Consent
• Non-surgical options were not discussed with Mr R or his family
33. Mrs T strongly refutes that any discussions regarding non-surgical options took place. She says even at the point of raising their concerns, both her and her mother, Mrs R, were still unaware of what non-surgical options may have been.
34. In response to the complaint, the Trust has explained that different management options were discussed, and it is documented that this was extensively discussed with Mr R and his family.
35. We can see from the records that during an appointment with the neurology team on 6 February 2020, Mr R was told he had a suspected diagnosis of myasthenia gravis. A neurology clinic letter from 26 February 2020 detailed that his myasthenia gravis was stable and there was no evidence of generalised disease. For this reason, the team had withheld the management option of pyridostigmine or stronger immunosuppression. Mr R was being treated with daily prednisolone and had been referred to the lung MDT due to the finding of a possible thymoma on his recent CT scan and was to be seen by the cardiothoracic surgeon. The clinic letter details that Mr R had been provided with patient information leaflets on myasthenia gravis and steroid use.
36. Mr R was reviewed in the neuro-ophthalmology clinic on 3 March 2020 and the letter confirms that his symptoms remained stable. The consultant decided they did not need to see him in clinic, but advised an appointment should be made if symptoms worsened.
37. A neurology clinic letter from 25 March 2020 reported Mr R’s symptoms as stable. The same is reported in a neurology clinic letter from 22 April 2020, and the consultant has noted there was no indication for pyridostigmine. This is further repeated in a neurology clinic letter dated 8 July 2020 in which it is explained that Mr R’s symptoms appeared to be limited to ocular rather than any generalised involvement.
38. Mr R was seen in the neurology clinic on 8 July 2020. It was noted that his myasthenia gravis symptoms remained stable with no indications of generalised myasthenia. A discussion regarding treatment took place, and the consultant explained they usually recommend surgical removal of the thymus gland as this helps with the overall management and stability of myasthenia gravis, as well as reducing complications relating to it. The clinic letter goes on to explain that patients with ocular myasthenia tend to respond just with steroids, as in Mr R’s case, and to date, because they had not seen any clinical evidence of generalised involvement, they had not opted to commence pyridostigmine or any background immunosuppression.
39. The consultant neurologist explained he had also asked for a second opinion on whether pyridostigmine was indicated. The letter goes on to explain that if they were to commence him on the usual standard myasthenia management, this would include immunosuppression in addition to regular blood monitoring and follow ups. The advice from the second opinion was to continue with the current management. The neurologist explained that because Mr R was stable on a low dose of steroids, there were no indications to introduce pyridostigmine.
40. A clinic letter from 19 August 2020 explained Mr R remained stable from a neurology perspective and explained that they were still supporting the need for a thymectomy to help optimise his overall health and wellbeing whilst minimising the risk of the recognised complications of generalised myasthenia.
41. Mr R saw the neurologist again in an appointment on 2 October 2020. It is detailed that because the surgery was on hold, they discussed in more detail the management they would employ if he began to develop generalised myasthenic symptoms. It was agreed in this appointment they would trial him with pyridostigmine to see if it would have any impact on his fatigue.
42. Mr R attended the cardiothoracic clinic on 4 November 2020. The consultant noted that they discussed the indications for surgery, and the concerns that whilst the thymoma appeared stable on scans it may have been contributing to his symptoms. Neurology clinic letters from 1 December 2020 and 10 February 2021 detailed that Mr R remained clinically stable.
43. It is evident from the clinic letters detailed above that Mr R’s myasthenia gravis symptoms were quite mild at the time of his diagnosis and the decision to offer surgery. Our neurology adviser explained that myasthenia gravis often starts off in this way and progresses and worsens over time. For this reason, treatment is necessary in most cases to manage the symptoms.
44. We understand that because Mr R was stable, there may have been an option to continue treatment the myasthenia gravis with medication alone, however, there was a possible finding of a thymoma.
