James Paget University Hospitals NHS Foundation Trust

7. Dr K complains the Trust did not provide her uncle, Mr W, with routine follow up appointments after it removed a cancerous lesion from his forehead in July 2016. She also complains the Trust failed to note, or act on, a biopsy result taken in July 2019 that showed probable metastatic skin cancer. This is a type of skin cancer that has spread to other parts of the body.

8. Dr K says she is left not knowing if her uncle may have survived, or if his life could have been prolonged if the Trust had made the correct diagnosis earlier. She also says he experienced avoidable suffering at the end of his life and extreme, uncontrolled pain. She said this was very difficult for the family to witness.

9. Additionally, Dr K complains about the Trust’s complaint handling. She says it took too long for the Trust’s complaint process to deliver service improvements that would prevent the failings happening again. Dr K says the repeated delays in complaint handling exacerbated the family’s distress at what was a very difficult time for them.

10. As an outcome to her complaint, Dr K is seeking an acknowledgement of failings, an apology for the impact of those failings, and assurances that measurable service improvements have been made to both the clinical and complaint handling processes.

11. In July 2016, the Trust removed skin cancer from Mr W’s forehead. He attended for a follow up appointment in August 2016 with the surgeon. No further check-ups were scheduled.

12. In April 2019, Mr W’s GP referred him back to the Trust after he presented at the GP surgery with further suspicious lesions on his body.

13. In May, the Trust took biopsies of the lesions. Further tests confirmed they were cancerous. They were removed, and the Trust booked Mr W in for six monthly check-ups.

14. Mr W’s GP then made a further urgent referral to the Trust after Mr W presented with a lump in the left parotid gland. The parotid glands are two salivary glands that sit just in front of the ears on each side of the face.

15. In June Mr W saw an ear nose and throat (ENT) consultant. They requested a range of tests including two types of biopsies. The biopsies were taken on 1 July.

16. The first biopsy result was available on 9 July. It showed a possible high grade primary salivary gland tumour or squamous cell carcinoma (SCC, a type of skin cancer). The second biopsy result was available on 16 July it showed cervical lymph node small lymphocytic lymphoma. This is a slow-growing type of blood cancer.

17. Mr W was referred to the haematology department (the department that deals with blood disorders) to treat a diagnosis of lymphoma. In August he began chemotherapy. The Trust did not begin any treatment for a possible high grade primary salivary gland tumour or SCC.

18. In September the Trust found the chemotherapy was not working as expected. This was particularly abnormal as this sort of chemotherapy usually has a high success rate. It ordered a further biopsy of the lump in the left parotid gland.

19. On 9 October the Trust recognised the diagnosis of probable metastatic poorly differentiated SCC (first made on 9 July) and on 15 October the Trust began a root cause analysis investigation (RCA) to consider why it did not treat this earlier.

20. An RCA is an investigation a Trust is required to complete if it suspects there was an avoidable event that could have caused harm.

21. Alongside this it performed further biopsies and Mr W began palliative radiotherapy in December.

22. In December Dr K made a written complaint to the Trust. At that time its RCA was ongoing.

23. The Trust concluded its RCA in January 2020. The RCA found there had been a failure to provide follow up appointments in 2016 and a further failure to access biopsy results in 2019.

24. The RCA made no recommendations regarding the first failure. In relation to the second failure, it recommended doctors are reminded to access results for tests they request. The Trust concluded those failings had caused ‘no harm’ to Mr W.

25. Dr K met with the Trust to discuss the RCA in February. During the meeting she reiterated several concerns about the care her uncle had received. She also questioned the RCA’s conclusions and actions.

26. Sadly, Mr W died in March.

27. In early June the Trust provided its complaint response. This included its rationale for the ‘no harm’ rating. The recommendations remained the same.

28. Dr K raised a further complaint about the RCA towards the end of June. The Trust reviewed the RCA and amended the rating to ‘major/permanent harm’.

