Care between 28 March and 17 May 2018
Disagreement between the GCC and ENT teams
33. Mrs A says on the second day of her mother’s admission, family members witnessed disagreement between the GCC and ENT teams about how to approach her mother’s care. Mrs A worries the ENT team decided to do tests over a long bank holiday weekend before deciding on a treatment plan. She says this led to delays in her mother’s treatment and her being sedated for longer.
34. The Trust said its ENT consultant met with the family on 31 March to explain the plan for treatment and staff thought they had reassured the family. It did not find any failings with the ENT team’s actions.
35. After Mrs B’s emergency admission on 28 March, the medical team secured her airway. It is written in the medical records that the team found inserting a tube to help her breathe very difficult because of swelling in her airway.
36. The CT scan showed a large mass in Mrs B’s neck. The radiologist reported a multinodular goitre was pressing on Mrs B’s trachea and was pushing it to the right. The GCC team at first thought the compression of the trachea along with a swelling in the glottis (the opening between the vocal cords) may have caused Mrs B to stop breathing.
37. Because of these findings, Mrs B was referred to the ENT team to be reviewed. They decided she should be kept sedated, have an ultrasound of her neck and a biopsy of the goitre (a surgical procedure to take a sample of tissue to examine it). The team would then discuss her case with the multidisciplinary team (MDT is a meeting made up of clinicians from different specialisms) to decide an appropriate treatment plan.
38. On 30 March, the GCC consultant and ENT consultant discussed Mrs B’s case. The GCC consultant thought Mrs B would need a thyroidectomy (removal of her remaining thyroid) as soon as possible, and/or a tracheostomy. They did not think keeping Mrs B sedated over a long weekend without a plan for treatment to be in her best interests.
39. The ENT consultant discussed Mrs B’s case with another senior colleague and their view was that immediate action would not be appropriate and further tests would be important to decide on the course of treatment.
40. GMC guidance says doctors must ‘provide a good standard of practice and care. If [they] assess, diagnose or treat patients, [they] must: • adequately assess the patient’s conditions, taking account of their history (including the symptoms and psychological, spiritual, social and cultural factors), their views and values; where necessary, examine the patient • promptly provide or arrange suitable advice, investigations or treatment where necessary’.
41. Our ENT adviser explained that when Mrs B was admitted, because she had stopped breathing the clinical team’s main priority would be to secure her airway. The records show they did this without delay. Once her airway was secure, this gave the team time to investigate to decide on the right management plan.
42. Our ENT adviser says when a patient has had a cardiorespiratory arrest (their breathing and heart stopped), treatment should not be delayed. But it is also appropriate for the clinical team to get all the relevant information about the patient’s condition before they make any decisions.
43. Our ENT adviser said the tests and investigations requested by the ENT team were relevant to investigate the nature of the goitre, for example, to see if cancer was the cause, and to examine the structure of the neck and surrounding area. It was also reasonable to do another scan days later to see if anything had changed. The timing of a repeat test would depend on the clinical situation at the time.
44. Based on this, we think it was appropriate for the ENT team to take time to fully assess Mrs B’s condition before deciding on treatment. We have not seen delays with the tests during this period, or that the disagreement between the clinical teams led to delays in care or to Mrs B being kept sedated longer than necessary.
45. We understand why Mrs A is concerned and appreciate this must have been a very worrying time. We hope we have been able to explain why we think the Trust’s management of her mother’s care was in line with GMC guidance.
The multinodular goitre and tracheostomy coming out of place
46. Mrs A complains that once the clinical team found her mother’s goitre was benign (not cancerous), they did not think about its impact on her breathing or give any treatment for it.
47. The Trust’s investigation report says its ENT consultant and two head and neck radiologists reviewed the scans and did not think the goitre was compressing Mrs B’s windpipe. Tests did not show evidence of disease or injury of the larynx (voice box). Based on these results, the team decided the goitre did not need to be removed.
48. The medical records show the ultrasound scan and biopsy were done on 1 April. The biopsy results showed the goitre was benign. A neck and head radiologist recommended a repeat CT scan to be certain of the findings and this was done on 3 April. The radiologist reported the goitre had been there for some time and it was causing some displacement of the trachea (causing it to be out of place), but it was not compressing it.
49. RCR guidance says ‘a radiology report should be actionable and prompt care for the patient. It should answer the clinical question’. The report should offer a possible diagnosis where an abnormality is seen and suggest further investigations where this will help to decide on a treatment plan.
