Northern Lincolnshire and Goole NHS Foundation Trust

4. Mr P complains the Trust misdiagnosed his partner Miss G with alcohol-related liver disease in July 2021. He complains from then until her death in November 2022, the Trust failed to consider her liver problems an autoimmune response to COVID-19 vaccines, failed perform tests for autoimmune conditions or take a liver biopsy to find a definitive cause. He complaints the Trust failed to reconsider the accuracy of the diagnosis despite Miss G’s cirrhosis worsening after she reduced then later stopped her alcohol intake completely.

5. Mr P also complains that from March 2022 the Trust failed to act upon gallbladder findings on ultrasound, misinformed Miss G about her next appointment and failed to provide her any follow-up outpatient appointments as her condition worsened. Mr P questions the appropriateness of a blood transfusion given in October 2022 and the lung drain inserted in November 2022.

6. Very sadly, Miss G died in hospital on 30 November 2022. Mr P says the above failings labelled Miss G as an alcoholic and left her without the treatment she desperately needed, causing her condition to deteriorate. He says misleading information about follow-up appointments led to her cancelling a private consultation, which may have provided Miss G with care to avoid her liver becoming decompensated. He says the blood transfusion immediately caused Miss G’s liver to decompensate, possibly contributing to her death which he says was avoidable and directly caused by these failings in combination, culminating in the lung drain insertion.

7. Mr P says he has been caused immeasurable, lifelong distress and trauma witnessing Miss G’s health collapse and having ultimately lost her. He says his distress is considerably exacerbated by thinking her condition was mislabelled and she was not afforded the care she should have been.

8. To resolve his complaint, Mr P would like the Trust to acknowledge its failings and to apologise for their impact. He seeks improvements at the Trust, for lessons to be learned and action taken to ensure these events do not happen to anyone else in future. Mr P also seeks a financial payment in recognition of the impact caused by these Trust failings.

9. Miss G’s GP referred her to the Trust’s gastroenterology department in July 2021 with abnormal liver function tests and CT scan findings of portal hypertension and cirrhosis.

10. When abnormal, liver function tests imply the liver is damaged and not working as it should. Cirrhosis is scarring of the liver caused by long-term liver damage. Portal hypertension is increased blood pressure in the portal vein, the vessel leading to the liver, due to cirrhosis.

11. Miss G was seen at the Trust on 29 July 2021 and diagnosed with compensated liver cirrhosis secondary to alcohol excess. In compensated cirrhosis, the liver can still perform its functions, although sometimes reduced, despite the damage. In decompensated cirrhosis, liver function declines, other serious symptoms develop, and it can be life-threatening.

12. At the July 2021 appointment, the Trust requested a gastroscopy to screen for varices. Sometimes known as an endoscopy, a gastroscopy is a camera test that looks inside the body. Varices are swollen blood vessels that develop when blood flow to the liver is blocked by cirrhosis.

13. The gastroscopy was done on 17 October and on 8 November the gastroenterologist wrote to Miss G’s GP to explain the gastroscopy found no varices, only gastritis (inflammation of the stomach lining) and mild reactive duodenum changes (inflammation of the first section of the small intestine). The Trust planned for follow-up appointment in the next two months.

14. This appointment took place by phone on 13 January 2022. The gastroenterologist wrote to Miss G’s GP, noting Miss G had not stopped but had reduced her alcohol intake. The Trust planned for ultrasound surveillance for hepatoma (liver cancer).

15. This ultrasound was taken on 13 March 2022 and found no evidence of cancer. The Trust requested an endoscopy to screen for varices and scheduled a follow-up for 23 June. This appointment was later cancelled by the consultant who wanted to first await endoscopy results, which had been requested but not yet done.

16. Miss G attended the Trust’s emergency department (ED) on 27 August reporting three months of easy fatigability and shortness of breath on exertion. A gastroscopy found portal gastropathy (a condition affecting the stomach lining due to portal hypertension) and gastric antral vascular ectasia (GAVE, a condition causing GI bleeding). Miss G was anaemic (lacking iron). She had blood transfusions and was discharged home on 1 September with a planned colonoscopy, CT scan and gastroenterology review in four weeks’ time.

17. Miss G next attended the ED on 3 October reporting dizziness, lethargy and dark tarry stools (a sign of upper GI bleeding). Miss G was discharged home on 4 October, with the discharge summary noting she was anaemic, denied any bleed and declined a camera test. She received a blood transfusion and was given medication for cirrhosis. Miss G requested blood testing at her GP, and the Trust arranged for her to return for a blood transfusion on 13 October.

