take a set of observations (NEWS) when the doctor reviewed him. This instruction is not documented in the records and no NEWS took place.

66. Staff statements say that around 11.30pm the CCOT nurse went to the ward and observed Mr R, noting he looked settled with a good breathing pattern. Observing a patient in this way is known as ‘an end of bed review’. Good pattern of breathing means breathing, which is quiet, rhythmic, and with relatively still upper chest movement. The CCOT nurse would be qualified to recognise this.

67. Our physician adviser said signs of over sedation include signs of increased effort of breathing, noisy breathing/snoring and being very sleepy. They said the normal breathing pattern observed by the CCOT nurse suggests the level of sedation was fine at that time.

68. We consider the CCOT nurse’s review of Mr R was sufficient to meet the NMC guidance at paragraph 59.

69. Around the same time, a nurse went to check Mr R’s CIWA score and saw he was asleep. In line with the Trust AWMP, they scored his CIWA as zero at that time. This was a further opportunity to take Mr R’s NEWS but they did not do so.

70. The on call doctor came to review Mr R at around 12.30am on 17 March, in response to the earlier request. On arrival, a nurse told the doctor Mr R was now asleep and settled and no longer needed a review. The doctor left the ward without reviewing Mr R.

71. GMC Good medical practice says in providing clinical care, doctors must adequately assess a patient’s condition.

72. We consider attending the ward and speaking to staff about Mr R was in line with the GMC guidance. This is because the reason for requesting the medical review had resolved, namely Mr R was no longer experiencing those symptoms. This meant he did not require a more formal assessment by the doctor.

73. We have considered what happened after that point. There is some evidence in the statements that after the doctor left the ward, a nurse saw Mr R was still in deep sleep. This was not a formal review but was when they were dealing with another patient in the bay.

74. There is some limited evidence that a health care assistant (HCA) saw Mr R at 1.30am while attending to another patient. We note there is no detail provided around this and this event is not documented in the records, either contemporaneously or retrospectively.

75. In any event, our physician adviser said the only way to tell whether someone is asleep or unconscious is to wake them up. An HCA would not be qualified to differentiate between normal breathing and work of breathing. Therefore, an HCA seeing Mr R does not indicate what his clinical condition was at that time.

76. A 3.30am the HCA went to do Mr R’s observations but found he had sadly died. His observations had not been done since 9pm, some six and a half hours earlier. This gap was longer than the frequency initially set by the score at 9pm.

77. After 9pm, Mr R’s condition and the medication administered to him meant his NEWS should have been done much sooner, by around 10.30pm. Unfortunately, it appears the CCOT did not adequately handover to the nursing staff about the need for earlier NEWS.

78. Further, nursing staff did not consider the high levels of sedation Mr R had been having and that he had taken both lorazepam and chlordiazepoxide within a short space of time. There was potential for serious side effects from these medications.

79. A nurse and HCA briefly seeing the patient is insufficient replacement for the objective observations of a NEWS. We have found the Trust failed to adequately monitor Mr R.

Over sedation consideration

80. As set out in paragraph 49 the doses of benzodiazepines administered to Mr R were within the maximum amounts set out in the BNF guidance. However, over sedation can still occur, particularly with high doses.

81. There is some conflicting evidence from the Trust about Mr R’s level of sedation. The initial record saying Mr R was ‘unsafe to swallow’, which we have referred to in paragraph 62, suggests Mr R may have been over sedated. However, there is other evidence, from the CCOT nurse which suggests the level of sedation at around 11.30pm was fine.

82. We have some concerns about the reliability of the records and the evidence we have seen. However, we do not have enough evidence about Mr R’s level of consciousness and his physiological state to say, even on balance of probabilities, whether he was over sedated.

83. The lack of evidence is due to the failure of the Trust to complete Mr R’s NEWS for more than six hours before he was found to have died. The observations taken during a NEWS check would have shown whether he was asleep or unconscious, whether his breathing rate or heart rate was reduced, and whether his blood pressure had dropped.

84. Without this information we are unable to give the family answers about Mr R’s level of sedation.

Summary of findings

85. In summary, we have found there was no failure by the Trust in it not providing cardiac monitoring to Mr R. We think the Trust did not fail in its prescription of lorazepam and chlordiazepoxide or in the amount of sedative medication it administered to him.

86. However, we have found the Trust failed to move Mr R on to a daily regular reducing regime after 24 hours and failed to monitor his vital signs and his symptoms of alcohol withdrawal. Due to the absence of evidence, we are unable to say whether Mr R was over sedated.