45. Our thoracic adviser has explained that whilst many patients with myasthenia gravis can be managed with medication alone. There is evidence that the removal of the thymus gland can reduce symptoms, reduce the need for medication, reduce the frequency and severity of thymic crises and, in some cases, cure the condition. Thymectomy is most effective in young patients (<50 years) and in those with evidence of a thymoma on scanning (N Engl J Med 2016).
46. Our neurology adviser explained that when a patient with myasthenia gravis has what looks like a thymoma, the priority management is surgery due to the risk it may convert to a cancer. It is possible this can also help with the management of the myasthenia gravis.
47. Our neurology adviser also explained an alternative would have been medication to treat the suspected cancer but stressed that surgery is the preferred and more-effective treatment option.
48. The GMC’s consent guidance explains that patients must be given information they want or need to make a decision, including options for treating and managing the condition, including the option to take no action (point 9).
49. The GMC’s Good Medical Practice guidance explains that when assessing diagnosing or treating patients, clinicians must adequately assess the patient’s conditions, promptly provide or arrange suitable advice, investigations, or treatment where necessary, and refer a patient to another practitioner when this serves the patient’s needs (15 a, b, c). It also says that clinicians must only prescribe drugs or treatment where they are satisfied it serves the patient’s needs (16a).
50. We can see that initial discussions were had about the medical management of myasthenia gravis, and it was explained to Mr R why further medical management was not yet required. We consider there is evidence that the clinical team discussed the management options for myasthenia gravis (medication and surgery) and provided an explanation of why decisions had been made in Mr R’s case to proceed without additional medication at the time. The neurology team also sought a second opinion about Mr R’s medication regime. We consider these actions were in line with the GMC’s Good Medical Practice guidance outlined above.
51. We have not seen supporting evidence that all avenues prior to surgery were explored, there is no evidence that a discussion was held about what Mr R’s treatment pathway would be, should he decide not to have surgery.
52. We cannot see in the records that there was a detailed discussion about the clinical benefits of a thymectomy in a patient such as Mr R against the strategy of continuing with medical treatment. Whilst treatment with medication was discussed on several occasions, this was to manage symptoms in the run up to surgery, and not with any long-term outlook.
53. We consider this was not in line with the GMC’s guidance we have outlined in points 48 and 49 above, as not all long-term options for treating and managing Mr R’s condition (including taking no action) were discussed with him and his family.
54. For these reasons, we consider there has been a service failure. We will address the impact of this later in our report.
• The potential risks and complications of Mr R’s surgery were not fully communicated to Mr R or his family
55. Mrs T and Mrs R complain that the potential risks of surgery were significantly played down in conversations with the consultant prior to surgery, and this led to them believing Mr R was undergoing a straightforward surgery. They feel that the risks of the surgery were not adequately explained to them.
56. In response to the complaint, the Trust has said the risks of the surgery were documented on the signed consent form, and Mr R would have had a detailed discussion with the consultant before signing this.
57. In our review of the records, we can see that Mr R was seen by the thoracic surgeon on 11 March 2020. The clinic letter detailed the consultants view that Mr R was appropriate for a VATS thymectomy, albeit with higher operative risks. It is detailed that the consultant advised Mr and Mrs R he may need a cardiac intensive care unit (CICU) bed post-operatively in case there were difficulties due to the anaesthetic. The consultant also noted that the risks were documented on the consent form.
58. The consultant went on to explain that the benefits of the surgery included better management of Mr R’s ocular myasthenia gravis, as well as eradicating the risk of leaving the suspected thymoma long-term (i.e., possibility of cancer spreading). It was confirmed that Mr R had signed the consent form. The risks on the consent form are detailed as infection, pain, bleeding, phrenic nerves (2%) and death (2-5%).
59. During a neurology clinic appointment on 8 July 2020, it is noted a discussion took place about the recommendation for surgery, with the potential benefits being that it would help with the overall management and stability, as well as reducing complications relating to myasthenia. A similar discussion took place in a clinic appointment on 19 August 2020 in which the neurology team explained they were still supporting the need for a thymectomy to help optimise Mr R’s overall health and wellbeing, whilst minimising the risk of the recognised complications of generalised myasthenia.