50. Our radiology adviser reviewed the CT scan images from 28 March and 3 April along with the radiology reports and confirmed the Trust’s radiology reporting meets RCR standards. On 3 April, the radiologist compared the results to the report from 28 March to check for any changes. Our radiology adviser says the reports interpret the scans correctly.
51. Mrs B had a surgical assessment of her airway on 5 April and the Trust’s investigation report says this showed ‘minor bulging of the tracheal wall’, but that this was not seen as significant. It was also noted that Mrs B ‘appeared to have a bilateral vocal cord palsy’.
52. During the surgical assessment, a tracheostomy was done after Mrs B developed noisy breathing when the breathing tube was removed. There was no obvious cause for this. The team thought that vocal cord palsy with upper airway swelling caused by an infection could have led to the respiratory arrest. Vocal cord palsy can cause this because the vocal cords can get stuck in a position that stops the airway from opening fully.
53. An MDT team discussed Mrs B’s case on 5 April and decided there was ‘no active ENT issue’, and no treatment for the goitre was needed.
54. Our ENT adviser has agreed that based on the first investigations, there was no reason to remove the goitre. It would also not be sensible to do this surgery so soon after someone has had a respiratory arrest without there being a clear clinical need. Based on what we have found, we think the Trust did the right tests to find the cause of Mrs B’s respiratory arrest, in line with GMC guidance.
55. Mrs B continued to be monitored and had more tests to find the cause of the vocal cord palsy. An ENT consultant reviewed the case after Mrs B’s death and said the tests did not find a cause for the palsy. The Trust’s report says they had no historical details of the status of Mrs B’s vocal cords and so they decided to see if her vocal cord function would improve with time. By July, her vocal cords were assessed as normal.
56. Mrs A is concerned that when her mother’s tracheostomy moved on 14 April, this showed the goitre was causing problems with her airway. She is concerned that moving her mother to a different ward may have led to the tracheostomy tube coming out of place.
57. The records show Mrs B was transferred from intensive care to the cardiac intensive care unit on 13 April. Nurses have written that she had disrupted sleep that night and they heard an audible leak from the tracheostomy. They noted that Mrs B had been moving around in the bed and putting her hands by the tube. At 6.40am, it is recorded that she was distressed because the tube had come out of place. Nurses sent a respiratory arrest alert for doctors to come immediately.
58. Doctors were unable to reinsert the tracheostomy tube and put Mrs B back on a ventilator to help her breathing. ENT doctors reviewed her at 9.49am and decided she should have surgery to reinsert the tube. This happened the next day. The team noted the tracheostomy wound was infected. They cleaned it and removed the dead tissue.
59. NTSP guidance explains the ‘red flags’ to look out for in a patient with a tracheostomy. Red flags are warning signs of a potential critical incident. Mrs B showed these signs: • audible air leaks from the tracheostomy (a red flag for an airway problem) • tracheostomy tube out of place (a red flag for something being wrong with the tracheostomy) • anxiety, restlessness and agitation (general red flags).
60. NTSP guidance says that when red flags are seen, there should be a ‘prompt assessment of the tracheostomy and the patient … by someone who is competent to’. The clinician should be able to work out what the problem is and solve it. NTSP guidance says, ‘Interventions could range from a simple reassuring assessment, a fibreoptic inspection of the tube or airways, or replacement of the tracheostomy tube.’
61. Our ENT adviser explained that when Mrs B had a respiratory arrest, the medical team attended without delay and took appropriate action to quickly secure Mrs B’s breathing.
62. We understand Mrs A’s concern that this happened when she was moved to the cardiac intensive care unit. Looking at the evidence, we can see that the doctor who first attended the respiratory arrest call took advice from a critical care consultant. Mrs B was reviewed that morning by a GCC consultant and by an ENT consultant who decided the plan for her care.
63. NTSP guidance says a tracheostomy tube can come out of place ‘by coughing, because of its weight or the weight of the attached breathing circuits, or by patient interference’.
64. As noted above, Mrs B had a restless night leading up to this event and this may have led to her moving the tube by accident. Our ENT adviser said it is possible that another physical issue caused the problem, like pressure from the goitre affecting the position of the tube. We have not seen any evidence to suggest that the ward move led to the tube coming out of place.
65. We note that Mrs B had two CT scans in the two weeks before and these did not show any problems with the goitre. We can also see that after the tube was reinserted, Mrs B’s condition stabilised and she was well enough to go home the next month. It was not until July that she started to report problems with the tracheostomy. Because of this we are not critical of the Trust’s treatment of the goitre during this period.
66. We consider that the medical team properly assessed Mrs B and managed the problem with the tracheostomy tube, in line with the NTSP guidance.
