Surveillance plan
24. Mrs E told us she questioned whether the surveillance programme she was put on after her original cancer treatment in April 2021 was adequate. The delay in finding out about the cancer returning was such a shock so we understand why this raised doubts.
25. The guidance on how to manage post operative surveillance (NG151) recommends patients be offered regular surveillance. It says both CT scans and CEA blood tests (measuring the protein CEA, which people with some types of cancers have in higher than normal levels) should be carried out in the first three years.
26. The guidance does not specify how frequent these tests should be. The NICE guideline committee approving the guidance noted that previously standard care was considered to be a minimum of two CTs of the chest, abdomen and pelvis, as well as six-monthly blood tests during these three years.
27. The Trust placed Mrs E on a five year follow up plan, rather than just three years. This is more than the guidance quoted above recommends.
28. We can see that under this follow up plan, the Trust carried out the surveillance recommended by the guidance. The Trust gave Mrs E CEA tests regularly and the records show evidence of normal results on at least the following occasions: July, August and December in 2021 and February and June in 2022.
29. We can see evidence Mrs E had a CT scan on 27 August 2021 at the local specialist trust, and this showed no evidence of disease.
30. The Trust arranged a further scan on 1 June 2022, which was also in line with the guidance quoted above.
31. To conclude, the level of surveillance the Trust carried out was more frequent than the minimum recommended by the guidance. For this reason we found no failings in the surveillance plan.
Delay with 1 June 2022 scan
32. Mrs E was deeply affected by the delay. She told us how it had affected her mental health, and that she worried about other patients who may have been affected. She was concerned the delay might have affected her treatment options.
33. She explained her concerns about such a weak system that could fall down so easily, and expressed disbelief this could happen. Mrs E told us she had made a number of telephone calls to the department between mid June and early July 2022 asking about the results of the CT scan, as she was going away on holiday and was anxious to find out if all was well. She says she was told on each occasion that there were delays in results being uploaded from the radiology department and the team told her to go on holiday and try to forget about it.
34. She said if there had been any problems she would have cancelled her holiday plans. She said she felt falsely reassured by the fact that the Trust kept telling her if there were any issues with the scan, it would have been escalated.
35. We do not doubt Mrs E's account, her medical records show that phoning and checking is something she tended to do. She told us she did not understand why someone did not check on any of these occasions.
36. There are clear failings in the Trust’s actions in following up on the scan, and the Trust has acknowledged this and apologised.
37. The National Patient Safety Agency (NPSA) safer practice notice in 2007 recognised what a serious issue this was. It gave clear guidance about what should happen to prevent a situation such as this:
‘This Safer Practice Notice advises healthcare organisations to make changes to ensure that radiology imaging results are communicated and acted on appropriately.
Radiology imaging tests are requested by a registered health professional who relies on a report and image usually generated by a radiologist or radiographer. These are sent to the referring health professional, who then acts on the result. This system is unreliable and has been proven to fail.
Between November 2003 and May 2006, the National Reporting and Learning Service (NRLS) received 22 reports where failure to follow up radiological imaging reports led to patient safety incidents, mostly involving fatalities or significant long-term harm. NHS Litigation Authority data for the 10 years to May 2006 included 69 cases, some of which involved significant harm and monetary claims.
The NRLS recommends that all healthcare organisations providing or commissioning radiological imaging services should:
• ensure that all radiological imaging reports are communicated to, and received by, the appropriate registered health professional and that action is taken in a manner appropriate to their clinical urgency; • ensure registered health professionals design ‘safety net’ procedures for their specialty; • make clear to patients how and when they should expect to receive diagnostic test results; • review relevant policies and procedures in line with the detailed recommendations outlined in the notice.’
38. Following this the Royal College of Radiologists (RCR) wrote in 2016:
‘it is the responsibility of the trust or other equivalent healthcare organisation to provide systems whereby, as soon as a verified imaging report had been produced, it is easily available to be read and acted upon by the referrer, their team and other relevant clinicians’
and
‘it is the responsibility of employing organisations to ensure appropriate reporting and fail-safe systems are in place and to audit regularly’
39. Our adviser gave details of the types of methods trusts use to support failsafe reporting of scan results, and especially abnormal results, to the person who arranged the scan. These include, but are not limited to:
• A digital reporting system that automatically emails the person who ordered the scan • A radiologist who notes red flag results then rings or emails the person who ordered the scan • A red flag message to the requester of the scan sent via the electronic patient record (EPR, a centralised electronic health records system which holds detailed information about a person's health including medication, appointments, test results and medical history) • A nurse led surveillance pathway to chase any late results • A doctor to automatically book a follow up appointment for when the scan result is expected • A specialist nurse adding the patient back on to the MDT for discussion if the scan result wasn’t reported and patient has concerns.
