NOE
13. Ms O complains the Practice failed to detect when her father’s ear infection developed into NOE, despite her raising it as a possibility, or refer him to secondary care when the infection failed to improve.
14. The Practice described the kinds of treatment Mr O received between May and September. It explained why it was the Practice nurse who had responded to Ms O’s email and having listened to the telephone call from 13 June, the Practice accepted the nurse displayed a lack of knowledge about NOE.
15. The Practice concluded there had been a delay in diagnosing Mr O with NOE and accepted this could have been done through more assessments of Mr O’s ear and symptoms. It said investigation of this complaint had identified a learning need across all staff regarding NOE, and it had taken steps to address this gap in knowledge.
16. We asked our ENT adviser if it was possible to say when Mr O’s otitis externa developed into NOE. On 16 May, Mr O described severe pain in his right ear, which was not responding to pain medication. Our ENT adviser pinpointed this to be the likely onset of NOE. Although this pattern would have been clear to any ENT specialist, our adviser felt it important to note this would not have been obvious to primary care professionals, such as GPs. They explained that because of this, ENT input is generally sought for patients with NOE after eight to nine weeks of treatment in primary care, because it is not often seen.
17. Our nurse adviser explained there is some overlap in the symptoms between acute, and chronic otitis externa, and NOE, which can cause challenges in reaching a specific diagnosis. At 92, Mr O was of advanced age and had diabetes, which our adviser explained can change the way infections present.
18. Our GP adviser also informed us that in over three decades of practice, neither they, nor any colleague, had seen a case of NOE. We can appreciate, given this, how unlikely the Practice may have thought the diagnosis to be, and it is important that we bear that in mind.
19. Mr O was being treated for Otitis Externa and so, we looked at when the Practice should reasonably have submitted a referral or sought input from ENT for either management advice on this condition, or for concerns it had progressed to NOE. Our nurse adviser explained that the NHS referrals system is electronic and allows two-way communication. Our GP adviser also highlighted that communication with ENT was also available through the local hospital’s on-call service.
20. The National Institute of Clinical Excellence (NICE) Otitis Externa Management (September 2021) provides a list of factors for those of increased risk of otitis externa developing into NOE. This includes older age and previous ear irrigation, meaning Mr O had some risk factors.
21. NICE guidance for otitis externa management says clinicians should consider seeking specialist advice or making a referral to ENT ‘If:
• symptoms persist despite optimal treatment in primary care.
• there is severe infection not responding to management in primary care.
• the person is elderly, • the person has poorly controlled diabetes, mellitus, or another cause of immunocompromise, depending on clinical judgement.
• there is external ear canal occlusion due to ear discharge, swelling, or debris which is stopping topical treatment working effectively.’
22. The swab taken on 16 June, following Ms O’s discussion with the Practice, which we address in more detail later, showed the infection was still heavily present and had a sensitivity to a drug called ciprofloxacin. Our GP adviser explained this meant ciprofloxacin would predictably clear the infection up so, it was reasonable to have waited to assess the success of the recommended drug.
23. The records show the GP planned to attend a home visit for physical examination of Mr O’s ear if another ear swab still showed infection. The swab showed infection, and on 22 June, the GP prescribed more treatment, in place of the planned home visit. It is not clear why the plan of action changed. There is also no evidence the Practice considered the risk factors of Mr O being elderly, and diabetic, or that he had only shown minor improvement to treatment before deciding to continue treatment in primary care. Without consideration of an ENT referral, physical examination and with the additional factors set out in national guidance, we consider that this would have been an appropriate time to seek advice from ENT or submit a referral.
24. The GP visited Mr O on 20 July and noted that his ear infection improved on medication but did not abate. It then appeared to worsen again once treatment ended. Another swab, which came back on 25 July, showed light infection growth which indicated Mr O’s infection was slowing, but not stopping, in line with the GP’s observations.
25. Our GP adviser highlighted this swab result on 25 July, around nine weeks after treatment began, as the point Mr O could be considered in treatment failure. This is because he had received multiple rounds of different optimal treatments that had not resolved the problem. With additional risk factors, the evidence indicates that the Practice should have sought ENT input here. Had this been done, he would, most likely, have been seen that day.
26. On 10 August, the Practice received a request from a local audiology department titled ‘ENT referral required.’ This described foul smelling discharge completely blocking Mr O’s right ear canal, which was another new symptom. We can see no evidence the Practice took any action on this request. Our ENT adviser noted this would have prompted a same day ENT appointment.
27. On 23 August, the Practice again prescribed more antibiotics. On 1 September following physical examination by a GP, the Practice sent Mr O to hospital on a same day ENT referral, where he was admitted and diagnosed with NOE.
