Anticoagulant 28. Mrs L complains the Trust failed to advise her husband to stop his anticoagulant prior to the nephrostomy tube change procedure. She quotes from BSIR/BSH guidance which recommends holding therapeutic anticoagulants one day prior to the procedure.
29. In response to the complaint, the Trust said pre-procedural antithrombotic medication instructions can vary. It said the risks and benefits are considered and anticoagulants are sometimes not discontinued, or they can be stopped from 12 hours to one day beforehand, according to the patient's needs. The Trust said considering Mr L’s recent pulmonary embolism (blood clot in the lung) there may have been a higher risk of pulmonary embolism recurring compared to the risk from bleeding, had anticoagulants been stopped.
30. Mrs L is accurate in relaying BSIR/BSH guidance. Mr L was not advised to hold his anticoagulant, and the Trust therefore did not follow BSIR/BSH guidance. We asked our radiology adviser about this, to understand this further. They emphasised that this is guidance only, explaining the importance of clinicians using their experience and judgement to best manage each patient’s anticoagulation before and after an intervention.
31. Mr L attended for a routine, low-risk procedure, that was reasonably expected to be straightforward. The Trust’s Interventional Radiologist (IR) was happy to proceed without holding his anticoagulant, having considered the low-risk and Mr L’s recent medical history. Our radiology adviser explains it is common practice in this specialist area of healthcare, to carefully consider the risks and benefits for each patient individually.
32. This approach was in line with GMC guidance, which says clinicians must provide a good standard of practice and care. It says if clinicians assess, diagnose or treat patients, they must adequately assess the patient’s conditions, taking account of their history.
33. We recognise BSIR/BSH guidance was not followed, and yet we consider this deviation from guidance reasonable, and following alternative GMC guidance, considering the clinical rationale for the circumstance. We therefore do not consider what happened unreasonable, or the result of any service failure.
Tube change procedure 34. Mrs L says during the nephrostomy change, her husband was advised by those performing the procedure they had trouble inserting the new tube. This has led Mrs L to question whether something went wrong to cause a bleed.
35. We carefully considered the procedure report. Whilst it was reasonable to expect this to be a routine, straightforward tube exchange, the IR found the tube was kinked and partially displaced outside of the kidney collecting system, where it needed to be. The report describes the IR making several attempts to navigate a guidewire back into a more secure place, to guide a new nephrostomy tube back into the correct position within the collecting system, to drain the urine. This appeared to be difficult and required a different manoeuvre.
36. During those attempts, the IR noted contrast medium had gone into some of the blood vessels. Contrast medium acts like a dye and is used to help clinicians visualise internal structures during this type of procedure. Our radiology adviser says this finding means interventional equipment had either gone into or created a communication with the kidney’s blood vessel, causing an unintentional injury.
37. The IR also noted contrast medium leaking into the space around the kidney. This could represent three possibilities: contrast extravasation (a leak of the contrast into a dry space opened by the interventional equipment), a urine leak, or a haematoma.
38. Our radiology adviser confirms the cause could not be determined from the report or on the fluoroscopic images taken at the time. They explain a minor injury to a blood vessel caused by a wire will heal by itself and does not require treatment. Similarly, minor contrast extravasation, a small urine leak or small haematoma around the kidney will normally settle without treatment. A new nephrostomy tube was successfully put into the kidney collecting system by the end.
39. Our radiology adviser explains there is no specific guidance on how a nephrostomy exchange should be performed. Having reviewed the records including the fluoroscopic images taken at the time, our radiology adviser confirms the report described the procedure accurately.
40. The nephrostomy exchange turned out to be unexpectedly difficult and was eventually successful. Whilst most are expected to be straightforward, our radiology adviser explains they can be difficult on occasion, particularly when the exiting tube is not entirely within the kidney collecting system, as happened in this case.