Communication about the tracheostomy coming out of place
67. Mrs A complains that when her mother’s tracheostomy tube moved on 14 April, staff gave her and her family different accounts and they were not told it led to a respiratory arrest. This made them doubt if the clinical teams were giving them accurate information and added to their concern about what was happening.
68. The Trust has acknowledged this and apologised for the different stories staff gave family members about what happened. It said feedback would be shared with the critical care unit so they could learn from this to make sure staff give accurate information to families.
69. GMC guidance says doctors ‘must be considerate to those close to the patient and be sensitive and responsive in giving them information and support’.
70. There are two entries in the records of conversations doctors had with Mrs A’s family. An entry at 11.40am on 14 April says the consultant explained to Mrs B’s daughter and husband, ‘difficulty ventilating this morning, now sedated, ventilated…’.
71. An entry from a doctor at 2.40pm on 14 April says they spoke with Mrs B’s daughter and ‘explained – tube dislodged this am. respiratory’.
72. These records show two different clinicians spoke to different family members. The notes say there were discussions, but they are not word-for-word accounts. We would not expect word-for-word accounts to be noted in the records.
73. The note of the first conversation suggests the doctor discussed the difficulty of inserting the breathing tube. The note from the second conversation states ‘respiratory’, but it is not possible for us to say from this exactly what the doctor told Mrs B’s daughter, or whether this referred to a discussion about the respiratory arrest.
74. We do not dispute what Mrs A told us about the conversations being confusing. We also note the Trust has not denied that the family was given different information that day.
75. On balance, we think staff did not give the family clear and consistent information about what had happened on 14 April. This standard of communication does not meet the GMC guidance and this was a failing.
76. Mrs A told us it was only when they got her mother’s medical records that she and the family found out the full details of what had happened. This caused a lot of distress and concern and made them question why this had happened.
77. We have carefully considered the actions the Trust has taken in response to this concern. It has acknowledged that something went wrong, it has apologised and it has given feedback to the team so they can reflect on this case and learn from it.
78. We are satisfied these actions are appropriate to address the impact Mrs A experienced and we are not asking it to do anything more. We hope the Trust’s actions are reassuring for Mrs A.
Equipment given after discharge
79. Mrs A complains that after her mother was discharged in May, she and her sister had to call the Trust for advice about tracheostomy care and chase up equipment, like oxygen masks.
80. The Trust said staff referred Mrs B to the district nursing team before her discharge and they visited her on the ward. The district nursing team reviewed her and had training so they could meet her needs once she went home. They planned to visit her twice a week.
81. The Trust’s discharge policy says it is the role of the discharge team to order any specialist equipment necessary to support a patient’s discharge. The team will advise of any necessary referrals and make sure these are completed. The nurse responsible for discharging the patient should make sure they have any ‘equipment required following discharge’.
82. Mrs B’s records include a tracheostomy discharge and education planner. This lists the items that should be given to the patient or their family or carers so they can manage the tracheostomy appropriately at home.
83. The form stated the number of items needed, who is responsible for ordering them and the date it was done. It also lists the skills necessary to teach the patient or their carer, including understanding the importance of some of the key equipment and what to do in an emergency. The records show that staff trained Mrs B’s family on tracheostomy care before her discharge.
84. The record of the meeting with the district nursing team on 17 May shows the critical care team decided the district nurses were ‘competent’ to provide care for Mrs B’s tracheostomy. It says, ‘equipment due to be delivered tomorrow’ and that Mrs B had enough to take home with her until then.
85. The discharge planner says that some of the equipment was due to be ordered by the ward, but then the ongoing responsibility for future orders was with the district nursing team. This included the tracheostomy oxygen mask.
86. Our nursing adviser confirmed the family were given the relevant training and the documentation clearly lists the equipment the Trust provided and who had responsibility for this once Mrs B was at home. We think the nursing team made the right arrangements for discharge in line with the Trust’s discharge policy.
87. We are sorry to hear of the difficulties Mrs A and the family had getting the equipment they needed. We hope we have been able to clearly explain why we think the Trust did what it should have done to supply equipment and to set out the plan for the ongoing supply of this.
Care between 19 and 29 July 2018
Care provided by the ED
88. Mrs A complains that her mother went to the ED three times in July and each time doctors made mistakes in how they managed the problems she was having with her tracheostomy.
89. The Trust’s report said Mrs B went to the ED three times because she was experiencing discomfort trying to replace the inner tracheostomy tube. It was sticking and causing her pain. On 19 and 20 July, the ENT team reinserted the tube and sent her home. On 21 July, the ENT team decided to admit her and start the process of removing the tracheostomy (decannulation).