40. This did not happen, the Trust followed none of these options.
41. The Trust has provided unclear brief explanations of how the failing occurred. These seem to focus on a staff member leaving, and: ‘the system did not pull through the results at the time of review, so scans which were delayed or had not been reported remained on the previous unacknowledged results and did not appear on the page which was being worked on’. The Trust seems to be saying the reporting delay was caused by a combination of an inadequate reporting system and human factors.
42. There is no evidence of a detailed root cause analysis of what caused the failing. There should have been a clear failsafe process and it does not appear there was, and so the Trust’s actions were not in line with the NPSA or RCR guidance.
43. We asked our adviser for his view about whether the failing was likely to have affected Mrs E’s treatment plan.
44. Our adviser said that on the balance of probabilities he does not think Mrs E had a poorer health outcome, or that the outcome would have been any different if the scan had been acted upon without delay. His view is based on his experience of similar previous cases, and the fact Mrs E responded well to subsequent treatment.
45. He explained the scan of June 2022 showed disease was not just present in a solitary lymph node, but there were signs that it was likely present in other nodes as well. He said if there had been one location of disease it is possible the outcome could have been different, but there were multiple sites. Sadly, this meant the cancer was already incurable. The scan in October confirmed these multiple sites of disease and may have shown some progression.
46. Our adviser then considered whether earlier treatment would have meant a longer period of lesser symptoms over the whole palliative treatment course. We know this was of great concern to Mrs E. Our adviser said he did not think this would have made any difference to her treatment plan or physical health.
47. There is no evidence of a faster deterioration due to not starting the palliative chemotherapy sooner than November, when it began. The records show Mrs E’s condition did not deteriorate from June and she was still fit for treatment in November and responded well.
48. To summarise, our adviser said even if chemotherapy had been started sooner there would have been no option for a different treatment that would have had a better outcome. Mrs E had an initial good response to palliative chemotherapy. This would have likely been the same if it had been started sooner. Even then, it would not have had a curative effect. There is no evidence to show the outcome or symptoms and reactions to the treatment would have been different if treatment had been started sooner.
49. We think the delay did not have an impact on Mrs E’s treatment options, the disease progression, or her prognosis. It is clear she was impacted by her worries and thoughts about what happened and we are sorry for the worry this caused in her last months.
50. We have made recommendations for the Trust to recognise the impact of these failings, and make changes as outlined in the recommendations section of this report.
Reassurance that other have not been affected
51. Mrs E told us her main concern was how many other people may have been failed by this system, who might have died or not known about delays. She wanted to make sure this did not happen to anyone in the future.
52. The Trust responded to Mrs E’s concern about this, saying: ‘We would like to assure you that at the time the breakdown in our process was reported on the Trust’s risk database (datix), investigated appropriately and improvements were made to ensure that this does not happen to future patients. The colorectal clinical team took this incident extremely seriously and do not want any other patient to experience distress as a result of an incident such as this’.
53. We understand why Mrs E was not reassured by this response. The paragraph is not clear and, other than assuring Mrs E that it would not want other patients to experience a similar incident, it contains no actual information about what was done and whether this was a wider problem affecting a wider patient group.
54. The Trust has provided us with a copy of the datix. This is brief and parts are not completed. It gives the background as: ‘Issues with colorectal database noted and all patient scans reviewed to ensure no missed results and the patient was identified as possibly coming to harm as a result of the delay reviewing the CT scan result from June’. It gives the actions to reduce recurrence as: ‘colorectal database currently being micromanaged by the specialist nursing team’.
55. The datix does not provide reassurance that the Trust has taken action to check whether others have been affected by delays. The section relating to duty of candour, which requires organisations to consider possible harms caused by an incident, was blank. We will consider these points further below.
Service improvements and what should have happened
56. The Trust provided some information to Mrs E in the complaint responses about the changes it had made to prevent a recurrence of the delay in reviewing the CT scan report.