29. In relation to the follow up appointments it recommended a patient audit and review of the treatment pathway. In relation to the failure to access the biopsy results, the RCA recommended a patient audit, a review of the systems, technology and safety netting, and training for doctors (including locums).

30. The Trust provided its complaint response to Dr K in December.

31. In January 2021 Dr K submitted a follow up complaint which included concerns about how the RCA had initially been completed. The Trust met with her to discuss this and provided its final written response in March. The response set out the improvements the Trust had made to the RCA process.

Follow up appointments

36. In July 2016 the Trust removed a lesion from Mr W’s forehead. The histology report stated the lesion was ‘poorly differentiated squamous cell carcinoma, 3.4mm thick’.

37. In August Mr W had an outpatient appointment with the Trust. The Trust did not see him again until April 2019, after his GP re-referred him to the dermatology department with further lesions.

38. The relevant guidance here is the SIGN guidelines. It says poorly differentiated SCC are considered high risk. Patients with high-risk SCC should be offered follow-up appointments every three to six months for 24 months following treatment. It also says one further appointment at three years may be appropriate depending on the clinical risk.

39. The Trust did not offer regular follow up appointments. That was not in line with the guidance and is a failing.

40. Dr K says had the Trust done what it should have at that stage, her uncle may have been diagnosed sooner and survived, or at least his life could have been prolonged.

41. We looked at the impact of the failing. Firstly, we looked at what would have happened if the Trust had offered follow up appointments in line with the guidance.

42. The Trust said, based on Mr W’s records, it should have reviewed him every six months, for three years. This means it is likely Mr W would have been seen in February and August of 2017, 2018, and 2019.

43. GMC guidance says doctors should promptly provide or arrange suitable advice, investigations, or treatment where necessary.

44. We asked our PS adviser what investigations would have been suitable. This allows us to determine if the actions were in line with the GMC guidance.

45. Our adviser explained Mr W’s appointments would have included examination of the forehead and the neck for any enlarged lymph nodes. This area includes the front of the ears, where a lump was later found.

46. If the Trust had offered appointments and carried out examinations in line with GMC guidance the clinician would have examined the area where Mr W had a lump.

47. Secondly, we looked at the probability of the lump being detectable at the check-ups.

48. Had the check-ups been scheduled in line with guidance, Mr W would have likely been seen for a check-up in February 2019.

49. Mr W was seen by the Trust in June 2019. The clinic letter states he told the Trust the lump had ‘been present for only about a month’. This suggests Mr W first noticed it in early May 2019. He also reported no further new symptoms when questioned by the Trust about his hearing, weakness of the face, and watering eyes.

50. The Trust documented the lump was large on examination in June. Further tests were completed in July and November 2019. Comparison of those results by the Trust concluded the mass was rapidly growing.

51. We considered if a trained examination of the area may have detected a lump sooner than Mr W self-examining. We asked our PS adviser if the lump would have been detected earlier.

52. Our adviser said there are features of the lump such as its attachment to the facial nerve and surrounding skin that suggest it is possible it might have been detected earlier by a trained examiner. However, in their opinion, considering when that examination should have happened (around February 2019) it is most likely the lump would have been spotted around the same time it was.

53. When we balance the available evidence including the rate of growth, the time the lump was noticed, and likelihood it would have been identifiable at the routine check-up in February, it would not have been likely that the lump would have been picked up even if the failing had not happened.

54. We recognise not knowing if follow up appointments would have made a difference to Mr W’s care was a source of worry for Dr K and this would have been avoidable had the failing not happened.

55. The Trust’s RCA recognised the clinical failing. In response it created a new cancer pathway across its sites. This has been rolled out. It has also updated its alerts system.

56. In its complaint response the Trust apologised for the failing. The Trust also provided a specific apology for the subsequent distress the failing caused to both Mr W and Dr K.

57. Our principles for remedy say organisations should take proportionate steps to put things right, taking the complainant’s requests into consideration.

58. Dr K told us she is looking for an acknowledgement of failings, apology and reassurances improvements have been made following the failing.

