East Suffolk and North Essex NHS Foundation Trust

2. Mr A complains about the care and treatment provided by East Suffolk and North Essex NHS Foundation Trust (the Trust) to his daughter, Miss B, in March and April 2023. He says the Trust:

• Failed to identify his daughter was suffering with a severe infection and inappropriately discharged her from A&E on 4 separate occasions (31 March 2023, 4, 5 and 6 April 2023)

• Failed to identify and treat her infection early enough following her attendance on 8 April 2023

3. Mr A says the Trust missed several opportunities to identify that his daughter’s condition was due to a severe infection. He says the Trust missed several opportunities to provide treatment which may have prevented his daughter’s death. Mr A says the death of his daughter was preventable and the circumstances under which she died have caused him a great deal of distress.

4. Mr A would like the Trust to acknowledge the failings in care and the impact they had and apologise. He would also like the Trust to put in place service improvements.

5. Miss B had a history of persistent and recurrent right ear infections which she had previously attended the Trust’s Ear, Nose and Throat (ENT) outpatient department for in 2019. During her treatment in 2019 the Trust’s ENT specialist registrar considered cholesteatoma (a rare inner ear condition) as the cause of her condition but as her symptoms improved with treatment the Trust decided not to perform additional scans to rule it out at this time.

6. She attended the Trust on 5 occasions between 31 March and 8 April 2023 with right ear pain and discharge. On her first attendance the Trust diagnosed her with otitis externa (OE, an infection of the outer ear canal) and put in place a treatment plan of pain relief and antibiotics. Following her attendance on 8 April 2023 the Trust admitted her to hospital as her symptoms had worsened.

7. Miss B’s condition deteriorated in hospital and the Trust performed a CT head scan on 11 April 2023. The scan identified diffuse cerebral oedema (swelling of the brain), herniation of the cerebella tonsils (a condition where the cerebellar tonsils descend below the opening at the base of the skull causing compression of the brainstem and spinal cord) and signs of aggressive infection and/or cholesteatoma.

8. The Trust performed brain stem tests on 12 April 2023 which confirmed Miss B had suffered brain stem death. The Trust withdrew her ventilation on 13 April 2023 and she sadly died.

9. Following her death the Trust carried out a patient safety investigation which found failings in some aspects of the care it provided to Miss B. The report said although the failings represented a missed opportunity for the Trust to provide treatment sooner, it could not conclude that Miss B’s death could have been prevented.

13. The GMC guidance says:

‘You must provide a good standard of practice and care. If you assess, diagnose or treat patients, you must:

• adequately assess the patient’s conditions, taking account of their history, their views and values; where necessary, examine the patient • promptly provide or arrange suitable advice, investigations or treatment where necessary • refer a patient to another practitioner when this serves the patient’s needs

In providing clinical care you must:

• provide effective treatments based on the best available evidence • consult colleagues where appropriate’

14. The cholesteatoma guidance says:

‘Be aware that cholesteatoma may be asymptomatic or present with mild or intermittent symptoms in its early stages, and diagnosis is often delayed.

Suspect a diagnosis of acquired cholesteatoma if a person presents with possible clinical features due to growth with or without the destruction of adjacent structures:

• Recurrent or persistent unilateral purulent ear discharge, which does not respond to appropriate treatment for OE.

• Progressive hearing loss or tinnitus.

• Ear pain, vertigo, or facial weakness (due to facial nerve involvement) — may suggest advanced disease.

• Abnormal otoscopic examination, including tympanic membrane perforation.

If a person presents with suspected cholesteatoma, arrange emergency hospital admission, or seek urgent ear, nose, and throat (ENT) specialist advice if a person has:

• An associated facial nerve palsy, neurological symptoms or signs, or is systemically unwell — may indicate more extensive or advanced disease.

• Clinical features suggesting a serious or life-threatening complication such as acute mastoiditis, intracranial abscess, or meningitis.

If admission is not needed, arrange prompt referral to an ENT specialist for further assessment, confirmation of the diagnosis, possible surgical intervention, and follow-up.

Specialist assessment may include CT or MRI of the temporal bone (may show soft tissue mass and focal areas of bony erosion of the middle ear and mastoid).’