41. Injury to the kidney’s structures and surroundings can occur during attempts to navigate the wire and new tube into the correct position. We know Mrs L is concerned that something went wrong to cause a bleed. In this case, the injury that did occur is a known complication, which can happen during a difficult nephrostomy exchange. Mr L therefore suffered from a complication from the procedure, rather than his injury being caused by any wrongdoing. We do not find any evidence to suggest this was because of any service failure.
Pain 42. Mrs L complains from their arrival in the ED, despite her vocalising that her husband’s pain scored 10/10, he was left without analgesia to appropriately meet his needs.
43. RCEM guidance recommends using a numeric rating score for all patients who present to the ED. It advises using a 0-10 scoring system, where 0 means no pain, 1-3 is considered mild, 4-6 moderate and 7-10 severe. For all scores, RCEM guidance says pain should initially be assessed within 15 minutes of the patient’s arrival, and for those presenting with moderate and severe pain:
‘All emergency departments should ensure patients with moderate and severe pain receive adequate analgesia within 15 minutes of arrival.
All emergency departments should ensure patients in severe pain have the effectiveness of their analgesia re-evaluated within 15 minutes of receiving the first dose of analgesia.
All emergency departments should ensure the routine recording of pain in a similar manner as the regular documentation of vital signs.’
44. Records show Mr L was seen by the triage nurse within 15 minutes of his arrival. Whilst his observations were taken, his pain was not assessed using a numeric rating as recommended in RCEM guidance – the pain score part of the record is left blank. The triage nurse does write about pain, noting Mr L’s presenting complaint was: ‘severe L [left] flank pain’. For severe pain, RCEM guidance following on from the above, states:
‘Patients in severe pain should be transferred to an area where they can receive appropriate intravenous, inhaled or rectal analgesia within 15 minutes of arrival.
Patients in severe pain should have the effectiveness of analgesia re-evaluated within 15 minutes of receiving the first dose of analgesia.’
45. Records show Mr L was given oral morphine (an opioid analgesic), not intravenous (IV) or alternatively recommended administration methods, better suited to meet his needs with pain described as severe. Our ED adviser says whilst oral analgesia can be appropriate with lesser pain, it typically takes some time for the patient to report whether it is effectively meeting their needs, and if not, needs giving again. IV administration is recommended for severe pain as it can have a more immediate effect to meet those more severe pain needs.
46. Records show Mr L was given 10mg oral morphine at 4pm, 6.15pm, 8.37pm and at one further, untimed, occasion. He was therefore not given analgesia within 15 minutes of arrival to the ED, as per RCEM guidance.
47. In addition, and in accordance with RCEM guidance, Mr L’s pain should have been scored numerically, he should have been given IV opiates, and his pain re-assessed 15 minutes after first administration, with further IV administration if and as required. There is no evidence to show this happened. We identify this as service failure, and we address the impact later in our report.
Action in the ED 48. Mrs L complains that despite a CT scan identifying a haematoma, two unsuccessful attempts to flush the tube, and no evidence it was draining, the ED failed to take any action.
49. Whilst Mr L remained within the general ED location during this period, the Trust explained when the ED comes under extreme pressure due to the volume of patients in attendance, it will move those patients with a lower acuity need to a ‘fit to sit’ area. Our ED adviser explains this area is typically managed by ED nursing staff and the relevant specialty – urology, in Mr L’s case – will oversee the patient’s care whilst they remain in this area, awaiting bedspace elsewhere in the hospital.
50. We therefore asked our urology adviser about these events, considering Mrs L’s concerns, and we go through the chronology of what happened. Our urology adviser explains there is no specific standard that applies to this circumstance, it is a matter of clinical judgement and GMC guidance applies.
51. Mr L arrived at the ED at 3.07pm. Whilst he presented in pain, the observations taken at 3.21pm showed his vital signs were within the normal range, indicating he was not an acute, emergent patient. The Trust determined to take a CT scan, which our urology adviser confirms was an appropriate investigation for his presentation of pain and considering his procedure just hours before.
