Detection of cholangiocarcinoma 13. Mrs R believes that with the tests her sister was having for her breast cancer, the Trust should have picked up she was suffering from another type of cancer.
14. The Trust has said regular blood tests or CT scans are not provided as routine follow up of breast cancer patients and are only done if any unusual symptoms develop. It says that since Ms E’s cancer was localised to the breast and her lymph nodes were not involved, no staging CT or bone scans were indicated.
15. The records indicate Mrs R underwent treatment for breast cancer between November 2018 and June 2019. She then received yearly mammogram to screen for recurrence.
16. The Royal College of Radiologists (RCR) Guidance on screening and symptomatic breast imaging explains breast cancer patients with low-risk disease typically have one mammogram per year for the first five years after treatment to monitor for local recurrence.
17. This guidance also states: ‘Metastatic disease at presentation occurs in only 4–6% of patients; whole-body staging is not required in the vast majority of cases’.
18. Also, NICE guidance on Early and locally advanced breast cancer requires: ‘1.13.1 Offer annual mammography for 5 years to all people who have had or are being treated for breast cancer’.
19. Our breast surgeon adviser explains low-risk patients, such as those with node-negative cancer (as Ms E had), have no routine investigations such as blood tests or regular body scans as part of their standard follow-up. These investigations are usually only prompted by symptoms reported by the patient, which was not the case here.
20. Therefore, the actions taken by the Trust in screening Ms E once a year with a mammogram were appropriate and in line with the guidelines outlined by RCR and NICE. There was no clinical indication to conduct any further tests which would have picked up on Ms E’s cholangiocarcinoma.
21. We appreciate the family’s view that the Trust should have been able to detect the new cancer with all the checks Ms E was undergoing. We hope that our report provides some reassurance that appropriate action was taken.
Care in hospital 22. Mrs R complains there was a lack of urgency and an unclear plan of care for Ms E following her admission on 28 June 2021. She says Ms E was not admitted to a specialist ward and subject to delays to scans, medical specialists and identifiable treatment.
23. Mrs R says Ms E waited three days for a CT scan. She also says the decision to put Ms E under intubation was problematic and could have contributed towards her death.
24. The records show the indication for the CT scan was to exclude either metastatic breast cancer to the liver or bile duct obstruction as a cause of Ms E’s jaundice. The initial request was for a liver ultrasound made on 28 June and then converted to a contrast CT scan of the liver the following morning on the advice of the radiology team.
25. NICE guidelines on recognition and referral of suspected cancer from 2015 says: ‘Consider an urgent, direct access ultrasound scan (to be done within 2 weeks) to assess for liver cancer’.
26. Ms E underwent a CT scan within three days. This was within the timeframe set out by the NICE guidelines.
27. Mrs R also says Ms E should not have undergone intubation. She says intubation may have led to her premature death.
28. The European Guidelines for the management of acute liver failure state: ‘In the scenario of an evolving HE (hepatic encephalopathy - a brain disorder that can occur in people with advanced liver disease), there is an indication for intubation and sedation to ensure a controlled and safe transfer.
29. Ms E was suffering from HE. HE is an altered level of consciousness because of liver failure. It is documented throughout her inpatient notes her HE was worsening and this is one of the documented reasons for intubation.
30. Since the Trust’s decision to intubate Ms E is in line with the suggested action in the guidelines, we see no failing here.
31. Ms R also says there was a lack of urgency transferring Ms E to a specialist ward, and for her to be seen by medical specialists.
32. The Trust say Ms E was on the gastroenterology ward for two days prior to being transferred to ITU on 30 June 2021. It says during these days she was not ill enough to be in ITU, however when her condition deteriorated it appropriately increased the intensity of the treatment it provided.
33. The records show initially Ms E was clinical stable. Notation from 28 and 29 June note a stable appearance and observations. Her NEWS (a tool which improves the detection and response to clinical deterioration in adult patients; Scores 1-3 indicate low risk, 5-6 indicate medium risk and 7+ indicates high risk) score was 2 at 12pm on 28 June and 1 at 7:50pm on 28 June.
34. On 29 June at 3am, the NEWS score was 1, and it was 1 again at 11:24. On 30 June, the NEWS score was 2 at 4pm. However, at 7:52pm this rose to 6. At this point, in line with the NICE guidelines on interpreting NEWS scores, the Trust should have conducted an urgent review to decide on the escalation pathway.
