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East Suffolk and North Essex NHS Foundation Trust

P-003335 · Statement · Decision date: 6 February 2025 · View East Suffolk and North Essex NHS Foundation Trust scorecard
Drugs / medication Tests Communication Communication Communication Treatment Duty of Candour implementation Complaint record keeping failures
Complaint (AI summary)
Mrs B complained about various failings in her fertility care, including delayed medication, mislabelled tests, poor communication, cancelled procedures, and the Trust's inadequate complaint handling.
Outcome (AI summary)
The complaint was closed. The Trust either acted appropriately or remedied minor mistakes; some events lacked evidence for a decision.

Full decision details

The Complaint

3. Mrs B complains about aspects of the fertility care and treatment she received from the Trust.

4. Mrs B says the Trust: • did not offer her medication to help her conceive naturally (letrozole) until March 2023 • mislabelled a follow up blood test so it could not use it • did not provide her with the information she needed after it prescribed a second course of letrozole • did not get back to her with answers to questions she asked about a laparoscopy and dye test (an operation using keyhole surgery to look at the abdominal and pelvic organs, particularly the fallopian tubes) prior to the procedure, then cancelled it • repeatedly ignored letters from her GP asking for information and updates • will not provide her with any further NHS funded fertility treatment.

5. Mrs B also complains about the Trust’s complaint handling, and says it asked her to stop contacting it, and refused to deal with her.

6. Mrs B says as a result, she has wasted two years of fertility treatment, and this has also set her back in pursuing private treatment. Mrs B also says this has had an emotional impact.

7. As an outcome, Mrs B is looking for an apology and financial remedy.

Background

8. Mrs B previously sought treatment from a fertility clinic in another area in 2018, as she and her husband had been struggling to conceive. The clinic’s investigations showed Mrs B possibly had a blocked fallopian tube, but it could not see this on a repeat scan. The clinic discharged Mrs B and advised her to continue trying naturally.

9. Mrs B approached her new GP in March 2022, following COVID-19 and a home move, and she met with a consultant at the Trust in October 2022. At this point Mrs B was 40 and had been trying to conceive for seven years.

10. The Trust arranged a HyCoSy (hysterosalpingo contrast sonography) test (an examination of the uterus, ovaries, fallopian tubes, and pelvis using ultrasound) and AMH (anti-Mullerian hormone) test (a test which gives an indication of a person’s ovarian reserve) for Mrs B. These showed Mrs B’s fallopian tubes were patent (not blocked), and she had a AMH level of 3.9pmol/L, which is very low.

Findings

Letrozole

14. Mrs B complains the Trust did not offer her letrozole until March 2023.

15. The Trust said it does not normally offer letrozole to patients who require a higher level of fertility treatment, like Mrs B. The Trust offered it to Mrs B as per her request, in an attempt to be supportive while her IVF (in vitro fertilization, where an egg and sperm are combined in a laboratory, before the embryo is transferred into the uterus) application process was ongoing.

16. Mrs B’s records detail the Trust discussing other fertility options with her, including ovulation induction treatment, during a consultation on 29 March. Mrs B was keen to try this, so the Trust prescribed letrozole for her.

17. The BFS website says, ‘Many studies have recently shown that using Letrozole for ovulation induction results in better rates of successful ovulation’.

18. Our adviser told us a lack of ovulation was not the cause of Mrs B’s fertility problems. Mrs B had tests to confirm she was ovulating regularly and normally. This means there was no indication for the Trust to prescribe letrozole for Mrs B either in March 2023, or at any point earlier in her care. While there was no indication for the Trust to prescribe letrozole for Mrs B, our adviser confirmed taking this medication would not have had any negative physical impact on her.

19. We understand why Mrs B would have questions about why the Trust did not prescribe letrozole for her sooner than it did. We have seen there was no indication for the Trust to discuss letrozole with Mrs B, or offer to prescribe it for her, any sooner than it did. We will therefore not consider this aspect of the complaint any further.

Blood test

20. Mrs B complains the Trust mislabelled a follow up blood test so it could not use it. This blood test was a day 21 progesterone blood test, which indicates if ovulation is occurring.

21. The Trust acknowledged it mislabelled Mrs B’s blood sample, and it apologised for this.

22. We have not seen anything in Mrs B’s records which details this event. However, the records do detail the Trust prescribing a second course of letrozole for Mrs B on 26 June.

23. NHSE information says ‘Ensure correct labelling and double check for any errors – this is particularly important for hand-labelled samples’.

