The Practice
Appointments in September and November 2019
34. Mrs B says her daughter attended appointments at the Practice complaining of increasing bone pain. She complains the GPs who saw Miss D should have been vigilant to her medical history and the error that had occurred in her care at the Trust in 2017. She says this should have led to the Practice promptly referring her for an MRI or CT scan to check if her breast cancer had spread.
35. The GMC’s Good Medical Practice says doctors who assess, diagnose or treat patients must, ‘adequately assess the patient’s conditions, taking account of their history’, and where necessary, ‘examine the patient’. They should also, ‘promptly prove or arrange suitable advice, investigations or treatment where necessary’ and ‘refer to another practitioner when this serves the patient’s needs’.
36. On 2 September 2019, Miss D attended the Practice reporting neuropathic pain that was affecting her hands and feet. Neuropathic pain is pain caused by problems with the nervous system. Miss D said she had seen a hospital consultant who had advised she could take gabapentin; this is a medication used to treat nerve pain. The GP agreed to prescribe this.
37. The next relevant appointment was on 23 September. Miss D attended for a review of the gabapentin, and she reported she now had hip pain. The records say she described this as a throbbing sharp, shooting pain that felt worse at night.
38. Our GP adviser has said this type of pain that is throbbing and feels worse at night can be a sign of metastatic breast cancer in the bone.
39. At this appointment, the GP queried if the pain could be nerve entrapment, or, in consideration of Miss D’s history of breast cancer, if there was a more serious underlying cause. The GP ordered an urgent X-ray.
40. The referral to the hospital explains the GP’s reason for requesting the X-ray. It notes Miss D’s history of breast cancer and the purpose of the X-ray was to ‘ensure no pathological fracture [fracture caused by a disease] or metastases [spread of cancer] casing pain’.
41. Our GP adviser has said this information means the radiologist reviewing the X-ray would have been specifically looking for any signs of disease. The radiology report says the X-ray showed no abnormalities.
42. Mrs B questions why the GP did not refer her daughter for an MRI or CT scan straight away. Our GP adviser has said an X-ray was an appropriate first test to help rule out the possibility of cancer.
43. Miss D next attended the Practice on 14 October and reported she was still feeling pain in her hip, she also now had this in her lower back and leg. The GP discussed how she could manage the pain and referred her to a physiotherapist.
44. Our GP adviser has said the referral to physiotherapy was appropriate because a physiotherapist specialises in muscular-skeletal issues. They can carry out a thorough evaluation of the person’s medical history, physical symptoms and functional abilities.
45. The records show the Practice offered Miss D different dates to see the physiotherapist and booked this for 16 November. Miss D attended two further GP appointments before this date. The GPs noted she was due to have the physiotherapy review and discussed her pain medication while she was waiting for this.
46. On 16 November, Miss D attended the physiotherapy appointment. The physiotherapist examined her and noted her increasing pain in addition to her history of breast cancer. Despite the recent X-ray result, they decided she should be referred for an urgent MRI scan of her whole spine.
47. The Practice arranged the referral and Miss D had the MRI scan on 29 November. This showed evidence of tumour deposits in her spine which meant the cancer had spread to her bones. We are sorry for how devastating this news was for Miss D and her family.
48. Our GP adviser has carefully reviewed the appointments Miss D attended between September and November 2019. They have summarised that when she first attended reporting hip pain, the GP wanted to rule out cancer as a possible cause and requested an X-ray. When the X-ray came back as normal but the location of her pain spread and continued, they referred her to physiotherapy. They helped manage her pain with medication while she waited for the appointment.
49. Our GP adviser has said these actions were appropriate to investigate what was going on, and to support Miss D during this time. They also commented the MRI scan showed tumour deposits in Miss D’s spine, not her hip. The reason she was feeling pain in her hip could have been due to the tumour deposits causing pain to radiate down into her hips. This can feel like nerve pain.
50. In consideration of the advice we have received, we find the care and treatment Miss D received between September and November to investigate her symptoms met with the GMC guidelines quoted in paragraph REF _Ref174547040 \r \h 35. We consider the Practice recognised Miss D’s medical history and wanted to rule out cancer. It made appropriate referrals to investigate this, and did not delay in acting on these concerns. We have therefore not seen failings here.
51. We recognise how strongly Mrs B feels the Practice should have acted with greater urgency in response to Miss D presenting with red flags for secondary breast cancer. She has told us she considers an earlier diagnosis could have allowed Miss D to start a trial of treatment before the COVID-19 outbreak that resulted in its cancellation. We are sorry this remains a source of considerable distress to Mrs B. We hope we have been able to clearly explain why we have not found failing in the Practice’s management of Miss D’s care.
Pain medication prescriptions
52. Mrs B complains that as Miss D’s symptoms worsened in 2020 and she required strong painkillers to manage her pain, reception staff at the Practice questioned why she was asking for them. Mrs B says her daughter was having to use crutches to move around by this point, she was exhausted and in pain. She considers the Practice staff’s behaviour showed a lack of understanding of the needs of a terminally ill patient.