18. Miss G returned to the ED on 11 October. She was reviewed and discharged home with it noted she had a planned blood transfusion appointment for 13 October. Records document Miss G attended on 13 October and the transfusion was completed.

19. Miss G attended the ED again on 15 October reporting lethargy, being bed-bound, having pitting oedema and pitting to the mid-thoracic region with abdominal distension. Pitting oedema is a type of swelling caused by a build-up of fluid, that leaves an indentation when pressure is applied. The Trust admitted Miss G and diagnosed her with decompensated alcohol-related liver disease.

20. Miss G was reviewed by the surgical team who noted she had chronic liver disease Child C (a classification giving a 70-80% mortality rate), she was very jaundiced (yellowing of the skin and whites of the eyes from a build-up of bilirubin as the liver is not functioning to remove it) with swollen legs and abdominal distension from ascites (a build-up of fluid in the belly).

21. The plan was for conservative management as Miss G was considered too unwell for surgery. She developed a large bowel perforation with peritonitis (an infection of the tissue that lines the abdomen) and pneumonia. The Trust inserted an ascitic drain (to remove ascites) and a chest drain for pleural effusion (to remove fluid found in the space between the lungs and the chest wall).

22. Miss G sadly died in hospital on 30 November. Her cause of death is documented as acute decompensated liver failure with underlying chronic liver disease.

Misdiagnosis 26. We know how strongly Mr P believes the Trust reached the wrong diagnosis. We hope to assure him we do not see any indication of failure here.

27. When seen in July 2021, Miss G was a reasonably fit 55-year-old with multiple sclerosis. She had established cirrhosis on CT, abnormal liver function tests and a long-standing history of alcohol excess. The clinic letter notes: ‘She admits to drinking at least three bottles of wine every week and she has been doing this for a long time’. This aligns with information about Miss G’s alcohol intake within her GP’s referral sent weeks earlier.

28. Clinically, Miss G’s long-term alcohol intake meant she had a high risk of liver-related damage. Her clinical history, CT scan findings and blood results were sufficient to make a diagnosis of advanced chronic liver disease secondary to alcohol use, with early portal hypertension. This is an appropriate evidence-base for this diagnosis, in line with NHS website information on alcohol-related liver disease and EASL guidelines, the latter of which say:

‘Diagnosis of ALD is usually suspected upon documentation of regular alcohol consumption of >20 g/d [per day] in females and >30 g/d in males together with the presence of clinical and/or biological abnormalities suggestive of liver injury.’

29. NHS information on alcohol units explains one unit measure equals 8g of pure alcohol. There are 10.5 units in one bottle of wine. At the consultation in July 2021, Miss G reported an intake of at least 31.5 units weekly, equating to 36g/day. This far exceeds EASL guidelines and, along with CT and blood results showing liver injury, supports the diagnosis reached.

30. We considered Mr P’s complaint that the Trust did not take a liver biopsy. EASL guidelines do not recommend liver biopsy for all patients considered to have alcohol-related liver disease. They recommend liver biopsy where there is diagnostic uncertainty and where precise staging is required – neither of which were the case for Miss G. We do not see any indication of wrongdoing here, as EASL guidelines say:

‘…a liver biopsy is an invasive procedure with significant morbidity. Severe complications, such as intrahepatic bleeding, pneumothorax and others occur in approximately 2% of patients. Therefore, a biopsy is not generally recommended for all patients with suspected ALD…’

31. We know Mr P is concerned the Trust did not consider Miss G’s liver problems an autoimmune response to COVID-19 vaccines. We can assure Mr P that the Trust did perform tests for autoimmune conditions. We find evidence to show blood tests taken in October 2022 screened for autoimmune problems. The results provide biochemical confirmation that Miss G did not have any autoimmune-related liver disease. As the clinical evidence supported the diagnosis reached, there was nothing to clinically indicate the Trust should have suspected or investigated any COVID-19 vaccine involvement with Miss G’s presentation at any time.

32. We also considered Mr P’s complaint that the Trust failed to reconsider the accuracy of the diagnosis, despite Miss G’s cirrhosis worsening after she reduced then later stopped her alcohol intake completely.

33. Our adviser explains only alcohol abstention would have improved Miss G’s prognosis. Records show she reported continued alcohol intake up until her admission in October 2022. When Miss G did advise the Trust of her abstinence, we find her reported accounts vary. Numerous entries during Miss G’s admission in October and November 2022 note that she reported differing pictures on different occasions of for how long she had abstained, the shortest being just weeks before admission.

