Consent and risks
18. 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 we have found no signs something has gone wrong.
19. Miss W complains the Trust did not inform her of the 1 in 100 risk of capsular rupture (a tear in the membrane surrounding the lens of the eye) or the 1 in 1,000 risk of endophthalmitis (swelling within the eyeball). Miss W said if doctors had informed her of these risks, she might not have gone ahead with the surgery.
20. The Trust explained to Miss W she consented to these risks when she signed the consent form on 13 November 2020.
21. Miss W’s records show she signed a consent form on 16 August 2019 agreeing to cataract surgery.
22. The consent form lists the following significant, unavoidable or frequently arising physical risks:
• 1:1,000 risk of severe or permanent visual loss (e.g. retinal detachment, endophthalmitis or severe infection, major haemorrhage [significant blood loss]) • 1:100 risk of need for further surgery • 1:20 complications which can be rectified at the time of surgery or after the operation (e.g. anterior vitrectomy [clearing the front part of the eye of remaining cataract or vitreous material], peripheral iridectomy [removing a small part of the iris]) • 1:10 need for laser treatment for posterior capsular opacification [cloudy vision from abnormal cell growth on the lens capsule]).
23. Miss W also signed to say the ‘Moorfields cataract leaflet has been provided’.
24. On 13 November 2020, Miss W signed another consent form on the morning of the surgery. The terms of the consent form were the same as the one Miss W signed in August. The only differences are the addition of some definitions and that ‘1:100 risk of need for further surgery’ could be required to rectify a problem.
25. The consent form does not say whether the Trust gave Miss W an information leaflet on this occasion.
26. On 13 November 2020, Miss W also signed the Trust’s ‘Statement of patient’. This statement shows Miss W agreed to the procedure, knowing her options and rights, and medical staff told her about additional procedures which might become necessary during her treatment. She signed and dated the statement on the day of surgery.
27. We asked for clinical advice from a consultant ophthalmologist.
28. The adviser referred to the ‘Learning Outcomes’ set out by the RCO, which say ophthalmologists need to obtain valid patient consent in accordance with GMC, national and NHS trust guidelines. The RCO does not state what risks need to be listed in consent forms, but it does provide a ‘Cataract Consent Form’ template. The template is not required by law, but it provides guidance for trusts if they want to provide a written consent form.
29. Section 22 of the GMC ‘Decision making and consent’ guidance states, when discussing benefits and harms, doctors should recognise the risks of harm that anyone in the patient’s position would want to know. They should also consider the risks of harm and potential benefits the patient would consider significant, and any risk of serious harm, however unlikely it is to happen.
30. The adviser explained there is no set format for the consent process. They explained the consent form and processes vary in the level of detail and format across different trusts. They explained some trusts choose to have a consent form, while others choose to obtain verbal consent from the patient.
31. The adviser explained the Trust’s consent form was in line with GMC guidance, as it clearly outlines the risks associated with the surgery and the probability of these risks happening during surgery. The Trust’s consent form documented risks which were similar to those noted by the RCO as guidance in the RCO’s consent form. The adviser said if the RCO thought the risks were important enough to include in its own template, and the Trust has documented the same risks in its own consent form, then this is sufficient to show the Trust’s consent form complies with GMC guidance.
32. The adviser explained the Trust’s consent forms, both signed by Miss W, state there is a 1:100 risk of further surgery, with the second form documenting this could be to rectify a problem.
33. Medical staff gave the consent forms, which clearly explained the risks and the likelihood of them happening, to Miss W to read and consider before she signed them. We recognise discussions around surgery and risks can be daunting and sometimes confusing for patients. We would expect if a patient has signed two consent forms, they would have read them, and if they required further clarification, they would ask for this. Miss W had two opportunities to read the risks and the likelihood of them happening.
34. Miss W signed the consent form after being presented with the risks and statistics of them happening. The adviser explained the risk of 1:100 need for further surgery relates to the complication Miss W experienced in 99% of cases.
