4. Ms P complains she contracted hepatitis B from the Trust during surgery on 19 March 2024.
5. Ms P says this has led to her losing trust in the NHS and she is now scared to go to hospital. She says this has adversely affected her, causing her feelings of anxiety and worthlessness.
6. Ms P is seeking an apology and financial remedy.
7. In February 2024 the Trust diagnosed Ms P with uterine cancer. On 19 March the Trust conducted a total hysterectomy on Ms P.
8. On 10 April Ms P attended a different hospital trust for a blood test. The results revealed she had hepatitis B.
9. Hepatitis B is a viral liver infection that is spread through bodily fluids. This can be by blood, saliva, semen or vaginal fluids. It can also be passed from mother to baby during childbirth.
10. The Trust prescribed entecavir 0.5 (antiviral medication) to treat the virus.
11. On 27 May Ms P had a blood test and was informed the virus had subsided. In June a further blood test indicated the virus had cleared. On 27 November a blood test showed no indication of hepatitis B or liver damage.
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.
16. Ms P believes she contracted hepatitis B whilst undergoing surgery at the Trust on 19 March 2024. Ms P considers she must have contracted the virus due to negligence and poor sterilisation of surgical equipment.
17. Ms P says there is no way she had the virus prior to surgery. She says she had a pre-assessment blood test a week prior to the surgery and there was no indication of hepatitis B or liver disease.
18. Ms P also says she has never been exposed to hepatitis B. She says she has not been sexually active since 2018 when she got a diagnosis of breast cancer and underwent cancer treatment. She says her social life has been limited due to her health challenges, and she works from home.
19. Ms P considers if she was previously infected then this must have occurred when she underwent a double mastectomy in May 2019 at the same trust and required a blood transfusion.
20. The Trust says Ms P could not have contracted hepatitis B when she underwent surgery on 19 March 2024. They have checked the sterilisation and cleaning protocols for all medical equipment used during the surgery with its Sterile Services. It says it can confirm the service washed and sterilised all equipment to the correct standards. It adds all items went through the thermal disinfection process prior to sterilisation. This process removes or kills almost all bacteria, viruses and fungi, including hepatitis.
21. NHS England guidance sets out best practice on the management and decontamination of surgical instruments used in acute care. This explains how organisations should maintain appropriate levels of cleanliness and hygiene for reusable medical devices. It refers to the reusable surgical instrument cycle which involves sterilisation, cleaning, disinfection and inspection from the point of purchase, through storage, transport and use.
22. We can see from the Trust’s response, it followed protocols and processes in line with this guidance. We have not seen any evidence that Ms P contracted hepatitis B due to unsterile, unclean equipment.
23. The Trust says it has reviewed the blood test taken on 10 April. It says the test for hepatitis B surface antigen produced a negative result. This means Ms P was not infected with hepatitis B at this time. The test for hepatitis B core total antibody was positive. This indicates Ms P has previously had the hepatitis B virus and the antibodies were present in her blood. Antibodies are proteins produced by the immune system to fight off foreign substances such as viruses. As Ms P had hepatitis B antibodies, this indicates she has had hepatitis B in the past.
24. The Trust says it would not be possible to pinpoint exactly when Ms P had hepatitis B, and it could have occurred many years ago. It says there is no evidence to suggest Ms P contracted the virus in a healthcare setting.
25. We asked our adviser whether there was evidence to support Ms P’s view she contracted hepatitis B during her surgery. Our adviser said the test results in April 2024 do not suggest Ms P acquired the virus in March 2024. Our adviser said the test result indicates occult hepatitis B. That means it shows a previous rather than active infection. Additionally, they say there is no evidence of jaundice or liver test abnormalities post-surgery. This adds weight to the likelihood Ms P did not have recent exposure to hepatitis b.
26. Our adviser explained the incubation period (the time it takes to develop symptoms after exposure to a virus) for acute hepatitis B is 40 – 140 days, with the average incubation period being 90 days. The World Health Organisation says the incubation period of hepatitis B virus ranges from 30 to 180 days. The virus can be detected within 30 to 60 days after infection.