35. The records show expert advice was sought by the responsible doctors on 1 July from the Queen Elizabeth Hospital (Birmingham) at 5:39am. This discussion resulted in a request to contact the Royal Free Hospital (London). The Trust spoke with the Royal Free Hospital at 7:52am, to see if Ms E could be transferred to a specialist unit. The advice was to manage in a tertiary care centre such as Queen Elizabeth. The records show a discussion with the consultant hepatologist at Queen Elizabeth Hospital at 11:42am on 1 July, at which time it was clear Ms E was too unstable to transfer to the Birmingham liver unit.
36. The European Guidelines for the management of acute liver failure state the recommendations for ward and intensive care clinical management and the need to refer to a liver transplant unit. It states:
‘All patients with a significant ALI (acute liver injury) should be considered for transfer to a liver transplant or tertiary care unit. Even in those who are unlikely to be candidates for transplant should be considered for transfer to offer improved chances of survival. Clinical deterioration with extrahepatic organ involvement (problems with other organs as well as the liver) should result in transfer to critical care and tertiary centre’.
37. As explained above, the Trust made enquiries with Birmingham to establish whether Ms E was suitable for transfer to a liver unit, and this was found not to be the case. Our gastroenterologist adviser explains the Trust’s decision was appropriate based on the record of Ms E’s condition.
38. The European guidelines for the management of acute liver failure also recommend:
’Frequent senior clinical review (twice daily minimum) and assessment of physiological parameters, blood results and metabolic status should be carried out (evidence level III, grade of recommendation 1)’.
39. The records show Ms E was reviewed by senior clinicians several times on each day she was in hospital. Therefore, the Trust met this recommendation.
40. The European guidelines go further to require:
‘Hourly urine output should be assessed as a marker of renal function, alongside creatinine (evidence level III, grade of recommendation 1)’.
41. We can see the urine output was extensively measured throughout Ms E’s hospital admission, there are entries several times on each day of admission documenting urine tests for the purpose of renal screening. Our gastroenterologist adviser has explained this was done adequately by the Trust, in line with the guidelines.
42. To summarise, the care we have considered here has been provided in line with the relevant guidance. None of the guidance we have reviewed stipulates a specific time frame for management of acute liver failure. Although, the guidance describes the rapidly progressive and severe nature of the syndrome requiring prompt instigation of specific supportive treatment. The records reflect the Trust acted in line with this. This position is supported by our gastroenterologist adviser.
43. Therefore, the records indicate that the Trust responded in an urgent and effective manner to treat Ms E’s acute liver failure with prompt and appropriate escalation of care and with expert tertiary liver centre input. We understand how quickly Ms E’s disease progressed and the significant trauma this must have caused for her family. We hope our findings will provide some reassurance that the treatment provided to her in hospital was appropriate.
Tamoxifen prescription 44. Mrs R says the Trust failed to sufficiently inform Ms E of the risks of taking tamoxifen. She says this includes increased risk of blood clots and venous thromboembolic disease (a blood clot in a vein that can occur in the legs, arms, or lungs). Mrs R believes if she had been properly informed then she would have had the option of alternative treatment and this may have prevented problems with her liver occurring.
45. The Trust has said tamoxifen is not known to increase the risk of developing cholangiocarcinoma.
46. The records show the Trust prescribed tamoxifen to Ms E on 15 January 2019. The note from the appointment highlights the oncologist discussed the potential side effects of hot flushes and other menopausal symptoms such as mood swings and vaginal dryness, as well as a risk of venous thromboembolic disease and very rarely endometrial cancer.
47. Our oncologist adviser confirmed the associated risks of tamoxifen include mood changes, vaginal dryness, clots, and a rare risk of endometrial cancer. There are no clinical guidelines which outline what the Trust should have informed Ms E in terms of potential side effects. Our oncologist adviser explains tamoxifen can increase some of the liver function, which show in tests. However, this is not significant enough to raise it as a potential risk of causing cholangiocarcinoma or other hepatic cancers. Because of this, it would never be part of the standard process to mention this as a risk.
48. As such, in spite of a lack of guidance, the evidence suggests the actions of the Trust were in line with recognised medical practice and thus there is nothing to suggest a failing occurred here.