35. Medical staff also provided Miss W with the cataract leaflet in August 2019, and she signed the ‘Statement of patient’ on 13 November, which also documented the risk of further surgery.
36. On review of the evidence we have seen, both consent forms contain the 1:100 risk of needing further surgery, which applies most commonly to a rupture of the posterior capsule (the event Miss W experienced).
37. We understand this must have been a distressing time for Miss W and we are sorry to hear she required further surgery.
38. On this basis, we can see the Trust informed Miss W of the risks and side effects of the surgery. We have found no signs of service failure.
Surgery
39. Miss W complains the surgeon ruptured the posterior capsule in her right eye. The Trust says posterior capsule rupture is a well-recognised complication of cataract surgery.
40. We obtained clinical advice on this matter. We are aware surgery can sometimes be unsuccessful, without this necessarily being the fault of the surgeon, so we wanted to consider whether the surgeon’s actions fell below what is considered good clinical care and treatment.
41. The adviser explained no specific guidance is available for what happens when a known complication arises during surgery. They explained the GMC’s ‘Good medical practice’ guidance, section 15, states doctors must provide a good standard of practice and care to patients, and they must refer a patient to another practitioner when it serves the patient’s needs.
42. We asked the adviser to consider ‘The Ombudsman’s Clinical Standard’ to establish what would have been good clinical care and treatment in the situation complained about. We then considered whether what actually happened fell short of that standard.
43. During the surgery on 13 November, the surgeon caused a rupture of the posterior capsule in Miss W’s right eye. In simple terms, the membrane holding the lens in a central position ruptured, and a piece of cataract broken up by the surgeon fell to the back of Miss W’s eye. The clinical records state the surgeon noted the rupture after they had broken up the cataract and had started to remove it. Following the rupture, the consultant surgeon took over the surgery and tried to remove the remaining cataract and make the eye safe.
44. The adviser explained the surgical note states ‘nucleus was seen in the vitreous’ (the broken pieces of cataract had fallen to the back of Miss W’s eye), and to proceed with the surgery would harm the patient. The adviser said the safest thing to do was to make the eye safe and refer Miss W to a vitreo-retinal surgeon (a doctor who specialises in surgery at the back of the eye), who would then operate on the back of Miss W’s eye.
45. There is nothing in the records to suggest the surgeon’s actions were not of a good standard. The action of referring Miss W to a vitreo-retinal surgeon was in line with GMC guidance, which advises referring a patient to another practitioner when this serves the patient’s needs. This is what happened and doctors made the referral as quickly as possible.
46. The adviser said the transitional period following surgery does involve intensive use of eye drops, and Miss W’s experience of using many eye drops is common when such complications happen.
47. The adviser said rupture of the posterior capsule is a well-recognised, longstanding complication of cataract surgery, with a range of consequences and outcomes. This includes the need for additional surgery, as stated in the Trust’s consent forms Miss W signed in August 2019 and November 2020. Despite timely intervention, the healing of the eye can and does vary.
48. Before the clinical advice discussion, Miss W sent an email explaining she had seen a consultant who noted she had an epiretinal membrane in her eye. This is a thin, almost transparent layer of fibrous tissue, which forms a ‘film’ over the macula (the central part of the retina) at the back of the eye. Miss W and her consultant said this means her eyesight has been affected.
49. The adviser said it would be difficult to link the development of an epiretinal membrane more than two years after the second procedure directly to the initial cataract operation. This is because epiretinal membranes are a well-recognised, age-related disease in many people. The adviser said although the surgical course of events in this case may have contributed to the epiretinal membrane, the age-related aspect cannot be ignored, as it may have developed, even if no surgical complication had taken place.
50. From what we have seen, we understand what happened during Miss W’s surgery is a well-recognised complication, and it does not mean the treatment the Trust provided to Miss W was below the expected standard.
