York and Scarborough Teaching Hospitals NHS Foundation Trust

8. Miss A complains about the Trust, following the death of her sister on 9 March 2020.

9. She complains:

• the Trust failed to properly investigate suspicious findings at the time of Mrs C’s hysterectomy in November 2020; and

• the Trust failed to provide follow up treatment, despite the suspicious findings following the operation in November 2020.

10. Miss A says that the lack of diagnosis and treatment led to Mrs C’s sudden death 12 weeks later. She says had the Trust taken the appropriate action sooner, it may have identified the primary cause of her sister’s cancer. She says knowing that Mrs C was so poorly and not receiving the treatment she should expect to save her life caused her and her family extreme distress; even more so as Mrs C had received a letter stating that no further treatment was required.

11. She also complains the Trust’s SJCR focused on the last days of Mrs C’s life, rather than on the entire period of care as it should have. Miss A said this meant the Trust failed to highlight how Mrs C had been let down before her sad death and this has not reassured the family that the Trust has learnt from Mrs C’s experience.

12. As an outcome to her complaint, Miss A would like the Trust to improve its services to prevent similar failings in future.

13. In September 2020, Mrs C saw the Trust’s gynaecology team as she had some unexpected vaginal bleeding. The Trust completed an ultrasound, and this showed a possible ovarian cystic mass.

14. The ultrasound showed a large complex ovarian mass and that the lining of Mrs C’s womb appeared a little thickened. The level of her CA-125 blood test (which measures the level of the protein CA-125 in the blood and can indicate cancer) was mildly raised at 54. The normal reference range for CA-125 levels in the blood is generally considered to be less than 35. The Trust considered Mrs C likely needed a hysterectomy with removal of both fallopian tubes and ovaries. The Trust decided to complete an MRI (Magnetic Resonance Imaging), which is a scan that takes images of the inside of the body, to obtain more detail about the cyst.

15. In October 2020, the Trust held a Gynaecology Multi-Disciplinary Team (MDT) meeting to discuss the results of the MRI. An MDT refers to a group of healthcare professionals who work together to plan and deliver comprehensive care for a patient. The MDT was concerned as the MRI suggested Mrs C had a borderline ovarian cystic tumour, which means she had abnormal cells that form in the ovary. The MDT recommended removal of Mrs C’s tumour. This recommendation was supported by the wider area MDT, with a recommendation to take an omental biopsy. The omental is the fatty tissue that covers the abdomen, so this recommendation meant the Trust would take a sample of that tissue for examination.

16. On 26 November 2020, Mrs C was admitted to the Trust for planned surgery to remove her uterus (a procedure called a total abdominal hysterectomy), both ovaries and fallopian tubes. The surgery was also intended to carry out the recommended omental biopsy and take samples of abdominal fluid (known as peritoneal fluid aspiration) for testing.

17. During the surgery, clinicians removed a cyst from Mrs C’s left ovary and found a large amount of fluid, called ascites, in Mrs C’s abdomen. The Trust took a tissue sample and also sent some fluid for testing to see if Mrs C needed further treatment. The Trust considered the surgery had gone well, and Mrs C made a good recovery.

18. Following the biopsies, the Trust held a further MDT in December 2020. The Trust then told Mrs C she had a low-grade tumour with a low chance of malignancy, i.e. a low chance of abnormal cell growth becoming invasive. This was called a borderline serous cystadenofibroma of the ovary, which is a kind of cyst on the ovary. It was staged as 1c3, which means abnormal cells were in the fluid from the abdomen but had not spread to nearby lymph nodes or other sites in the body. The biopsies confirmed Mrs C’s fallopian tubes, ovary, womb, and cervix were normal.

19. Mrs C had a telephone clinic appointment on 7 January 2021. The Trust said that it would monitor Mrs C over the next few years, with six-monthly checkups and tests of her CA-125 levels. It organised the first CA-125 test for May 2021.

20. In February 2021, Mrs C started to report new symptoms, which included worsening abnormal discomfort, and bloating with urinary and bowel incontinence. She attended the gynaecology assessment unit and the on-call doctor reviewed her. The Trust completed an ultrasound and a CA-125 level check. Mrs C’s CA-125 levels came back at 421. As explained in paragraph 14, the normal range is up to 35, so this result was very high. The Trust MDT discussed Mrs C’s case on 26 February and decided she should have a CT scan of her abdomen.

21. However, Mrs C’s condition then deteriorated very quickly and she was admitted to hospital on 4 March 2021. She sadly died on 9 March 2021.

Failure to properly investigate suspicious findings and failure to provide follow up treatment

25. Miss A said Mrs C did not suffer complications from the hysterectomy but, after the operation, the Trust said Mrs C may need a small amount of chemotherapy due to a consultant’s suspicions of Mrs C’s abnormal cell growth.

26. In December 2020, Mrs C received a letter which said no further treatment was needed. She said for her and her family this was the most serious concern as she feels that Mrs C was misled that the cell growth was harmless.

27. Miss A said in the months following the operation her sister had a lot of problems and this was when her condition deteriorated, and the family then thought it was due to the hysterectomy.

28. Miss A said that she did not know why the Trust did not do more to rule out its suspicions about the nature of her sister’s abnormal cell growth. She said had it acted sooner, it may have identified the primary cause of cancer and Mrs C’s death 12 weeks later might have been avoided.