Impact
28. Ms O tells us her father described the pain in his ear as ‘like a monster boring into his head.’ NOE is a severe infection that spreads to the bones of the head, including the base of the skull. We have absolutely no doubt that this was incredibly painful and distressing for Mr O. The records show Mr O reported this problem to Practice staff multiple times. Seeing her father in so much pain must, in turn, have been very distressing for Ms O. Ms O is a healthcare professional and with that knowledge and experience, she suspected and raised the possibility of NOE with the Practice. As we shall go on to discuss, this was not acted on and this must only have served to compound her distress.
29. Once diagnosed, hospital staff performed a specialist microsuction procedure, which eased Mr O’s pain. Understandably, Ms O considers that had he been referred sooner, he’d have been treated, and in less pain, sooner.
30. We consider that the Practice should have sought ENT input sooner than September. There were three clear opportunities: 22 June, 25 July, and 10 August. This means when he was admitted on 1 September, this admission had been delayed through lack of ENT input, by somewhere between 4 and 10 weeks.
31. We looked at what would have happened if Mr O had been referred on 25 July because this was the average nine-week point, and also the point our GP adviser noted he could be considered in treatment failure. From the perspective of primary care, our GP adviser explained that Mr O’s clinical picture would have prompted an urgent referral, with the expectation of an appointment in two to six weeks. However, our ENT adviser explained an urgent, same day referral for Mr O would have been accepted at multiple points because of the risk factors and directions set out by NICE.
32. We asked our ENT adviser to outline what would have happened if Mr O had been referred in July. They explained that NOE would have immediately been apparent to a specialist, who would have cleared Mr O’s ear under a microscope to relieve the pain. He did receive this treatment when he was admitted on 1 September. Because he was not referred, our adviser explained Mr O would have endured severe and unremitting pain. We were saddened to read both the records and Ms O’s correspondence at the time shows this to be true.
33. Mr O was discharged from hospital to continue treatment at home through the community care channels. Our ENT adviser explained he also benefitted from a multidisciplinary approach to the general management of his health, and pain control.
34. Mr O went on to be readmitted to hospital in October with suspected pneumonia. Here he later had a stroke and sadly died a few days later. The coroner listed NOE as a secondary cause of death.
35. Mr O’s stroke was diagnosed from his symptoms. He did not have a head scan after the onset of his symptoms, however, given the stroke affected his left-side, Ms O points out that this means the occlusion that caused it was in the right-hand-side of his brain. She is, therefore, concerned that the deep-seated infection, which was on the right-hand-side, may have been the cause of the occlusion.
36. The absence of a scan after the onset of Mr O’s symptoms regrettably means there is no evidence of the type of stroke he had or where in the brain any occlusion was. This means that even on balance, we could never reach a view on whether NOE caused or contributed to Mr O’s stroke.
37. Whilst NOE was a secondary cause of Mr O’s death, on the balance of probabilities, we do not consider that his death could have been prevented by faster referral. He received treatment, which thankfully he was responding to. However, it is clear he would have been in significantly less pain for much longer. Ms O’s concern and worry is clearly documented in this care period, as is her distress over the pain her father was experiencing. It is our view much of this could have been avoided and that this is an injustice to her.
38. Mr O’s pain and associated symptoms of NOE also led to a reduced quality of life, which in turn reduced the quality of the time Ms O spent with him. This was a further injustice to her.
39. The Practice’s Significant Event Analysis (SEA) meeting identified what went wrong, in line with our findings. The SEA resulted in a range of service improvements related to its systems and organisational learning specific to NOE. We are satisfied that these actions are sufficient to ensure similar mistakes do not happen in the future. It has also apologised, in line with the outcomes Ms O is seeking.
40. Whilst we are satisfied the Practice has made appropriate systemic improvements, we think an apology is not sufficient in respect of Ms O’s impact and therefore ask that it take some further action.
Response to Ms O’s concerns
41. We considered what the nurse should have done when addressing Ms O’s concerns about her father’s condition. The Nursing and Midwifery Council Professional Standards of Practice (2018) says nurses must communicate effectively with colleagues, share information to identify and reduce risk, and make a timely referral to another practitioner when required.
42. At the time of the call with the nurse, Mr O was on home visit provision. The nurse tasked district nurses to attend and take another ear swab to assess the infection and the suitability of an ENT referral. Our ENT adviser explained the ENT clinic would not have accepted a referral at this stage, because Mr O was still completing a course of treatment with the Practice. They explained ENT would want to see the response from this treatment first.
43. Our ENT adviser noted that the nurse had not communicated Ms O’s concerns of NOE to any other clinical colleagues. Although the nurse documented in the records that Ms O was concerned about her father’s ear infection, the notes do not mention the specific concern of NOE. Whilst another swab would have been beneficial for ENT to see the results of, this was a missed opportunity to identify the problem, and we consider that this inaction was not in line with the Code.
Duty of Candour
44. The Practice had internal meetings about Mr O’s care in August 2023, in the knowledge it had not been up to standard. Ms O says staff failed to raise the fact something had gone wrong, which breached their Duty of Candour. She says this was further evidenced by the Practice’s comment that it was expecting her complaint.