24. We recognise this mistake would have been frustrating for Mrs B, and caused a delay in her finding out her progesterone levels. We are sorry this happened to her. The delay would have had little impact on Mrs B’s fertility treatment, as she was already ovulating regularly before taking letrozole. We have seen the Trust rectified its mistake, by prescribing a second course of letrozole for Mrs B as soon as she contacted it to make it aware she had not received her results. We recognise Mrs B has further concerns about what happened with this second prescription, but we will consider those separately later.

25. Our Standards say if failings are found which have had an impact of any kind, the first step is to provide a meaningful apology.

26. We consider the Trust’s apology is enough to remedy the impact of its mistake here. We will therefore not consider this aspect of the complaint any further.

Letrozole information

27. Mrs B complains the Trust did not provide her with the information she needed after it prescribed a second course of letrozole. Mrs B says she was not sure whether she needed another blood test before taking the tablets, so did not take them.

28. The Trust said it reiterated the relevant information to Mrs B when it prescribed the second course of letrozole for her.

29. Mrs B’s records do not contain notes which support what the Trust said about providing her with any information about the second course of letrozole.

30. Mrs B says she contacted the Trust for more information about what to do, but it did not get back to her. We have seen a copy of a letter about this dated 29 June 2023 from Mrs B’s GP, which is addressed to the Trust. There is no evidence of this letter in Mrs B’s records from the Trust.

31. The copy of the email from Mrs B’s GP which we have seen says it was sent to ‘chu-ftr.obsandgynaesecs@nhs.net’. We have not seen this is an active email address for the Trust, which may explain why it did not receive it, and in turn did not respond. We found a similar email address ‘ObsAndGynaeSecs@esneft.nhs.uk’, so this may have been an error on the part of the Practice.

32. We do not dispute Mrs B attempted to contact the Trust regarding her second course of letrozole through her GP. We have not seen any evidence the Trust received this contact or any other. We do not dispute the Trust’s recollection it provided the relevant information to Mrs B. We also do not dispute Mrs B’s recollection this was not the case.

33. We recognise that treatment options can often be confusing, and Mrs B would have wanted to ensure she was following the correct instructions. As we were not there at the time, we cannot say with any certainty what happened here. As we do not have any further corroborating evidence, we would be unable to form a view on what happened. This means, if we did go on to a detailed investigation of Mrs B’s complaint, we would be unable to reach a robust decision on this aspect due to a lack of evidence. We will therefore not consider this aspect of the complaint any further.

Laparoscopy and dye test

34. Mrs B complains the Trust did not get back to her with answers to questions she asked about a laparoscopy and dye test prior to the procedure, then cancelled it. Mrs B says the Trust left her unsure as to whether this procedure was safe for her.

35. The Trust said Mrs B cancelled pre-operative assessment appointments for 15 May and 10 July, and on 10 July queried the appropriateness of the operation. The Trust said as it had confirmed the rationale for the procedure any risks involved with Mrs B prior to it placing her on the waiting list, it removed her from it on 26 September.

36. Mrs B’s records confirm what the Trust said in terms of the pre-operative appointments. The records do not detail Mrs B contacting the Trust with any questions about the laparoscopy and dye test until 10 July. The Trust did not respond to these concerns, and just removed Mrs B from the waiting list.

37. The Trust’s letter to Mrs B’s GP following the consultation on 29 March says, ‘Risks of laparoscopy include infection, bleeding, injury to organs and venous thromboembolism.’ It is not clear, but this suggests the Trust may have explained this to Mrs B. If not, the Trust did at least inform her GP.

38. Our adviser told us it was reasonable for the Trust to remove Mrs B from the waiting list for the laparoscopy and dye test. This is because it is clear Mrs B had concerns about the surgery, and was not sure about whether she wanted to go through with it. It would have been good practice however for the Trust to have had a discussion with Mrs B about this afterwards.

39. Our adviser added the results of the laparoscopy and dye test would only have been for Mrs B’s information, as regardless of the outcome the appropriate treatment would have been IVF. We cover this in more detail in the final section of our statement. The Trust also told Mrs B as early as January 2023 she would need to pursue self-funded IVF. The other treatment options the Trust explored were at Mrs B’s request.

40. We have seen it was reasonable for the Trust to remove Mrs B from the waiting list for a laparoscopy and dye test. While the Trust should have discussed this with Mrs B, we have not seen this had any impact on her ongoing fertility treatment. We will therefore not consider this aspect of the complaint any further.

GP letters

41. Mrs B complains the Trust repeatedly ignored letters from her GP asking for information and updates. Mrs B has provided copies of letters dated 2 December 2022, 29 June 2023, and 6 September 2023.

