London North West University Healthcare NHS Trust

5. Mrs U complains about aspects of the care she received at London North West University Healthcare NHS Trust on 14 November 2024. The Trust admitted Mrs U for investigation following a decline in health and a fall at home. Mrs U says the Trust failed to: • properly consider the risks of using contrast (a special dye used to enhance the visibility of internal structures, making it easier to diagnose conditions) in her CT scan before performing the scan • accurately assess and communicate the cause of her decline in kidney function, offering inaccurate explanations to deflect from the CT scan being the genuine cause.

• explain the risks of performing a contract CT scan in patients with chronic kidney disease (CKD) to her or her family, and failed to obtain patient consent before doing the scan 6. Mrs U says the failings caused a decline in her renal function leading to readmission, further treatment and a worsening of her CKD. She says this increased her physical vulnerability and caused ongoing emotional distress (including fear of hospitals, lack of sleep, and reduced appetite). She says it also raised concerns that other patients with chronic kidney disease may face similar harm.

7. Mrs U is seeking formal acknowledgment of the failings, an apology, service improvements and a financial remedy.

8. Mrs U has CKD. This means her kidneys do not work as well as they should. Her condition is stage four because her usual kidney function is low. She lives alone, has carers visit four times a day and uses a Zimmer frame to move around.

9. On 14 November 2024, Mrs U had a minor fall at home. She was also vomiting, had a high temperature, was shivering, had high blood pressure and a fast heart rate, and had more symptoms linked to passing urine. An ambulance took her to the Trust’s Emergency Department.

10. Mrs U’s first blood test results on 14 November showed new problems with how her liver was working. They also showed signs of inflammation, which can happen when the body is fighting illness or infection. This made the Trust concerned she may have had an infection in her gallbladder or pancreas.

11. The Trust arranged a CT scan with contrast for Mrs U. Contrast is a special dye used during some scans to help doctors see inside the body more clearly. The scan showed no problem in her abdomen.

15. Before we decide if we should conduct a detailed investigation of a complaint, we look at whether there are signs the organisation has got something wrong. We do this by comparing what should have happened with what did happen.

CT scan 16. Mrs U says the use of contrast during her CT scan was inappropriate. She says Trust doctors proceeded with the contrast CT despite a junior doctor raising concerns over the impact this could have on her CKD condition. She says after having the contrast CT scan her renal function declined further leading to readmission, further treatment and a worsening of her CKD.

17. After assessing Mrs U’s symptoms on 14 November 2024, the Trust was concerned that she might have an infection in her gallbladder or pancreas, which are part of the digestive system. They decided to perform a contrast-enhanced CT scan to help diagnose or rule out any problems.

18. In its explanation of events, the Trust said it considers the contrast CT scan to be the ‘gold standard’ for investigating problems in the gallbladder, bile ducts, or pancreas, such as blockages, infections, or inflammation. It explained that a senior consultant carefully considered the junior doctor’s concerns about using contrast dye for patients with kidney disease as this is one of the considerations made when deciding the risks of a procedure. It reassured Mrs U that the senior consultant balanced the risks and benefits of the procedure before making the decision to go ahead.

19. Our advisor explained that the contrast used in a contrast CT scan does have the risk of raising creatinine levels, which for patients with CKD can be a higher risk of making their condition worse for them. They went on to explain that because of this, doctors need to consider the risks and benefits to decide what the best course of action for the patient is.

20. Our adviser explained that in some cases, the risk of Contrast Induced Acute Kidney Injury is outweighed by potential benefit from the contrast study. They said imaging should not be delayed when the benefit of imaging clearly outweighs the risk of waiting.

21. In Mrs U’s case she had signs of infection, urine infection, hypovolaemia (dehydration, having a lower-than-normal amount of blood or fluid in your body), heart failure and raised creatinine kinase due to her CKD. These all had to be considered in making the decision about whether the risks of undertaking the CT scan were less than the benefits of finding out what was wrong with Mrs U and being able to treat this.

22. Our advisor explained based on the evidence and Mrs U’s condition, a delay in diagnosis would have been more harmful than the contract CT scan.

23. Guidance from the Renal Association, British Cardiovascular Intervention Society, and Royal College of Radiologists says that in urgent situations, imaging should proceed without delay, even for patients with impaired kidney function, as the benefit of timely diagnosis outweighs the risk of Contrast Induced Acute Kidney Injury. The Joint Advisory Statement highlights that when iodinated contrast is necessary for diagnostic-quality emergency CT scans, the benefit of accurate diagnosis should take precedence over concerns about kidney risks.

24. Both pieces of guidance show that using a benefit versus risk approach in situations like Mrs U’s is key. Therefore, it appears the Trust acted in line with this guidance in its decision-making process.

25. Based on the evidenced we have seen it appears the Trust acted in line with guidance to carry out a contrast CT scan. Based on this we will take no further action on this complaint. We hope that the information we have provided above and our independent clinical advice has given Mrs U and her family the reassurances they need to show the Trust did not get this wrong.

Decline in kidney function 26. Mrs U says the Trust used her fall and other factors to deflect responsibility from the impact of the contrast CT scan.

27. NICE guidance on Acute Kidney Injury says there are key risk factors and causes of a decline in renal function which include: • certain medication such as NSAIDs, ACE inhibitors, ARBs, and diuretics • hypovolaemia (Dehydration): due to fluid loss from diarrhoea, vomiting • sepsis • conditions like urinary tract obstruction which should be investigated and treated promptly to prevent further decline in renal function • chronic illnesses such as diabetes, hypertension, or heart failure.

