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London North West University Healthcare NHS Trust

P-002023 · Statement · Decision date: 30 June 2023 · View London North West University Healthcare NHS Trust scorecard
Complaint (AI summary)
Ms T complained the Trust performed cervix surgery incorrectly, causing heavy bleeding, and prescribed an antibiotic (clindamycin) to which she was allergic.
Outcome (AI summary)
The complaint was closed. The ombudsman found no sign that the Trust failed to follow relevant clinical guidance regarding the surgery or medication.

Full decision details

The Complaint

5. Ms T complains about the following aspects of the Trust’s care and treatment from 24 May to 15 June 2021:

• the Trust did not do the cervix surgery correctly on 24 May and she experienced heavy internal vaginal bleeding afterwards. She says the Trust did not explain what caused the bleeding • on 11 June the Trust prescribed clindamycin (an antibiotic) but she was allergic to it.

6. Ms T says she experienced heavy internal vaginal bleeding on 10 June which caused her a great deal of shock, anxiety and distress. She complains she has been in poor health since then. She says she experienced an allergic reaction to the clindamycin. She said she lost her ability to work and nearly lost her job.

7. Ms T would like an apology from the Trust and £2,000 financial compensation.

Background

8. In early 2021 Ms T had a colposcopy (a test to examine the cervix for abnormality) which showed mild and moderate dyskaryosis (abnormal cells covering the surface of the cervix).

9. In March 2021, she was diagnosed with stage CIN3 cervical intra-epithelial neoplasia (when the full thickness of the cervical surface layer is affected by abnormal cells). While this does not mean cancer, it means she was at high risk of cervical cancer in future if this condition went untreated.

10. Large loop excision of the transformation zone (LLETZ) is the most common treatment for cervical cell changes. The procedure uses a thin wire loop with an electrical current to remove the affected area of the cervix. The Trust recommended Ms T have this treatment in March 2021.

11. Ms T had LLETZ surgery on 24 May 2021. On 10 June 2021 she developed increased vaginal bleeding and attended A&E. After review, the gynaecology team put her under anaesthetic for an examination and diathermy (a procedure using electric currents to heat the target muscle for muscle relaxation) to stop the bleeding.

12. On 11 June 2021 Ms T was reviewed by a gynaecologist who found her fit for discharge. The doctor prescribed clindamycin. Four days later, Ms T had an allergic reaction and developed a skin rash.

Findings

LLETZ surgery causing bleeding and failing to communicate the cause of the bleeding

17. Ms T complained that about two and a half weeks after LLETZ surgery, she developed heavy vaginal bleeding and had to go to A&E. She explained she had to have an emergency procedure to stop the bleeding. She said she woke up from the procedure with no idea what had happened and what caused the bleeding.

18. Ms T told us the bleeding was abnormal and something went wrong with the surgery. She told us the bleeding was ‘scary’ and ‘traumatising’ and she experienced significant shock, anxiety and distress that has had a negative impact on her work and daily life.

19. The Trust said before the surgery it explained to Ms T the risks of the procedure included pain, bleeding and infection, among other things. It said during the procedure there was minimal blood loss and no complications. It referred to guidance from the RCOG to say bleeding is commonly seen in patients after LLETZ surgery.

20. The Trust noted that on 10 June 2021 Ms T developed vaginal bleeding and was taken to theatre for examination and a procedure to stop the bleeding. It apologised that after the surgery, the team did not immediately see Ms T to explain to her what had happened. It said doctors generally prefer to tell patients once they have been transferred to the general ward and have recovered, because patients cannot take in information until the effects of the anaesthesia have passed. The Trust said a doctor assessed Ms T on 11 June 2021 before she was discharged.

21. GMC guidance sets out the standards for communication for doctors:

‘You must work in partnership with patients, sharing with them the information they will need to make decisions about their care, including their condition, its likely progression and the options for treatment, including associated risks and uncertainties.’

22. RCOG guidance describes the risks of bleeding after LLETZ as:

‘About 85 in 100 (85%) people experience bleeding after LLETZ. About 15 in 100 (15%) people do not experience bleeding. This is expected after LLETZ and can last between 2 days to up to 4 weeks.

You may have bleeding because of the soft scab that forms on the cervix where the cells were removed. This may bleed while it heals. The bleeding is usually like a period, but may be slightly heavier than your normal period. About 10 days after treatment, the bleeding may get heavier. This is common and a sign that the scab is healing.’

23. The BSCCCP guidance states:

‘Risks: • Infection and bleeding • There is small risk of late miscarriage or premature delivery in subsequent pregnancies; However this depends upon the length of LLETZ biopsy, the type of abnormal cells found and number of times LLETZ procedure has been done.

• A small minority of women might need a repeat procedure because of incomplete removal of abnormal cells.

After treatment: You will experience some vaginal bleeding and discharge, and this may last up to four to six weeks on and off. The blood will be fresh (bright red) to begin with and then turn brown and watery.’