90. NTSP guidance for red flags says that reports of increasing discomfort or pain are a warning of a problem with the tracheostomy. A red flag should lead to a ‘prompt re-assessment of the person and the tracheostomy’.
91. Our ENT adviser explained that when Mrs B went to the ED on 19 July, it was the first time she had reported a problem with the tracheostomy. There were no obvious concerns of anything more serious happening so it was reasonable for doctors to reinsert the tube and send her home. This standard of care was in line with the GMC guidance for assessing and treating patients.
92. Mrs B went to the ED again the next day because she was still finding the tube changes painful and had seen a small bit of tissue stuck on the tube the night before. The doctor who saw her noted that the outer tube had some blood-stained mucus on it.
93. Our ENT adviser explained that a second visit the next day with a new report of pain and difficulty changing the tube should have rung alarm bells for the ENT team. As set out in NTSP guidance, this was a red flag and should have alerted the Trust to reassess Mrs B to find the cause of her problems.
94. By 20 July, it had been three months since Mrs B last had a CT scan. She was now reporting repeated difficulties with the tube and while we can see the ENT team noted a build-up of tissue around the tracheostomy wound, there is no sign that they considered what was causing this.
95. While we did not find failings in how her tracheostomy tube was managed on 14 April, our ENT adviser explained that this event should have been one of the factors the ENT team reviewed when Mrs B reported new problems. This is because it could have been a sign that the problem with her airway was not resolved.
96. NTSP guidance does not say what steps a medical team should take to assess a patient, but our ENT adviser said the team should have done a repeat CT scan to look for any changes that could explain Mrs B’s problems. A thyroid MDT should also have discussed her case before deciding a plan for her care.
97. On 21 July, Mrs B visited the ED for a third time in three days. The records show the doctor replaced the inner tracheostomy tube and used a size six tube instead of a size eight to match the size eight outer tube. Our ENT adviser confirmed the size of the inner tube should match the size of the outer tube. The priority for the team is to secure the airway and we can see they did this.
98. Our adviser explained how a smaller size inner tube may have affected Mrs B. They explained a smaller tube would have reduced the airflow through the tube, which likely reduced the amount of air she was able to breathe. But there are no signs in the records that this caused her any distress.
99. The doctor reviewed her and saw a build-up of tissue around the wound. They noted that she was ‘not coping at home’. The doctor admitted her under the care of the ENT team to ‘consider capping tomorrow’. The plan had been to start the process of removing the tracheostomy on 30 July, but this was brought forward to resolve the problems she was having with the tube.
100. After replacing the inner tracheostomy tube on 21 July, we think staff should have arranged to reassess Mrs B in line with NTSP guidance. This was Mrs B’s third visit with the same issue, which should have concerned the ENT team. There is no evidence the team considered the possibility of another issue causing problems with her airway.
101. Our ENT adviser explained that when a goitre grows, it can displace the trachea. This was seen on Mrs B’s CT scan on 3 April. At that time, the goitre was measured as being 8.4 x 5.5cm (a thyroid is usually a maximum length of 5cm). Our adviser said a goitre of this size was the most likely cause of the continuing issues Mrs B experienced with the tracheostomy tube. The size of the goitre was likely affecting the position of the tube because would have been competing for space.
102. In summary, the ENT team did not reassess Mrs B on 20 or 21 July to fully consider her medical history, symptoms and any other factors that could have been causing her problems. This standard of care does not meet the NTSP guidance and this is a failing.
103. We understand this will be difficult for Mrs A to read and we are very sorry for her distress. We discuss the impact of this failing later in this report.
Observations during the capping process and response to concerns
104. Mrs A complains that staff did not properly observe her mother during the capping process. She is unhappy that her mother was moved to a side ward where nursing staff would not have been able to see her easily. She says that when her mother and the family raised concerns about how she was coping, they were not taken seriously.
105. The Trust said nursing staff checked Mrs B every two hours and were in and out of the room giving her meals, caring for the tracheostomy tube and giving general care. It said it often nurses patients with a tracheostomy in a side room, unless they are confused or at a high risk of a fall. Mrs B was neither of these and was able to use a call bell.
106. In its investigation report, the Trust said staff noted the difficulties Mrs B had during the capping process but they thought any anxieties were ‘short-lived’. There was no evidence of respiratory distress, meaning she was having to work hard to breathe.
107. NTSP guidance says, ‘extra caution’ should be taken throughout the whole process of decannulation with patients who have had ‘a previously documented difficult intubation’. It also says the clinical teams must be able to ‘recognise the signs of clinical deterioration or improvement and slow/ stop/ restart/ speed up the weaning process as indicated’. This is to increase the chances of success and to minimise risk to the patient.