28. Our adviser explained that having considered Mrs U’s medical records the decline in her renal function was potentially caused by some of the conditions Mrs U had, such as dehydration, heart disease and medication she was taking. They also explained the CT scan could have caused some additional damage as this is a risk of using the contrast.

29. Having considered the evidence available and our clinical advice, it does not appear the Trust’s explanations about possible other causes of her renal decline was to deflect from using the contrast CT. The information provided is in line with the NICE guidelines above.

30. Based on the evidence we have seen we are satisfied the Trust did not get anything wrong when it explained the possible other causes of her decline in renal function along with the possibility of the contrast CT scan adding to this. We hope the information we have given above gives her some reassurances about what the Trust told her.

Communication 31. Mrs U says the Trust did not explain the risks of using contrast in the CT scan and did not obtain any patient consent.

32. RCR guidance on standards for using contrast gives information about consent for contrast CT scans. It says patients should be provided with clear, accurate, and tailored information about:

• the purpose of the scan and the use of contrast media to enhance certain images • potential risks associated with the contrast agent, such as allergic reactions, nausea, and rare complications like Contrast-Induced Acute Kidney Injury (CI-AKI) • patients at higher risk (those with impaired renal function, diabetes, or a history of allergic reactions) should be informed about the specific risks relevant to their health condition.

33. It says the clinician should discuss risks and recommends they explain the balance of risks versus benefits. It also says for routine, low-risk procedures which is most contrast CT scans, verbal consent is appropriate and should be documented in the patient’s medical records. For higher-risk cases such as patients with a history of severe allergies or significant renal impairment, written consent may be more suitable.

34. Our advisor explained that formal written consent for a contrast CT scan procedure is not general practice. They said medical professionals should explain risks to the patient in context of the potential benefit of proceeding with the study.

35. Based on the evidence we have seen, it appears the Trust did not fully follow the guidelines above when it discussed the contrast CT scan with Mrs U before carrying it out. We cannot be sure based on the evidence we have seen that it fully explained the risks of performing a contrast CT scan, especially given she had CKD.

36. When we see an organisation might have got something wrong, we go on to consider what impact this might have had.

37. We cannot be sure if Mrs U would have made the decision to not have the contrast CT scan had the Trust explained the benefit verses risk rationale. But we do know she lost the opportunity to consider the risk and potentially refuse the contrast CT scan.

38. Mrs U told us she thinks the contrast CT scan caused a decline in her renal function leading to readmission, further treatment and a worsening of her CKD. She says this increased her physical vulnerability and caused ongoing emotional distress.

39. As we have explained above, our adviser has explained in Mrs U’s case the benefits of ruling out the serious conditions of pancreatitis or gallstones outweighed the possible risks of using the contrast with Mrs U’s CKD. Our advisor explained Mrs U had many existing health conditions and if there was a delay in diagnosis and treatment, it could have made her more unwell and increased her risk of decline.

40. As we have also explained above our adviser also explained that there are other conditions Mrs U had that may have caused or contributed to her decline in renal function. This means we cannot be sure, even if Mrs U did refuse the contrast CT scan, that her renal function would not have declined.

41. We consider the Trust’s failure to fully explain the risks and benefits of the contrast CT scan before it took place to be a missed opportunity to give Mrs U the information she needed to make an informed decision. This caused her worry and uncertainty about whether her decision could have changed the outcome, even though the clinical evidence suggests that not proceeding with the scan could have led to a worse result.

42. Our Principles for Remedy says where failings have had an impact, public bodies should try to offer a remedy that returns the complainant to the position they would have been in otherwise. An appropriate range of remedies will include an apology, explanation, and acknowledgement of responsibility.

43. The Trust has acknowledged that it did not properly communicate with Mrs U about the contrast CT scan. It apologised for not discussing or explaining the rationale to proceed with a contrast CT scan before it took place. The Trust also advised it would make improvements in communication and arrange patient information leaflets to better inform patients about this procedure. These actions are both in line with our Principles for Remedy above and are part of the outcomes Mrs U told us she wanted.

44. Mrs U also told us she wanted financial compensation. Based on the evidence we have seen, and the worry caused by what went wrong, we are satisfied that this sits at level one of our Severity of Injustice scale. As such we are satisfied the actions taken by the Trust are in line with our Principles to remedy the worry and concern that Mrs U experienced.

45. We will take no further action on this complaint. We thank Mrs U for bringing this complaint to us and appreciate the time and effort this took. We are sorry to hear about the distress Mrs U and her family have experienced, and we hope our decision explains how carefully we have considered the concerns they raised.

1. We have carefully considered Mrs U’s complaint about London North West University Healthcare NHS Trust (the Trust). We were sorry to hear about her experience and the difficulties she says she has faced following her CT scan in November 2024.

2. We have looked at all the evidence provided to us by Mrs U, her daughter, Miss L, and the Trust. We have seen that the Trust followed relevant guidance in relation to how it considered the risks and benefits of using contrast in the CT scan and how it assessed and communicated the cause of Mrs U’s decline in kidney function.

3. We have also looked at how the Trust explained the risks of the contrast CT scan to Mrs U and her family before the scan took place. We have found that this was not fully in line with relevant guidance, as the Trust has accepted it did not discuss or explain the rationale for proceeding with the scan before it happened. We saw the Trust acknowledged and apologised to Mrs U for this and took learning to improve communication and patient information. We are satisfied this is enough to remedy this part of the complaint and we will therefore take no further action on the complaint.

4. We are sorry for any additional upset this may cause, and we hope our explanations below explain how we have fully considered this.