53. Following Miss D’s diagnosis of secondary breast cancer, the Trust referred her for palliative care. The Practice records show the palliative care team told the Practice what medications it should prescribe, and the dosages, to help manage Miss D’s symptoms.
54. Our GP adviser has said it would be expected for the Practice to respond to the palliative team’s instructions, and the records support it did this. There is a record from 23 December of the Practice issuing a prescription in-line with the team’s recommendations.
55. There is evidence of the Practice communicating with the palliative care team over the following months as they responded to Miss D’s developing condition.
56. On 13 March, Miss D called the Practice to say the palliative care team had increased her medication, but the Practice said they had not had any paperwork through about this yet. A GP tried calling the team but was unable to reach them and so left a message. The team called the GP back shortly after, they discussed Miss D’s new medication requirements and the GP prescribed these for her.
57. The GMC’s Good Medical Practice guidance that says doctors must, ‘prescribe drugs or treatment, including repeat prescriptions, only when you have adequate knowledge of the patient’s health and are satisfied that the drugs or treatment serve the patient’s needs.’
58. We do not therefore have concern the GP decided to check with the palliative care team about Miss D’s medication requirements before going ahead and issuing the prescription.
59. We understand Mrs B’s key concern is that Miss D faced questioning from the Practice’s reception staff when she requested repeat prescriptions for her pain medication. She says Miss D felt the team were accusing her of asking for too much medication, and they did not understand her needs.
60. The Practice did not keep records of the reception team’s communication with Miss D. Mrs C, Miss D’s sister, has provided us with a screenshot of communication Miss D sent to her on 13 February 2020.
61. Miss D’s message says reception staff were being ‘resistant’ to giving her a prescription for OxyNorm, this is a liquid opioid, a strong painkiller used for moderate to severe pain. She describes them questioning if she had used her previous prescription up already. Miss D said she was feeling anxious about speaking to them.
62. Miss D says she then spoke to a GP and ‘burst into tears’, explaining how bad the communication was making her feel. She says the GP seemed to finally understand and prescribed two bottles of the medication and agreed to speak to the staff in question.
63. The GP records document Miss D saw the GP that day and explained the one bottle of OxyNorm did not last long and the GP agreed to prescribe an extra bottle.
64. We have not seen reason to question the accounts and evidence Mrs B and Mrs C have given us regarding their conversations with Miss D about the communication she had with some of the staff at the Practice and how this made her feel.
65. Our Principles of Good Administration say public bodies ‘should behave helpfully’ and ‘treat people with sensitivity, bearing in mind their individual needs’.
66. We do not have concern with the GP’s discussions with Miss D around her medication needs and checking this with her palliative care team because it is their responsibility to prescribe responsibly. If the reception staff had concerns about Miss D’s repeat requests, these should have been discussed with a GP, not directed to Miss D. We do not consider the Practice staff communicated with Miss D in-line with our Principles.
67. Our Complaint Standards say that to address an impact someone has suffered, ‘staff [should] identify suitable ways to put things right for people. Staff [should] give meaningful and sincere apologies and explanations that openly reflect the impact on the individual or individuals concerned’.
68. In terms of how the Practice responded to what happened, it has apologised for how its staff made Miss D feel and the GP spoke directly to the staff involved so they could reflect on this.
69. We consider the Practice’s actions were appropriate in acknowledgement of Miss D’s experience and to address what happened. This meets with our Complaint Standards. For this reason, we will not ask the Practice to take any further action here.
70. We can see in the records Miss D was reporting increasing pain over the months in question. Our GP adviser has said bone pain can be unrelenting and very difficult to manage. We are sorry for how distressing it has been for Mrs B to consider Miss D struggled at any point to get the medication she needed, or that staff questioned her about this. We hope we have been able to offer Mrs B reassurance of the actions the Practice took to address this matter.
Complaint handling
71. Mrs B complains about how the Practice managed her complaint. She has told us its complaints process was unclear and it took too long to respond. She says this process added to her stress while she was grieving for Miss D and just wanted answers for what had happened.
72. Mrs B wrote to the Practice Manager on 17 November. She explained how devastated she and her family were by their loss and she had questions about Miss D’s care. She asked why the Practice had not referred Miss D for an urgent MRI scan in September due to her report of bone pain and in consideration of her medical history.
73. The Practice Manager responded the following day expressing their condolences for Mrs B’s loss. They said the Practice was ‘no longer the Data Controller of the records’ and Mrs B should contact Primary Care Support England.
74. Mrs B responded on 22 November to say she had not requested her daughter’s records and wanted to know the answers to her questions about Miss D’s care. The Practice responded the following day to say they needed access to Miss D’s records to be able to respond and they would be in touch.