49. Again we appreciate the concerns Ms E’s family had regarding this medication. Having reviewed the prescribing of tamoxifen in this scenario, we are satisfied it was done so with adequate communication of the risks involved.
Communication and record keeping 50. These two issues overlap and involve similar issues. Therefore, we will address them together.
51. Mrs R complains the Trust did not keep the family updated about her sisters condition. She says it did not inform them when she deteriorated and went into the critical care unit (ITU). Mrs R says this resulted in the family being completely unprepared for her ill health and consequently her sudden death. Mrs R specifically mentioned some family members were unable to see Ms E before she died as a result. She also complains there are unacceptable discrepancies and errors within the nursing documentation on 30 June 2021 to report that the family were aware of her transfer to ITU which is an incorrect record of events.
52. The Trust has accepted it did not communicate appropriately with Mrs R’s family. It also accepts there are discrepancies with the record keeping regarding communication with the family.
53. NICE guidance: Patient experience in adult NHS services: improving the experience of care for people using adult NHS services (7) recommends:
‘1.3.10 Clarify with the patient at the first point of contact whether and how they would like their partner, family members and/or carers to be involved in key decisions about the management of their condition (or conditions). Review this regularly. If the patient agrees, share information with their partner, family members and/or carers.
1.5.14 Explore the patient's preferences about the level and type of information they want. Based on this, give the patient (and their family members and/or carers if appropriate) clear, consistent, evidence-based, tailored information throughout all stages of their care. This should include, but not be limited to, information on: • their condition (or conditions) and any treatment options • where they will be seen • who will undertake their care • expected waiting times for consultations, investigations and treatments.’
54. The Trust, in line with the above guidance, is required to share relevant information with the family.
55. The records contain a note from an on call gastroenterologist who wrote at 8:59pm on 30 June 2021 that Ms E needed to be reviewed by the critical care team. The critical care admission form notes the decision to admit Ms E was made at 9:30pm. A note from 10:06pm explains the critical care team accepted Ms E and she would be transferred within 1-2 hours.
56. The records from the critical care admission form on 1 July 2021 at 5am state ‘family updated on ward prior to transfer’ (to the ITU ward). However, a note later on in the records from 1 July at 10:30am (p97) states: ‘(Family) were only made aware of critical care admission this morning. Understandably upset about not having received communication regarding deterioration in her condition. I have apologised for there being an evident lapse of communication’.
57. The Trust’s response also says ‘The notes reflect that the ITU team were under the impression that the family had been informed of her admission to ITU prior to her transfer. That appears not to have been the case’. Therefore, the Trust has accepted the records are inaccurate regarding the family being informed about Ms E’s ITU admission.
58. The Trust informed the family at 10:30am on 1 July, this is 13 hours after it made the decision to admit Ms E to ITU.
59. GMC Good Medical Practice stipulates health providers should ‘be considerate and compassionate to those close to a patient and be sensitive and responsive in giving them support and information’.
60. The communication was not up to the expected standard of the Trust. This is not in line with the requirement laid out in the GMC guidance (mentioned above) for responsive information. The Trust has accepted it did not communicate with the family appropriately and missed opportunities to inform them of Ms E’s condition. It acknowledges it should have liaised with the family to arrange to visit sooner than it did. Therefore, the evidence demonstrates there was a failing regarding the Trust’s communication with Ms E’s family. This appears to have been contributed to by issues with the record keeping.
61. As a result, we find a failing with the Trust’s communication with Mrs R and her family. We consider the impact of this failing below.
Impact
62. We have found a failing regarding the Trust's communication with Mrs R and her family. Mrs R says they were caused significant distress by the Trust’s lack of coherent nursing documentation and poor communication. She says this meant they did not know about the seriousness or progression of Ms E’s illness. Mrs R specifically mentions Ms E’s father went for elective surgery on the day she died, which he would not have done had he known how serious her condition was.
63. We acknowledge the distress and upset caused to the family not knowing about the seriousness of Ms E’s condition will have caused. We are very sorry that the family were unable to all be with Ms E before she died. We see the Trust has already acknowledged the poor communication in this case, but we do not think this goes far enough. Mrs R is also seeking financial compensation. We consider this in our recommendations below.