60. Mr R attended the cardiothoracic clinic on 4 November 2020. The consultant noted that he felt the risks were relatively low, and that the risks of surgery were discussed with Mr R and his family. It is noted that these risks were documented on ‘consent form 1’, and the consultant said they had signed this form with the intention of countersigning by Mrs T, who had power of attorney. However, it was also detailed that the agreement was that the family would require further time to determine the way forward.
61. A neurology clinic letter from 1 December 2020 detailed that Mr R and his family had discussed management options following the appointment on 4 November 2020 and wanted to proceed with surgery. There is a consent form from 31 December 2020 signed by the consultant and Mrs T, which has been completed to state Mr R lacked the capacity to give or withhold consent because; he was unable to comprehend and retain information material to the decision, and he was unable to use this information in the decision-making process. It states there had been a capacity assessment completed by the neurologist and memory service, and that several discussions had been held about the proposed surgery.
62. The GMC’s consent guidance (2008) explains that patients must be given information they want or need to make a decision including the potential benefits, risks of harm, uncertainties about and likelihood of success for each option (point 9). In order to have an effective discussion about risk, the adverse outcomes that may result from the proposed options should be identified (point 29).
63. The GMC’s Decision making and consent (2020) guidance recognises that it would not be reasonable or proportionate to share every possible risk of harm, potential complication, or side effect, and advises that instead the discussions should be tailored to the patient, and shared with them in a way they can understand (point 22).
64. The guidance goes on to explain that clinicians should include the following information when discussing benefits and harms:
• A – recognised risks of harm that they believe anyone in the patient’s position would want to know • B – the effect of the patient’s individual clinical circumstances on the probability of a benefit or harm occurring • C – risks of harm and potential benefits that the patient would consider significant for any reason • D – any risk of serious harm, however unlikely it is to occur • E – expected harms, including common side effects and what to do if they occur (point 23).
65. We understand that consent is a multi-layered process and begins when the patient first meets the surgeon. The patient should be given information about the intended procedure, why the procedure is indicated, and the risks and benefits involved.
66. Our thoracic adviser explains that a thymectomy for myasthenia gravis is a multidisciplinary process requiring input from the anaesthetic team, surgical team, the ICU team, and the neurology team. It is not a straightforward surgery and requires input and skill from all associated specialties. Additionally, there are several intra-operative and post-operative risks.
67. There are some risks listed on the consent form from March 2020 but none on the consent form dated December 2020. The risks listed on the March consent form only quantify the risk of phrenic nerves and death. Our thoracic adviser explains that for an operation such as a thymectomy for myasthenia gravis, risks such as a myasthenic crisis, prolonged ventilation, no benefit from the procedure, and acute confusional states should be discussed with the patient (and their family) and clearly detailed on the consent form.
68. It is evident that some level of discussion took place about the risks and benefits of the surgery, including the possibility for ICU-level care post-operatively.
69. It is not evident from the records that the discussions and documentation went into the required detail for Mr R and his family to understand and appreciate the risks of the surgery and the range of possible outcomes. There is also no supporting evidence that a discussion was held with Mr R that surgery may not work or may even hasten the clinical picture from ocular myasthenia gravis to complete myasthenia gravis.
70. We appreciate that such risks may have been discussed with Mr R and his family on 4 November 2020, but the clinic letter and consent form (dated 31 December 2020) do not detail this in any way.
71. For these reasons, we consider there was a service failure in the communication of the risks of the proposed surgery with Mr R and his family. We will address the impact of this in the ‘impact’ section of our report.
• Mr R’s capacity was not formally assessed despite concerns
72. Mrs T considers a best interests meeting should have been held between the clinical teams involved in Mr R’s care, which involved Mr R and his family. She tells us that she and Mrs R refute the Trust’s response which says discussions took place about consent, that there was a consideration of a best interests meeting and a decision was made that it was not required. Mrs T says a best interests meeting was never offered, and never took place.
