Royal Devon and Exeter NHS Foundation Trust

4. Ms X complains about aspects of treatment she received at the fertility clinic (the clinic - part of the Trust) between September 2019 and March 2020. She and her partner, Mr D, had started the process to receive in vitro fertilisation (IVF) treatment to conceive a baby. The clinic rejected Mr D’s blood results because it did not have sufficient identification attached.

5. Ms X complains the fertility nurse did not provide her with the correct information regarding the requirements for identification of blood test results. She complains the clinic misinformed her about the reasons why it rejected Mr D’s blood results. She does not accept the clinic’s reason for rejecting the blood test results as it is not outlined in law or local policy.

6. As a result of the fertility nurse not providing the correct information, Ms X complains the clinic has rejected her and Mr D for IVF treatment. They complain this meant they lost their chance of having a family, which has been devastating.

7. As a result of the clinic’s misinformation about the blood test results and reasoning for the rejection, Ms X says she and Mr D have been devastated. They feel frustrated by the clinic’s reasons for rejecting the blood sample results. They feel uncertain about whether the clinic should and could have accepted Mr D’s blood results.

8. By bringing her complaint, Ms X would like the couple’s IVF treatment to continue on the NHS. If this cannot be arranged, Ms X would like financial redress to assist with the costs of alternative fertility options such as surrogacy. Ms X would like reassurance that there was no way for the clinic to have accepted Mr D’s blood test results.

9. In 2019, Ms X and Mr D were referred to the clinic for fertility treatment. They attended their first appointment with the doctor at the clinic in August 2019. The doctor provided information about the couple’s options including two cycles of IVF and what this treatment would involve. IVF is where an egg is removed from the woman's ovaries and fertilised with sperm in a laboratory. The fertilised egg, called an embryo, is then returned to the woman's womb to grow and develop.

10. The couple had a planning appointment with the fertility nurse in September 2019. They understood that during this appointment, they would need to give a blood sample to test for HIV. Mr D is ‘severely needle phobic’. Ms X made enquiries with several medical centres to see if they could test for HIV via any other means. A sexual health clinic (part of a different Trust) informed Ms X that it could test HIV from a finger prick test, which Mr D felt able to tolerate.

11. At the appointment with the fertility nurse in September 2019, Ms X says the nurse discussed the options for Mr D with regards to his blood test and his phobia. The clinic offered Mr D a blood test on the day to take place there, but he declined this. The fertility nurse told them that the blood test would also need to test for Hepatitis B Core, Hepatitis B Surface Antigen and Hepatitis C. The fertility nurse was unsure if a finger prick test would be suitable for the Hepatitis tests. The couple understood they needed to confirm this. Ms X says the fertility nurse told them they would need ‘something in writing’ in relation to Mr D’s blood test results. Ms X says the nurse did not give them any further information about Mr D’s blood results.

12. Ms X contacted the sexual health clinic to ensure that there would not be an issue in providing the result. The sexual health clinic confirmed that it could provide the results to the clinic and told her this was a process it was familiar with. However, the sexual health clinic informed Ms X it was unable to test for Hepatitis B and C via a finger prick test. With no other option available, Mr D had the blood test with a needle at the sexual health clinic in November 2019. Ms X says this was ‘extremely anxiety provoking’ but Mr D did it in the knowledge that it would be a one off. The sexual health clinic confirmed the test results were all clear in late November 2019.

13. Due to confidentiality rules around sexual health clinics, they do not use NHS numbers. The clinic received the results but then informed Ms X that there was an issue with the results because Mr D’s blood test results did not have an NHS number on them.

14. The clinic then informed Ms X that there were not three points of identification connected to the results. The sexual health clinic contacted the clinic confirming Mr D’s name, address and date of birth. Ms X says the clinic then informed her of a further issue. There were not three points of identification on the laboratory report itself. Ms X says that the clinic told her that it was a legal requirement to have three points of identification on the laboratory report itself.

