Portsmouth Hospitals University NHS Trust

4. Ms N complains the Trust failed to identify, record and treat complications that arose during Mr L’s large volume paracentesis (LVP) procedure on 12 September 2022.

5. Ms N says Mr L died on 13 September due to internal bleeding caused by the LVP procedure. She says she constantly relives the distressing events of 12 and 13 September and it has affected her physical and mental health. She says she had to sell her house because Mr L’s life insurance policy refused to pay out and she had to return to work full time.

6. Ms N wants the Trust to accept responsibility for Mr L’s death, apologise and give her a financial remedy.

7. What follows is our summary of events. We have not included all the details as those involved are already aware of this information but have included this brief background to put the complaint in context.

8. Mr L had a history of liver disease and cirrhosis, a condition where healthy liver tissue is damaged and prevents the organ from functioning properly. He had also developed ascites, which is an abnormal build-up of fluid in the abdomen.

9. The Trust treated his ascites with LVP. This is a procedure that drains the fluid buildup in the abdomen to provide symptomatic relief.

10. Mr L underwent an LVP on 12 September 2022. It was done as a day procedure and he was discharged the same day.

11. Mr L became unwell at home in the early morning of 13 September. Ms N called an ambulance and Mr L was taken to the Trust’s Emergency Department (ED). He was transferred to the Intensive Care Unit (ICU) where he sadly died later that evening.

12. Mr L’s primary cause of death was recorded as intraabdominal haemorrhage (bleeding into the abdominal cavity) secondary to portal hypertension (high blood pressure in the portal vein) and ascites treated with paracentesis, and liver failure secondary to alcohol induced cirrhosis.

16. When we consider 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 for Ms N’s complaint.

17. Ms N complains the Trust failed to identify, record and treat complications that arose during Mr L’s LVP procedure on 12 September 2022.

18. LVPs are performed by trained hepatology nurse specialists. Hepatology is the branch of medicine that studies the liver. Mr L had LVP procedures on 18 and 30 August, and on 12 September.

19. The BSG guidance includes an eight-point safety checklist to ensure minimum standards of care are met during an LVP procedure, which can be amended in accordance with local practice guidelines: • confirm presence of ascites by clinical examination • check patient identification and consent, including risks from the procedure; written consent is recommended.

• ensure patient and nursing staff are prepped for the procedure – intravenous access is in place, baseline observations (blood pressure, pulse, respiratory rate, temperature and pre-drain weight) have been taken, Human Albumin Solution (HAS) has been ordered, prescribed and available (100ml given per 2.5 litres of ascites drained) • check platelet count and clotting • apply dressing and leave on free drainage • take and send specimens of ascites for analysis (including white cell count) • document colour of initial fluid draining, there is a plan for HAS replacement, and note the time the drain is due to be removed • monitor colour of ascitic fluid (watch for blood in the drain bag), drain the output, monitor blood pressure, pulse, respirations and urine output, and check the drain site for pain and haematoma (collection of blood outside the blood vessel).

20. The Trust’s policy says it should be used in conjunction with the published international guidelines. In this case, the applicable published guidelines are the above BSG guidance. The policy includes: • there must be a current and appropriate plan of care for all patients, the plans must incorporate on-going evaluation and re-assessment of care and evidence that relevant interventions and observations have been recorded throughout the procedure and have been communicated to appropriate members of the multidisciplinary team • pre-procedure the patient should be told the risk of significant hemorrhage is approximately less than one in 1,000 • during drainage the patient’s temperature, pulse and blood pressure should be checked at two to four hourly intervals • allow free drainage of fluid, ideally until dryness • patient can be discharged 30 to 60 minutes after the procedure if they are asymptomatic and observations are stable.

21. In line with the BSG guidance, Mr L was asked to sign a consent form on 12 September, before the LVP started. The form said a hepatology nurse specialist explained the procedure to Mr L, including that serious or frequently occurring risks of the procedure were ‘infection, bleeding, failed procedure, scar damage to underlying structures, gut perforation’.

22. During the procedure, nurses completed a LVP Local Safety Standards for Invasive Procedure (locSIPP). A locSIPP is a Trust specific checklist. They recorded: • Mr L’s pre drain weight was 68kg • they inserted the drain at 9.50am • a sample of ascitic fluid was sent for analysis and his red blood cell count was 2,880 cells per microlitre • 8,300ml litres of ascitic fluid was drained (records show this was 1,000ml at 10.00am, 2,500ml at 11.00am, 2,100ml at 12.00pm, 1,200ml at 1.00pm, 1,000ml at 3.00pm and 500ml at 4.00pm) • they gave Mr L three units of HAS (records show these were given at 11.00am, 12.00pm and 3.00pm) • they removed the drain at 5.30pm • his post drain weight was 60kg.