73. The Trust’s SI investigation report explains that all appropriate measures should have been taken to enable Mr R’s capacity to make the decision about having surgery, and a formal capacity assessment should have been made if there was a suspicion he lacked capacity. It also stated that if Mr R lacked capacity, this should have been made clear to the anaesthetic team in preparation for the anaesthetic consent at the pre-assessment clinic, and to the theatre and CICU teams.
74. The report goes on to say that if it had been established that Mr R lacked capacity, the consent form signed by Mr R on 11 March 2020 should not have been countersigned by the surgical registrar. At this stage, his interests would have been represented by Mrs T as the lasting power of attorney, and the consent form signed on 31 December 2020 should have been used.
75. Furter to this, the report acknowledges that only once Mr R had been identified as lacking capacity to make a decision about a proposed treatment should Mrs T’s role as lasting power of attorney been introduced. At this point, a best interest meeting and balance sheet should have been completed. This process would have considered the proposed procedure, its risks, benefits, and alternatives and best matched these to Mr R’s holistic needs and wishes. Ultimately, until it had been determined Mr R lacked capacity, Mrs T should not have been asked to sign the consent form.
76. The Trust’s mental capacity policy adheres to the principles set out in the Mental Capacity Act 2005. The Act tells us that a person must be assumed to have capacity unless it is established otherwise, and a person is not to be treated as unable to make a decision unless all practicable steps to support them to do so have been taken without success (outlined in point 7.2 of the Trust’s policy). Furthermore, where there is any doubt about a person’s capacity to consent, prior to performing any treatment or delivering any care, an assessment of capacity should be undertaken (outlined in point 8 of the Trust’s policy).
77. The Trust’s policy says there is a duty on medical professionals to consult with family and involve them in decisions about capacity and best interests. An assessment of capacity and best interest decisions should involve consultation with family members and all other relevant people interested or involved with the person, and any assessment or decision must always be recorded in a clear and factual manner, detailing the evidence for the outcome (points 8.1, 9).
78. In our view, there is evidence within the records shows there was clear doubt about Mr R’s capacity. This is demonstrated in clinic letters from the memory services, the neurology team, and cardiothoracic team, in the lead up to surgery. In particular we have focused on clinic letters from 22 December 2019 onwards, which is when Mr R was referred to the memory clinic as his symptoms had not improved despite interventions with medication and counselling. The letters detail a progressive deterioration in terms of Mr R’s cognitive impairment. References are made to concerns about his memory, particularly his short-term memory.
79. A clinic letter dated 25 June 2020 written by the neurology team explains that Mr R’s cognitive decline was complicating his management, and that the cardiothoracic team were keen for a formal diagnosis and a best interest input from the memory services to determine if proceeding with the surgery was the right way forward. A clinic letter from 8 July 2020 also states the priority was Mr R’s cognitive impairment, and that he would benefit from a best interests meeting.
80. The memory service had been reviewing Mr R, but no specific diagnosis had been made. He was undergoing assessments and unfortunately, they were incomplete due to limitations on appointments during that period because of Covid-19. However, the team explained that Mr R was showing signs of impairments in the domains of information processing and working memory. A letter from the memory service dated 22 October 2020 stated that whilst the diagnosis remained unclear, Mr R was for an assessment of interval change prior to the reconsideration of the risks and benefits of surgery.
81. Our thoracic adviser explained that the procedure Mr R underwent requires input from surgery, anaesthetic, the ICU and neurology teams, and all relevant parties should have been made aware of any limitations in capacity to make a decision in Mr R’s best interests, and most certainly before any operative procedure. Whilst there is evidence within the records that all these teams had all highlighted concerns about Mr R’s memory, there was no wider discussion or consideration made to his capacity.
