Ureteroscopy
12. Miss O says mistakes were made during a ureteroscopy which has left her with ongoing kidney problems. Miss O says she was advised the consultant had tried and failed to fit a stent during the procedure carried out on 1 May. Miss O believes this is the reason for the ongoing kidney problems she has experienced.
13. A ureteroscopy is the inspection of the inside of the ureter and kidney. The ureter is the small tube which carries urine from each kidney to the urinary bladder. A fine telescope is passed through the urethra and urinary bladder up the ureter and can go all the way up to the inside of the kidney.
14. A stent may be necessary to avoid ureteric obstruction from tissue swelling after the ureteroscopy and encourage healing. Stents can be associated with symptoms such as blood in urine or pain in the bladder or kidney.
15. Risks of ureteroscopy include blood in urine, infection, failure, ureteric injury or ureteric obstruction.
16. The Trust said on 1 May 2020, it carried out a right ureteroscopy. The Trust said this procedure showed there was a narrowing at the end of the sacro-iliac joint but no evidence of a tumour, cancer or any other worrying features.
17. The Trust said after reviewing the operation notes, it concluded there was no attempt to pass a stent as it was deemed unnecessary, as no tumour or other obstruction had been identified. The consultant told Miss O in the consultation of 3 June 2022 he did not fit or attempt to fit a stent.
18. The records show the consultant used a ureteric access sheath during the ureteroscopy but did not leave a ureteric stent afterwards. Stenting is not mentioned on the consent form prior to the operation and is not mentioned in the operation notes.
19. Access sheaths are self-lubricated tubes that are inserted into the ureter under X-Ray control to facilitate the introduction of the ureteroscope. Our urologist adviser told us ureteric access sheaths are helpful but often split the lining and wall of the ureter because of their size. Our urologist adviser said this does not matter provided a stent is placed afterwards. Without a stent, the patient may suffer severe pain due to ureteric obstruction.
20. On 4 May Miss O was admitted to hospital via the ED with blood loss and sudden pain. Her ureter had become completely obstructed and there was concern she had an infection in her kidney. A nephrostomy tube was inserted into the kidney to decompress and drain the infected urine.
21. The Trust said there had been a miscommunication by a junior doctor in the ED on 4 May regarding the fitting of a stent on 1 May. It explained the notes from Miss O’s operation on 1 May were not available on the electronic patient record system at the time of her admission to the ED on 4 May. The Trust said a discharge letter and original operation notes were added onto the patient record system on 1 June, neither of which mentioned a stent fitting.
22. We have referred to NICE guidance for renal and ureteric stones. Although Miss O was not being assessed for stone disease, our urologist adviser told us there are no guidelines about the use of ureteric stent which apply specifically to Miss O’s case, but the general principles for ureteroscopy in patient with or without stone disease are the same.
23. NICE guidance for renal and ureteric stones states stents may be needed in some cases where further treatment is anticipated, or there is evidence of an infection or obstruction.
24. Our urologist adviser told us when completing a ureteroscopy, the surgeon must decide whether a ureteric stent is required. If there is any possibility of subsequent urinary leakage or ureteric obstruction, a stent should be inserted.
25. Our urologist adviser told us the decision to fit a stent after a ureteroscopy is dependent on an individual clinician’s experience and the suspicion of ureteric injury. NICE guidance does not specifically state when a stent should be fitted. However, ureteric stenting is routine in urology and should be considered after every ureteroscopy. Only if the procedure has been atraumatic and there is no visible sign of injury, can stenting be omitted.
26. Our urologist adviser told us ureteroscopy can injure the ureter and it would be expected the consultant would check the ureter for damage when completing the ureteroscopy. The operation notes from 1 May do not provide documented evidence these checks were made.