108. A doctor assessed Mrs B on 22 July and set out a plan to start capping the tracheostomy tube. The note says, ‘cap tube today, leave uncapped overnight. Remove cap if not tolerated’.
109. From 22 July, Mrs B’s tracheostomy tube was capped for increasing periods of time. It was capped overnight from 24 to 25 July and was removed on 25 July.
110. The nursing records for the period mainly say Mrs B was not showing any respiratory distress and did not have shortness of breath.
111. There are no national guidelines to say how often checks should be done on a patient, or how often they should be assessed. Our nursing adviser explained this decision is made by a health professional taking into account the patient’s individual needs.
112. The records show Mrs B was checked every two hours, except for 24 July when there seems to have been a four-hour gap in checks because she was ‘off ward’. Nurses consistently noted that she felt ‘comfortable and safe’, she did not need anything and was tolerating the capping.
113. The nursing team’s observations over the six days of Mrs B’s admission show she was stable throughout with no abnormal results. Her oxygen saturation levels stayed within normal limits. The observations did not show any cause for concern.
114. Our nursing adviser said side rooms can be appropriate as they can reduce the risk of infection for vulnerable patients, like tracheostomy patients. There are no specific guidelines to say if tracheostomy patients should be nursed in a side room or not.
115. The nursing records show Mrs B always had access to a call bell and was able to tell staff if she needed anything. She was checked every two hours and her observations stayed within normal limits. This means there were no signs to suggest she was not suitable to be nursed in a side room. We have not seen a failing in this part of the care.
116. While the nursing team did not have concerns about how Mrs B was coping with having her tracheostomy tube capped, the medical records show doctors were aware she was experiencing some difficulties.
117. Between 23 and 26 July, the records show that Mrs B told doctors she was feeling anxious and was not confident to have the tube capped. On 24 July, she told a doctor she had removed the cap during the night because she felt she could not breathe. Doctors decided to continue with the plan for decannulation and this went ahead on 25 July.
118. On 26 July, it is noted that she had a ‘panic episode last night otherwise tolerating well’. An ENT consultant reviewed her that day and noted that there were ‘no concerns with breathing’ and, after a speech and language therapy review, she was discharged later that day.
119. While there is discrepancy between how the medical team and the nursing team assessed Mrs B as coping with capping, our ENT adviser said a person may be observed as stable, but they can experience irregular problems. Any sign of difficulty with the airway and coping with capping should be taken seriously. This is because these difficulties can be a warning sign of a more critical problem.
120. There is no evidence in the records that the clinical team discussed and assessed if Mrs B was coping with the capping process as expected. There is no evidence of whether they considered pausing or stopping the process in response to the episodes of anxiety and panic she was experiencing.
121. We note that when Mrs B was capped overnight from 24 July and woke early the next morning with the cap in her hand reporting difficulty breathing, this did not seem to raise concern with the clinical team. The records show the plan as before.
122. The ENT team does not seem to have acted with caution when deciding whether to continue with the decannulation process. Our ENT adviser said that in line with the NTSP guidance, there should have been periods of close observation when Mrs B was experiencing problems before deciding what to do. Our adviser said Mrs B’s difficulties should have prompted a repeat CT scan if this had not already been done.
123. Mrs A also told us she and her family were not taken seriously. She said it was very distressing to feel that her mother’s concerns were not being listened to. We understand why this led her to question if this should have been handled differently and if something went wrong.
124. There is no record of the conversations with the family during this time, but we do not doubt what Mrs A told us. Staff did document some of Mrs B’s concerns and anxieties in the records. There is no record of staff discussing this with Mrs B’s family.
125. We have decided the ENT team should have recognised the signs that Mrs B was not coping with the capping process. They should have responded to this by pausing decannulation and observing Mrs B or stopping the process to rethink the plan for her care. This did not happen and is a failing. We have discussed the impact linked to this later in our report.
Removal of the tracheostomy
126. Mrs A complains that her mother’s tracheostomy should not have been removed when she was struggling to breathe without it.
127. The Trust’s report says it ‘does not have a standard single protocol for decannulation following tracheostomy and clinicians use a variety of regimes to decannulate patients’. Its ENT consultant said the decision to decannulate was only made after the team was satisfied this was medically safe to do so.
128. NTSP guidance says, ‘prior to the removal of a temporary tracheostomy tube, there must be multidisciplinary agreement that the indication for the tracheostomy has now been resolved successfully.’ The MDT ‘must have a thorough knowledge of the individual patient’s condition including indication for tracheostomy, established indicators for decannulation’, and a plan for any ‘further assessments or interventions’.