82. Given the clear concerns the clinical teams and the family had, we consider a formal assessment of Mr R’s capacity, and a best interests meeting should have taken place. We consider not doing so was a service failure and was not in line with the Trust’s mental capacity guidance.
83. We will address the impact of this below.
Impact
84. We will now consider the impact of the failings we have identified, which are:
• Long-term non-surgical treatment options were not discussed with Mr R and his family, • Discussions and written information about the risks and complications of surgery did not go into the required level of detail, • Not carrying out a formal assessment of Mr R’s capacity or holding a best interests meeting.
85. There are risks and benefits of proceeding with surgery, and of opting to not having surgery and taking medication only. We can see from the records that Mr R’s family were present at his clinic appointments, and so they were involved in discussions about the surgery and the benefits of the surgery Mr R was to undergo. They were given time to consider the information presented to them, to reach a decision.
86. In this case, the option of, and the risks and benefits of, treatment by medication alone were missing from the discussions held with Mr R and his family in the decision-making process.
87. We consider the impact of this was that the family did not have all the information they needed. By not discussing the non-surgical treatment options and fully quantifying the risks involved in the surgery, it took away the family’s opportunity to make the most informed decision possible on a way forward for Mr R.
88. We consider that if a formal assessment of Mr R’s capacity had taken place, a formal meeting with the family and the medical teams would have been held and a discussion taken place to ensure this surgery was in Mr R’s best interests. This would have led to thorough discussion about the risks, benefits, and alternative treatment options with all clinical specialities, to ensure a holistic approach was taken.
89. We consider this would have also given the family additional reassurance that the correct pathways for assessing capacity were undertaken, and that Mr R’s best interests had been thoroughly considered by all involved.
90. Whilst we cannot say definitively that the decision the family made would have been different, Mrs T tells us that her family is naturally risk-avoidant, and therefore we know they would have seriously considered alternative treatments had they been discussed. We recognise this means there is a possibility a different decision may have been made.
91. We also recognise this has had a lasting emotional impact on Mrs T and Mrs R, due to them being left with outstanding questions about what the alternative treatments may have been, and if things may have been different. We understand this has compounded their grief and made the bereavement process much more difficult for them. We also recognise the findings of our report are likely to bring back some of those feelings.
92. We consider the Trust should do more to remedy these aspects of the complaint, and we will detail our recommendations at the end of this report.
Operation
• A scan which was 11 months old was relied upon on the day of the operation
93. Mrs T has questioned whether it was appropriate to rely on an 11-month-old CT scan during surgery, and whether a more up to date scan should have been undertaken prior to surgery.
94. In response to the complaint, the Trust acknowledged it was not ideal to have relied on the second scan but considers it unlikely that a repeat would have changed the indication or recommendation for the surgical resection of the presumed thymoma, in the setting of myasthenia gravis.
95. The GMC’s Good Medical Practice guidance states that in providing clinical care you must prescribe treatment only when you have adequate knowledge of the patient’s health and are satisfied that it serves their needs. Effective treatments should be provided based on the best available evidence (16 a, b).
96. From the evidence we have considered, we can see that the first CT scan took place on 18 February 2020. The second CT scan took place on 23 July 2020. The surgery took place on 10 June 2021.
97. The use of this scan was not the most up to date/best evidence the surgical team could have relied upon when operating on Mr R, and we consider the Trust could have carried out a further CT scan to assess for any further interval change, to determine if any reconsideration of the risks/benefits of surgery were needed. Both the Trust and our adviser have agreed it was not ideal to have relied on the scan which was 12 months old, and our adviser explains that the ideal would be less than four weeks old.
98. For this reason, we consider this was a service failure, even when taking into consideration the slow growing presumed thymoma and the post-Covid-19 environment.
99. With regards to impact, we have explored this with our thoracic adviser, who is of the opinion that an up-to-date CT scan would not have made a material difference to the outcome of the case. Therefore, we consider the Trust’s conclusion that this would not have changed the recommendation for surgical resection is appropriate.