23. From our adviser’s advice we can see Mr L’s red blood count from the sample taken was within normal range. His count was 2,800 cells per microlitre; a haemorrhage is indicated if the count is above 50,000. Nurses took Mr L’s observations (respirations, oxygen saturation, blood pressure, pulse and temperature) at 9.05am (before the procedure began), 10.30am, 11.22am, 1.00pm, 2.00pm and 5.30pm. This is in line with the two to four hourly BSG recommendations.

24. We understand from our adviser Mr L’s observations throughout the day do not show any cause for concern. While his blood pressure dropped slightly over the course of the day, that is in keeping with a recent drainage of a large volume of fluid and was still within a normal range.

25. DHSC hospital discharge guidance says patients should be discharged when clinically ready in a safe and timely manner. Staff should conduct patient-initiated follow-up (PIFU). This is when a patient initiates an appointment when they need one, based on their symptoms and individual circumstances. They should be given the direct number of the ward they are discharged from to call back for advice. This is often known as ‘safety netting’.

26. We cannot see a clinical review was completed prior to Mr L’s discharge. We can see, however, the ascitic fluid was fully drained by 4.00pm and Mr L’s final observations of the day were taken an hour and a half later. As explained above, Mr L’s observations were within normal range, and so the evidence available shows Mr L was clinically ready to be discharged. However, we cannot see that staff gave Mr L safety netting advice before he left.

27. Ms N says she woke sometime between 4.00am and 5.00am the next morning and could hear Mr L groaning. She says that was not unusual. She fell back to sleep and woke about 6.30am. She woke Mr L, who had an upset stomach and said he wanted a bath. Mr L collapsed in the bath and Ms N called an ambulance.

28. Mr L was taken to the ED. He was in cardiac arrest, meaning his heart had stopped beating, when he arrived. Mr L was assessed by a doctor at 10.34am. They said their impression was Mr L had intraabdominal bleeding (bleeding in the abdomen) which was possibly a complication of the LVP drain. The doctor noted they spoke with a nurse who said they had seen Mr L the previous day. The nurse said there was some blood in the drain bag during the LVP procedure, but the team was happy bleeding was ‘minimal and controlled’ when he was discharged.

29. A hepatology nurse specialist (records do not clarify if this is the same nurse who spoke to the ED doctor) wrote notes about the LVP procedure at about 11.00am. This is about 17 and a half hours after the LVP procedure ended. They said the notes were written in retrospect, although they did not say why, and: • the ascitic fluid was blood stained • Mr L felt well throughout the day • he remained haemodynamically stable (meaning his blood pressure, heart rate, and oxygen saturation were within normal ranges).

30. Mr L was transferred to the ICU. A consultant radiologist reviewed a CT scan and reported Mr L had a bleed from a vein at the site of the recent drain. Unfortunately, treatment was unsuccessful, and Mr L sadly died just before 11.00pm that evening.

31. With the help of our adviser we can see that unfortunately, by the time Mr L arrived at the ED, his condition was critical and could not be reversed by treatment. Even if he had arrived earlier, the risk of death due to worsening of liver failure, hepatic encephalopathy (when the liver is unable to filter toxins from the blood), kidney failure and infection following a significant bleed remained very high.

32. On 14 September a hepatologist nurse specialist wrote a discharge letter to Mr L’s GP. A discharge letter provides information about the patient’s treatment and future care needs. They said it was typed on 14 September and was in respect of the LVP procedure on 12 September. The letter did not say Mr L had died since. The nurse said: • the ascitic fluid was blood stained • Mr L was monitored closely in view of this • his observations were stable, and he was discharged.

33. We have thought about whether these failings had an impact on Mr L, with the help of our adviser. We can see Trust records do not show when nurses first saw blood in the drained fluid, but we have considered Ms N’s recollection of events. She says a nurse told her about half an hour after the procedure started that there was blood in the ascitic fluid. This means blood was visible from at least 10.20am.

34. In line with the BSG guidance, as there was blood in the fluid, we can see observations should have been done more regularly than two to four hourly, and that is what happened here. Mr L was monitored over a period of more than seven hours from the time staff first became aware of the blood, and during that time his observations were taken five times, i.e. with less than two hours between each observation. From the evidence available to us, those observations, including the last ones at 5.30pm, did not indicate any complications, including a haemorrhage, that might warrant a longer period of observation or investigation.