52. GMC guidance says clinicians must promptly provide investigations where necessary. We are satisfied the CT scan went ahead in an appropriately prompt timeframe, just over an hour later at 4.12pm. GMC guidance also says clinicians must consult colleagues where appropriate. Records note when Mr L was taken for this CT, consultation with the IR who performed the earlier procedure took place. They confirmed the tube was in the correct position and advised that as it was not draining, it needed to be flushed.
53. The CT scan was reported in a timely manner, in line with GMC guidance, at 5.02pm. This further confirmed the nephrostomy tube was in the correct position and reported a: ‘Small left retroperitoneal collection could be a small urine extravasation or haematoma’. The term ‘retroperitoneal’ describes the area between the abdominal cavity and the inner surface of the back muscles, and ‘extravasation’ refers to the leakage of a fluid.
54. Our urology adviser explains it was not possible to know the cause of the collection from CT imaging. The imaging requested by the ED at that time shows the collection was small. Mr L’s vital signs were appropriately checked again at 5.30pm, further showing that aside from his pain, his vital signs were within the normal range.
55. The next decision at 6.30pm to attempt to flush the tube was appropriate, in line with the advice given by the IR. Our urology adviser explains it was entirely possible the problem was the result of a tube blockage, which flushing would resolve. As the CT scan confirmed the correct positioning, an attempt at a flush was reasonable to proceed with. Records show the tube was flushed with only 1-2mls and the attempt was stopped appropriately, in response to Mr L’s pain.
56. The documented plan was clinically appropriate, to reassess again in 30 minutes and re-attempt a flush. If the tube was then draining, the plan was to arrange an outpatient appointment in two days’ time for ultrasound-guided repositioning, and if not, to arrange a renal triphasic angiogram. This is a specialist imaging test that can look more closely at the blood vessels in the kidneys. Our urology adviser confirms this was the appropriate next investigation, in the circumstance of the tube still not draining.
57. Mr L was reviewed again and notes at 7.16pm state he remained in a lot of pain with the tube still not draining. The clinically appropriate decision was made to admit Mr L, and the note contains a tick, indicating the renal triphasic angiogram scan had been requested.
58. Mrs L is concerned that despite these events and findings, the ED failed to take any action. We hope to assure her that the Trust’s actions in determining need for CT scan before attempting to flush, and on review determining the need to admit Mr L and requesting further investigation via angiogram were all appropriate actions, considering his earlier procedure and his presentation in the ED. Our urology adviser confirms this was in line with what is reasonably expected as good clinical judgement, and in line with GMC guidance as we have explained.
59. We hope to further assure Mrs L, that it was not the case that the ED failed to act after the scan, the flush attempt and knowledge of the retroperitoneal collection. Evidence shows the Trust enacted an appropriate clinical plan, to arrange the next appropriate imaging investigation and to arrange admission. Unfortunately, his wait in the ED holding area appears to have been unavoidable.
60. We are not critical that the Trust could not admit Mr L onto a ward sooner. We can see the appropriate action to determine the need for admission was taken and cannot see the delay was in any way within the Trust’s control. We are also not critical of the wait for the next imaging scan. At the time it was requested there was no clinical urgency, and it was an evening. Arranging this specialist scan promptly, without urgent need and into a night shift does reasonably result in some time to wait.
61. Mr L remained under ED nursing observation and receiving input from urology specialists, as we go on to explain. We do not find evidence to support the view that no action was taken in this regard.
Monitoring 62. Mrs L complains the ED failed to monitor her husband appropriately or escalate his care as required. NEWS guidance applies here.
63. NEWS stands for the National Early Warning Score. It is a tool used across the country to improve the detection and response to clinical deterioration in adult patients. Using NEWS, six vital signs or physiological parameters are measured and assigned a score, depending upon whether they are within the normal range, or outside of it. NEWS guidance says:
‘The NEWS should be used to inform the frequency of clinical monitoring, which should be recorded on the NEWS chart.