15. Cholesteatoma is a condition caused by the accumulation of debris such as dead cells in the ear which become infected and it can behave destructively by eroding surrounding bone. Our adviser said it commonly presents with persistent or recurrent ear discharge, often foul-smelling, and may also cause hearing loss, ear pain, dizziness, headache, facial weakness, or intracranial complications (including meningitis, brain abscess and death) if untreated.

Failed to identify his daughter was suffering with a severe infection and inappropriately discharged her on 4 separate occasions

16. The Trust patient safety report says:

‘During the 31 March 2023 attendance to A&E due to ear pain (the first A&E attendance), Miss B was reviewed and referred to the ENT nurse who undertook an appropriate examination although was unable to undertake a full examination or microsuction as the necessary equipment is located in the ENT clinic room and is not available out of hours. Following their examination, the NP concluded Miss B had classical symptoms of OE, prescribed suitable treatment and arranged a follow up appointment with ENT a few days later. This appears in line with expected practice. The slightly raised WBC and CRP indicates an inflammatory process which was reasonable to attribute to the ear infection. In retrospect, the degree of pain, WBC & CRP were red flags for more severe disease and could have been discussed with the ENT registrar although there was no guidance dictating this at the time.’

At the ENT clinic follow up appointment on 4 April 2023 the ENT nurse undertook an appropriate examination and, finding Miss B continuing to experience pain and her ear to be full of discharge, advice from the ENT consultant was sought. As a lesion was noted within Miss B’s ear, the possibility of a cancer was considered and a two-week wait scan (urgent) was requested. The appointment was made for 10 April 2023. Whilst taking a scan at this point would have provided additional information to guide diagnosis and management, the request was made in accordance with current guidance. It is unlikely the scan could have been expedited at this point unless there was suspicion of brain infection which, as she did not have any obvious neurological symptoms at this point (significant dizziness, light sensitivity, confusion, seizures), was not suspected.

The ENT nurse accessed the laboratory system to review the results of the swabs taken a few days earlier. However, these were unavailable at the time. It is not unusual for swab results to take 48-72 working hours to be published. The result was published later that afternoon and, as the organism was identified as pseudomonous, a common cause of ear infections, is it unlikely an earlier result would have changed management.

5 April 2023 at 03:44 (the second A&E attendance) attendance with ear pain dizziness and nausea. As Ipswich Hospital did not have ENT specialists available on-site out of hours, she was advised she could attend Colchester ED herself, wait to be seen by the ED doctor who may refer to Colchester Hospital ENT department which may involve a lengthy wait, or attend her GP in the morning. Miss B was given analgesia and opted to leave the department. In hindsight, although this is in line with normal process, as Miss B reported dizziness and nausea, potential red flags, it would have been beneficial for Miss B to have been reviewed by ENT at this time or early the next morning.

6 April 2023 at 20:11 (the third A&E attendance) attendance with ear pain. The ED doctor undertook an appropriate examination of Miss B and, being concerned about the degree of pain, further attendance to hospital, rising white blood cell count and C-reactive protein level (CRP, a protein produced by the liver that rises in the blood in response to inflammation, infection, or tissue damage) correctly contacted the ENT registrar at Colchester Hospital. Following discussion that, Miss B’s remaining observations appeared normal, the Colchester Hospital ENT registrar advised to discharge with current treatment.

In hindsight, as Miss B’s pain was not improving and required morphine to gain some relief, her infection markers were rising and she had reported dizziness when attending the previous day, it would have been beneficial to have a face-to face review by ENT to consider whether her condition was more complicated than first thought, whether the scan should be expedited and whether Miss B should have been admitted to hospital at that point.’

17. In its complaint response to Mr A the Trust concluded the only failing was the lack of face-to-face review by ENT doctors on 6 April 2023. It says:

‘given Miss B’s number of visits to ED with ongoing pain and rising infection markers, she should have had a face-to-face review by the ENT doctors (following her attendance on 6 April 2023). It would have been appropriate to either transfer her or arrange for her to be seen the next morning by the ENT department.’

18. The Trust apologised that Miss B did not receive a face-to-face review by an ENT doctor on 6 April 2023 and said it has discussed the ENT on call process and updated it to reduce the risk of such incidents happening again.

