University Hospitals Sussex NHS Foundation Trust

5. Mrs A complains about the actions of the Trust between January 2022 and December 2022. Specifically, it:

• did not consent her properly before gallbladder removal operation in January 2022 • left her on anticoagulation therapy (blood thinners) for longer than necessary between February 2022 and June 2022.

6. Mrs A developed worrying side effects (rashes/ulcers/hair loss/fevers/legs aching and swelling). She says her requests for advice and help were not dealt with promptly. This took a severe toll on her physically and mentally, impacting on her family and work. She required cognitive based therapy after her experience.

7. Mrs A wants recommendations to ensure patients have access to specialist anticoagulation clinics to monitor therapy. Mrs A wants a financial remedy for the impact described above.

8. The Trust diagnosed Mrs A with trapped gallstone in her pancreatic duct in July 2021 after she went there with two weeks of abdominal pain. The Trust agreed with Mrs A to perform elective surgery (a planned, non-emergency procedure scheduled in advance). On 18 January 2022 the Trust removed Mrs A’s gallbladder.

9. Mrs A had post-operative complications. She was readmitted to the Trust in January, February and June 2022.

10. On 29 January 2022 the Trust diagnosed Mrs A with superior mesenteric vein thrombosis (SMV – a rare, life-threatening blood clot in the vein that drains blood from the small intestine) and on 8 February 2022 advised Mrs A start anti-coagulation therapy.

11. On 15 February 2022 the Trust diagnosed Mrs A with pancreatic cysts. It started Mrs A on anti-coagulation therapy (warfarin - a blood thinner used to treat, prevent, and reduce the risk of dangerous blood clots). Mrs A had her cysts drained on 7 April 2022.

12. Mrs A reported worrying symptoms to her GP from March 2022 to June 2022 (including rash, swelling in legs, fevers and hair loss). Both she and her GP contacted the Trust for help.

13. The Trust advised Mrs A stop taking warfarin on 17 June 2022. On 21 June 2022 the Trust began suspecting Mrs A was suffering a possible drug induced vasculitis (a group of rare autoimmune diseases that cause inflammation in your blood vessels) after she was admitted with painful leg swelling.

14. In July 2022 the Trust diagnosed Mrs A with Leukocytolastic Vasculitis (LCV – a form of small-vessel inflammation that primarily affects the skin, causing a rash of reddish-purple spots known as palpable purpura, usually on the lower legs).

15. We were reassured Mrs A was reporting no new symptoms or flare ups by October 2022.

The Trust did not consent her properly before gallbladder removal operation in January 2022

20. Mrs A told us at no point did the Trust explain to her the risks of the surgery or potential after affects from it. She said she was consented for this procedure as she was being prepared to go into theatre.

21. The law (section 9 of the Health Service Commissioners Act 1993) says a person needs to make their complaint to us within a year of becoming aware of the problem. We cannot investigate complaints brought to us after one year, unless we consider there is a good reason to.

22. Mrs A was readmitted to the Trust with post-operative complications, including pain and discomfort, on 28 January 2022 and then again on 14 February 2022. She suffered a clot and pancreatic pseudocysts.

23. We consider Mrs A’s date of awareness for her concerns would have been at the latest mid-February 2022. By this date she had been readmitted twice with complications post-surgery, which she indicated she had not been told to expect before or after her surgery on 18 January 2022. To be within our time limit Mrs A needed to complain to us by mid-February 2023. Mrs A complained to us on 20 January 2025. This complaint is 23 months out of time.

24. Mrs A complained to the Trust on 22 May 2023. This is at least 15 months after the events. The Trust responded to this concern on 10 September 2024 and a provided a final response on 2 October 2024.

25. We accept that local resolution took a long time. From May 2023 to October 2024 – around 17 months). However, even excluding that time Mrs A took a significant time to raise her complaint in the first place. We asked Mrs A about that delay.

26. Mrs A said she you did not become aware she had a reason to complain until she discussed the consent process with her advocate in March or April 2023. She said it is unreasonable to expect a patient to know what proper consent involves at the time of your procedure. She said the Trust were never told in full the risks of her surgery.

27. We do not consider this sufficient reason alone to waive the time limit here. We do not think Mrs A needed to know the precise details of what a consent process should involve to know she had cause to complain. The Trust may not have told Mrs A of all the potential risks from her surgery. Mrs A was readmitted twice within weeks of her surgery in January 2022 and February 2022. The impact she described of not being consented properly – the postoperative complications she experienced - occurred in January and February 2022 which necessitated further Trust intervention. We consider at that point she would have know she was experiencing complications she had not been warned about. We therefore do not accept the date of awareness being March/April 2023 after Mrs A discussed her concerns with her advocate.

28. Mrs A gave us no other reason for not complaining sooner.

29. In summary, this part of Mrs A’s complaint is out of time and we will not consider it further.

The Trust left Mrs A on anticoagulation therapy (warfarin) for longer than necessary between February 2022 and June 2022

30. The NICE CKS guidance says:

‘For people with deep vein thrombosis (DVT) and pulmonary embolism (PE): • Duration of treatment will vary for each person, depending on a variety of factors.

• Experts are not unanimous on the optimal duration of warfarin treatment, but usually it should be continued: ▪ For at least six weeks in people with isolated distal DVT (calf vein thrombosis).