We recommend that for patients scoring 0, the minimum frequency of monitoring should be 12-hourly, increasing to 4–6 hourly for scores of 1–4, unless more or less frequent monitoring is considered appropriate by a competent clinical decision maker.
We recommend that the frequency of monitoring should be increased to a minimum of hourly for those patients with a NEW score of 5–6, or a red score (i.e. a score of 3 in any single parameter) until the patient is reviewed and a plan of care documented.’
64. When Mr L was triaged soon after his arrival at 3.21pm he had a NEWS of 2. His vital signs were all within the normal range. It was his pain that gave him a score of 2. Under NEWS guidance, he next required monitoring in 4-6 hours’ time. His next set of observations were taken in line with this, in fact much sooner than required, just over two hours later at 5.30pm.
65. At 5.30pm Mr L’s NEWS was 0. Again, his vital signs were within the normal range. We note his pain score was documented as a 0, despite handwritten entries at 4.20pm and 6.30pm reporting pain. His NEWS of 2 at 3.21pm was due to a raised respiratory rate, which our ED adviser thinks most likely because Mr L was breathing quickly due to his pain. Whilst his NEWS was 0 at 5.30pm, we think it likely he was in pain at this time, but this was not affecting him to the extent of raising his pulse or respiratory rate.
66. Under NEWS guidance, a score of 0 meant Mr L did not require monitoring for the next 12 hours. For the NEWS of 2 we think it should have been, he would have required monitoring in 4-6 hours. We are pleased to see that in response to the complaint, the Trust has already acknowledged this pain score was not correctly recorded, offering deep apologies to Mrs L and explaining the feedback given, to learn and improve from this inaccuracy.
67. Despite the apparent error in documenting Mr L’s pain, we find his next observations were taken in line with the 4-6 hourly recommendation, just over five hours later, at 10.38pm. At this time, Mr L’s NEWS was 1. Under NEWS guidance, his observations were required in 4-6 hours’ time. Yet, we find these were not taken again until 5.45am, one hour outside of the timeframe required by NEWS guidance.
68. We recognise this was a delay outside of recommendations within guidance and as such, we identify this as a failing. That said, with Mr L’s low and stable NEWS up to that point in time, the short delay that occurred here is not considerable and we find the reasons for it clearly explained by the context of the environment at that time.
69. Our ED adviser comments on how the ED was clearly overwhelmed, with more patients than bed space both within the ED itself and elsewhere in the hospital to enable admissions onto the ward. ED nurses were therefore managing a greater number of patients than their resource, on top of this being a night shift, typically meaning a reduced staffing level without a reduction in the patients present.
70. It remains a breach of NEWS guidance and appropriate we identify this as service failure. We address the impact later in our report. It also remains appropriate we acknowledge the context and recognise the strain on resource that led to this occurring.
71. When Mr L’s NEWS was taken at 5.45am, it was 3 from a single parameter, his low blood pressure. As stated in the NEWS guidance excerpts above, not only does a score of 3 in any single parameter increase the frequency of monitoring to a minimum of hourly, it also says:
‘A single red score (3 in a single parameter) is unusual but should prompt an urgent review by a clinician with competencies in the assessment of acute illness (usually a ward-based doctor) to determine the cause and decide on the frequency of subsequent monitoring and whether an escalation of care is required.’
72. On awareness of the NEWS 3 red score at 5.45am, not only should Mr L have had his observations taken again no later than 6.45am, but by that same time he should also have been reviewed by a clinician. There is no evidence to show this, or indeed any action, was taken by the Trust as it should have here. We identify this as service failure, and we address the impact later in our report.
Bleeding 73. Mrs L complains despite clear red flags, the ED failed to consider or act upon her husband’s internal bleeding. To explain our thinking, we go through the chronology again, with this issue specifically in mind.
74. Our ED and urology advisers both confirm Mr L’s initial presentation did not show any cause for concern for active bleeding. His observations at 3.21pm were within the normal range and he only scored a NEWS of 2 due to his pain. His bloods were taken at 3.30pm and reported as normal.