59. We have outlined the steps the Trust has already taken, and it is our view that the Trust has already done what Dr K asked for and the injustice has been put right. For that reason, while there are failings, in recognition they have already been rectified we are not upholding this part of the complaint.

60. We hope this explanation reassures Dr K we have carefully considered her concerns and the Trust’s response.

Biopsy results

61. The Trust took two biopsies from Mr W following his appointment in June 2019. Both results were available by 16 July.

62. The records show the consultant only noted the results from one biopsy, which was suggestive of lymphoma. The Trust’s complaint investigation confirmed it did not look at the other test result, which was suggestive of SCC. Consequently, Mr W was referred to the haematology department with a diagnosis of lymphoma.

63. The relevant standard for this is GMC guidance which states doctors should promptly provide or arrange suitable advice, investigations, or treatment where necessary.

64. The records suggest the first biopsy results were not considered. That was not in line with the guidance and is a failing. In line with NICE guidance if the test results had been viewed together, Mr W would have had further testing under the ENT department. He would not have been transferred to haematology.

65. Dr K says had the Trust also done what it should have at that stage, there was another possibility her uncle may have been diagnosed sooner and survived, or at least had his life prolonged.

66. She also says that he experienced avoidable suffering at the end of his life, as the lack of palliative options meant that he had extreme, uncontrolled pain. She said this was very difficult for the family to witness.

67. Firstly, we looked at what difference, if any, an earlier diagnosis in July would have made to Mr W’s chances of survival.

68. When Mr W was diagnosed in October/November the Trust considered surgery to remove the lump. Unfortunately, at that stage, the lump’s growth prevented surgery from being beneficial. The Trust also considered a different type of chemotherapy but at an MDT in November it decided by that point Mr W was not fit for that treatment.

69. We asked our oncology adviser if an earlier diagnosis would have made a difference to Mr W’s survival.

70. Our adviser explained the lump was a sign the skin cancer had spread to other parts of Mr W’s body. In their opinion, the way the cancer had spread (that prevented the surgery in November) and the location of it, shows it was an advanced cancer that would have most likely still been too advanced to prevent curative surgery if it was detected in July.

71. As we have seen no evidence there was a curative option in July, we cannot say Mr W’s overall chances of surviving the cancer were likely to have been different had the failing not occurred.

72. Secondly, we looked at what difference, if any, an earlier diagnosis in July would have made to Mr W’s treatment options.

73. GMC Guidance says doctors should do their best to make sure all patients receive good care and treatment that will support them to live as well as possible. We asked our ENT and oncology advisers about what treatment options would have been available if Mr W had received the correct diagnosis in July.

74. Both advisers said it was likely surgery would have been offered to lessen his pain. We can also see from the cancer drugs fund list that cemiplimab (a type of immunotherapy that helps the body fight cancer cells) would have been a treatment option.

75. Taking all that into account, we think it is likely Mr W would have been offered both of those options. Based on his engagement with other treatment offered, we think it likely he would have taken both those options.

76. While the surgery carries some risks and the immunotherapy is not always effective, on balance, we are satisfied those treatments would likely have helped manage his symptoms of fungating cancer (when cancer breaks cells break through the skin). Something which was excruciatingly painful to him. Consequently, it is our view Mr W experienced more pain than he should have, which was distressing for both him and his family.

77. The Trust’s RCA recognised the clinical failing. In response it created a new process for prompting electronic review of results, including digital signatures that show when results have been reviewed. The Trust also now completes routine reporting of unread results.

78. Finally, the Trust's investigation found the error had been made by a locum doctor. Consequently, it has completed an educational exercise with the staff involved and other relevant staff, including locums.

79. In its complaint response the Trust apologised for the failing, and the missed opportunity to begin palliative treatment sooner. However, we have not seen evidence it has specifically recognised the impact the failing had.

80. Because we have seen a failing that had an impact that has not been fully remedied, we partly uphold this part of the complaint. We have made recommendations for action the Trust should take at the end of this report.