34. Our adviser explains if a person stops drinking alcohol completely for a prolonged period of several months, the liver can recover even in a patient with established cirrhosis. However, the chance of recovery from alcohol abstention diminishes with the severity of liver disease. This is particularly the case if the patient has symptoms of liver failure arising from cirrhosis such as ascites or jaundice. We can see that sadly, Miss G demonstrated both.

35. This means a person’s symptoms and complications arising from cirrhosis can worsen, even after they have abstained from alcohol, if that abstinence only started after significant damage had already been done.

36. We recognise how strongly Mr P feels about this, and how difficult this will be for him to read. Very sadly, it appears Miss G’s reported abstinence in October 2022 came at a point where her liver damage was already too advanced, for such a short period of abstinence to have had any impact. The fact her condition worsened whilst abstinent at that point in time is not indicative of a misdiagnosis.

Gallbladder findings 37. The ultrasound taken in March 2022 found evidence of gallbladder sludge. This is a term used to describe a thick substance that forms in the gallbladder when bile stays there for too long. Mr P recalls the person who took the ultrasound describing ‘squidgy things’ in the gallbladder. It is this comment that has led to his concern about the Trust’s lack of action in response to that finding. We think gallbladder sludge was the cause of that comment.

38. The ultrasound was taken as surveillance for hepatoma. Gallbladder sludge was an incidental and inconsequential finding of the surveillance scan, and our adviser confirms it was of no clinical significance in Miss G’s case. We see nothing to indicate any clinical need for action in response to this finding.

Misinformation on follow-up appointment 39. The Trust’s plan following this ultrasound in March was for Miss G to have an endoscopy and an outpatient appointment, which was scheduled for 23 June. The purpose of this endoscopy was to screen for oesophageal varices.

40. Our adviser confirms the plan for endoscopy to assess for varices was appropriate, as was the plan for outpatient appointment in June. Nothing seen on the March ultrasound had any clinical significance to have warranted any additional or alternative action. We can assure Mr P there was nothing at that time – from Miss G’s known condition, prior investigation results or the March ultrasound results – to suggest need for any urgency in either endoscopy or the follow-up appointment proceeding.

41. The 23 June appointment was cancelled as the consultant wanted to await results from the endoscopy before reviewing Miss G. At each of her previous follow-up appointments, the clinician had been able to review the most recent investigation results, enabling them to make appropriate plans for the next steps in Miss G’s surveillance and follow-up care. Without knowledge of the endoscopy findings, the follow-up appointment lost its primary purpose.

42. The Trust explained the endoscopy had been requested but not yet done. It said unfortunately there can be delays for non-urgent procedures due to unavoidable pressures on resource from waiting lists. It apologised it was not possible to carry out the procedure and have the results available for the arranged appointment date.

43. Mr P’s complaint is that the Trust misinformed Miss G about her next appointment. We do not find this to have been the case. The Trust informed Miss G of plans for endoscopy and follow-up in June. The appointment was cancelled as the endoscopy could not be done in the timeframe anticipated, for unavoidable reasons. We do not see indication of misinformation here. Instead, it seems Miss G was informed of the plans for follow-up, and subsequently informed these plans had changed, in response to later events.

Lack of follow-up appointments 44. Mr P complains the Trust failed to provide Miss G follow-up outpatient appointments as her condition worsened.

45. Miss G’s requested endoscopy was non-urgent, for surveillance only. She G had last been checked for varices at the gastroscopy in October 2021. This found no evidence of varices. British Society of Gastroenterology Best Practice Guidance sets out recommendations for variceal screening in people with compensated cirrhosis. It says:

‘In patients undergoing endoscopic screening for varices, the frequency of surveillance and need for primary prophylaxis depend on the finding at endoscopy and whether liver disease is active.’

46. The guidance goes on to recommend 2-3 yearly surveillance where there is no prior evidence of varices. It says this recommended period depends on whether liver disease is active, for example where there is continued alcohol consumption.

47. As Miss G’s liver disease was active, we think it reasonable her planned surveillance was more frequent than set out in recommendations. Yet, this simply means more frequent than 2-3 yearly. Miss G had last undergone surveillance in October 2021. The endoscopy was not done as anticipated before the appointment scheduled for June. Miss G then had a gastroscopy as part of her inpatient care in August 2022.