129. The records show the decision to proceed with decannulation was made after a registrar discussed this with a senior clinician. As noted above, the capping process was completed over a four-day period before a doctor removed the tracheostomy on 25 July.
130. There is no evidence of an MDT discussion to agree Mrs B’s tracheostomy was ready to be taken out. As noted in the NTSP guidance, clinicians should be satisfied that the reason for the patient having a tracheostomy has been resolved before considering its removal. While the team were satisfied that Mrs B’s vocal cord palsy had resolved, they had not found the cause of this.
131. Our ENT adviser also said that as part of the discussion at an MDT, the clinical team should put a plan in place in case decannulation does not work. There is no evidence the clinical team did this.
132. We do not think the plan to decannulate Mrs B was completed in line with NTSP guidance.
133. We have already found that the ENT team did not appropriately respond to Mrs B’s difficulties during the capping process. Our ENT adviser said Mrs B’s anxious and panicked response suggests she was not ready for decannulation.
134. The combination of the lack of MDT agreement for decannulation and the lack of consideration of the difficulties Mrs B had during the capping process means we do not think the team should have gone ahead with decannulation on 25 July. The Trust’s actions do not meet the standards explained in the NTSP guidance. This is a failing. We have discussed the impact of this later in this report.
Record of breathing problems
135. Mrs A complains that the records do not say her mother was having difficulties breathing on the day of her discharge. Mrs A says it was difficult to listen to and she raised the concern with staff who said this was normal after having a tracheostomy. She is unhappy this has not been documented in the medical records.
136. The Trust said it was satisfied Mrs B was suitable for discharge on 26 July. The oxygen levels in her blood were normal and she did not develop signs of respiratory distress before she was discharged.
137. A nurse who was caring for Mrs B commented in a statement to the Trust’s complaints team that on 26 July, Mrs B was talking well in full sentences, she was not showing signs of being short of breath and was keen to go home. The nurse said Mrs B and the family did not tell nursing staff she was having breathing difficulties.
138. In support of her concerns, Mrs A has given us screenshots of text messages she had from her mother. A message from 25 July says, ‘slept we[l]l but cap kept falling off’. At 8am on 26 July, the date of her discharge, she sent a message saying, ‘finding it difficult to breathe but [I] suppose its going to take time’.
139. As noted above, Mrs B raised concerns throughout the capping process. On 25 July, it is documented that Mrs B was not showing any signs of difficulty breathing. The nursing records from 26 July say, ‘no respiratory concerns noted’ and that she was ‘verbally communicating her needs and wants’. The notes say she ‘fully understood’ the plan for her discharge. The entries on this date suggest that staff were engaging with Mrs B and she was able to voice any concerns.
140. We understand Mrs A feels frustrated the records do not show what she thinks was an accurate reflection of her mother’s condition on that date, or their concerns. There are different accounts of what happened on this date so we have weighed up the evidence to reach a decision.
141. After careful consideration, we do not have reason to question what Mrs A has told us, or the messages her mother sent to her explaining how she was feeling on 26 July. But it is not clear if Mrs B or the family shared these concerns with staff.
142. Both the accounts from Mrs A and from the Trust are reasonable and there is no other evidence to persuade us which account is most likely what happened. We do not doubt that Mrs B struggled with breathing after decannulation, or that the family spoke to staff about this. At the same time, we do not ignore the records from that time, or the account of nursing staff who say they did not have any concerns.
143. It is not possible to say what was discussed between staff and the family and this means we cannot make a decision on whether the records are accurate on this date. We are sorry for the disappointment this may cause and for the distress Mrs A has experienced.
Impact of the clinical failings
Care on 20 and 21 July
144. We have found that Mrs B should have been reassessed on 20 or 21 July and this assessment should have included a CT scan. A CT scan would have shown if there had been changes to the goitre, for example, if it had grown bigger and if it was pressing on the trachea. Our ENT adviser told us the goitre was likely causing Mrs B’s problems with the tracheostomy tube.
145. At the time, there was no national guidance or specific standards for thyroid disease to tell us the treatment options for managing the goitre. NICE guidance was published in November 2019, a year and half later. We thought carefully about if it is appropriate for us to refer to these standards.
146. NICE’s recommendations for managing non-cancerous thyroid nodules and thyroid goitres was ‘broadly in line with current clinical practice and [was] therefore not expected to have significant impact’. So we are confident that this guidance represents what was already seen as good practice leading up to 2019. For this reason, we think it is appropriate for us to refer to the NICE guidance.