15. A clinician from the sexual health clinic wrote to the clinic confirming that the laboratory report was linked to Mr D’s full name, address and date of birth. However, the clinic still did not accept the results.

16. The clinic sent Ms X an email in December 2019 informing her that ‘the main issue is linking a letter to the actual lab results, which only show date of birth. It also includes a lab number which we assume is [Mr D]’s anonymised number, Therefore, if the sexual health clinic can also include this number their letter, this may be suffice [sic]’.

17. The clinic decided it was unable to accept the results and the only way forward was to repeat the blood tests for Mr D. Mr D felt unable to do this. Ms X and Mr D were not able to continue with their IVF at that time.

Fertility nurse and identification requirements

20. Ms X complains that at the planning appointment in September 2019, the fertility nurse did not provide the correct information regarding the requirements for identification of blood results.

21. Ms X says she made it ‘absolutely crystal clear’ both before the appointment (via telephone conversations) and during the appointment that Mr D is severely needle phobic. She explained that Mr D would ‘really struggle’ to have a blood test with a needle, even with appropriate measures in place. Mr D declined the offer of a blood test on that day at the Trust.

22. The fertility notes support Ms X’s account that she made Mr D’s needle phobia clear at the appointment. The notes also indicate that both Ms X and Mr D were having their tests external to the clinic (although the Trust did take Ms X’s at the main hospital site). The fertility notes say ‘[Mr D] -> bloods to be done at another clinic due to needle phobia’. Ms X reports that the fertility nurse said that they would just need ‘something in writing’ regarding the results.

23. The Trust responded to this acknowledging that the fertility nurse wrongly assumed that Mr D was having his sample taken at an NHS GP surgery rather than a sexual health clinic. If an NHS GP surgery had provided the results, the Trust says the sample would have had ‘standard identifiable information’. Because a sexual health clinic took Mr D’s blood sample, it was unable to include the identifiable information required due to confidentiality. It said the clinic had not experienced this issue before. It said it would be looking at how to include this information at planning meetings in future.

24. The Royal College of Nursing Fertility Nursing subject guide says the fertility nurse is responsible for providing a holistic approach to investigation, treatment, and early pregnancy through compassionate, informed and evidence-based practice. The Royal College of Nursing: Fertility Provision for the UK guidance says the role of registered nurses working in fertility services is to fully inform prospective parents of the options and implications of treatment, and to support them psychologically throughout the process.

25. The clinic’s 'Your first fertility clinic appointment' explains what to expect at your first fertility clinic appointment. One of the questions on this leaflet explains what tests the couples will need to have. It states ‘blood test for HIV and Hepatitis B&C for both partners, if you go on to need assisted conception treatment’.

26. The Human Fertilisation & Embryology Authority (HFEA) Code of Practice (eight edition r.11) (in date at the time of these events) says under T52b ‘donors must be negative for HIV1 and 2, HCV, HBV and syphilis’. Under T53, it says the licenced centre (the clinic) must ensure that the laboratory tests required by licence condition T52 are carried out at a qualified laboratory, which has suitable accreditation using a ‘CE marked’ testing kit where appropriate.

27. The Trust provided the ‘IVF planning document’ it uses in planning appointments. On the first page it says ‘blood and investigations sheet check all relevant blood, screening and investigations completed’. It further says ‘if no, comment on the course of action taken’. The fertility nurse has recorded ‘[Mr D] having done at another clinic – see notes’.

28. The Trust recognised that the fertility nurse assumed (wrongly) an NHS GP was taking Mr D’s blood sample. Its response suggests that they would not have expected the fertility nurse to discuss the identification requirements because this issue had not occurred previously. We consider that it was the patient’s choice in these circumstances to decline the blood test with the clinic and find an alternative location. The Trust advised it has never had a patient go to a sexual health clinic for a blood sample for fertility purposes. The likelihood of this situation arising is therefore low and the assumption the fertility nurse made, is not unreasonable.

29. However, the HFEA code of practice suggests that it is the clinic’s responsibility to ensure that qualified laboratories take the blood tests. If the clinic did not clarify where Mr D was having his tests done, it cannot have confirmed that it was a qualified laboratory.