27. Our urologist adviser told us in their clinical experience the decision not to fit a stent should be recorded in the operation notes because it would be unusual to not use a stent in this procedure. They told us this is because the potential for ureteric injury from an access sheath is high and the use of a stent would mitigate the risk. Our urologist adviser also explained even with the use of a stent there would still be risk of injury or blockage.
28. Our urologist adviser told us they have no doubt the readmission on 4 May and need for a nephrostomy to drain the kidney was as a result of the ureteroscopy carried out on 1 May.
29. Our urologist adviser told us it was unlikely Miss O’s long term kidney problems were directly caused by the ureteroscopy carried out on 1 May.
30. We saw no evidence in the records to suggest the consultant fitted or attempted to fit a stent on 1 May.
31. Evidence shows the consultant did not record they had checked for damage after the procedure and did not record their reasoning for not fitting a stent. Subsequently we have no way of knowing if there was injury to the ureter on 1 May which would have necessitated a stent.
32. GMC professional standards say you must make sure formal records of your work including patient records are clear, accurate, contemporaneous and legible. You should take a proportionate approach to the level of detail, but patient records should usually include decisions made and actions agreed including decisions to take no action.
33. We cannot say the decision not to fit a stent was a failing as NICE guidance does not state a stent must be fitted, we are told clinical judgement should be used based on suspicion of ureteric injury.
34. We have identified failings in record keeping as the consultant did not record their reasons for deciding not to fit a stent. Due to this, we do not know whether or not the consultant checked for injury on completion of the ureteroscopy and was satisfied no stent was needed.
Issue 2 – consent
35. Miss O says she did not sign a consent form for the ureteroscopy, and she did not understand the procedure. Miss O says this has caused confusion and led her to feel upset and stressed.
36. A urology clinic letter dated 20 April 2020 states on 16 April the consultant tried to reassure Miss O as much as possible. The letter does not specify what Miss O’s concerns were or what reassurance was given.
37. The records show on 17 April 2020 a nurse called Miss O to provide support and enquire if she had any questions or concerns. It was noted Miss O did not have any further questions.
38. The pre-operative patient assessment form dated 24 April 2020 states, ‘very, very anxious lady – reassured. The form does not state what Miss O was anxious about, the form indicates the nurse reassured her.
39. The admission checklist dated 1 May 2020, under ‘patient education and support’, confirms Miss O was given advice on the procedure and post operation precautions.
40. General Medical Council, seven principles of decision making and consent states, ‘all patients have the right to be listened to, and to be given the information they need to make a decision and the time and support they need to understand it.’
41. We have seen evidence Miss O was given opportunities to ask questions about the procedure on more than one occasion. We have seen evidence she was anxious and upset and was reassured by both the consultant and nurse on different dates prior to the ureteroscopy taking place. Although the records do not document exactly what was discussed, it shows Miss O was given the opportunity to present any questions about the procedure prior to it taking place.
42. The records show on 1 May 2020 Miss O signed a consent form for the ureteroscopy which was carried out the same day.
43. Our urologist adviser reviewed the consent form and told us they would expect to see stenting mentioned due to the use of an access sheath. They explained as a general rule, when an access sheath is used in a ureteroscopy it would be expected a stent would be fitted as part of the procedure.
44. Our lead clinician agreed stenting should have been mentioned on the consent form as the access sheath increases the risk of tears to the ureter and so the risk of needing a stent was increased.
45. We have seen evidence Miss O signed a consent form for the ureteroscopy on 1 May 2020, but the consent form did not adequately describe the risks. We consider the Trust gave opportunities for Miss O’s questions to be addressed.
Impact
46. We next considered the impact of the failings we identified. Miss O told us she feels mistakes made during the operation of 1 May have led her to have ongoing kidney problems. The failings have caused her to feel stress and upset, for which she has received psychological treatment.
47. While we have been unable to link the failings to Miss O’s ongoing kidney problems we can see how the failings in record keeping and consent have caused feelings of uncertainty, stress and upset for Miss O. We therefore make recommendations to the Trust to address this.