31 March 2023

19. Miss B first attended the A&E department on 31 March 2023 and the A&E staff performed an assessment, made a provisional diagnosis of ear infection and referred her to the ENT nurse practitioner.

20. The ENT nurse practitioner diagnosed OE and provided treatment with pain relief medication, oral antibiotics, steroid ear drops and discharged Miss B to await a follow up appointment in the Trust’s ENT department. The follow up appointment was arranged for 4 April 2023.

21. Our adviser said the evidence in the records indicates the Trust failed to consider the possibility Miss B was suffering with a more serious infection or cholesteatoma when she attended on this occasion. Miss B reported right ear pain with foul-smelling discharge and dizziness. As set out in the cholesteatoma guidance this combination of symptoms, in particular the severity of the pain she reported and additional dizziness, is not consistent with a diagnosis of uncomplicated OE and would require further investigation to rule out more significant infection or advanced disease.

22. Our adviser said in line with the cholesteatoma guidance the Trust should have admitted Miss B for more detailed investigations including visualisation of her tympanic membrane (eardrum) and attic region (upper part of the eardrum) and a review with a senior ENT clinician.

23. We found the Trust missed an early opportunity to consider and possibly identify that Miss B had a serious destructive ear condition at this time. We found the Trust inappropriately discharged her on this occasion with an inaccurate diagnosis of uncomplicated OE.

4 April 2023

24. Miss B’s next attendance was at her ENT outpatient appointment on 4 April 2023. The records indicate she was reviewed by an ENT nurse practitioner who noted she continued to experience pain in her ear. The ENT nurse practitioner examined her ear and found it contained discharge and a lesion. The nurse practitioner sought advice from the ENT consultant, drained the discharge from her ear (microsuction) and referred Miss B for a CT scan under the two-week-wait criteria for suspected cancer.

25. Our adviser said the records indicate that by her attendance on 4 April 2023 the evidence to support her condition being due to severe infection or cholesteatoma was stronger. The records indicate Miss B reported ongoing right ear pain with foul-smelling discharge and dizziness. She also reported sharp stabbing pains around her ear and the back of her head. After microsuction, only a partial view of her tympanic membrane was possible and a lesion was seen in the attic/superior external auditory canal (the passage from the outside of the ear to the eardrum).

26. Our adviser said this combination of symptoms was highly suspicious for cholesteatoma and warranted immediate specialist-led management rather than referral for routine outpatient investigation. In accordance with the cholesteatoma guidance the purpose of a CT scan in this context should have been to assess the extent and possible complications of suspected cholesteatoma and should have been performed urgently following admission to hospital.

27. We found the Trust missed a further opportunity to consider and possibly identify that Miss B had a serious destructive ear condition at this time and not uncomplicated OE. We found the Trust missed an opportunity at this point to escalate her care and provide appropriate treatment sooner.

5 April 2023

28. Miss B returned to the A&E department at 3.44am on 5 April 2023. The records indicate the ED triage nurse reviewed Miss B and noted her diagnosis of OE and that she was under the care of the Trust’s ENT department.

29. The records indicate the A&E triage nurse offered Miss B pain relief medication and suggested, as she had a diagnosis of OE and was already under the care of ENT, she could either attend a different hospital where the ENT team were available out of hours, or wait to be seen by the A&E doctor. The records indicate Miss B decided not to stay in A&E on this occasion.

30. Our adviser said this repeated attendance at A&E indicates Miss B’s condition was not behaving like uncomplicated OE. Miss B presented with persistent symptoms despite the treatment provided by the Trust and the ENT investigations carried out the previous day had already identified significant concerns. Our adviser said in these circumstances, this further attendance with persistent, worsening symptoms should have raised concerns about the accuracy of the working diagnosis and prompted admission to hospital for urgent senior ENT review.

31. Our adviser said persistent or worsening symptoms after treatment, particularly in the context of foul-smelling discharge and a suspected attic/superior canal lesion, should have increased concern for a condition more serious than uncomplicated OE. We found Miss B’s symptoms should have raised concerns of a condition more severe than uncomplicated OE at this time.