75. Our Complaint Standards define a complaint as, ‘an expression of dissatisfaction, either spoken or written, that requires a response. It can be about: an act, omission or decision you have made, and/or the standard of service you have provided’.
76. Mrs B’s contact with the Practice on 17 November meets the criteria of a complaint. It sets out her concern her daughter did not have an earlier MRI scan, she asks for the reason for this and explains her concerns about the impact this caused.
77. Mrs B has said she found the Practice’s initial response to be evasive and obstructive. We consider the Practice appeared to misunderstand the purpose of Mrs B’s contact and therefore missed identifying this as a complaint.
78. In terms of the timeline of the complaint, once the Practice recognised Mrs B’s contact required a response, it sent its first letter on 26 November (although Mrs B tells us she did not receive a readable copy of the letter until 1 December).
79. Mrs B wrote to the Practice again on 13 December setting out why she remained unhappy with what happened with her daughter’s care. She says the Practice did not tell her the timeframes within which it would respond.
80. The Practice issued a second response on 15 January 2021. Mrs B continued to respond to the Practice with the assistance of a complaint advocate which led to a further response letter on 24 March and a final response on 19 April.
81. NHS Complaint Handling Regulations say organisations should issue a written response to a complainant ‘as soon as reasonably practicable after completing the investigation’. If this takes longer than six months, the organisation should write to the complainant to explain why.
82. In consideration of how long it took for the Practice to respond to Mrs B, we can see it did so well within six months of receiving the complaint. We therefore do not have concern with how long it took the Practice to respond to Mrs B’s complaint.
83. Our Complaint Standards also say staff should ‘give clear timeframes for how long it will take to look into the issues’ raised in a complaint. They should ‘make it easy for everybody to understand how the process works’, and this includes being clear about what will happen next.
84. Mrs B has told us the Practice did not tell her what to expect through the complaints process and she felt frustrated by this and that the Practice was being obstructive when she just wanted answers for what had happened. We have not seen evidence to support the Practice told her about its complaint process or when to expect responses by.
85. We also note the letter the Practice issued on 26 November ends by saying it hopes it has satisfied Mrs B’s queries. It does not tell her what she can do if she remains dissatisfied. We do however recognise the later letters issued contain information about our service should Mrs B remain unhappy.
86. In summary, while we have not seen concern with how long it took for the Practice to respond to Mrs B’s complaint, we have found issues in the way it first responded to her, and in its lack of communication about the complaints process. These actions do not meet with our Complaint Standards quoted in paragraph REF _Ref194391213 \r \h 83 and so we consider these issues are failings in complaint handling.
87. We understand the way the Practice managed Mrs B’s complaint caused her upset and stress at an already very difficult time. We are very sorry to hear of how this affected her. We have set out our recommendations for the Practice at the end of our report.
88. Mrs B has also complained about the content of the complaint responses. She says the Practice did not answer all her questions and she does not agree the accounts it has given are accurate. We are very sorry to hear of Mrs B and Mrs C’s accounts of finding it heartbreaking to read through Miss D’s medical records so they could challenge the Practice’s responses.
89. Our Complaint Standards say organisations should give fair and accountable responses to complaints. They should give a ‘clear, balanced account of what happened based in established facts’. Our Standards say organisations should give colleagues directly involved in the issues the opportunity to have their say.
90. We understand Mrs B has particular concern the Practice did not make it clear the physiotherapist who saw Miss D in November prompted the arrangement of the urgent MRI referral.
91. The Practice said an MRI was arranged after Miss D saw the physiotherapist. This ‘was also discussed with us’ and they agreed an urgent scan was necessary.
92. The record of the physiotherapy appointment on 16 November says, ‘Urgent - MRI whole spine to be sent today’. The Practice notes show it confirmed to the radiology team the referral was urgent.
93. Following careful consideration of what the Practice said in its response, we do not think this is inaccurate information. We recognise Mrs B’s concern the physiotherapist prompted the MRI referral and we think the Practice has acknowledged this.
94. Mrs B also does not consider the Practice understood her view that if Miss D had an MRI sooner, she would have had an earlier diagnosis and could therefore have started the trial cancer treatment earlier, before this was cancelled due to the pandemic.
95. In its letter dated 26 November, the Practice obtained comments from Miss D’s oncologist at the Trust. The oncologist is quoted as saying an earlier MRI scan would not have affected Miss D being able to start the drug trial. This was because Miss D started with a first line treatment, and it was when they identified this was not working for her that her team decided to move her to the trial treatment. Unfortunately, this happened at the time the pandemic halted the trial.
96. We acknowledge Mrs B’s point that an earlier diagnosis could have allowed time for the team to identify earlier that the first line treatment was not working and could have moved her to the trial before March 2020. We understand it has caused Mrs B significant distress to think of how things could have been different for her daughter.