100. We recognise that a more up to date scan would have provided the family with reassurance that the clinical team were acting on the most up to date evidence available to them, therefore reassuring them that the cause of the complication was not due to the use of the 11-month-old scan.
101. We cannot see that the Trust has acknowledged this in its responses to the complaint, nor has it taken any learning from this. We will be making recommendations for the Trust to address this part of the complaint.
Complaint handling
• Delay in reporting the events of 10 June and 17 June 2021 onto Datix, and the delay in holding a meeting with the consultant.
102. Mrs T has raised concerns that the two incidents were not reported via Datix until 23 July 2021 given the scale of harm which resulted from the complications of surgery. She also complains that on 11 June, after the first surgery, the registrar was left to feed back to the family without the support of the consultant. The family recall him being significantly affected and distressed by the events the previous day. Mrs T explains that they felt this was not appropriate, nor a sufficient way of handling the family’s concerns at that point. The family then had to call a meeting with the clinical team on 23 July 2021.
103. In response to the complaint, the Trust has explained that there was a team debrief at the end of the day, and it was at this time that the decision was made by those present that the events which occurred did not need to be recorded as a significant incident on Datix. It has also explained that a need for raising a Datix was not established by the theatre team.
104. In the SI investigation report it is acknowledged that there was an unacceptable delay in recording the two incidents on Datix. It is recognised that both events fulfilled the criteria to be considered an incident, and attaching the resultant level of harm to the incident would have automatically escalated the incidents to be reported as ‘serious incidents’ to be investigated and prompted discussion with Mr R and his family.
105. The report also accepts the delay in holding a meeting as a failure to fulfil the professional duty of candour, and states there were significant delays in discharging the statutory written duty of candour as the letter was sent on 30 July 2021.
106. We consider this represents a service failure. The two incidents crossed the Trust’s threshold for governance reporting, and an incident form should have been submitted the day of, or the day following, the initial bleed during the thymectomy.
107. We understand that the registrar should not have seen the family on his own on 11 June 2021, as ultimately the consultant was responsible for the care of Mr R and should have been present.
108. Furthermore, the family should not have had to request a meeting with the consultant nearly two weeks after the incident as there should have been an open channel for communication. The two incidents should have been reported in a timely manner, and the clinical team should have been visible and approachable to the family to address any concerns they had.
109. We recognise that this failing affected the family significantly. As the SI investigation report has acknowledged, the family endured an emotionally stressful period, and this was not helped by failures in communication and delays in responding and acknowledging to this incident. It recognised this caused a lot of anxiety for the family.
110. We also consider this contributed to the family’s feelings of a lack of trust, and their concerns that the Trust was not being fully open and honest, nor taking these incidents seriously due to the delays which occurred.
111. The SI report informs us that the family were given an apology from the consultant surgeon at the meeting of 23 July 2021, and we can see that a recommendation was made for the consultant surgeon to reflect on this incident and his own personal practice during his appraisal, as well as ensuring there was directorate-wide education on the Duty of Candour.
112. We understand that a new Duty of Candour policy was shared with all cardiothoracic consultants, and they were directed to complete refresher training. The governance lead was asked to monitor compliance with this and escalate any concerns which arose.
113. The cardiothoracic medical team were also directed to complete training on the importance of incident reporting and the process of reporting, with refresher sessions on incident reporting also offered to CICU and theatre staff.
114. We consider the Trust has provided an explanation of why things went wrong and has identified a proportionate way to put things right to ensure learning takes place. We can see that the SI report has acknowledged the impact this had on the family and has provided an apology for this.
115. Overall, we consider the Trust has taken several steps to address this failing in line with the NHS Complaint Standards. We consider these steps are enough to put things right for the family and ensure learning takes place on incident reporting. For this reason, we do not uphold this part of the complaint as it was fully remedied before our Office received the complaint.
• When Mr R’s case was discussed at the morbidity and mortality meeting, there was no discussion around consent and capacity, as recommended by the Trust’s serious incident report.
