23. 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 seriously wrong. We do this by comparing what should have happened with what did happen. We have done this and have not found any indications that something has gone seriously wrong. We will address each of the heads of complaint detailed in the complaint summary individually.
Cancer Surveillance 24. In May 2021 Mr D did not have signs of cancer in his bladder. Mrs D complains there was a 19-week gap after he was told he did not have cancer and before her husband’s surveillance tests started, on 30 September 2021, after which, he was told his cancer had returned.
25. The Trust say Mr D received intravesical BCG maintenance treatment before the surveillance testing on 30 September. The surveillance sadly showed three patches in the bladder that required biopsies which were later identified as cancer. This news was shared with Mr D on 18 October 2021.
26. NICE guideline NG2 tells us at paragraph 1.3.6 that BCG treatment or a radical cystectomy should be offered to people with high-risk non-muscle-invasive bladder cancer. Paragraph 1.4.9 goes on to say that patients who have high-risk non-invasive bladder cancer should be offered a cystoscopy follow up ‘every 3 months for the first 2 years…’
27. This means that Mr D should have had follow up cystoscopies every three months for the first two years. In addition to the follow up cystoscopies Mr D should also have been offered BCG therapy.
28. If accepted, the BCG therapy guidance outlines the BCG protocols and says at paragraph 7.4.3.4 that the optimal BCG induction schedule is six weekly instalments of treatment to begin with and then three weekly maintenance instalments at 3,6 and 12 months.
29. Mr D first started the intravesical BCG treatment in September 2020. He had six sessions from 21 September and 2 November 2020. Following the BCG treatment, further cystoscopy and bladder biopsies were completed on 30 November. This is in line with the BCG protocol.
30. Mr D’s bladder biopsies showed that cancer was still present but showed change due to the BCG treatment. A multidisciplinary team (MDT) recommended a ‘re-induction’ of BCG, another six cycles and that he may need to consider a cystectomy in the future. This was discussed with Mr D in an outpatient appointment on 26 January 2021. Mr D agreed to further BCG treatment and which was administered in six sessions between 1 February and 8 March.
31. Mr D went on to have a flexible cystoscopy on 26 April that showed red areas in his bladder. On 13 May he had a cystoscopy and a bladder biopsy. The biopsy showed no sign of cancer recurrence. An MDT was held on 1 June and recommended further BCG treatment that took place on 20 July, 26 July and 2 August and as per the BCG protocol, on 30 September he had a cystoscopy.
32. With the cystoscopy taking place on 30 September there was a delay of approximately a month in the cystoscopy routine as outlined in NG2 at paragraph REF _Ref188446342 \r \h 26. Our urology adviser says that the delay of one month is not a significant deviation from what is recommended, and this would not have had any impact on Mr D’s disease progression as he received treatment in accordance with the BCG protocols.
33. After full consideration of the available evidence, our urology adviser’s comments and the relevant guidance, we have not seen any indication of failings in relation to the length of time it took for Mr D’s surveillance test to begin. Mr D was treated with two six-week schedules of induction BCG installation and a maintenance BCG treatment three months later, all before September 2021. This means that Mr D’s treatment was in keeping with BCG guidelines, but the surveillance was a month outside what is recommended in NG2. We do not consider that this would have had an impact on Mr D’s disease progression given that his treatment was received in line within the recommended protocols.
Consideration to remove bladder
34. Mrs D complains that the option to remove her husband’s bladder was not considered when the cancer recurrence was detected.
35. As we established earlier, on 30 September Mr D had surveillance tests which sadly showed three patches in the bladder that require biopsies to determine if his cancer had returned. The records show that Mr D agreed that if the results were positive, he would like to be considered for the surgical removal of both his bladder and prostate.
36. On 15 November, doctors confirmed that sadly, a growth had been identified in the bladder and also on the prostate. The doctor confirmed that the biopsies would need confirming by the lab and gave a general timeframe for this. We will discuss the length of time it took for the lab results to be returned in the next section.