147. NICE guidance says, ‘do not offer treatment to adults with non-malignant thyroid enlargement, normal thyroid function and mild or no symptoms unless: • they have breathing difficulty or • there is clinical concern, for example, because of marked airway narrowing’.
148. As noted above, a CT scan would have shown how the goitre was affecting the trachea. The tracheostomy tube had been keeping Mrs B’s airway open and so a CT scan was necessary to see if the goitre had grown larger and if it was pressing on the trachea.
149. NICE guidance says that in cases where the adult has normal thyroid function and a multinodular goitre but enlargement of the thyroid is causing compressive symptoms, doctors can consider surgically removing the goitre. This is particularly important where there is marked airway narrowing. Doctors could also consider using radioactive iodine ablation, which is where the radioactive iodine destroys the cells of the goitre. Or they could use percutaneous thermal ablation, which is the use of heat to destroy the cells.
150. Mrs B’s post-mortem says the ‘most likely’ cause of her death was the compression of her upper airway. A ‘possible mechanism’ for this was ‘sudden enlargement of the goitre secondary to bleeding within a cystic component of the goitre’.
151. Our ENT adviser explained a bleed in the goitre would cause it to swell quickly. This increased size would put pressure on the veins supplying blood to the trachea which would then stop fluid from draining away normally. This causes the inside lining to swell. It is this swelling that restricts the airway leading to respiratory arrest.
152. Had the team treated Mrs B’s goitre after doing a full reassessment on 20 or 21 July, this could have prevented her death. Because the Trust did not reassess and investigate the goitre, we are missing information that would help us to say what treatment she should have had and the difference this would have made. We recognise this uncertainty will cause much distress to Mrs A. Our recommendations to address this impact are at the end of this report.
Failure to pause the capping process and decision to decannulate
153. We think an MDT should have discussed Mrs B’s suitability for decannulation to decide if this should go ahead. Because this did not happen, there was a missed opportunity for doctors to think about the full clinical picture. If this had happened, doctors may have found the warning signs that the goitre was affecting Mrs B’s airway and been aware of the risk of removing the tracheostomy tube. This could have led to looking at different treatment options in line with the NICE guidance.
154. We recognise an MDT may still have decided to go ahead with decannulation, but there was a missed opportunity for the team to reconsider the plan for her care and to have a back-up plan in place for if Mrs B showed signs of struggling to breathe.
155. We also found the ENT team did not listen to Mrs B’s concerns about capping and went ahead with decannulation when she was not ready. We think the team should have stopped or paused decannulation and done more assessments before deciding what to do next. If the team had paused or stopped the decannulation process, we think it is likely that the tracheostomy tube would have still been in place on 27 July.
156. On 27 July, Mrs B suffered airway compression, likely caused by the sudden enlargement of the goitre. Had the tracheostomy tube still been in place, our ENT adviser explained that the tube would have protected her airway and it is likely she would have survived this event.
157. Medical teams would then have considered the appropriate treatment options for Mrs B. It would have been clear by this point that the goitre was affecting the airway. Our ENT adviser said the NICE guidance says the goitre should have been surgically removed. And, if there were any clinical reasons for this not to happen, Mrs B could have been given a permanent tracheostomy.
158. Our view is it is more likely than not that Mrs B’s death could have been avoided if she had the right care.
159. We understand that reading these details will be very upsetting. We hope the recommendations we make at the end of this report help to bring some closure to these sad events. We also understand we cannot change what happened and this will always be a very distressing experience for Mrs A.
Complaint handling
Decision not to send a complaint response
160. Mrs A says that after her mother’s death, she and her family wanted answers to explain what had happened. She said the Trust delayed responding to her complaint and never replied in detail. She also complains that the complaints team missed agreed deadlines and actions were delayed. She says they agreed in April to get an opinion from the Royal College of Surgeons, but it did not follow this up until July.
161. The Trust has accepted its handling of the complaint was unhelpful for the family. It recognised that the family wanted to have as much information as soon as possible and it apologised that it did not allow for this. It also apologised for the delays in its actions and for not updating the family.
162. Our ‘Principles of Good Complaint Handling’ say organisations should ‘deal with complaints promptly’, ‘treat complainants sensitively’ and ‘respond flexibly to the circumstances of the case.’ Organisations should be open and honest and give ‘clear, evidence-based explanations, and reasons for their decisions’.
163. The Trust’s complaint policy says in cases where a person’s death is subject to an inquest (investigation), it has three possible options: • ‘to investigate the complaint as usual • to agree with the complainant the issues that should be responded to through the complaints process, and the issues that will be left to the inquest • not to proceed with the complaint until the inquest has taken place’.