116. The recommendations in the serious incident report which relate to this point of the complaint were as follows:
(1) To ensure there is a directorate wide education on the mental capacity act and informed consent process, (2) To share the learning from this incident at the departmental morbidity and mortality meeting.
117. The action plan created by the Trust outlined that for point (1), the Trust MCA specialist would attend the cardiothoracic morbidity and mortality meeting to provide training around consent, best interests and the MCA, and the medical team would access via Trust ‘palms’ training system.
118. For point (2), the action plan detailed that there would be communication with all staff identified in the incident, and learning would be shared with: the cardiothoracic surgery team, theatre team, CICU teams, through a mortality and morbidity case presentation and also at the cardiothoracic governance meetings, the directorate management team meeting, and the patient safety and risk committee.
119. We understand Mr R’s case was discussed in a mortality and morbidity meeting which took place on 2 December 2022, and the minutes of this meeting have been shared with both our Office and the family. We have reviewed the minutes of this meeting. We can see that the surgical team concentrated on the technical aspects of the surgery. There was no mention of the capacity issues or the validity of the consent as recommended in the SI report.
120. The Trust provided us with additional information which says the issue regarding consent and capacity was discussed with an invited speaker on 3 September 2021 as part of the mortality and morbidity meeting. It also explained that Mr R’s case was discussed during a meeting on 6 January 2023, which focused on ‘thoracic returns to theatre’.
121. We also understand the Trust carried out a complete consent audit, and that the governance lead was tasked to monitor compliance with the consent and best interests processes and escalate any concerns which arose. The Trust’s action plan details that compliance with these processes was to be reported regularly in cardiothoracic department meetings.
122. We recognise that the information shared with the family fell short of explaining the additional actions the Trust has taken, and that this led to concern that it had not complied with the recommendations set out in its SI report.
123. We can see there has been department wide learning on capacity and consent, and we understand the consultant and registrar have had the opportunity to reflect on what happened individually during their appraisals.
124. For these reasons, we consider the Trust did comply with this recommendation, and we do not uphold this part of the complaint.
• The registrar and surgical team were not interviewed as part of the serious incident investigation.
125. NHS England’s Serious Incident Framework guidance explains that the level of response (or investigation) should be dependent on, and proportionate to, the circumstances of each specific incident. The appropriate level of investigation is therefore decided during the initial review of the case.
126. It highlights the importance of involving staff in the investigation process, as they will want to know what happened and why, and what can be done to prevent the incident happening again. Undertaking interviews with staff is not a mandatory step but is highlighted in the guidance as a valuable way to gather the relevant evidence and information needed for the investigation.
127. We consider interviewing the registrar and surgical team may have given more insight into their recollections of the events of the operation, rather than the investigation relying on the operation note alone. This is because it is not clear specifically what happened that led to the damage to the vein based on these notes. This may have provided more re-assurance to the family.
128. We can see the following recommendations were made in the Trust’s SI investigation:
• Ensure the consultant surgeon reflects on this incident and personal practice at appraisal in line with Good Medical Practice guidelines.
• Give the surgical registrar opportunity to reflect on the incident and discuss with their educational supervisor and at their annual training review. Offer psychological support and training opportunities.
129. We consider it was a shortcoming, rather than a failing, to not interview the registrar and surgical team, as we can see that these recommendations provided the consultant and registrar the opportunity for learning and support, to ensure they learn from what has happened, and improve their practice going forward. This would have allowed them to explore what happened and identify any contributing factors specific to them.
130. This means that although they were not interviewed during the process, there has still been the opportunity to further understand what went wrong, and to identify any specific contributing factors and root causes.
131. We do not consider the lack of interviews had an impact on the SI report, as it has drawn several key conclusions and has highlighted the failings in the care provided to Mr R. As we have detailed in points 120 and 121 of the report, we know that learning from the incident was shared in departmental meetings, as well as wider directorate learning and reflection on the issues this case has raised.
132. For this reason, we do not uphold this part of the complaint.