97. While we recognise the Practice has not directly acknowledged Mrs B’s point on this, we can see it tried to address her concern through asking Miss D’s oncologist for their view. The Practice also did not consider it delayed requesting an MRI for Miss D, and so we can understand why it did not further explore this.
98. We consider the Practice obtained further information to try and address Mrs B’s concern. We recognise Mrs B found this unhelpful. Following careful consideration, however, we do not think the Practice’s approach to responding to this part of Mrs B’s complaint falls below our Complaint Standards.
99. Mrs B has further complained the Practice referred to Miss D as still being under the care of the breast cancer team in 2019. Its response said ‘she was already undergoing investigations’ and this is why they did not refer Miss D back to the oncology team.
100. Mrs B has told us Miss D was only attending hospital in 2019 for post reconstructive surgery care. She has told us the Practice’s comment added to her distress and she felt it was not being open and honest with her.
101. From the information we have seen, there is no evidence Miss D was under-going further investigations at the Trust during this time, and so we recognise Mrs B’s concern. This appears to be an inaccuracy in the Practice’s response. However, we also note the Practice considered it acted appropriately in how it managed Miss D’s care during this time, and this reflects our view.
102. We recognise the Practice’s explanation was unhelpful to Mrs B. Following careful consideration, we do not find this issue falls so far below our Complaint Standards that this was a failing.
103. Following review of the content of the Practice’s complaint responses, we consider it provided detail that reflects the information in Miss D’s medical records. We think it reasonably responded to Mrs B’s questions and have not seen evidence it provided information that fell below our Complaint Standards.
104. Mrs B wanted clear answers about what had happened with Miss D’s care and treatment in 2019. We acknowledge Mrs B disagrees with the Practice’s explanations and this has been a considerable source of distress for her. We hope we have been able to explain why we have not found failing in the content of the Practice’s complaint responses.
The Trust
Our approach
105. In 2017, Miss D underwent mastectomy surgery intended to remove the cancer from her breast. A few months later, Miss D felt a lump in the same area and reported this to her surgeon. The surgeon arranged follow-up tests and at an appointment in May 2018, told Miss D they had missed removing her tumour during her surgery.
106. The surgeon operated on Miss D again in June 2018 and removed the tumour. Clinical staff did not report or escalate this error and so no investigation took place at the time to understand what had happened and why.
107. Mrs B and her daughter Mrs C’s complaint to the Trust in January 2021 led to it determining it needed to carry out an SI investigation. Through its investigation, the Trust confirmed Miss D’s breast cancer team should not have assumed her treatment was a success in 2017 when the histopathology report of the removed tissue found no evidence of the marker clip inserted prior to the surgery, and no evidence of a tumour.
108. The Trust found staff had not reported anything had gone wrong and this should have happened at the time of the events. Following discussion with Mrs B and Mrs C, the Trust also considered its breast cancer Clinical Nurse Specialist (CNS) team could do more to support patients.
109. The Trust provided complaint responses to Mrs B and Mrs C for issues not included in its SI investigation.
110. Through its work, the Trust agreed to take a number of actions and produced an action plan in response to the findings of its SI investigation. Mrs B and Mrs C did not feel the Trust has yet fully addressed the impact of what happened to Miss D, and so they brought their complaint to us.
111. Mrs B told us she feels heartbroken there was such a serious error in her daughter’s care. She has told us of the considerable shock she suffered, not just because of her significant loss but also through knowing what Miss D endured. She describes Miss D going through extensive radiotherapy after her second surgery and she has no doubt that if the surgeon had correctly removed the tumour, Miss D could have avoided all this additional treatment.
112. Mrs C also provided us with a copy of a letter Miss D wrote around the time of these events. In this letter, Miss D describes the surgeon telling her about the mistake in her surgery and that she was devastated to hear this after already enduring six months of treatment and knowing she now had to face more.
113. Miss D described her life being on hold as she was now going through ‘endless hours of hospital appointments, constant worrying, suffering horrendous side effects from treatment and the prospect of multiple hospital admissions’. She described the significant impact this was having on her mental and physical wellbeing, and how terrified she felt for the future.
114. We thank Mrs C and Mrs B for sharing Miss D’s words with us. We recognise this reinforces their drive to make sure positive changes happen as an outcome for all they have been through as a family.
115. The Trust has not disputed errors occurred in Miss D’s care. Our approach has therefore been not to re-examine these issues, but to consider if the actions the Trust has since taken sufficiently address the impact of what happened. We address these concerns in turn.
Concern 1: The error in Miss D’s 2017 surgery
116. The Trust’s SI investigation report says that when the histopathology report of Miss D’s breast tissue did not find the marker clip or evidence of a tumour, this should have prompted investigation and re-assessment of the surgery. This did not happen.
117. In response to what went wrong, the Trust agreed to take the following actions:
• Develop and implement a Standard Operating Procedure (SOP) to strengthen and provide consistency for the management of all mastectomy specimens.