30. While the clinic may not have come across this situation before, it appears to remain the responsibility of the fertility nurse to have ensured Ms X and Mr D were making an informed choice. If the nurse had informed them the results needed to be attached to Mr D’s NHS number, Ms X would more than likely have checked this with the sexual health clinic before proceeding. We can say this as she made additional enquiries with the sexual health clinic to ensure suitability based on the information the clinic had provided. This could have led to Mr D finding an alternative place for his blood sample.

31. Therefore, we consider there is an indication of service failure in the information it provided to Ms X and Mr D about the clinic’s identification requirements.

32. Ms X says because the fertility nurse did not provide this information, she and Mr D have lost their chance at having a family. This is because Mr D is unable to take another blood test due to his needle phobia. This blood sample was a one-off to allow their IVF journey to begin.

33. We have confirmed with both Ms X and the clinic that the reason treatment stopped was the rejected blood sample. However, the clinic said that it would have accepted a second sample (as long as it had the required identification) if Mr D was willing to provide one. Ms X confirmed that Mr D was not willing to do this.

34. While we do consider there is an indicated failing, we are not reassured that the injustice reported by Ms X flows. The indicated lack of communication about the identification requirements led to Mr D having a blood test that did not satisfy the requirements. Therefore, it follows that there is an injustice that Mr D needed to have another blood test. He felt he was unable to. We understand that for Mr D this is extremely distressing and anxiety-provoking. However, we do not feel that this indicated failing led to Ms X and Mr D being unable to proceed with treatment.

35. We consider there is an indicated failing that has led to the clinic rejecting the blood sample. This caused a huge amount of distress. However, the clinic would have accepted a further test. It was Ms X’s and Mr D’s choice not to accept this. We acknowledge that in ordinary circumstances, the offer of a further test to continue treatment would be remedy enough. However, when we consider Mr D’s phobia and the clinic’s knowledge of that phobia, we consider that does not go far enough. The Trust did not acknowledge this injustice within its response to Ms X.

36. Ms X wanted to achieve a financial remedy to her complaint. Looking at the Ombudsman’s Severity of Injustice scale, we consider that having to undergo an additional blood test would be a Level One injustice (relative short duration, inconvenience, one-off occurrence). In Level One injustices, we usually consider that an apology alone is a sufficient remedy. However, given the severity of Mr D’s phobia, and the clinic’s knowledge of Mr D’s phobia, we consider that a financial remedy would be appropriate in this instance.

37. The impact of knowing he had to do another blood sample would be more distressing to Mr D than the average person. However, we do have to consider the short-term nature of the distress to Mr D. Ms X and Mr D made the decision very quickly that he would not be having another blood test. Ms X confirmed in December when the clinic gave her its final decision that Mr D would not be able to do it.

38. We acknowledge that the suggestion of having another blood test would have caused Mr D additional distress in light of his extreme phobia. As such, we consider a payment of £100 to Ms X and Mr D in recognition of the impact the indicated failing had on them, would be an appropriate remedy. The Trust has agreed to this.

Misinformation about why the clinic rejected the blood result

39. Ms X complained the clinic misinformed her about the reasons for rejecting Mr D’s blood results. Ms X said that the clinic told her that the blood sample needed to be linked to Mr D’s NHS number.

40. The fertility notes show the sexual health clinic provided Mr D’s results to the clinic in November 2019 via telephone. The clinic actioned the results in early December. The notes stated ‘no 3 patient identifiers so not adequate. Need full un-anonymised report from lab’.

41. Ms X contacted the sexual health clinic in December to ask it to link its anonymised laboratory number to Mr D’s NHS number. The sexual health clinic explained that, even with Mr D’s consent, it was unable to do this due to its patient confidentiality policy (with it being a sexual health clinic).