75. The small retroperitoneal collection reported on CT at 5.02pm, as our urology and radiology advisers both explain, could have been a small leak of urine as much as a small bleed. As we have explained, this can occur due to the nature of the procedure, with minor events normally able to settle without treatment.
76. What was seen at that point in time was not of any immediate concern. The imaging shows this was small and there was no suggestion of ongoing bleeding. The urologist discussed this with the IR who performed the procedure, and there was no evidence of or need for further clinical concern of active bleeding at that time.
77. Mr L’s observations at 5.30pm resulted in a NEWS of 0, although as we explained, we think it likely he was in pain at this time, just not to the extent it was affecting his vital signs. These were again in the normal range, and this did not indicate any suspicion of active bleeding.
78. When next checked at 10.38pm his pulse rate was very slightly raised, giving a NEWS of 1. Our ED adviser explains this could reasonably be ascribed to Mr L’s pain. Our urology adviser confirms this was not a clear or apparent sign of active bleeding and did not require any further action than to repeat observations in line with NEWS guidance.
79. Mr L was seen by urology at 11.30pm who noted he looked ‘pale and lethargic’. The tube was still not draining and the plan included repeat bloods and antibiotics. Bloods were taken and tested, and urology returned at 3am to review the results.
80. In comparison to the earlier bloods taken soon after arrival, these results showed Mr L’s white blood cell count (WCC) had increased significantly in a relatively short space of time, alongside a falling haemoglobin (Hgb) level. White blood cells are cells of the immune system that help protect the body against disease, bacteria, virus, etc. Hgb is a protein stored in red blood cells, helping them transport oxygen around the body.
81. Our urology adviser explains this review of repeat blood results at 3am gave the first indication of bleeding. The urologist appropriately noted the plan for admission and that Mr L was still awaiting a bed space. Unfortunately, his wait in the ED holding area appears unavoidable. The urologist also confirmed starting antibiotics which our urology adviser confirms was a reasonable action. However, nothing further was done.
82. Our urology adviser says on awareness of the increased WCC and dropped Hgb at 3am, this should have triggered another set of observations and commencement of clinical resuscitation in the form of IV fluids, bloods and medication. It should also have expedited the angiogram that had been requested the previous evening. This would have resulted in Mr L receiving a blood transfusion and fluids to stabilise him before going into the angiogram suite.
83. The next action taken, was when observations were documented at 5.45am, one hour later than NEWS guidance recommended. The NEWS of 3 from this single blood pressure parameter should have resulted in escalation, with clinical review within the hour. This was another point when bleeding should have been suspected, and the same action as we describe above should have taken place.
84. We identify failings in the lack of appropriate action on both occasions when bleeding should have reasonably been suspected.
Impact 85. Having identified several failings in Mr L’s care, we have carefully considered the impact. Mrs L tells us her husband was discharged from the nephrostomy change procedure in obvious and apparent pain, and they had need to return to the ED to seek medical assistance, resulting in the course of events as explained in this report.
86. Our radiology adviser says Mr L should not have been discharged home after the nephrostomy change. As we have explained, in most cases, a minor injury to a blood vessel, minor contrast extravasation, a small urine leak or small haematoma around the kidney will normally settle without treatment.
87. However, Mr L was at higher risk of bleeding because he remained on his anticoagulant. GMC guidance which explains the importance of clinicians using their experience and clinical judgement to best manage each individually patient, applies here.
88. Considering the difficulty of the procedure, the known vascular complication, the already evident collection around the kidney, and his higher risk of bleeding from anticoagulation, we think the Trust should have admitted Mr L for observation after the procedure.
89. Our radiology adviser comments on Mr L’s pain being an alarming symptom. The procedure report was timed at 2.18pm and by 3.07pm Mr L had returned and presented to the ED in pain he described as severe. Our radiology adviser says the degree of pain is out of proportion after this procedure, and a sign of collection building up around the kidney.
