The decision to stop TPN treatment in March 2022 and July 2022
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. We have done this and have not found any indications that something has gone wrong in regard to Mrs A’s TPN care.
16. Mrs A says the Trust incorrectly decided to stop her TPN care between March 2022 and July 2022. She also complains it did not reinstate her TPN care on 15 July 2022. She says she lost significant weight, and her mental health deteriorated as a result.
17. It must have been very worrying for Mrs A when her treatment plan changed. We appreciate this had a significant impact on her life and we are sorry to hear the stress surrounding this decision had a negative impact on her mental health.
18. NICE CG32 guidelines explain healthcare professionals have a duty to provide support and review a patient’s nutritional goals at ‘regular intervals’. This should include considering the benefits and risks of their nutritional care. Further, it says parenteral nutrition should be considered for patients with ‘inadequate or unsafe oral and/or enteral nutritional intake’. It explains there is no minimum amount of time a patient should be on parenteral nutrition, and this should be stopped ‘when the patient is established on adequate oral and/or enteral support’.
19. The records show Mrs s TPN care was stopped and her Hickman line which delivered her TPN care was removed in March 2022 as she developed sepsis. Mrs A developed Covid-19 two times whilst waiting for her appointment at the Trust. The Trust could not get the Hickman line put back in. Mrs A had blood tests during this time and had a fibro scan (a scan to assess the damage to her liver) from having TPN treatment.
20. On 15 July 2022, the Trust decided to discontinue Mrs A’s TPN care. It said it made this decision because Mrs A appeared to be getting adequate intake of food and fluids orally. It also said her blood tests were in normal range and her weight was stable.
21. Our dietician adviser reviewed Mrs A’s TPN care and treatment. They explained her TPN treatment prior to March 2022 was providing a relatively small number of calories and nitrogen. This was noted to be 1L bag 7 nights per week, providing approximately 500kcal per day, plus electrolytes, vitamins and trace elements.
22. The records indicate Trust staff correctly followed NICE CG32 guidelines in March 2022. They reviewed the ‘benefits and risks’ of Mrs A’s TPN care and correctly decided to stop it as there was risk of her developing sepsis and liver damage again. Our dietician adviser said this was an appropriate clinical decision, given the small amount of calories Mrs A was receiving via TPN care, compared to the potential overall risk to her health.
23. Trust staff said they would wait to put her TPN care back in place once it had completed further blood tests and scans. We consider this was an appropriate treatment plan. NICE CG32 guidelines explain clinicians have a duty to carry out ‘regular reviews’ of a patient’s nutritional goals. We would expect Trust staff to carry out the relevant tests to thoroughly review Mrs A’s nutritional care.
24. The blood tests, scan results and Mrs A’s weight measurements indicate her weight was clinically stable between March 2022 and July 2022. Her blood tests showed she had stable levels of electrolytes and kidney function whilst off TPN treatment. She was not receiving TPN or IV fluids at this time. On this basis, Trust staff decided not to reinstate her TPN care.
25. We are sorry to hear how unwell Mrs A felt without the TPN care. We recognise it must have been disappointing to hear Trust staff would not reinstate it in July 2022. NICE CG32 guidelines says TPN treatment is required for patients who are unable to meet their nutritional needs. It explains TPN treatment should be stopped when ‘adequate oral intake’ is established.
26. We have seen evidence Mrs A was managing her nutritional needs without TPN treatment. Her weight was stable, and her blood test results and scans were normal. On this basis, we consider the Trust made an appropriate decision not to start her TPN care again in July 2022. We have decided not to investigate this complaint further.
The Trust treating Mrs A with MCBs
27. Mrs A complains the Trust incorrectly decided to change her compounded nutritional bags to MCBs in September 2022. She says the MCBs gave her bad side effects including thunderclap headaches.
28. We are sorry to hear Mrs A suffered pain from her thunderclap headaches. We can appreciate this would have caused her further distress and frustration especially as she had just recovered from sepsis and Covid-19.
29. The ESPEN guidance explains when a patient needs TPN treatment, clinicians should use either ‘ready to use MCBs’ or ‘customised compounded TPN bags’ for their TPN care. Further, the ESPEN guidance says clinicians should monitor patients at ‘regular intervals’ to review ‘the efficacy and the risks of treatment’.
30. The records show the Trust discharged Mrs A on 6 October 2022 to continue her TPN care at home. Mrs A was prescribed standard MCBs to use at home. The type of MCB bag was a ‘Lipoflex Peri 1250ml’ bag. It explains on the EMC website patients can experience headaches as a ‘rare side effect’.