• It said the SOP would include clarification of which specimens require an X-ray, for multi-disciplinary team meeting (MDT) minutes to document the signs of tumour response and whether the clip has been located, and for histopathology reports to include identification of marker clips.
• Following the introduction of the SOP, the Trust planned to audit staff compliance with the SOP and act on the results as necessary.
118. The Trust also shared a copy of its SI report and the learning taken from this at governance meetings and a safety and risk forum meeting. These meetings took place in 2021.
119. Our Complaint Standards say, when responding to a complaint, organisations should:
• Act to make sure any learning is identified and used to improve services. To do this, organisations should determine the impact of the failing they have identified and the impact on the person making the complaint.
• Actions to address an impact may include, ‘revising policies and procedures to stop the same thing happening again’ and reassuring the person complaining of the difference its actions will make. To do this, organisations can consider sharing draft copies of proposed policy and process changes with the complainant and sharing objectives of new training planned.
120. The Trust shared a copy of its new SOP with Mrs B. This is called: ‘Specimen x-rays to be performed on all mastectomies’. It sets out the steps the clinical team should take, including putting the specimen of tissue into a clear bag and container and sending this to radiology for X-ray.
121. The SOP says the images taken by the radiology team will be available for the surgical team in theatre to view before closing the skin. It also says MDT meeting minutes must document the signs of the tumour response, and whether they found the marker clip. The histopathology report of the tissue sample must also include identification of the marker clip.
122. In response to seeing the SOP, Mrs B asked the Trust what would have happened in Miss D’s case had this been in place in 2017. The Trust said the team would have X-rayed Miss D’s mastectomy specimen. When the X-ray did not show a marker clip, they would have arranged a follow-up mammogram six weeks later.
123. The Trust went on to share that after rolling out the SOP, it completed an audit on compliance. The audit found X-rays were completed in 91% of applicable cases, with a clinically appropriate rationale given in the remaining 9% of cases to explain why X-rays were not done.
124. Our breast cancer surgeon adviser has reviewed the Trust’s actions. They have confirmed further action is required if following a mastectomy, clinicians do not find evidence of either the cancer, fibrosis indicating a cancer response (tissue damage caused by chemotherapy), or the marker clip in the removed tissue. The team should not assume this is due to a complete response to chemotherapy treatment.
125. Our adviser has commented that while the Trust has said that the team will arrange a mammogram six weeks later if X-rays do not show a marker clip, this is not set out in the SOP. There is also no advice for what should happen if the mammogram does not show the clip.
126. Our adviser has said marker clips can become displaced, or even fall out, during mastectomy surgery. This means if a post-operative mammogram does not show a clip, this can provide false reassurance the cancer has been removed. A marker clip is an indicator of the cancer location, and the key issue is not what has been taken out of the patient, but what may have been left inside. Our adviser has commented it could be sensible to consider other types of scans should this circumstance arise, such as an ultrasound or MRI to check no cancerous tissue remains in the patient.
127. We recognise the Trust’s SOP ensures that in applicable cases, any tissue removed during a mastectomy is X-rayed so the operating team know if the clip is present before completing the surgery. It does not tell the team what to do if they do not find the clip, which is what would have happened in Miss D’s case.
128. We consider the lack of a documented process could lead to variance over time in how teams respond to this scenario.
129. Mrs B has told us they did not feel assured by the Trust’s actions and she remains concerned they will not make a difference to patient safety. We understand how much this means to her.
130. In consideration of the advice we have received, we find the Trust’s actions partially address the error that occurred in Miss D’s surgery. We recognise how seriously the Trust has taken this complaint and we can see it has improved its procedures. However, we do not consider the action taken offers sufficient assurance the error that occurred in Miss D’s case will not happen again.
131. We consider the Trust’s actions do not fully meet our Complaint Standards referred to in paragraph 119 and this is a failing. We have set out our recommendations at the end of this report.
Reporting and escalation of the incident
132. The Trust’s SI investigation found that although Miss D’s surgeon and a nurse told her about the error in her surgery in May 2018, and MDTs discussed her case, staff members did not escalate and report the incident. It was not until Mrs B and Mrs C raised their complaint with the Trust in January 2021 that it became aware of what had happened and this prompted its investigation.
133. The SI report referred to the Trust’s Incident Management Policy which says serious incidents that have had a serious impact on an individual must be reported on DATIX (a reporting system for incidents and risks) ‘immediately or at the earliest opportunity’. NHS England’s Serious Incident Framework says a serious incident should be reported ‘without delay and no longer than 2 working days after the incident is identified’.
134. The Trust also did not send Miss D a Duty of Candour letter. The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014: Regulation 20 says that an NHS organisation that becomes aware of a safety incident must notify the person of this, provide them with support, complete a written record of what happened and give the person a follow-up written notification of the incident.