37. NG2 says at paragraph 1.3.6 says that patients should be offered the choice of BCG treatment or radical cystectomy to people with high-risk non-muscle invasive bladder cancer and base the choice on a full discussion with the person.
38. Paragraph 1.3.9 goes on to say that ‘for people in whom BCG had failed, the specialist urology multidisciplinary team should assess the suitability of radical cystectomy…’.
39. A radical cystectomy is a surgical procedure used to treat bladder cancer that has spread to the muscle of the bladder wall or beyond. It involves removing the entire bladder, nearby lymph nodes, and sometime other organs such as the prostate.
40. When Mr D’s bladder biopsies showed he had developed persistent high-grade cancer, he saw his consultant where they discussed the option of a cystectomy as per what was outlined in his urology MDT plan. An information leaflet was also given. In the clinic letter from 15 November 2021, the consultant mentions that Mr D was keen to preserve his bladder, as he felt that would not be able to do his job with a stoma bag. Therefore, both the consultant and Mr D agreed to continue with BCG treatment.
41. While the records do not contain full details of what clinicians told or gave to Mr D, they support that a discussion was had, information about the treatment options were shared and his views were taken into consideration when deciding on a future treatment plan.
42. Considering what Mrs D has told us, that the removal of his bladder was her husband’s preferred treatment plan, we can see that his clinicians discussed this with him in more detail and as a result, Mr D changed his mind. The discussion about early cystectomy as a definitive treatment choice, between Mr D and his consultant is clearly documented in the clinic letters. This is in line with NG2 at paragraph 25.
43. In addition to the discussions with Mr D, The Trust held an MDT on 21 November 2021 and established that because the cancer appeared to have progressed rapidly within a short time and due to its advanced stage, the MDT decided that Mr D was unsuitable for cystectomy as an option of curative treatment. Our urology adviser says that when muscle-invasive bladder cancer affects the lymph nodes and spreads to the spine, treatment is usually aimed at disease and symptom control, rather than cure from the disease.
44. Following careful review of the available evidence, we consider that discussing Mr D at the MDT is in line with NG2 in paragraph 38.
45. To summarise, we consider that the staff took Mr D’s views into consideration when choosing his treatment plan. Staff discussed the options with him in detail. When Mr D expressed he did not want to go ahead with the cystectomy, staff discussed further options with him which resulted in their decision to continue to treat his cancer with BCG therapy.
46. We are sorry to hear Mrs D’s concerns about the Trust’s consideration about her husband’s treatment options. We hope we have been able to explain how we have reached our view on the basis of the evidence we have considered.
Histology results 47. Following on from the surveillance tests in September 2021 showing three new patches in the bladder, the Trust took biopsies on 15 October to determine if his cancer had returned.
48. On 15 November, he was diagnosed with a high-grade muscle invasive cancer which had gone through the bladder lining into the prostate.
49. Mrs D complains that it took from 15 October to 15 November to receive histology results confirming that his cancer had become muscle invasive. She says the delay removed alternative treatment options missing opportunities to prolong her husband’s life.
50. The Trust say in its complaint response of 21 April 2022 that it chased the pathology services directly and through its Cancer Services to ask that specimens are reported on more quickly. It explains the delay will not have changed Mr D’s outcome, but it may have led to a more proactive management of his deteriorating situation if the cancer had been confirmed earlier. Understandably, this last comment from the Trust confirms Mrs D's belief that more could have been done to treat her husband and potentially prolong/save his life.
51. The Royal College of Pathologists cellular pathology key performance indicators say that provisional expectations are that 80% of cases would be reported within seven calendar days and 90% of all cases are reported within ten calendar days.
52. Each cellular pathology service should have a documented system to identify cases remaining unreported longer than is anticipated and should have a documented system to manage and report these cases. Exception reporting shall be undertaken of all cases remaining unreported after 20 calendar days.
53. Mr D’s final pathology results were not available for a month (31 calendar days). This is not in line with the guidance referenced above at paragraphs REF _Ref184221742 \r \h 51 and REF _Ref184221798 \r \h 52.
54. We asked our urology adviser to explain what impact the delay in reporting Mr D’s biopsy results would have had on him.