57. The first complaint response said: ‘The CNS [cancer nurse specialist] Team have met with the Information Technology Lead and discussed how to better use the database. The Team has also appointed a dedicated person to manage the database, to ensure that this does not occur again’.
58. The second complaint response said: ‘A new database management system has been developed and is currently in the implementation phase, with the required resource for management, including resilience planned for sickness and absence. The delay in implementation of this was outside of the control of the CNS and Colorectal Clinical Team’.
59. These responses do not provide reassurance of sufficient action to introduce a failsafe system as required by the NPSA and RCR guidance. There are different explanations of the cause and no clear description or evidence of the actions the Trust has taken.
60. We would expect the Trust to be able to provide a clear analysis of what happened and look at probable causal factors. The Trust has not provided evidence of any root cause analysis or other information about how it reached its conclusions. It has not provided an action plan or other evidence to show exactly what improvements have taken place.
61. The actions detailed in the responses are not specific enough to provide reassurance about what the new system involves and how this would prevent a recurrence. They do not describe a failsafe system and are susceptible to possible human factor failings.
62. The sentence: ‘The delay in implementation of this was outside of the control of the CNS and Colorectal Clinical Team’ is not helpful. By noting that delays were outside the control of the specific team, it does not show a wider organisational acceptance of responsibility. The sentence appears to pass responsibility to another unnamed party.
63. Mrs E asked for reassurance that this did not affect other patients. The response was inadequate and did not provide this reassurance.
64. Our adviser said it would be reasonable to expect the Trust to have carried out an audit for a limited period of three or six months, to look at when scans were ordered, when they were reported, and when they were acted on.
65. This would provide an evidence base of possible causes of the failing to inform any future improvements. It would provide reassurance the Trust had adequately followed up other patients. This would be in line with the RCR guidance which says: ‘it is the responsibility of employing organisations to ensure appropriate reporting and fail-safe systems are in place and to audit regularly’.
66. There is no evidence the Trust acted in line with the requirements of the statutory duty of candour. This statutory duty requires Trusts to act in an open and transparent way with people receiving care or treatment from them. The regulation also defines: ‘notifiable safety incidents’ and specifies how registered persons must apply the duty of candour if these incidents occur.
67. The guidance says:
‘A notifiable safety incident must meet all 3 of the following criteria: - It must have been unintended or unexpected.
- It must have occurred during the provision of an activity we regulate.
- 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. This element varies slightly depending on the type of provider.’
68. At the time the incident occurred, to be in line with the guidance we would expect the Trust to show evidence of how it considered duty of candour, and its consideration of whether this was a notifiable safety incident. The datix quoted in the complaint response, as outlined in paragraph 54, provided no evidence the Trust had considered its duty.
69. As well as the statutory duty of candour there is also a professional duty of candour. The joint NMC GMC guidance: ‘Openness and honesty when things go wrong: The professional duty of candour’, 2016, says:
‘You should speak to the patient as soon as possible after you realise something has gone wrong with their care. When you speak to them, there should be someone available to support them (for example a friend, relative or professional colleague). You do not have to wait until the outcome of an investigation to speak to the patient, but you should be clear about what has and has not yet been established.
You should share all you know and believe to be true about what went wrong and why, and what the consequences are likely to be. You should explain if anything is still uncertain and you must respond honestly to any questions. You should apologise to the patient.’
70. We can see the Trust first noted the abnormal scan on 22 September 2022. It discussed this scan on 28 September in an MDT.
71. The Trust phoned Mrs E on 28 September but gave her very little information, and no apology. On 5 October the Trust had another telephone call with Mrs E and explained the incident was being investigated but: ‘unsure if a full explained reason would be found’. The Trust told Mrs E she could make a complaint, but again did not give an apology. Mrs E was eventually seen by a consultant surgeon on 25 October, when they gave her a proper apology and told her she would be informed of the outcome of the investigation in due course.
72. It does not seem Mrs E was spoken with as soon as possible, and the information and apologies given were not in line with the guidance, until 25 October. It is reasonable to conclude these delays impacted on Mrs E, and the unclear explanations of how this happened undermined her confidence in what the Trust had done to put things right.
73. We have seen no evidence the Trust has recognised its actions have been in adequate, in relation to the steps it has taken to remedy the impact of the failings.