135. Through its investigation, the Trust found several members of staff were aware of what had happened, but they did not log the incident on DATIX or escalate this through its governance route. The Trust’s report said, ‘we have been unable to identify why this did not happen’ and confirmed this should have been done.
136. On review of these events, we can see Trust staff did not report and escalate the error in Miss D’s care in-line with the NHS England guidance or the Health and Social Care Regulations referred to above. We find failing in this.
137. To address what happened, the Trust said it would take the following actions:
• produce a Trust-wide communication to ‘raise the profile of incident reporting’ • under-take a spot-check audit of reported incidents to review how long it took for incidents to be reported and depending on the results, share the outcome and take further actions as necessary.
138. In June 2021, the Trust reminded staff of their responsibility to report incidents and in September 2021, it carried out an audit of this.
139. During our investigation, the Trust told us that while carrying out these actions, it spoke to the staff involved and identified the reason they did not report or escalate the incident. It found staff did not recognise the error in Miss D’s care as a safety incident, did not identify the seriousness of the issue, and considered the impact of what happened was unknown. For this reason, they did not report or escalate this.
140. NHS England’s Serious Incident Framework says an investigation must be conducted using a root cause analysis approach to identify the problem, the contributory factors that led to the problem and the ‘fundamental issues/ root cause (the why?) that need to be addressed’.
141. Identifying why an issue arose is key to determining any possible issues or weaknesses in a system or process that need to be addressed so this does not happen again. The Trust’s SI investigation did not identify ‘the why?’ behind the lack of action by staff. We consider this was a gap in the Trust’s investigation.
142. Due to the investigation not identifying why staff did not report the incident, Mrs B still has questions about this. She is particularly concerned this may have arisen due to staff feeling unsafe or unable to report concerns confidentially.
143. The Trust has told us it does not consider this is the case and referred to policies it has in place to ensure staff have avenues to be able to raise concerns outside of the formal reporting process. This includes having a Freedom to Speak Up guardian who provides a confidential way for staff to raise any concerns.
144. It also has a ‘Speaking Up – Freedom to Speak Up: Raising Concerns (Whistleblowing) Policy’. This is a process which allows staff to speak up about a range of issues, including ‘anything that gets in the way of patient care’, and anything that does not feel right, such as ‘a way of working or a process’ not being followed. We recognise Mrs B and Mrs C have continued concerns around this issue, but we consider these processes are appropriate to enable Trust staff to raise their concerns in confidence.
145. On review of the actions the Trust took following the outcome of its SI investigation, its audit of reported incidents focussed on the timeliness of the reporting. It’s Trust wide communication focussed on raising the profile of incident reporting. Staff who were involved in the case were also ‘reminded of the importance’ of this.
146. The actions the Trust has taken aimed to raise the profile of incident reporting and the timeliness of reporting. We consider these actions will ensure that once staff identify a safety issue, they report this in a timely way and are aware of how to do this. However, we do not consider they address the root cause of ensuring its staff can identify a patient safety issue in order to follow the correct reporting process.
147. Having considered the NHS England guidelines and our Complaint Standards, we find failing in the Trust’s SI investigation to fully identify and address this issue.
148. It is relevant to recognise that in 2022, NHS England replaced the Serious Incident Framework with the Patient Safety Incident Response Framework (PSIRF). Its purpose is to make sure there is an effective patient safety incident response system in place across NHS organisations. The Trust confirmed to us it has since rolled PSIRF out.
149. PSIRF replaces the approach of using a root cause analysis and instead promotes a wider approach that considers the systems in place and human factors that may have led to the safety incidents. We recognise this will have made a difference to how the Trust investigates incidents.
150. The Trust’s Incident Management Policy underpins PSIRF. The current version of this says, ‘individual employees have a responsibility to report all incidents and near misses’. We do not consider the Trust’s actions yet explain how it supports its staff understanding how to identify a safety issue and how it monitors this, in-line with this policy.
151. Mrs B remains concerned this issue could happen again, and this causes her continued distress. This is an outstanding impact to Mrs B and so we have set out recommendations out at the end of this report.
SI Investigation
152. In terms of how the Trust completed its SI investigation, Mrs B complains it did not interview the staff involved in Miss D’s care. She considers this means the individuals involved have not learned from what happened and have not been held accountable.
153. The SI Framework says organisations should have clear procedures in place for staff to follow immediately when a serious incident has occurred. This involves taking ‘written accounts/statements from those involved’ and ‘interviews with relevant individuals’.
154. Due to the three-year delay in the SI investigation taking place, the Trust said it no longer employed some staff, including Miss D’s surgeon. The Trust explained the surgeon was no longer a practicing clinician and had been removed from the GMC’s [General Medical Council’s] register. The GMC regulates doctors in the UK.
155. At Mrs B’s request, the Trust agreed to contact the GMC to make it aware of the findings. We note the Trust did not initially agree to do this but acted following Mrs B’s insistence in recognition that retired clinicians can still re-register with the GMC.