24. We have reviewed Ms T’s medical records to see what happened during her care and treatment.

25. From the records, we can see a Trust nurse wrote to Ms T on 1 April 2021 about her condition (abnormal cells on the cervix), explaining that LLETZ treatment was necessary to prevent the abnormality getting worse. The nurse also attached a leaflet with more information about LLETZ treatment. This leaflet contained the following information on what patients may expect in the recovery period:

‘You will have some vaginal bleeding that should last for only 1 to 2 days. If you had a LLETZ, the bleeding can last up to 4 weeks.’

26. On the day of surgery, we can see the Trust provided a patient consent form to Ms T. This consent form contained the following statement from the consultant who did the surgery:

‘I have explained the procedure to the patient. In particular, I have explained the intended benefits: to treat cervical cell changes. Serious or frequently occurring risks: pain, bleeding, infection...’

27. We can see Ms T signed to say she had read this and agreed to the procedure or course of treatment described on the consent form.

28. Based on this evidence, before the surgery the Trust took the appropriate steps to tell Ms T she might experience vaginal bleeding up to four weeks after the procedure.

29. The operation notes say there was 5ml of blood loss. Our adviser explained this was minimal and records showed there were no complications during surgery.

30. Operation notes showed that on 10 June 2021, Ms T attended A&E for vaginal bleeding. She was examined under anaesthesia and had a diathermy to the cervix to stop the bleeding. Her estimated blood loss (EBL) was 350ml. She was found fit for discharge the next day.

31. Our adviser said the likely cause of the bleeding was infection and the scab over the surgical area coming loose. They explain this commonly happens after this type of surgery (as described in the guidance).

32. There is no indication the LLETZ procedure had gone wrong, or that there were any unexpected or unexplained side effects in the recovery period. The bleeding itself did not mean something had gone wrong.

33. We have considered what happened on 10 and 11 June 2021 after Ms T went to A&E with increased vaginal bleeding and had treatment to stop the bleeding. The Trust apologised that staff did not explain what happened as soon as she woke up from the anaesthesia, as the on-call team had to prioritise emergency A&E patients, but a doctor reviewed her the next day.

34. Our adviser explained in these circumstances, they would have expected the gynaecologist to speak to the patient on the general ward the next day and to arrange a follow-up colposcopy.

35. From the records, we can see this is what the Trust did. Ms T was reviewed on the general ward on 11 June 2021 as she recovered from the anaesthesia and procedure. The discharge plan included a follow-up colposcopy.

36. We realise Ms T likely experienced anxiety and upset while she was recovering. We think the Trust gave enough information before the surgery to explain bleeding was an expected and common risk of the procedure. The Trust also arranged a review and follow-up colposcopy without delay.

37. Our overall decision is there is no sign the Trust failed to do the procedure correctly or that it failed to communicate the risks and causes of the bleeding.

Prescription of clindamycin

38. Ms T complained that on 11 June 2021, the Trust prescribed her with a course of clindamycin to which she was allergic. She said she developed a skin rash which she reported to her GP.

39. The Trust explained the plan was to give her three doses of intravenous antibiotics (clindamycin through her veins) over a 24-hour period and then to discharge her with the same medication to be taken orally for seven days. The medication was meant to treat any existing infection in the raw area and to stop further infection. Unfortunately, Ms T developed a skin rash four days later. The Trust said this reaction was not very common (less than 1%) and there was no way it could predict if anyone would have a reaction.

40. GMC guidance sets out the responsibilities of doctors in prescribing medication as:

‘In providing clinical care you must: a. prescribe medicine or treatment, including repeat prescriptions, only when you have adequate knowledge of the patient’s health, and are satisfied that the medicine or treatment serve the patient’s needs b. provide effective treatments based on the best available evidence.’

41. We can see from the records the Trust completed a care plan on 10 June 2021 which included a section on history of allergies. At the time, the clinicians were not aware Ms T had any allergies. The discharge sheet dated 11 June also showed she had no known drug reactions or allergies at the time.

42. Clindamycin is known to be an effective drug and our adviser felt the Trust acted appropriately in prescribing it to prevent infection.

43. We consider the Trust took the right steps to assess Ms T for allergies before prescription, as shown by the care plan. The doctors identified the need to use medication to prevent infection, and they were acting on what was known about Ms T’s history at the time. We have not seen any signs of failings to follow the GMC guidance in prescribing clindamycin.

44. We hope the above explanation gives Ms T some reassurance that we have looked at her complaint carefully. We are sorry she went through a difficult and distressful time after her procedure. We wish her all the best with her recovery.

Our Decision

1. The Parliamentary and Health Service Ombudsman has carefully considered Ms T’s complaint about the London North West University Healthcare NHS Trust (the Trust).

2. We are sorry to hear about Ms T’s experience of anxiety and stress after she had treatment for abnormal cervical cells.

3. We have considered the evidence and we have seen no sign that the Trust failed to follow the relevant clinical guidance.

4. We understand Ms T may find this disappointing. We hope our statement below clearly explains how we have reached this decision.

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