42. Ms X said following her contact with the sexual health clinic in December the clinic then told her that the sample needed to be linked to three pieces of identifiable information. An email between Ms X and the clinic confirms this. Ms X contacted the sexual health clinic and organised for the sexual health clinic to email the clinic with Mr D’s name, date of birth and address. This would then be three pieces of identifiable information linked to the anonymised laboratory number. The clinic told Ms X ‘the main issue is linking a letter to the actual lab results, which only show the date of birth. It also includes a lab number which we assume is [Mr D]’s anonymised number. Therefore, if the [sexual health] clinic can also include this number in their letter this may be suffice [sic].’

43. The sexual health clinic confirmed that it gave this information to the clinic in December. However, it explained that the laboratory number was not Mr D’s anonymised number, it was purely a laboratory test reference number. It confirmed that it did link to Mr D’s tests.

44. The clinic’s notes state that in December ‘the blood results are not adequate due to all identifiable information not being on the same page’.

45. In late December, the fertility notes suggest the clinic made enquiries with the sexual health clinic to see if it could do anything further. The sexual health clinic told them it was not able to contact the laboratory and ask for Mr D’s name and other identifiers to be put on the laboratory results sheet.

46. Finally, Ms X said that the clinic told her that the identifiable information had to feature on the actual laboratory result. She questioned why she had been chasing information from the sexual health clinic if it would have never been acceptable.

47. Our Principles of Good Administration say ‘policies and procedures should be clear and there must be accurate, complete and understandable information about the service’ and ‘public bodies should aim to ensure that customers are clear about their entitlements, about what they can and cannot expect from the public body, and about their own responsibilities’. Our Principles also say ‘public bodies should communicate effectively, using clear language that people can understand and that is appropriate to them and their circumstances’.

48. We can see from the evidence available that the clinic did provide Ms X with differing reasons as to why it had not accepted Mr D’s results. This resulted in Ms X attempting to resolve each issue. We can see that this would cause Ms X (and Mr D) distress. This is because the clinic raised their hopes that it could resolve the issue by obtaining additional information. However, it appears it would not have been able to resolve the issue as the fertility clinic needed the information on the results themselves.

49. We can see that communications appear to show that the clinic was attempting to help Ms X. However, it is also understandable that Ms X was left feeling that they had her chasing information that would never been enough. Therefore, we do not believe the clinic’s communication about the reason for rejecting Mr D’s blood sample was in line with our Principles around communication. The message appeared to change when Ms X provided the information the clinic requested. We consider there is an indication of a service failure.

50. The Trust apologised for the inconsistent information it gave to Ms X. It acknowledged this may have caused a delay in it providing Ms X with its final decision on the blood results. It admitted staff could have escalated the situation to a senior team member in a timelier manner. It further explained the fertility clinic team had discussed Ms X’s case to learn from the miscommunication errors. The response acknowledged the stress it caused to Ms X and Mr D.

51. We do not underestimate how stressful this experience was for both Ms X and Mr D. We can see the miscommunication lasted for a short duration in December. This delay did not impact upon the clinical time limits for Ms X and Mr D pursuing IVF.

52. Considering our severity of injustice scale, we believe this impact falls within Level One. This level talks about annoyance, frustration, worry and inconvenience, typically arising from a single (one-off) incidence of maladministration or service failure. In these circumstances, the impact on the individual(s) is of short duration and there are no other adverse effects or ongoing wider impacts.

53. We appreciate that the wider issues here are around the continuation of IVF treatment and do not wish to downplay the seriousness of the context of the miscommunication. However, focusing on the communication issues themselves, the Trust has acknowledged and apologised for the stress caused. It said how it aims to improve in the future and learn from its errors in this case. Therefore, we consider that the Trust has already done enough to remedy this indicated failing.

The reason the clinic rejected the blood result was not outlined in law or policy

54. Ms X complained the clinic’s reasons for rejecting Mr D’s blood sample results are not outlined in law or local policy. The Trust told Ms X it required three pieces of identifiable information on the blood sample results. However, it acknowledges this is not explicitly specified in the HFEA code of practice. The Trust said it adhered to:

· the Trust’s ‘Identification of Patients Policy and Procedure Policy’

· the Trust’s ‘specimen labelling procedure’

· the National Patient Safety Agency safety notice.