51. We recognise that no matter how small or big surgical complications are, they still affect patients and we do not wish to minimise Miss W’s experience. We are sorry there were complications during Miss W’s surgery which meant she required further treatment.
52. Based on the evidence we have seen, we have found no signs of service failure.
Hospital transport
53. Miss W complains the Trust did not inform her about the availability of hospital transport. Miss W says she spent around £500 on taxis from her home to the hospital on City Road. Miss W believes the Trust should pay her travel expenses to attend appointments after the initial surgery because of the mistakes made by the surgeon.
54. The Trust told Miss W more frequent reviews in clinic are necessary following any complication during surgery. The Trust said it does not refund the travel costs of patients who doctors need to see more frequently in clinic. However, if a patient requires transport, they can book this through the Trust’s transport provider, DHL. The Trust apologised if staff did not explain this to her when she attended the clinic.
55. We asked the Trust for a copy of its Non-Emergency Patient Transport (NEPT) policy. The policy sets out guidelines for those who qualify. To be eligible for NEPT, a patient must have a clearly defined medical condition which prevents them from using public or private transport. Eligible patients are those who have medical conditions, learning difficulties, mobility problems and/or are vulnerable adults.
56. The policy then states: ‘Patients with sight loss, either congenital or acquired, are not automatically entitled to hospital transport. Due to the nature of the patient’s visit to Moorfields Eye Hospital, it is required that further information is provided other than providing details of the patient’s ophthalmic condition.’
57. We asked the Trust whether Miss W would have been eligible for patient transport based on her condition following surgery. The Trust explained as it is an eye hospital, temporary or permanent sight loss does not automatically mean a patient qualifies for NEPT. The Trust said staff had not recorded Miss W on the appointment system as a patient who needed transport assistance. This means the Trust would not book transport for the patient for any appointments or for day case admissions.
58. We asked the Trust whether it is the Trust’s duty to inform the patient NEPT is available, or is it for the patient to raise the issue with the Trust if they have difficulty attending future appointments. The Trust explained this is not something it normally shares with the patient, unless the patient enquires about it, and there is nothing in the Trust’s policy to tell staff to arrange patient transport to the main site. The Trust said it is ‘asking the question’ internally whether the Trust should do this in the future, but this is at a very early stage.
59. The Trust explained if Miss W had asked staff about transport, they would have advised her to contact DHL, so the process could be followed. I asked the Trust what the process was, and they provided a flow chart.
60. We have considered the NEPT pathway flow chart. The first question is whether the patient can use a taxi, public transport, drive or be driven.
61. Miss W has not said the sight loss meant she was unable to arrange private transport to City Road. The Trust had not recorded Miss W as needing assistance with arranging transportation. Miss W was able to take a taxi to and from City Hospital for her surgery.
62. The Trust’s policy does not state hospital staff must inform patients about the availability of NEPT.
63. After the operation on 13 November, the Trust informed Miss W about what happened and the need for her to attend City Road for further surgery the next day.
64. We recognise Miss W had just found out something had happened during her surgery, which meant she needed further surgery the next day. We also note Miss W had little to no sight in her eye following surgery, and needed to use eye drops for the foreseeable future. We accept this must have been an intense and difficult time for Miss W, and the thought of arranging transport may not have been at the forefront of her mind.
65. Miss W did attend City Road the next day for her surgery. If Miss W had any issue with taking a taxi or getting to her appointment, it would have been reasonable for Miss W to communicate she would not be able to attend.
66. From the Trust’s assessment of Miss W on 17 November (the day of the corrective surgery), we can see Miss W arranged her own transport and was able to travel by herself. If there was any reason Miss W was unable to use private transport following surgery, this would have been another opportunity for Miss W to raise this issue.
67. We appreciate Miss W’s frustrations and upset at having to spend £580 on taxis to and from appointments, and why Miss W believes she should be refunded this cost because the surgery went wrong.