48. We recognise this was not scheduled, and the result of her attending the ED unwell. Yet, this means Miss G had variceal surveillance 10 months after the last, in October 2021.

49. We acknowledge the concern caused to Mr P and Miss G, when they were awaiting news on when the endoscopy could go ahead, to allow the next follow-up appointment to take place. Considering the guidance, and the lack of any clinical concern following the ultrasound in March, we do not see anything to suggest the time spent waiting here was so considerable nor had any clinical implication, to indicate a service failure.

50. Our view is further supported by the following. We are sorry for any upset that may be caused to Mr P by sharing with him, that Miss G’s prognosis was very poor even at the time of her first presentation to the Trust in July 2021.

51. Our adviser explains that liver-related mortality can be assessed using a variety of prognostic scoring systems: The Child-Pugh Score for Cirrhosis Mortality (CPS, see reference Pugh RN et. al); the Model for End-Stage Liver Disease (MELD, see reference Singal AK et. al); The United Kingdom Model for End-Stage Liver Disease (UKELD, see reference Barber et. al).

52. Miss G’s CPS in July 2021 was B9, giving her a predicted risk of death of 10-20% at one year. In March 2022 her MELD was 14 giving a greater than 6% mortality rate at 3 months, and her UKELD was 52 giving a greater than 10% risk of death at 12 months. Her CPS was also B9 in March 2022. Sadly, her continued alcohol intake of even small amounts following her first presentation, only worsened her prognosis.

53. This means that even if Miss G had been seen at an outpatient appointment before her hospital attendances from 27 August 2022, it is highly unlikely this would have resulted in any change to her clinical care, treatment or management. Knowing of her clinical presentation in August, our adviser says with confidence that even had the outpatient appointment gone ahead in June, or at any point before this admission, any treatment potentially suggested would have been supportive, not curative.

54. We know Mr P is further frustrated by the discharge summary dated 1 September, which included a plan for gastroenterology follow-up in four weeks’ time which did not go ahead. Miss G attended the Trust’s ED on 3 October, and so received a clinical review very soon after this stated timeframe. It is not ideal when stated times for outpatient follow-up are not met, and we recognise the distress this has clearly caused Mr P.

55. It remains we do not see anything to indicate this amounted to a service failure. There is no stated timeframe by which Miss G needed to be seen. Whilst timeframes should be realistic and met as stated, we do not see that the Trust made plans with any purposeful intention of not meeting them. Unfortunately, those plans were not realised in the stated timeframes for understandable, unavoidable reasons.

56. Very sadly, by that point in time, our adviser explains that any subsequent follow-up care and treatment that could have been offered to Miss G would have been supportive not curative, in view of the progression of her liver disease and continued alcohol use.

Blood transfusion 57. We know Mr P is concerned by the Trust’s response to his complaint which said Miss G was admitted before the planned transfusion could go ahead. We identify this as an error on the Trust’s part, a likely oversight considering the number of blood transfusions and hospital attendances that took place around this period.

58. We find records showing Miss G did attend for her scheduled appointment on 13 October, and we find records documenting the transfusion was completed: ‘with no ill effects noted’.

59. Mr P questions the appropriateness of this blood transfusion. We do not see anything to indicate any failing with the blood transfusion given. Furthermore, our adviser explains there is no clinical evidence to link blood transfusions with any negative impact or deterioration of liver damage. Clinically, there is nothing to suggest the blood transfusion was responsible for the deterioration of Miss G’s liver function.

Drains 60. Mr P questions the appropriateness of the drain inserted during Miss G’s admission in November 2022. Whilst Mr G refers to a ‘lung drain’, records show Miss G had two drains inserted: a chest drain to help remove fluid from her pleural effusion, and an ascitic drain to help remove ascites from her abdomen.

61. Our adviser confirms there is nothing from the clinical evidence to suggest anything wrong with either drain. By this admission, Miss G had significant progressive liver failure. Both drains were appropriately provided for symptomatic relief, in the terminal stage of her liver failure.

1. Mr P complains the Trust misdiagnosed his partner Miss G’s condition in July 2021, and about aspects of the treatment she received up to the time of her death in November 2022.

2. We have considered the evidence carefully and we do not see any indication of failings in the Trust’s diagnosis, its subsequent information or action taken in Miss G’s follow-up care.

3. As we have seen no indication of wrongdoing, we have decided not to investigate further. We recognise how important this complaint is to Mr P and we extend our condolences to him, on the loss of his beloved partner Miss G.