45. The Health and Social Care Act 2008, Regulations 2014: Regulation 20, known as the Duty of Candour Regulations, came into effect for GP Practices in 2015. This defines a ‘notifiable safety incident’ as one which appears to have resulted in the death of, or moderate to severe harm to, the patient.’
46. Whilst we could not say that NOE led to Mr O’s death, the delayed diagnosis left him in significant, prolonged pain.
47. Regulation 20 says that under Duty of Candour, a notifiable safety incident can be advised if an event meets the three criteria:
• It must have been unintended or unexpected • It must have occurred during an activity the CQC regulates • In the reasonable opinion of a healthcare professional, already has, or might, result in death, or severe or moderate harm to the person receiving care
48. We think it is likely the delay in referring Mr O amounted to a ‘notifiable safety incident.’
49. Regulation 20 sets out specific steps that should be taken under Duty of Candour. It says the organisations’ representative must, as soon as possible: • tell the relevant person that a notifiable safety incident has taken place • apologise • provide a true account of what happened, explaining whatever you know at that point • explain to the relevant person what further enquiries or investigations you believe to be appropriate • follow up by providing this information, and the apology, in writing, and providing an update on any enquiries • keep a secure written record of all meetings and communications with the relevant person 50. The ‘relevant person’ is the patient or their representative. The Practice did not proactively contact Mr O or Ms O when it found out about his diagnosis of NOE, which is when it must have known this had been missed. We think this was a failing.
51. The Practice has apologised, explained what happened and investigated the events through a Significant Event Analysis (SEA). There are no timescales set out in law, but these things should happen ‘as soon as possible,’ and the SEA did not take place until 11 months after the event. The delay was lengthy, with no identifiable reason why and on balance, we do think this should have happened much sooner.
52. We thought about how this impacted on Mr O and Ms O. Clearly, they knew about the diagnosis of NOE when it was made. They also suspected that there had been a delay in referring Mr O to ENT. So, in that regard, without wishing to minimise matters, the failure to notify them fortunately did not deprive them of any information.
53. The Practice did eventually take significant steps in light of Ms O’s complaint to learn from what happened. We accept that had it done this immediately, this may have given Ms O more faith in those actions. In summary, while the actions should have been done sooner, we think they were carried out in the end.
54. CQC guidance says that a person who has been in pain for 28 days or more, as a result of the incident, should meet the threshold for reporting to its organisation and we cannot see this happened. However, as part of our Final Report process, we will ask the Practice to share this report with the CQC, so we do not need to make a formal recommendation for this issue.
Complaint handling
55. Ms O complained to the Practice in May 2023. The Practice responded on 19 July, and said staff planned to discuss Mr O at a significant event meeting on 9 August. Ms O complains she has never been informed of the outcome. She feels she has only been given the vague reassurance that learning had been put in place for the relevant staff members. She says this has not served to reassure her and shows a lack of transparency.
56. In its complaint response, the Practice documented this planned meeting. We cannot see any correspondence that indicates anything further was conveyed to Ms O. We asked the Practice to provide evidence of the meeting on 9 August, titled Significant Event Analysis (SEA).
57. Our Complaint Standards say an organisation should clearly set out how it is accountable if it finds it got things wrong.
58. The SEA details what happened. It concludes that Mr O was housebound and should have had more in person clinical assessments. The Practice identified it should have sought advice from ENT sooner. It found the system of named GPs it was using to allocate correspondence was inefficient. This, and time limitations, meant the Practice missed the bigger picture. The SEA also found it had not taken concerns raised by relatives seriously. These issues are in line with our findings.
59. The standards also say organisations should make sure people are kept involved and updated on how the organisation is taking forward learning or improvements relevant to their complaint.
60. The SEA yielded education and a specific flowchart relevant to otitis externa, when to consider NOE and what to do. The Practice also changed the system it used to allocate tasks and correspondence to GPs, to ensure better continuity. All the information, learning and actions set out in the SEA were identified during the Practice’s investigation of Ms O’s complaint and are reflected in its complaint response. We are satisfied that in doing this, the Practice worked in line with our complaint standards.
61. Regarding Ms O’s complaint about the Practice saying it would seek comment from specific staff, this relates to actions taken by the district nursing team. This team works for an NHS trust rather than the Practice and was about an issue that did not involve the Practice. We can see the Practice set this expectation but did not follow up, which left Ms O waiting for answers she did not receive.
62. It also left her with some outstanding questions related to the initial treatment Mr O received in April 2022.
63. The Practice should have done what it said it would do. It overlooked this element of the complaint, and Ms O did not raise it again before complaining to us, meaning it didn’t have an opportunity to fix its oversight. We appreciate that this was not ideal. We have considered complaint handling in the round and consider that despite the oversight, overall, the Practice handled this complaint well and that the oversight does not amount to maladministration.