156. This issue links in with the concern we have considered above about the delay in the investigation taking place. If the investigators had interviewed the staff involved in Miss D’s care as part of the investigation, or had taken written statements, it is likely this would have uncovered the root cause behind staff not reporting the incident at the time of events.
157. We consider it would have been appropriate for the Trust to speak to the staff involved in Miss D’s care where possible when completing its investigation. We find failing it did not do this, in-line with the SI Framework.
158. As noted above, the Trust has since rolled out PSIRF which replaces the SI Framework. The Trust says it has done a ‘significant amount of promotion and education’ on good quality investigations and learning responses. It says that investigations are completed by someone with the necessary level of training and it is now confident that ‘all staff involved in such an incident would routinely be interviewed as part of this process in a timely manner’.
159. Mrs B further complains she and her family were not involved in the SI investigation process. She says the Trust did not give her the opportunity to see a copy of the SI investigation report before it was finalised in June 2021 and shared with its Clinical Commissioning Group (CCG). CCGs were responsible for commissioning NHS services (they have since been replaced by Integrated Care Boards (ICBs)).
160. The SI Framework says there should be ‘early, meaningful and sensitive engagement with affected patients and/or their families/carers, from the point at which a serious incident is identified, throughout the investigation, report formulation and subsequent action planning through to closure of the investigation process’.
161. The Trust met with Mrs B and her daughter Mrs C on 8 November 2021. They explained the report had led to many more questions about Miss D’s care, and did not address all their concerns. They also found the language inappropriate, in particular the use of the words a ‘recurrence’ of Miss D’s cancer and a ‘new lump’, instead of it being clear the tumour had not been correctly removed in 2017.
162. The Trust initially told Mrs B and Mrs C it was too late to change the report, but after their complaint advocate asked if the CCG would accept an amended version, the Trust agreed it would listen to her feedback and make changes. Mrs B provided us with a timeline of what happened and this shows she went on to see further versions of the report, accepting the fifth version as being accurate. The Trust re-shared this version with the CCG.
163. We consider that had the Trust involved Mrs B and her family in the investigation process from the start, in-line with the SI Framework, this would have avoided inaccuracies in the first version of the report and the distress caused by this. It could also have led to an earlier agreement on a final version of the report. We find failing this did not happen.
164. The Trust has told us the introduction of PSIRF means they now make sure they include patients and their families in investigations (as appropriate), and ‘give them the opportunity to review the draft report and take their feedback into account before signing the report off as concluded’.
165. Mrs B has told us how challenging it was to go through the Trust’s investigation process, and that she and Mrs C had to work hard to state their case, and why they were not satisfied with the initial responses. We are sorry to see how hard this was for them when they were already going through a very difficult time following their loss. We recognise Mrs B and Mrs C fought hard to make sure all their concerns were heard.
166. From the evidence we have reviewed, we recognise the Trust has learnt from Mrs B’s experiences, and we can see the introduction of PSIRF has led to substantial changes to the way it investigates serious incidents. We thank the Trust for the detailed information it has shared with us to assist with our work. However, the Trust has not yet shared these details with Mrs B.
167. This means there is a remaining impact to Mrs B as she still feels concern the errors that occurred in the investigation process could happen to someone else, and this is a source of distress for her. We have therefore set out our recommendations out at the end of this report.
Clinical nurse specialist (CNS) team
168. Mrs B and Mrs C have told us Miss D felt very alone in her final months and did not feel supported by the CNS team. They have told us the team did not reach out to Miss D and she would try calling and they would not always contact her back. When they met with the Trust, Mrs C highlighted that over a period of 114 days, the CNS team had only had contact with Miss D on 17 occasions.
169. The Trust said that when a patient is diagnosed with cancer, at their first appointment with a CNS, they are given a card with contact details for the team. The Trust explained the team is small, but they aim to return any missed calls within 24 hours. They listed the contacts Miss D had with the team from May 2018 to June 2019.
170. In response to the feedback from Mrs B and Mrs C, the Trust agreed its CNS team could do more to support patients, and they had let Miss D down. They agreed to take actions in response to this concern. It reviewed the information packages given to patients and developed a leaflet for patients setting out the role of the CNS team and what to expect.
171. The Trust provided a copy of this leaflet to us and our breast cancer surgeon adviser commented the leaflet is a good step towards improving services. We consider the leaflet clearly sets out who the CNS team is, how to contact them and what to expect from their service. It also sets out the care pathway a patient can expect to travel through.
172. The Trust also told Mrs B and Mrs C they had employed a Macmillan co-ordinator to ensure the nursing team was supporting patients as necessary. The Trust has confirmed to us the co-ordinator has made a positive difference to the service. They also now have a CNS on site at hospital who is present at specific clinics to support patients. We hope this offers reassurance to Mrs B the Trust has committed to this improvement in its service.