6 April 2023

32. Miss B attended A&E again the following day on 6 April 2023. The A&E doctor noted her earlier attendances, her diagnosis of OE, her care under the ENT department and the plans for a CT scan for suspected cancer which had now been confirmed for 10 April 2023. The doctor noted her right ear was discharging and the tympanic membrane was partially visible.

33. The doctor discussed her condition with the ENT registrar who advised she could be discharged to continue her outpatient treatment and await her CT scan. Miss B was discharged home with advice to re-attend if she experienced a high fever, hearing loss, swelling around her ear, vomiting or if she began to feel generally unwell.

34. We acknowledge the Trust’s patient safety report says Miss B’s condition should have been managed differently on this occasion and she should have had a face-to-face review with the ENT doctor. However we think the failings are more significant than the Trust’s patient safety report concludes.

35. Our adviser said by this point Miss B had several repeated presentations over a very short period with persistent, severe symptoms indicative of a condition more significant than OE, abnormal ENT findings and her condition had not improved with treatment. In accordance with the cholesteatoma and GMC guidance this attendance should have triggered an immediate admission to hospital, reassessment of her diagnosis and urgent investigations and treatment aimed at potential complicated, extensive cholesteatoma. This should have included a review from a senior ENT clinician and scans to assess the temporal bone (the bone at the side of the skull which protects the structures of the ear).

36. We found the Trust missed a further opportunity on this occasion to consider and possibly identify that Miss B had a serious destructive ear condition rather than OE. We found this compounded the previous missed opportunities to escalate her care and provide appropriate treatment sooner.

37. We carefully considered Mr A’s complaint and the supporting information he has provided. We also considered the information in the records, the guidance and the advice we have received. Taking the 4 attendances together we found the Trust failed to identify a clinical picture which strongly suggested cholesteatoma or other serious destructive ear disease during this period.

38. Miss B attended several times over a few days with persistent foul-smelling discharge, severe ongoing pain, dizziness, incomplete visualisation of the tympanic membrane, and a lesion in the attic/superior external auditory canal. These symptoms are recognised red flags for complicated ear infection which should have prompted urgent ENT-led assessment and investigation in line with the cholesteatoma and GMC guidance.

39. We found the failure to act on these symptoms, coupled with the failure to question the initial diagnosis of OE despite evidence to indicate a more serious condition, led to a delay in diagnosis, escalation and treatment of a serious ear condition with life-threatening intracranial complications.

Failed to identify and treat her infection early enough following her attendance on 8 April 2023

40. The Trust has acknowledged failings in this aspect of Miss B’s care. In its patient safety report it says:

‘The ENT registrar examined Miss B and provided treatment for the presumed OE. The registrar did not discuss Miss B with the ENT consultant as they felt able to manage OE without escalating to more senior staff. Miss B’s considerable pain which was not effectively under control, even with morphine, and raising CRP could, reasonably, have been escalated to the consultant. It is possible, diagnostic anchoring, where fixing on an initial diagnosis, and over reliance on normal observations may have occurred, reducing junior staff’s ability to consider other, more serious, diagnoses or to escalate to senior staff.

The remainder of Miss B’s clinical presentation during this examination did not suggest deterioration and the registrar believed it was appropriate to discharge her to attend the pre-planned CT scan at Ipswich Hospital (on 10 April 2023). When the nurse attended to arrange her discharge, they were concerned about her level of pain and contacted ENT colleagues at Ipswich Hospital. A decision was made for the pre-planned scan to be cancelled, for Miss B to remain at Colchester Hospital for a scan the following day (11 April 2023).

As Miss B required ongoing hospital admission, it may have been appropriate to arrange transfer back to Ipswich hospital for closer ENT observation, management and possible attendance of the scan. It is not clear if this would have made a difference to Miss B’s chance of survival but, again, may have given a clearer diagnosis, ability to optimising her symptoms and increased her chance of survival.’