55. The urology adviser explained that considering the high grade and stage and rapid progression of the bladder cancer for Mr D, it is unlikely that the delay of 3 weeks would have made a significant impact on the outcome. This is because Mr D initially had high grade non-muscle invasive bladder cancer, which was treated by tumour resection followed by a full course of intravesical and maintenance BCG treatment.
56. As we have noted in paragraphs REF _Ref187920672 \r \h 40 to REF _Ref187920738 \r \h 42 Mr D was given the option of an early cystectomy when his disease returned after his initial course of treatment. He opted to continue BCG treatment and surveillance of his bladder.
57. It is unfortunate that Mr D’s cancer progressed in a short time to muscle invasive, locally advanced and metastatic bladder cancer. Our urology adviser says that this shows the highly aggressive nature of the underlying disease. They say that even if histology results were available in in 7-10 days, his prognosis and outcome would not have altered significantly.
58. One of the outcomes that Mrs D said she wanted to achieve through our consideration of her complaint was service improvements. Failings are indicated by the Trust not providing his histology results within the recommended timescales but for Mr D, it did not cause any impact on his prognosis. We notified the Trust of what we identified so it can understand the reasons for the undue delay in this case and for it to take mitigating measures so it can prevent this happening again.
Discharge on 1 January 2022
59. Mrs D says her husband was discharged into an unsafe environment to meet his needs. She says he was living in shared accommodation with a shared bathroom with a mattress on the floor. She believes a risk assessment should have been completed before discharging him to ensure he was returning to a suitable and safe environment.
60. In its complaint response dated 15 July 2022, the Trust say that Mr D self-discharged, he was assessed as being able to self-care so at that time he did not need hospice care or other specialist care.
61. We have reviewed the records and there is no evidence of Mr D self-discharging. We asked our nursing adviser about what the discharge procedure should entail considering there were concerns from Mrs D about her husband returning to a safe environment.
62. The nursing adviser said that the discharge of a patient is not an isolated event. The Department of Health guidance ‘Ready to Go?’ makes recommendations for discharge planning and discharge of patients from hospital.
63. The guidance says that discharge planning should start on the day of admission and clinicians should: • identify if the patient has simple or complex discharge planning needs • co-ordinate the discharge planning process • identify an estimated discharge date • review the clinical management plan with the patient each day • take any necessary action and update progress towards the discharge or transfer date • involve patients and families so they can make informed choices that deliver a personalised care pathway and maximise their independence.
64. The Homelessness Reduction Act 2017 places a duty on hospital trusts, emergency departments and urgent treatment centres to refer people who are homeless, or at risk of becoming homeless within 56 days, to their local authority. This came into effect in October 2018 and requires as a minimum the individual’s contact details are passed to an agreed local housing authority, subject to the individual’s consent.
65. Referrals should be made for all patients at risk of or experiencing homelessness, even where the individual may have no recourse to public funds or may not be eligible or in priority need for housing assistance. In such cases, local authorities have a role in providing information and advice about homelessness prevention and alternative support options.
66. On 10 December 2021, whilst an inpatient, an occupational therapist (OT) reviewed Mr D and noted that upon discharge he required a ‘hospital bed and [package of care]’ saying that the ‘bed in situ not suitable – too low…’. The package of care proposed was twice a day from one carer. Mr D agreed to his bed being removed and a hospital bed and key safe (for carer and emergency services access) being organised. The OT assessment also recommended a commode, but Mr D declined this stating there was no room for it. There is no reference to shared facilities within his accommodation.
67. During his admission, Mr D told staff he was having issues with his accommodation due to his ongoing needs. On 13 December, he told staff he thought he had been evicted so nursing staff noted that the safe discharge procedure needed following and documented that social support regarding accommodation was required.
68. On 14 December, staff held a multidisciplinary team (MDT) meeting to discuss Mr D’s condition and discharge arrangements. Nursing staff advised they did not think Mr D required a package of care as he was mobile and independent, needing ‘minimal assistance’. Instead, the MDT agreed that Mr D would benefit from visits from the District Nurse to help with his nephrostomy care.