31. Importantly, Mrs A’s records indicate she was using MCBs during her inpatient stay and she had not experienced any headaches or adverse side effects. On this basis, it appears there was no concerns she could not tolerate this form of treatment. In line with ESPEN guidance, it was clinically appropriate to prescribe Mrs A MCBs to deliver her TPN care on discharge from hospital. We see no indications of failings here.
32. On 17 March 2023, Trust staff held a multidisciplinary team (MDT) meeting to assess Mrs A’s TPN care. The records show her weight had increased from 66kg to 75kg. This meant she was classed as ‘overweight’ on the body mass index scale (this is an NHS tool which calculates a person’s body mass based on their weight and height). Her test results also indicated she had high cholesterol levels (when there is a raised number of fatty substances in the blood). Based on these results, Trust staff decided to stop her MCBs and prescribe her ‘lipid free’ MCBs.
33. We consider Trust staff acted in line with ESPEN guidance during this review. They correctly ‘monitored’ Mrs A’s weight and cholesterol levels to thoroughly consider the impact of her TPN treatment. The records show Mrs A also had a history of fibrosis to her liver (a build-up of scar tissue). Our dietician adviser explained the intravenous lipid (fat) found in MCBs can lead to fat accumulation in the liver, which can result in damage to the liver.
34. Given her clinical history, BMI reading and cholesterol levels, we are satisfied Trust staff correctly weighed up ‘the risks of her treatment’ and decided to change her TPN treatment to lipid free bags. This was to reduce the risk of potential damage to her liver.
35. We are sorry Mrs A was unhappy with the Trust’s decision to prescribe her MCBs. We recognise it must have been very difficult to experience severe headaches when she was discharged from the Trust. We have seen evidence to indicate Trust staff followed ESPEN guidance when it made the decision to prescribe her MCBs. Mrs A had not experienced poor side effects whilst using MCBs in hospital, so it appears there was no concerns about the ‘efficacy’ of this medication when she was discharged. In March 2023, it appears Trust staff correctly monitored Mrs A’s condition, weighed up the risks of her treatment and made an appropriate decision to change her MCBs to lipid free TPN bags. Overall, we have not seen any indications of failings for this part of the complaint.
The Trust stopping TPN treatment
36. Mrs A complains the Trust stopped her TPN treatment and provided her with saline bags from April 2023 to June 2023.
37. It is clear Mrs A’s TPN care has had a big impact on her life. We appreciate the changes to her TPN treatment, would have felt scary and upsetting, especially as she had suffered poor side effects from the MCBs.
38. GMC guidance says clinicians have a duty to provide a good standard of clinical care and treatment. It says clinicians should consult colleagues and obtain specialist advice when it ‘serves the patient’s needs’.
39. The records show in April 2023, Mrs A told Trust staff she was experiencing poor side effects from the MCBs. As such, she had made the decision to stop using them as she was feeling very unwell.
40. On 19 April, the Trust decided to try her on a different type of MCB. It also sought advice about Mrs A’s care from St Mark’s Hospital (St Mark’s), which is a specialist intestinal and colorectal hospital. The team at St Mark’s advised switching Mrs A to IV fluids (saline bags) if she was unable to tolerate the MCBs. It said the Trust should also present her case for further advice at a St Mark’s MDT meeting.
41. At the MDT meeting, the St Marks team told the Trust as Mrs A had a stable weight and normal micronutrient levels, there was no indication she needed ongoing TPN care at home. It suggested to continue monitoring her for any changes to her condition. The Trust followed this advice and gave Mrs A saline bags on 2 June. It did not give her any further TPN compounded bags.
42. We consider the Trust’s actions were appropriate and followed GMC guidance. It correctly sought specialist advice from an intestinal and colorectal hospital when Mrs A reported adverse side effects to her MCBs. Having done so, it appears they correctly implemented the specialist advice when deciding on Mrs A’ treatment plan.
43. We consider the treatment plan was appropriate and in line with NICE CG32 guidelines. Mrs A’s test results showed her weight was stable. NICE CG32 guidelines explain TPN care is only needed when patients cannot meet their nutritional needs. There was no indication Mrs A’ nutritional intake had declined after she stopped using her MCBs. As such, it appears there was no clinical need to provide her with more TPN care from April to June 2023. On this basis, we have decided not to consider this complaint further.