42. The Trust did not address this aspect of Mrs B’s complaint in its responses.

43. Mrs B’s records show the Trust responded to the letter dated 2 December 2022 on 9 January 2023. The letter dated 29 June 2023 is asking the Trust to update Mrs B on what she needs to do regarding the second course of letrozole it prescribed for her. As explained earlier, this letter is not in the records the Trust provided us with. The letter dated 6 September 2023 is asking the Trust to confirm to both the Practice and Mrs B what investigations it has undertaken so far, the outcomes of these, and the intended next steps. This letter is also not in the records the Trust provided us with.

44. We previously determined it was possible the Trust did not receive the letter dated 29 June as the email address the Practice used was incorrect. While the letter dated 6 September does not detail the email address the Practice used, this may well be the case again here.

45. We recognise the Practice attempted to contact the Trust on Mrs B’s behalf. We have seen no evidence the Trust received these letters. As we cannot say the Trust received these letters, we cannot expect it to have responded to them.

46. We do not doubt how frustrating it would have been for Mrs B to feel like the Trust was ignoring her. We have seen no evidence the Trust deliberately ignored any letters from Mrs B’s GP. We will therefore not consider this aspect of the complaint any further.

Future treatment

47. Mrs B complains the Trust will not provide her with any further NHS funded fertility treatment.

48. The Trust said due to Mrs B’s low ovarian reserve, the only option left to her is IVF treatment. As Mrs B is not eligible for NHS funding, this would need to be self-funded treatment.

49. CG156 covers diagnosing and treating fertility problems in detail. Mrs B’s infertility was unexplained, as per the Trust’s letter to her GP in January 2023. CG156 says, ‘Offer IVF treatment… to women with unexplained infertility who have not conceived after 2 years (this can include up to 1 year before their fertility investigations) of regular unprotected sexual intercourse.’

50. The ICS guidance says, ‘Patients should only be referred for level 3 fertility services if they meet all of the following criteria at the time of referral… They met the criteria in the Policy ‘Subfertility investigation and treatment in secondary care’ and have completed further assessments and investigations indicated. As a minimum these should have included… AMH (anti-Mullerian hormone), which should be >5.4pmol[/L]’.

51. The Trust measured Mrs B’s AMH level to be 3.9pmol/L and 4.0pmol/L, so she was not eligible for NHS funded IVF as per the ICS guidance.

52. We recognise Mrs B and her husband want to explore all possible options available to them to help them conceive. We have seen the correct future treatment for Mrs B’s fertility problems is IVF, and she is not eligible for NHS funding. We will therefore not consider this aspect of the complaint any further.

Complaint handling

53. Mrs B complains about the Trust’s complaint handling. Mrs B says the Trust asked her to stop contacting it, and refused to deal with her.

54. The Trust provided responses to Mrs B’s complaint on 11 August 2023, 18 September 2023, and 11 January 2024. The Trust then sent a letter on 15 January 2024 confirming it had nothing further to add. On 29 February 2024, the Trust provided a further response to address concerns it hadn’t previously. It acknowledged it missed these concerns in its previous responses, and apologised for this. The Trust then sent a further and final response on 22 April 2024.

55. Our Standards say, ‘Staff actively listen and demonstrate a clear understanding of what the main issues are for the person who has made the complaint, and the outcomes they seek.’

56. We recognise Mrs B would have been frustrated when the Trust said it had answered all of her concerns when this was not the case. We have seen the Trust quickly addressed this by responding further just a few weeks later.

57. We appreciate it is frustrating to not receive the level of service you expect to when raising a complaint. When we consider complaints, we must focus on the most serious matters complainants bring us. This is because we are a publicly funded body, so we must work in a proportionate way and focus our attention on the matters that have had the most significant impact. The severity and length of Mrs B’s injustice would not meet the threshold for us to consider this aspect of the complaint any further.

Our Decision

1. We have carefully considered Mrs B’s complaint about East Suffolk and North Essex NHS Foundation Trust (the Trust). We recognise needing to seek help with fertility can be a difficult, time-consuming, and emotional process. We were sorry to learn your experience with the Trust did not go how you hoped it would.

2. We have decided not to consider Mrs B’s complaint any further. This is because we have seen the Trust either acted appropriately, or where this was not the case, it has either done enough to remedy the impact of its mistakes, or the impact we can attribute to them was relatively minor. There are also events where, as we were not there and there is a lack of further evidence, we would be unable to come to a decision about what happened.

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