41. Mr A says despite all the red flags his daughter was left on a morphine pump, which is unheard of for simple ear infection, with no doctors input until she died. The Trust has acknowledged this in its patient safety report and said:

‘Whilst ear infections can be very painful, they do not usually require significant doses of morphine and, ENT doctors confirmed, use of a PCA (patient controlled analgesia) is highly unusual. Nursing staff were concerned about the level of pain Miss B was experiencing, which was often 2-3 out of 3, and liaised with junior doctors to try to get it under control. As Miss B’s pain was disproportionate to her diagnosis and difficult to control, this could have been escalated to the registrar and consultant for review and consideration of expediting the CT scan.’

42. The Trust patient safety report goes on to say:

‘A medical decision for Miss B to remain in hospital and cancel the outpatient scan was made with a plan to rebook an inpatient scan at Colchester Hospital the following day (11 April 2023). A scan taken at this point would have provided earlier clarification of the cause of Miss B’s pain and is likely to have prompted referral to a neurological centre. Although it is unclear if the outcome would have changed, more effective management of her symptoms could have been initiated and her chance of survival would have been greater.

Whilst scans can be more difficult to obtain out of hours, emergency scans can be undertaken if requested by a consultant. Had there been a suspicion of brain involvement, this would likely have met the criteria for urgent inpatient scan. In retrospect, it would have been helpful to have carried out a scan at this point which would have provided indication of infection extending beyond the ear into the bone and/or brain. Had this been known, it is likely a referral, and possible transfer, to a neurological unit, would have been made for further treatment.

It is not possible to be certain this would have changed the outcome however it would have provided clarity, the chance of additional treatment which may have prevented her death and would have guided more effective management of her symptoms, particularly her pain.’

43. To address the failings in care identified in its patient safety report the Trust has taken the following action:

• It has reviewed its ENT on-call process across the hospitals to clarify routes of communication, escalation triggers, maintaining continuity of care, accessing health records and requesting investigations

• Reviewed the availability of ENT equipment for out of hours services and A&E

• Implemented training on identifying indications of and diagnosing cholesteatoma

44. In its complaint response to Mr A the Trust says:

‘As explained in the patient safety report, page 20, paragraph 2 details that as the diagnosis at this time was OE, the ENT team believed attending the planned two week wait scan on 10 April was appropriate.

As investigated in the patient safety report, that observations were taken broadly in accordance with Trust policy and did not trigger a need to escalate according to the NEWS policy. Miss B’s heart rate and blood pressure were a little low on occasions but in the absence of any other concerns, such as decreased urine output, fever and decreased consciousness these did not constitute red flag signs or the need to escalate.’

45. Our adviser said the records indicate that by her attendance on 8 April 2023 there was sufficient clinical evidence to suspect Miss B’s symptoms were being caused by cholesteatoma. She had a history of repeated attendances for persistent foul-smelling ear discharge, severe pain, failure to improve despite treatment and abnormal findings on previous ENT assessment. These features were not consistent with the Trust’s diagnosis of OE and should have prompted urgent specialist-led investigation and management as soon as she was admitted.

46. The records confirm she was suffering severe pain that was disproportionate to her diagnosis. Our adviser said pain that is disproportionate to examination findings or a diagnosis of OE is a recognised warning sign of serious underlying ear disease and should have prompted urgent reassessment of the diagnosis, senior ENT review, and investigation in line with the cholesteatoma and GMC guidance.

47. We acknowledge that when preparing her for discharge the Trust realised that further investigation was required and decided to reverse this decision and admit her to hospital. However our adviser said the overall management after she was admitted did not adequately reflect the severity of Miss B’s clinical presentation at this time.

48. Our adviser said the records indicate Miss B should have undergone urgent inpatient imaging and senior ENT-led reassessment. The cholesteatoma guidance recommends emergency admission or urgent specialist advice where cholesteatoma is suspected, particularly where advanced disease or complications are possible. Our adviser said although the Trust commenced treatment with antibiotics following her admission, there remained a delay in assessment and testing to establish the underlying diagnosis and the extent of disease.

49. The records indicate the cause of her condition and the extent of the disease was only identified after the CT scan of 11 April 2023 found extensive destructive disease involving the middle ear and mastoid (part of the temporal bone behind the ear), with erosion of the external auditory canal roof, tegmen (the bone above the eardrum) and ossicles (the bones of the middle ear), together with catastrophic intracranial complications. Our adviser said these findings are consistent with a longstanding aggressive disease process rather than a newly developed condition.