Complaint handling

81. Dr K complains about the Trust’s complaint handling. She says it took too long for the Trust’s complaint process to deliver service improvements that prevent the failings reoccurring. She says when she complained about this the Trust only changed its view because she is a doctor.

82. Our Principles of Good Complaint Handling say organisations should investigate thoroughly and fairly. They also say organisations should ensure that lessons are learned from complaints, and they contribute to service improvements.

83. The Trust's first RCA identified both failings in care that we have identified above, but it did not recognise the full impact of the failings. This meant it did not identify appropriate steps to prevent the failings happening again and it did not take any actions to improve the service. Consequently, it had to complete a second RCA (prompted by Dr K). Dr K told us how concerning this was for her.

84. Initially the Trust did not act in line with guidance and complete a thorough and fair investigation or seek to learn lessons and implement service improvements from its failings. That second RCA coincided with the COVID-19 pandemic and took 11 months to complete.

85. We are not criticising the Trust for taking that time because we know its resources were stretched during the pandemic. However, had the Trust recognised the impact of the failings in its first RCA then the RCA and complaints process would likely have been completed significantly sooner. It had the potential to be completed before Mr W died and before the Trust came under the pressure of the pandemic.

86. The additional unnecessary time taken was a cause of extended distress to Dr K and the family at a time when they were grieving. Dr K explained how her knowledge of the medical system contributed to her understanding the seriousness of the failing and added to her concern it could happen again.

87. The Trust has now made changes to its RCA process. We are satisfied the changes are appropriate to prevent the same failings reoccurring. However, we have not seen it has acknowledged or apologised for the significant impact its delays caused in reaching the right conclusions, or in the impact its service improvements had.

88. For this reason, we uphold this part of the complaint. We have made recommendations for action the Trust should take below.

1. We have carefully considered Dr K’s complaint about her uncle, Mr W’s, care and treatment at the James Paget University Hospitals NHS Foundation Trust (the Trust). We thank her for discussing her concerns with us.

2. We found the Trust did not offer follow up appointments for Mr W when it should have. We found this failing did not have any significant impact on the timing of his cancer being identified. But it meant Dr K and the family experienced avoidable worry that the failing had an impact on his care.

3. We also found it also took too long for the Trust to recognise and respond to Mr W’s test results. That led to a missed opportunity for Mr W to have treatment that would have made him more comfortable in his last months. He experienced more pain than he should have and that was distressing for both him and his family.

4. Additionally, we found failings in the Trust’s complaint handling that caused Dr K and the family avoidable worry and stress at what was an already difficult time.

5. In coming to our decision we have taken into account that the Trust has already recognised some failings and it has already undertaken work to prevent the failings happening again.

6. For these reasons we partly uphold the complaint. We recommend the Trust writes to Dr K to acknowledge and apologise for the impact of the failings it did not address in its own investigation.

89. In considering our recommendations, we have referred to our principles for remedy. These state that where poor service or maladministration has led to injustice or hardship, the organisation responsible should take steps to put things right. We also considered the actions the Trust had taken so far, as set out in each section above.

90. In line with this, the Trust should apologise and acknowledge the following by 17 October 2022:

· that it failed to offer follow up appointment to Mr W when it should have. That meant Dr K and the family experienced avoidable worry that the failing had an impact on his care.

· The Trust failed to respond to test results in line with the guidance. That meant Mr W did not receive the correct treatment at the right time, and he experienced more pain than he should have. That was distressing for both him and his family.

· Initially the Trust failed to thoroughly investigate the complaint. That meant there were avoidable delays in reaching the right conclusions and implementing service improvements, which caused unnecessary distress to Dr K and her family at what was a very difficult time.

91. We can see how important Dr K’s complaint is to her and her family. Our investigation has found her persistence and engagement with the complaints process has driven serious and substantial improvement at the Trust, that we can see have made a meaningful difference for patients going forward. We hope that our investigation and report help provide reassurance of this.