We can see the period of time between the surgery and the test results was 22 days.
27. This further supports the view that Ms P did not acquire the virus in March 2024, as it is unlikely she would have tested positive for antibodies within 22 days of exposure.
28. Ms P says the trust who did the blood test prescribed entecavir to manage the virus. She says blood tests in May, June, and November showed no sign of the virus still being present.
29. Ms P has done some research into the drug entecavir, and her understanding is this medication would not be able to cure chronic hepatitis. She therefore considers she could not have had hepatitis B prior to the surgery because it would have been at a chronic stage and therefore the entecavir would have been ineffective. She considers the virus was at an acute stage when the trust prescribed the entecavir, so it effectively managed the virus.
30. We asked our adviser if entecavir could be effective for both acute and chronic hepatitis B.
31. They reiterated the point that Ms P did not have hepatitis B at the point of testing, rather she had occult hepatitis B (indicating infection at some point in the past, not a recent infection). They informed us prescribers do not use entecavir to treat acute hepatitis B because in 95% of adult cases hepatitis b clears without treatment. Entecavir is reserved to treat severe hepatitis B.
32. GOV.UK guidance says ‘there is no specific treatment available for acute hepatitis B… Liver failure is a rare complication that requires specialist treatment. Antiviral drugs are not needed to treat acute infection’.
33. Our adviser said in Ms P’s case she was prescribed entecavir to prevent the reactivation of hepatitis B whilst she was undergoing treatment for the cancer. They explained cancer treatment can trigger a reactivation of hepatitis B in people with past or current hepatitis B infection.
34. EASL guidelines say people who test negative for hepatitis B surface antigens but test positive for hepatitis b antibodies (as Ms P did) should receive antiviral medication such as entecavir if they are at high risk of hepatitis B virus reactivation. This is effective in preventing hepatitis B reactivation and liver damage.
35. The evidence we have seen indicates Ms P did not acquire hepatitis B whilst undergoing surgery in March 2024. She believes if she did not acquire it at this point, she must have acquired it when she underwent surgery and had a blood transfusion in 2018.
36. The Trust say it is not possible to determine when Ms P contracted the virus. The Trust says there is no evidence to indicate Ms P contracted the virus in a health setting. Our adviser agreed it was very unlikely Ms P acquired the virus through a blood transfusion in 2018.
37. The NHS website says, ‘since 1972, donated blood has been tested for hepatitis B to make sure it’s as safe as possible. This means the risk of getting an infection from a blood transfusion from it is extremely low’.
38. We have not seen the evidence to indicate the Trust is responsible for infecting Ms P with hepatitis B. Unfortunately, we are unable to provide Ms P with an explanation of how she acquired the virus, which could have been many years ago. We recognise it is alarming for Ms P not to know how she became exposed to the hepatitis B virus.
39. We have not seen indications of failings so will not be taking Ms P’s complaint further. We understand this situation has caused Ms P anxiety at a time when she was already vulnerable with regards to her health. We hope she can consider our views and feel reassured we have seen no indications she was exposed to hepatitis B at the Trust. We hope our findings have lessened her concerns about accessing NHS services in the future. We thank her for bringing her complaint to us and wish her all the best for the future.
1. We have carefully considered Ms P’s complaint about Guys and St Thomas’ NHS Foundation Trust (the Trust). Ms P has told us how upsetting it was to realise she had hepatitis B. We are aware Ms P has experienced serious health issues since 2018, and this further compounded her anxiety. We understand this caused her stress and a sense of worthlessness. We are sorry to hear how this experience impacted on her.
2. Taking into account the evidence we have seen, we do not consider it likely the Trust was responsible for infecting Ms P with hepatitis B during surgery. We have seen evidence to suggest she had acquired hepatitis B prior to March 2024.
3. We want to thank Ms P for the time she has taken to bring her complaint to us. We hope our explanation below will explain why we will not be taking her complaint any further and provide her with some reassurance with regards to NHS services. We are pleased she is no longer hepatitis B positive. We hope she has improved health in the future.