173. Our breast cancer surgeon adviser has commented the Trust has taken positive action to address the level of CNS support available to patients. But they said there is no evidence of how the team assesses the level of support individual patients may require. Some patients may be satisfied with minimal interactions, whereas other patients who are perhaps vulnerable, who are young, or where an error has occurred in their care, may need additional support.
174. Our adviser has said it can be helpful to have a tiered level of support available. This requires assessment of the individual patient to determine the level of support that is right for them, and re-assessment of this need through the treatment pathway.
175. The Trust has since told us its CNS team assesses patients’ level of need and they develop an individualised care plan to meet this. We are pleased to hear the team offers this level of support; however, we recognise it has not yet shared this information with Mrs B.
176. Mrs B has told us she does not consider the Trust identified how vulnerable Miss D was. She does not feel the Trust’s actions show the CNS team will be able to identify other patients who like her daughter, may need more support. She has told us she feels the team needs to be proactive in keeping in touch with patients, and a leaflet alone is not enough to do this. As noted above, the Trust has done more work around this concern but it has not shared this with Mrs B. We therefore consider the Trust has not fully addressed the impact and this is a failing.
177. We consider the Trust should further explain the improvements to its CNS team to Mrs B, in-line with our Complaint Standards. We have set our recommendations out at the end of this report.
Complaint responses
Communication
178. Mrs B has told us a consultant telephoned Miss D on 24 March 2020 to tell her due to the evolving COVID-19 situation, a trial of treatment she had been scheduled to start had been suspended. At the time of taking the call, Miss D was sitting in the car park having been in the hospital building all day. Mrs B says Miss D video called her after speaking with the consultant and was distraught. She says Miss D understood there were no other options and this trial was her last chance of extending her life, and this was the end of the treatment pathway for her.
179. Mrs B has a recording of this video and shared it with the Trust to show the impact to Miss D. She complained the consultant should not have delivered such significant news over the phone, and feels the approach was inhumane. She considers the consultant should have asked where Miss D was and arranged for someone to be with her for support, such as a nurse, while delivering the news.
180. The Trust shared Mrs B’s feedback with the consultant for comment and reflection. The consultant said it was important for Miss D to know in a timely manner the trial had been suspended so she did not attend for procedures that had been scheduled in preparation for the trial starting. The consultant was working from home and decided to call Miss D as the lead for the trial, so he could personally deliver the news and fully explain the decision to her.
181. The consultant said he was upset and disappointed by the feedback from Mrs B. He said he spoken to Miss D on more occasions following this call and she did not raise concerns with how he had delivered the news. He recognised she was very upset she would not be taking part in the trial. He also explained this was a call to say the trial would not be going ahead, it was not to say there would be no more treatment for her.
182. We can see the consultant was informed of Mrs B’s feedback and reflected on this. The Trust explained the purpose of the consultant’s approach, but it also recognised and apologised for the distress caused.
183. Following careful consideration of the Trust’s response and actions, we think it listened to Mrs B’s comments and provided feedback to the member of staff. We consider the Trust’s explanation and apology for the impact is appropriate and it has suitably addressed Mrs B’s concern in-line with our Complaint Standards.
184. We recognise how much this concern means to Mrs B, and that she feels continued upset and distress about the impact this news and how it was delivered, caused Miss D. We hope we have been able to clearly explain why we will not ask the Trust to take further action here.
Expediting Miss D’s treatment
185. Mrs B complained that after Miss D was told in 2018, she needed further surgery, she had to wait six weeks for this to go ahead. Mrs B has told us this was an unacceptable wait for someone who has just been told something had gone wrong with their treatment.
186. The Trust said the surgery was arranged in the context of a caseload of patients all waiting for surgery, based on clinical need. However, it said that in consideration of Miss D’s circumstances: ‘we accept that a discussion around expediting her surgery could have been explored, and Miss D informed of the outcome to alleviate any additional anxiety caused by this wait’.
187. The Trust confirmed it should have taken the effect of the psychological distress to Miss D during this time into account. It has said this may not have resulted in Miss D having the surgery sooner, but it offered sincere apologies this did not happen.
188. The Trust said this issue was discussed at its Morbidity & Mortality and governance meetings as part of the investigation process. It was also fed-back to the team involved by the complaints manager and patient safety specialist. The Trust told us it did not consider this was a continued theme in any complaints it has since received.
189. We are satisfied that the Trust’s actions show it has appropriately recognised what should have happened and apologised. It has shared learning through its meetings and in feedback to staff. We therefore consider the Trust has taken sufficient action to address what happened, in-line with our Complaint Standards.
190. We understand the distress Mrs B suffered when she felt the Trust was not prioritising her daughter after it had identified a serious error in her care. We are sorry to hear of the continued concern she feels about this. We hope she is reassured by our consideration that the Trust has learned from this part of her complaint.