68. We have seen nothing from Miss W which suggests she was unable to take a taxi to the hospital. The Trust’s policy does not state patients must be informed about NEPT, and there was nothing in Miss W’s records suggesting staff should have told her about it. Even if Miss W had said she needed assistance from the Trust, it does not mean Miss W would have automatically received NEPT, as she would have needed to satisfy both the Trust’s and DHL’s requirements.
69. On this basis, we have seen no evidence of service failure.
Adverse incident
70. Before we decide if we should conduct a detailed investigation of a complaint, we look at whether there are signs the events complained about had a negative effect which the Trust has not put right. Having done so, we have found the Trust has already done enough to put right the impact of these events.
71. Miss W complains the junior surgeon who performed the surgery did not report the complication as an adverse event.
72. In their first response, the Trust explained to Miss W the junior surgeon had not reported the complication as an incident at the time of the event. The Trust said they have since explained to the surgeon the need to do so. The Trust said the surgeon now understands complications such as Miss W’s need to be reported as incidents to allow timely investigation.
73. In their second response, the Trust said all trainee doctors, which the surgeon was at the time, are required to keep a log book of all surgery they undertake so they can review this with their clinical educational supervisor. The Trust explained the junior surgeon and the consultant surgeon said they misunderstood the rules regarding incident reporting when a routine complication, for which the patient has consented, happens. The Trust told Miss W it had explained the requirement to the surgeons since it had received Miss W’s letter. The Trust concluded by saying it had documented the complication in Miss W’s health records, and the lack of reporting at the time did not negatively impact the care the Trust provided to Miss W.
74. The Trust’s Incident and Serious Incident Reporting policy states: ‘All staff are expected to report, or make sure that a report has been completed, for all incidents in which they are directly involved or become aware of.’ The policy also requires staff to report incidents as soon as they became aware of them, ideally within a maximum of 24 hours.
75. Neither the junior surgeon nor the consultant surgeon who took over the surgery reported the complication as an incident. This was not in line with the Trust’s policy.
76. Miss W said when she found out the junior surgeon had not reported the complication, she experienced a loss of confidence in both the Trust and the surgeon.
77. We can understand why Miss W would feel a loss of confidence upon realising the surgeon did not report the complication following her surgery. We can see the Trust recognised the surgeon did not comply with its own policy.
78. We asked the Trust for evidence the surgeon was now aware of the requirement to report such incidents. The Trust said it discussed the reporting of incidents, including when a complication happens during a surgical procedure, with the surgeon between 9 April and 14 April 2021. The Trust said at the incident review meeting, they discussed the need to report incidents in line with the Trust’s incident reporting policy, which included reporting complications during surgery. They also discussed the duty of candour requirements (the duty to be open and honest with patients when something goes wrong) for these instances.
79. Following this discussion, the Trust confirmed the surgeon reported seven further incidents, two of which were further surgical complications, before leaving Moorfields in July 2022 as part of their training rotation.
80. We recognise the surgeon’s actions were not in line with the Trust’s policy, which has left Miss W with a loss of confidence in the Trust and the surgeon.
81. Our Principles for Remedy state where a fault or poor service has led to injustice or hardship, public organisations should try to offer a solution that returns the complainant to the position they would have been in otherwise. The principles state an appropriate solution could be corrective action, which can include training or supervising staff.
82. We have looked at what remains unresolved between the complainant and the Trust. We can see the Trust has taken steps to offer a solution by talking to the surgeon and the consultant, to make sure they know the requirements going forward. We are satisfied with the Trust’s evidence the surgeon is now aware of the requirement to report complications as incidents, and we can see the surgeon has taken this information on board, as they went on to report seven further incidents.
83. We are satisfied the Trust has done enough to put this right. On this basis, we see no injustice requiring resolution.
84. We understand how upsetting it must have been for Miss W to undergo two rounds of surgery on her eye, and for her overall condition not to have improved. These are unfortunate and sad circumstances. We are very sorry for Miss W.