55. The Trust said it would not accept results that did not contain patient identifiable information for patient safety reasons. This is to avoid the possibility that laboratory results are associated to the wrong patient. This issue is raised in the National Patient Safety Agency safety notice.

56. However, having reviewed the above policies, there is nowhere within the Trust’s policies that states explicitly that the results must contain three pieces of identifiable information on the results themselves.

57. The Trust’s Identification of Patients Policy and Procedure says that patients should be identified using their NHS number as the primary identifier with other details to ensure the correct identification. The clinic confirmed that while this policy relates to patients themselves, it applies the same principles to samples. While it is not recorded in policy, the clinic says that it requires three points of identification in a combination of name, date of birth, NHS number or hospital number. The clinic says that this would usually be available to an NHS clinician taking the sample. It reinforced that this is not unique to the fertility service or even the Trust. It says this is the accepted practice across the country for patient safety.

58. The clinic confirmed it has never had a patient attend the sexual health clinic for a blood sample. Therefore, it has never accepted a sample from that clinic. The clinic told us that some patients choose to attend their GP for blood samples. They would not encounter the same issues as a GP would be able to provide the NHS number on the results for identification.

59. HFEA Code of Practice (eight edition r.11) says under T52b ‘donors must be negative for HIV1 and 2, HCV, HBV and syphilis’. Under T53, it says the licenced centre (the clinic) must ensure that the laboratory tests required by licence condition T52 are carried out at a qualified laboratory, which has suitable accreditation using a ‘CE marked’ testing kit where appropriate. The CE marking shows the product meets the EU safety, health or environmental requirements.

60. The Code of Practice also says that the licenced centre must ‘ensure that all premises, equipment, processes and procedures used in the conduct of licensed activities are safe, secure and suitable for the purpose’. T100 in the code says that the procedures must include ‘the unique and accurate identification of each patient/donor’ and ‘the unique and accurate identification of each set of gametes and embryos’.

61. We appreciate the frustration Ms X and Mr D have experienced in trying to understand the clinic’s reason for rejecting Mr D’s sample results. Ms X is correct that the policies the clinic has provided do not give the explicit requirements it used to justify its decision. However, the HFEA Code of Practice puts the responsibility on the individual clinic (the clinic) to ensure that procedures are safe. Therefore, if the clinic is not satisfied the procedure is safe, or that it has met the HFEA requirements, then it appears to be its decision to make and rationalise. A clinic’s failure to meet the standards might lead to suspension or revocation of a clinic’s licence. An error made in the fertility process could have catastrophic impacts such as a life being created from the incorrect donors. This is why the licenced clinic has to be extremely careful when processing samples.

62. Given the above, we cannot conclude there is an indication that the clinic did anything wrong in making its decision to reject the sample.

Summary

63. We acknowledge how frustrating and difficult this process was for both Ms X and Mr D. Having looked into the issues, we have decided we will not take any further action on Ms X’s complaint for the reasons explained above. We do not underestimate the emotional impact of the IVF journey as a whole and hope that the explanation above does not cause any further distress.

1. We have carefully considered Ms X’s complaint about the Trust in relation to its decision to reject a blood sample from Ms X’s partner, Mr D, during their fertility process. We acknowledge how devastating Ms X told us this experience has been.

2. There is an indication that the Trust’s communication about the identification requirements of Mr D’s blood sample was not fully in line with guidance. The Trust has now agreed to a resolution to address the impact of this on Ms X and Mr D. There also appears to have been a miscommunication about the reasons for the Trust rejecting Mr D’s blood samples. However, we consider the Trust has already done enough to put the impact of this indicated failing right. In relation to the decision to reject the sample, we have not seen any indications that anything went seriously wrong in the Trust’s decision making.

3. We will explain our decision in more detail below, including the resolution we have agreed with the Trust.