90. Admission from the procedure would have enabled close monitoring for clinical signs of ongoing bleeding, and monitoring and management of Mr L’s pain which we consider more likely to have been appropriate to meet his needs. A direct referral from the IR to urology would have facilitated important information about his procedure and any potential complication to be passed on to assist with a more effective management of his condition.
91. As Mr L was discharged, he had to access medical attention via the ED route this inevitably and unavoidably caused delays to the care and treatment he needed. We think this could have been avoided altogether. On the balance of probabilities, we think it more likely than not that under admission and monitoring with direct input from IR and urology in this setting, Mr L would not have been left in avoidable pain, and the appropriate care he did later receive would have been provided much sooner, likely avoiding his collapse.
92. We have thought carefully about the impact we think resulted from the individual failings we have identified, around poor pain management, inaction to indications of bleeding, delayed monitoring, and lack of clinical escalation from 3am. We find the same as per the above, that if not for these failings, Mr L would not have been left in avoidable pain and the appropriate care he did later receive would have been provided much sooner, and likely avoided his collapse altogether.
93. Our urology adviser explains had the Trust acted as we think it should have at 3am, the actions that happened after his collapse – clinical resuscitation and angiogram to identify the increased collection as a haematoma – would have reasonably occurred several hours sooner. The volume of bleeding in the haematoma would have been less than was found at 9.39am, and Mr L’s blood pressure would not have dropped even further, likely avoiding the collapse altogether.
94. We think it is highly likely that had observations been taken at this time as we think they should have, Mr L’s blood pressure would have been lower than noted at 10.38pm yet higher than recorded at 5.45am. Clinically his blood pressure would have continued to drop, but action would have been taken to stabilise and to hopefully improve it, before it dropped to the levels recorded at 5.45am, and to even lower levels which would have been the case prior to his collapse around 9am.
95. Had the 5.45am set of observations not been delayed and had they been taken by 4.38am – 4-6 hours after the NEWS of 1 documented at 10.38pm – this should have resulted in escalation for clinical review by 5.38am, sooner than otherwise. Had escalation been made at 5.45am when it should have, clinical review by 6.45am was a further chance for this same expedited care, treatment and action.
96. We know how strongly Mrs L considers her husband’s collapse an unrecoverable event, and that she views his subsequent death sadly inevitable as a result. Whilst we do think the collapse could have been avoided, we do not think the collapse itself was an unrecoverable event, or that it had any direct relation to Mr L’s very sad death on 13 August.
97. Records describe Mr L responding to verbal commands throughout the period of collapse, indicating that he remained conscious. It was not a collapse that resulted in any arrest to require revival, in the manner suggested. Later records note that within an hour to ninety minutes after his collapse, Mr L had responded to the appropriate care and treatment given to him and significantly improved.
98. Mr L did therefore recover, somewhat swiftly following the appropriate care given after his collapse. He did not require any ongoing intensive or critical care, and recovered to such an extent he was managed on a ward and lived for some time afterwards. He remained an inpatient for a further twelve days, with discharge records noting he declined nephrectomy, preferring not to have major surgery or transfer to intensive care. Following this Mr L was put on an end-of-life-care pathway prior to palliative care discharge to a hospice, where he sadly died six days later.
99. Our urology adviser expresses that this does not indicate the missed opportunities we identify, to have acted sooner to expedite Mr L’s care were any direct part of his very sad death some weeks later. Our ED adviser echoes this sentiment, explaining records show the collapse was a recoverable event to which Mr L recovered quickly. We cannot ascribe his death some 18 days later to this event.
100. It remains we think these avoidable events caused Mr and Mrs L significant emotional distress. We think Mr L was caused undue pain and distress, and Mrs L caused considerable distress having to witness her husband in pain, and knowing now that aspects of his care fell short without knowledge this may not happen to anyone else in future.