The policy says ‘ultimately, the complainants wishes on how to proceed will be respected and the complaint progressed accordingly’.
164. Mrs A complained to the Trust on 25 August 2018. At first, the complaints team started to gather statements from the clinicians involved in Mrs B’s care but the Trust decided to pause this work and wait for the inquest. It also cancelled a bereavement appointment with the family. Mrs A asked if they could have an earlier response because it was hard waiting for the inquest, but the Trust declined this.
165. In April, the family were told the coroner had ruled there would not be an inquest. Mrs A said she then expected to get the detailed complaint response the Trust had been working on, but she did not.
166. During this time, the Trust had sent its serious incident investigation report. The family met with Trust staff to discuss this and pointed out inaccuracies which led to it being reissued. The family also went to a meeting with senior staff and the chief executive to discuss their concerns. This led to the Trust arranging for an independent review from the Royal College of Surgeons.
167. The Trust sent its complaint response on 11 October 2019, 14 months after Mrs A made her complaint. This focused on how the Trust had handled the complaint. It addressed some of the clinical issues but did not cover the issues it expected the independent review to address.
168. In December 2019, Mrs A and her family went to another meeting at the Trust to discuss the review from the Royal College of Surgeons. This review had not found any concerns with the Trust’s care. Mrs A said this meeting was very upsetting and unhelpful because the staff there had not treated her mother and could only refer to the records. She explains a clinician made her sister and father cry when they said they would never know why Mrs B died and they should accept this.
169. We do not think the Trust respected Mrs A’s wishes of how she wanted the complaint to progress. It did not show sensitivity to her needs or respond flexibly. We think the Trust took it seriously and tried to address Mrs A’s concerns through the meetings it arranged and by arranging for the independent review. But this meant it did not complete a full written response which is what Mrs A wanted.
170. The Royal College of Surgeon’s investigation and the Trust’s serious investigation report reviewed Mrs B’s care but were not written to answer Mrs A’s complaint or to replace a complaint response. Both the serious investigation report and independent review took longer than Mrs A and her family were expecting and Mrs A had to chase the Trust to find out what was going on.
171. It took too long for the Trust to reply to Mrs A’s complaint and when it did, it did not give a complete response to her concerns. The Trust did not meet agreed timeframes for actions and did not update Mrs A. The Trust’s complaint handling does not meet its own complaint handling policy or our Principles and this was a failing.
172. Mrs A also complains that the Trust agreed to take actions and to involve her in some of this work. She said she wanted to do this but did not hear any more from the Trust.
173. Our ‘Principles for Remedy’ say that where there has been maladministration (fault) or hardship, the organisation should ‘provide an appropriate and proportionate remedy’. They should ‘ensure they keep any commitments to provide remedies, including ensuring they do not repeat any failures’.
174. When looking at Mrs A’s complaint, the Trust agreed to: • review the NHS guidance for Trusts working with bereaved families and carers and work with Mrs A to make changes • learn from the complaint to improve its services, make learning available to staff and to discuss this with Mrs A • explore having Mrs A complete a case study that could be used for learning • develop information for patients to take home after decannulation on the red flags to be aware of.
175. The Trust told us its bereavement booklet has not been updated since before the events of the complaint. It said it is happy with its decannulation process and so it took no further action on what information is available for patients on discharge. It was unable to give any more updates because the many of the staff involved at the time that agreements were made no longer work at the Trust and there are no records of what was done.
176. We understand the Trust may have changed its mind about taking some actions, but it should have told Mrs A about its decisions. Due to the lack of records available, it is not possible to say what work, if any, was completed. This does not meet with our Principles and we find this a failing.
177. We thought about how this affected Mrs A. She made her complaint soon after losing her mother and understandably this was a very difficult and distressing time for her. Mrs A told us the way the Trust dealt with her complaint made her distress worse and made her feel like it was refusing to hear what she had to say. She said she felt the Trust was not honest with her and wanted to cover up what had happened.
178. The Trust agreed that it did not get things right in managing her complaint and apologised for the impact this had on Mrs A and her family. Its complaints team took learning from this and has taken steps to improve its service. We are pleased to see this but we do not think it has acknowledged that when it did respond to Mrs A, it did not give a full complaint response clearly explaining the clinical decisions it made with her mother’s care. We have made recommendations to address this at the end of the report.
179. Mrs A told us the Trust’s lack of follow-up on the actions it agreed to has given her no reassurance that it took her complaint seriously or that anything has changed. We are sorry to hear of the frustration, anger and upset she described and understand why this has led to her losing faith in anything changing.