▪ For at least three months in people with proximal DVT or PE where there are known temporary risk factors and there is considered to be a low risk of recurrence.

▪ Long-term if there have been recurrent DVTs or PEs.

• People with unprovoked proximal DVT or PE should be considered for long-term anticoagulation, taking into account information that may help predict risk of recurrence and risk of bleeding in each specific clinical situation.

• Warfarin can be stopped abruptly without harm when the duration of treatment is completed.

31. Our clinical adviser said Mrs A’s SMV thrombosis was a form of DVT and the Trust anticoagulation therapy is accepted first line treatment. Mrs A started warfarin on 15 February 2022. In its discharge summary to her GP the Trust confirmed Mrs A would likely be taking it for three months. So at least until 15 May 2022. This is in line with the standard above regarding minimum treatment length for clots.

32. Mrs A said her clot had disappeared (on 18 March 2022 repeat Trust scan showed no evidence of thrombosis in the SMV) but she was still taking warfarin after this.

33. Our adviser said often patients will be kept on treatment for longer (often three to six months) to ensure a clot does not reappear even if the clot shows as having disappeared earlier than this. The guidance above allows for long term prescribing of warfarin indicating it is based on the risk of a clot reappearing.

34. The risk of a clot reappearing is assessed by monitoring of the anti-coagulation therapy. The Trust has no role in this. In Mrs A’s region her GP is responsible for this by way of conducting blood tests every five days, looking at a patients INR (International Normalized Ratio – monitoring essential for patients taking warfarin to ensure blood clots are reducing at an appropriate rate, usually a range of 2.0 – 3.0).

35. The Trust discharged Mrs A to her GP on 22 February 2022. Mrs A’s GP targeted an INR rate of 2.5. Mrs A’s GP record shows she did not achieve this target at any time before the Trust advised she stop taking warfarin on 17 June 2022.

36. The Trust said in complex cases GPs can refer to the Trust for advice. Mrs A said she and her GP reported worrying side effects to the Trust and queried if warfarin was the cause but the Trust ignored these requests.

37. GMC GMP standards say you must, ‘promptly provide or arrange suitable advice, investigations or treatment where necessary’.

38. Mrs A reported suffering new symptoms to her GP on 8 March 2022, then 23 May 2022 and 9, 10, 15 and 17 June 2022. Mrs A was suspicious these were due to her medication and said she had emailed Trust haematology with no replies. She asked her GP to obtain advice and to help expedite an appointment with the Trust.

39. The Trust said Mrs A first emailed it on 9 May 2022 and a haematologist scheduled a review appointment, asking for the next available date. The Trust said on 22 May 2022 it received a second email from Mrs A and addressed some concerns and told Mrs A it would organise a blood test to be certain Mrs A could stop anti-coagulation therapy at the time of her review appointment.

40. We have seen neither of these Trust emails, however we can see from Mrs A’s GP record she told her GP on 15 June 2022 she had been given the date for a telephone appointment with the Trust haematology team for 4 July 2022. Her GP confirms this in a letter dated 20 June to the Trust. We are satisfied this confirms the Trust had responded to Mrs A’s earlier request for help.

41. On 17 June 2022 the Trust responded to a call Mrs A made to its Cancer Clinical Nurse and advised she stop taking warfarin until she was reviewed.

42. The Trust said the first contact it had with Mrs A’s GP was letter dated 20 June 2022 (sent via email 24 June 2022). Mrs A’s GP asked the Trust to call her. The Trust confirms in letter to Mrs A’s GP of 24 June 2022 this is what it did (called her) but there was no answer.

43. Mrs A’s GP also attached an earlier letter dated 9 June 2022 requesting anti-coagulation therapy advice from the Trust. The Trust said it had no record of the 9 June 2022 letter.

44. In summary, we consider the Trust acted in line with NICE CKS and GMC GMP here. The length of time Mrs A remained on Warfarin is in line with expected time frames for this type of treatment for a clot. Trust haematology arranged to review Mrs A when she first contacted it in May 2022. The Trust advised Mrs A stop taking warfarin on 17 June 2022 when she contacted it with increased worry about her symptoms. After Mrs A was admitted in June 2022 and the Trust first had suspicions of vasculitis it promptly began investigating and arranged further tests to enable diagnosis.

45. The warfarin was necessary and we cannot say her reaction to it was avoidable. It was no doubt a distressing, painful and anxious time for Mrs A. Though it must have been frustrating not knowing the cause for the symptoms we were reassured to see the Trust did identify the cause and provide advice in the short time after being made aware of these which did improve Mrs A’s condition.

1. We have carefully considered Mrs A’s complaint about University Hospitals Sussex NHS Foundation Trust (the Trust). We know it has not been easy for Mrs A suffering complications from her gallbladder surgery and reacting badly to the anti-coagulation therapy she underwent after that. We are sorry to hear of the side effects she experienced.

2. Mrs A’s complaint about consent is out of time and we have decided there is no good reason to set aside the time limit on this occasion. We will not look at this part of her complaint.

3. We have seen no indication the Trust did anything went wrong regarding her anticoagulation therapy. Mrs A would have to take the blood thinning medication for at least three months to six months. The Trust started Mrs A begin the medication on 18 February 2022 and advised she stop on 17 June 2022.

4. We provide our reasons for our decision below.