Impact of these failings

87. As set out previously, sedation leads to the breathing rate slowing. With over sedation this reduces to dangerous levels which causes the heart to stop.

88. The post-mortem examination found Mr R had heart disease. It noted that people with those findings are at increased risk of sudden cardiac death. Our adviser explained an arrhythmia does not leave clear traces/signs in the body at post-mortem. The pathologist speculated that Mr R developed an arrhythmia which led to his heart stopping.

89. The NHS website explains arrhythmia includes bradycardia, which is where the heart beats more slowly than normal. Our physician adviser explained that if there was over sedation, this could have led to Mr R’s death. If someone is over sedated their breathing rate can slow to dangerous levels. This means insufficient oxygen gets to the vital organs. This can make the heart stop, causing death.

90. Unfortunately, respiratory depression leading to the heart stopping would not show up on post-mortem examination.

91. Mr R’s family has serious concerns about their father’s care and the impact of this. If he was over sedated, staff would have been able to give Mr R medication with the aim of reversing the sedative effect. As set out above, due to the lack of monitoring after 9pm we are unable to say whether Mr R was over sedated.

92. This means we are unable to offer them any reassurance about his final hours or the deterioration of his condition. They have been left with unresolved doubts about whether their father’s death was related to any failings in care. This is an everlasting injustice to them.

93. We can see in the Trust complaint response it has acknowledged the failure to monitor Mr R’s vital signs in the period after it gave him lorazepam. Although it has apologised for the ‘lapses’ in Mr R’s care, it has not acknowledged the impact of the failure.

94. For that reason, we consider the Trust has not done enough to put right this complaint. We have therefore set out below what we are asking the Trust to do for Mr E and Mrs O.

Our Decision

1. We have considered Mr E and Mrs O’s complaint about the care provided to their father, Mr R, before his death. We were very sorry to hear of the significant distress these events and their father’s death has caused them.

2. We found there was no failure in the Trust’s decision not to provide cardiac monitoring to Mr R or when it prescribed and administered sedative medications to him.

3. We found the Trust failed to move Mr R onto a daily regular medication regime after 24 hours and failed to adequately monitor him.

4. The lack of monitoring during Mr R’s final hours means we are unable, even on the balance of probabilities, to say how his condition deteriorated or whether he was over sedated. This has left Mr E and Mrs O with lasting uncertainty about their father’s death, which will continue to be distressing for them.

5. Although the Trust has acknowledged the failings in its investigation report, we do not think it has done sufficient to put right this complaint.

6. We therefore partly uphold this complaint. We have recommended that the Trust apologise to Mr E and Mrs O for the lasting uncertainty and distress these failings have caused to them. We ask the Trust to pay a financial remedy of £3,125 in recognition of this.

7. The Trust investigation report made recommendations for areas of improvement to address the failings it identified in Mr R’s care. However, we have seen no evidence confirming these recommendations have been actioned and completed. Therefore, we recommend the Trust to produce an action plan setting out what it has already done or will do to prevent a repeat of these events.

Recommendations

95. In considering our recommendations, we have referred to the ‘NHS complaint standards’. These state that where poor service or maladministration has led to injustice or hardship, the organisation responsible should take steps to put things right. If possible they should return the person affected to the position they would have been in if the poor service had not happened. If this is not possible, they should compensate them appropriately.

96. In line with this, we recommend the Trust write to Mr E and Mrs O to acknowledge and apologise for the lasting uncertainty and distress its failure to adequately monitor their father has caused to them. This means accepting responsibility and expressing sincere regret for the resulting injustice. The Trust should do so by 18 August 2024.

97. To decide on a level of financial remedy, we review similar cases where the person has experienced similar injustice, along with our severity of injustice scale.

98. Following this review, we recommend the organisation pay Mr E and Mrs O £3125 in recognition of the distress and uncertainty around their father’s death, which was caused by the Trust’s failure to monitor his vital signs after giving him high doses of sedative medication. It should make this payment by 1 September 2024.

99. Our complaint standards say that public organisations should look for continuous improvement, and should use the lessons learnt from complaints to make sure they do not repeat maladministration or poor service.

100. In line with this, we recommend the Trust produce an action plan setting out the actions it has taken or will take to prevent a repeat of these events. This should include details of the reason for the failure, the improvements to be made, the timeframe for doing so, and the person responsible. The Trust should send this to action plan to Mr E and Mrs O and us by 18 October 2024.

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