35. The NICE major trauma guidance says patients with active or suspected active bleeding should be treated with intravenous clotting products as soon as possible. Indicators of active internal bleeding include low blood pressure, increased breathing rate and increased heart rate.

36. We can see there was some blood in the ascitic fluid. However, Mr L’s stable observations during the eight hours he was on the unit do not suggest that he was actively bleeding at that time. There are case reports of bleeding up to a week after LVP, but it is not clear why delayed bleeding occurs, and we understand these incidents are very rare. It is possible that over the course of time, a tiny cut can progress into an ulcer that then bleeds rapidly at a later point. As such, we have not seen any indication of failings in the care and treatment given to Mr L during his surgery and up to his discharge.

37. We have also considered what happened at the point of discharge and whether Mr L was given the safety netting the DHSC guidance indicates should be provided. We can see no record that Mr L was given safety netting advice when he was discharged and so this is an indication of a mistake by the Trust. We have thought about the likely impact to Mr L.

38. DHSC hospital discharge guidance says safety netting means a patient should be told to contact a specific ward if they want advice. This means that, even if safety netting advice had been given, Mr L would only have been told to contact the LVP ward if he had any concerns. Early in the morning the day after the surgery, Mr L and Ms N called for an ambulance as soon as he became unwell and, as his condition was clearly already so serious at that time, contacting the LVP ward would not have been suitable for his needs. As such, we cannot see that failure to provide safety netting advice had any impact to Mr L or meant he lost out on an opportunity for further care from the Trust, which we hope reassures Ms N.

39. Ms N tells us that staff did not appropriately record the events of 12 September, and we do not think the record keeping on 12 September was in line with the NMC guidance set out in our evidence section. Sections 10.1 and 10.2 of the NMC Code says records must be made at the time or as soon as possible after an event and any risks or problems that have arisen, and the steps taken to deal with them must be identified. Specifically, we can see no records made on the same date of the LVP showing: • blood was seen in the ascitic fluid • the time of onset of bleeding • the amount of blood • that consideration was given to more regular observations given the blood • a clinical review was completed prior to Mr L’s discharge • Mr L was given safety netting advice.

40. We recognise how important good record keeping is. In this case, we have not seen anything to indicate poor record keeping led to any impact on Mr L’s care and treatment, which was in line with applicable guidelines and standards (with the exception of the safety netting, as we have explained above).

41. With the above in mind, we can see that bleeding is a recognised, albeit very small, complication of the LVP procedure. Mr L was made aware of this risk and gave his consent to proceed. Although we know there was blood in the ascitic fluid, he had stable observations throughout the day of the procedure. Specifically, the observations taken at 5.30pm support the appropriateness of his discharge at that time. We have not seen anything to suggest the sad outcome could have been avoided. We will therefore not consider this matter further.

42. Although we have not seen any indications of failings by the Trust leading to an impact to Mr L, we are pleased to see that following its own investigation into Mr L’s death, it has updated its LVP locSIPP to include the following if blood stained ascitic fluid is seen: • increased observations, one to two hourly • discuss with medical team prior to discharge • repeat full blood count after four hours • record postural blood pressures (blood pressure taken standing after sitting or lying down).

It has also updated its LVP safety netting to include informing patients of post procedure risks and to seek medical advice in case of emergency. We are glad to see the Trust has taken learning from this complaint and improved services as a result, in line with our NHS Complaint Standards, which say organisations should seek continuous learning.

43. We acknowledge the events leading up to Mr L’s death were, and continue to be, extremely distressing for Ms N. We hope the information we have provided here will go some way to explaining what happened and we have clearly set out how we have reached our decision in this case.

1. We have carefully considered Ms N’s complaint about Portsmouth Hospitals University NHS Trust (the Trust). We are very sorry to learn of the sad circumstances which led Ms N to approach us. We recognise Ms N has been through an extremely distressing experience and offer our sincere condolences on the death of her partner, Mr L.

2. We have found indications of failings by the Trust in not providing safety netting to Mr L, and in its record keeping. Having reviewed the evidence very carefully, we have not seen anything to suggest these errors had an impact on Mr L, nor that they contributed to his sad death, and therefore we have decided not to look at this matter further.

3. We understand this remains a challenging time for Ms N, and we hope the explanations provided below are helpful to her.