50. We acknowledge the Trust’s patient safety report found the initial decision to manage Miss B without specialist ENT-led reassessment or urgent imaging was not in keeping with expected standards of care. We acknowledge the Trust has accepted this was a missed opportunity to investigate her condition, reach a more accurate diagnosis and provide treatment sooner.

51. However we think the failings in the care provided to Miss B after her admission on 8 April 2023 are more significant than those identified by the Trust in its patient safety report as they compounded the earlier missed opportunities to recognise cholesteatoma sooner.

52. We agree with the Trust that earlier investigation and treatment would, on the balance of probabilities, have provided a significant opportunity to identify the disease before it developed into irreversible intracranial complications and it may have increased Miss B’s chances of survival.

53. Our adviser said it is not possible to state with certainty that earlier treatment would have prevented Miss B’s death. However if the underlying disease been recognised and investigated at an earlier stage, before it developed into catastrophic intracranial complications, there would have been a significant opportunity for definitive treatment of the ear disease and its complications. Such treatment, earlier in her illness, may have provided a substantial opportunity to prevent the intracranial injury that ultimately caused her death.

54. We carefully considered Mr A’s complaint and the supporting information he has provided. We also considered the information in the records, the Trust’s patient safety report, the guidance and the advice we have received.

55. It is clear the failings in the care led to a delay in diagnosis and escalation of her treatment. It is not possible for us to conclude that Miss B’s outcome would have been different had it not been for the failings as we cannot speculate on how successful the treatment she required would have been if it was provided to her sooner.

56. That said, not recognising the severity of her symptoms or reassessing her diagnosis and putting in place an appropriate management plan sooner meant the Trust missed the opportunity to provide treatment that may have increased her chances of survival. This has left doubt which cannot now be resolved about the impact any earlier diagnosis and treatment may have had, which is a significant injustice.

57. We think the failings in care were more significant than the failings identified in the Trust’s patient safety report and those acknowledged in its complaint response to Mr A. For this reason we think the Trust should review the action it has taken as a result of its patient safety report, in light of the additional failings in care we have identified, to ensure appropriate action is taken as a result of this complaint to address the failings in care and the impact they had.

1. We partly uphold this complaint. We cannot say with certainty that Miss B’s death was preventable, however the Trust missed several opportunities to identify cholesteatoma earlier and provide treatment that may have increased her chances of survival.

58. We make recommendations in line with our Principles for Remedy (our principles) which say public bodies should acknowledge failures, apologise, make amends, and use the opportunity to improve their services. Our principles say good practice with regard to remedies means:

• Getting it right • Being customer focused • Being open and accountable • Acting fairly and proportionately • Putting things right • Seeking continuous improvement.

59. Our principles are reflected in the NHS Complaints Standards which say organisations should offer fair remedies to put things right and identify learning and use it to improve services.

What we found 60. Through investigating this complaint we found the Trust missed opportunities to admit Miss B to hospital for investigations earlier. This may have led to cholesteatoma being identified and treatment being provided sooner, which may have increased her chances of survival. We do not think the Trust’s patient safety report adequately acknowledges the extent of the failings or the missed opportunities to identify the severity of her condition and provide treatment earlier in her illness.

61. We do not think the Trust’s complaint response to Mr A adequately reflects the failings identified in its patient safety report or the failings we have identified in our investigation. We do not think the Trust complaint response adequately acknowledges the extent of the failings, the missed opportunities to identify the severity of her condition and provide treatment earlier in her illness or the impact the failings had on Mr A and his daughter.

What the organisation should do

62. Our Principles for Remedy say organisations should acknowledge poor service and take steps to put things right when this leads to an injustice or hardship. With that in mind, we recommend that within one month of the date our report the Trust:

• Write to Mr A to acknowledge the impact the failings in care had on him and his daughter and apologise • Review the action it has taken as a result its patient safety report to ensure appropriate action has been taken as a result of the complaint to address the failings in care and reduce the risk of them happening again. It should do this in the form of an action plan which should be shared with us, Mr A, and the Care Quality Commission.

63. The Trust should send us evidence it has completed the recommendations. We will check the action plan to confirm it is appropriate to address the failings identified.