69. During the meeting staff also discussed that a key safe and hospital bed may not be possible in his current accommodation due to the space available. The discharge team were also made aware of the ‘unclear discharge destination’. Unfortunately, the documentation isn’t entirely clear but appears to say ‘Pt will need to source new accommodation. OT has discussed same with D/C team / referred for discussion with C.A’. Our nursing adviser says this means that staff would be discussing Mr D’s potential homelessness.
70. On 16 December, following the MDT, Mrs D measured the space available in Mr D’s accommodation and said that there would not be enough room for a hospital bed and if needed, they would purchase another mattress if there were any concerns or difficulties once discharged.
71. On the same day, Mr D confirmed to the nursing staff that his accommodation was now ‘stable’ for himself and his wife. Staff then made a referral to the district nursing as per the MDT meeting outcome for his ongoing nephrotomy care.
72. The Trust’s account of him self-discharging is not what is reflected in the nursing records. There is no evidence to support Mr D self-discharging. On 31 December 2021, Mr D was reviewed by the urology team who advised he could go home or stay in hospital if he wished. Records show Mr D told staff he was not ready to go home on 31 December. However, on 1 January 2022, he told staff he was ready to go home. He was given a discharge summary, referred to the GP for the care of his nephrostomies in addition to the referral to the district nurse, and given his medication along with a sick note.
73. The evidence supports that discharge was planned and agreed between Mr D and the MDT.
74. In summary, Mr D’s discharge was in line with overarching DOH ‘Ready to Go?’ guidance. The integrated discharge team (IDT) were made aware that he was homeless when Mr D informed staff this may have been a possibility. He then confirmed on 16 December 2021 that he was not homeless and that his accommodation was ‘stable’.
75. We acknowledge that it must have been an extremely worrying and distressing time for both Mr and Mrs D. Mrs D does not believe that her husband was discharged into a suitable environment. Staff discharged based on the information that was given to them about Mr D’s living accommodation and Mrs D confirmed that if any concerns of difficulties arose after discharge regarding the bed, they would purchase another and did not require a hospital bed.
76. We hope that we have been able to provide some reassurance that staff made all relevant considerations when discharging Mr D and we have not seen any indications of failing within the discharge process.
Cancer treatment during admission
77. Mrs D complains that her husband’s cancer was not actively treated when he was admitted on 24 January 2022 with sepsis. She believes the lack of cancer treatment caused him to lose his mobility and the use of his right arm as after the admission, he did not walk again. We acknowledge this must have been extremely distressing for both Mr and Mrs D.
78. Paragraph 16 of the GMC guidance says that when providing clinical care doctors must ‘prescribe drugs or treatment, including repeat prescriptions only when [they]have adequate knowledge of the patient’s health and are satisfied that the drugs or treatment serve the patient’s needs.’
79. When Mr D was admitted to the Trust on 24 of January, he had severe pain and difficulty in walking because of the spread of cancer to his spine. He also developed urinary sepsis and experienced multiple pulmonary emboli during this admission. Staff felt that a palliative care referral to give him relief of symptoms was perhaps the best option for him, while his general condition was steadily declining.
80. Our urology adviser says that these factors and the advanced spread of the disease rendered him too physically unwell and frail to withstand systemic chemotherapy (a type of chemotherapy that affects the whole body and disrupts the way the cancer cells grow and divide) throughout his stay.
81. Taking into consideration the evidence, the guidance and the comments from our urology adviser, we have seen no indication that staff did not act in line with the GMC guidance when considering appropriate treatment options for Mr D. We acknowledge that it must have been extremely distressing for Mrs D knowing that active cancer treatment was not being given to her husband as his condition was deteriorating and we can see why she thinks this caused his deterioration.
82. We are deeply sorry to hear about how upset Mrs D has been and how she has been affected. We extend our condolences to her. We understand how much this complaint means to her and thank her again for sharing the details. We hope this statement clearly explains why we will not be considering the complaint further and we regret any further distress this this decision may cause.