29. Miss A said that in her opinion Mrs C’s death is unexplained. She said one minute Mrs C was fine and the next the family were sat with her in the hospital while she died.

30. The Trust recognised that from a gynaecological point of view Mrs C’s death was unexplained. It confirmed Mrs C died of metastatic disease (cancer which has spread to many parts of the body) of an unconfirmed primary source, and it explained a CT scan showed Mrs C’s cancer had spread to many of her organs.

31. Our oncology adviser explained that with borderline serous tumours, the cells are atypical, i.e. they do not appear like normal cells and grow faster than they should, but not as fast as typical cancer cells. If they spread away from the primary site, they typically sit on the surface of abdominal organs. Unlike typical cancer cells, they do not invade the underlying tissue, blood vessels or lymph channels. We understand from our oncology adviser it is unusual for borderline ovarian serous tumours to recur and, if they do, this is often years after diagnosis.

32. The 2019 ESMO-ESGO guidance explains that ‘a bilateral salpingo-oophorectomy (removal of both ovaries and fallopian tubes) with or without hysterectomy is the standard management of borderline ovarian tumours in menopausal patients’.

33. Mrs C had a successful hysterectomy and there were some abnormal cells in the saline fluid used to wash the abdominal cavity during surgery (known as the washings). Our oncology adviser told us this is not unusual to find when abnormal cells have broken out of the wall of the ovary.

34. Miss A told us that Mrs C’s consultant at the time of the hysterectomy had suspicions, which led them to say that Mrs C may need a small amount of chemotherapy.

35. Our oncology adviser explained that washing is part of the staging process (staged as 1c3, as in Mrs C’s case), and we understand the ESMO-ESGO guidance does not set out that the Trust should have performed any other surgery or given chemotherapy based on these cells being present in the washings. This is because without clear signs of those cells spreading, invasive treatment such as surgery or chemotherapy could cause unnecessary harm. Our oncology adviser also explained, it should be noted that the cells are present, and this would not necessarily cause alarm. The cells may put a patient at a slightly higher risk of reoccurrence, but that would likely be after a significant period. It would not usually indicate widespread cancer only three months later, as happened in this case.

36. Regarding further treatment, the 2019 ESMO-ESGO guidance says that after surgery ‘follow up should be organised according to a locally agreed protocol. When follow up is planned, a reasonable approach involves patient assessment every 3-4 months for the first 2 years, and every 6 months during years 3-5, but follow up schemes may be individualised according to prognostic factors and treatment modalities’.

37. We understand from our oncology adviser the Trust arranged appropriate follow-up to monitor Mrs C’s CA-125 levels in six-months’ time. This was in line with the 2019 ESMO-ESGO guidance for an early-stage borderline tumour that had been completely removed. As explained previously, CA-125 is a protein found in the blood and monitoring its levels can help determine if ovarian cancer is present if found to be high. We understand that, based on the diagnosis and findings from the washings, the clinical evidence did not indicate Mrs C required any further treatment at that time.

38. Having considered the evidence, including our clinical advice, we have not seen anything to suggest there was cause for the Trust to further investigate findings from Mrs C’s hysterectomy. We can see that a follow up review in six months’ time was appropriate for an early-stage borderline tumour that had been completely removed, in line with the individual follow up approach set out in the guidance.

39. However, we understand from both our oncology adviser and gynaecology adviser that the Trust should have completed a CT scan of Mrs C’s chest, abdomen, and pelvis either before or after it completed the hysterectomy.

40. The 2013 ESMO guidance says CT scans are routinely used to determine the extent of disease and to aid in surgical planning. Imaging of the chest with CT or chest X-ray should be done to look for water on a person’s lungs and disease above the diaphragm.

41. Similarly, the BGCS guidance says, ‘CT imaging of the thorax, abdomen and pelvis is recommended to help define the extent of disease and to aid in surgical planning’.

42. Mrs C’s records show the Trust discussed her case at meetings on 15 October and 22 October 2020. According to NICE guidelines for ovarian cancer, a Risk of Malignancy Index (RMI) score should be calculated. In this case, Mrs C’s RMI score was 486. Scores above 200 are considered high risk for ovarian cancer. Mrs C’s score of 486 is well above this threshold, indicating likely malignancy. The NICE guidelines recommend that if the RMI score is high, a CT scan of the pelvis and abdomen should be performed, and MRI should not be used routinely for assessing women with suspected ovarian cancer, as happened in this case.

43. This means that, although the Trust treated Mrs C’s borderline serous tumour in line with the guidance, it did not act in line with guidance and standards by performing a CT scan around the time of the surgery. This means her clinical condition was not investigated to the extent she should have been. We conclude this was a failing.

Impact

44. Miss A said that the lack of a diagnosis and treatment led to Mrs C’s sudden death. She said had the Trust acted sooner, it may have identified the primary cause of her cancer. It is clear from what Miss A has shared with us that the quick and, at the time, unexplained deterioration of Mrs C’s condition would have caused the family significant distress.

45. We considered what impact the failing of not completing a CT scan earlier may have had on Mrs C. A short time before Mrs C’s death in March, the Trust completed a CT scan. This suggested her widespread metastatic disease was likely an adenocarcinoma (a cancer which starts in the glands of an organ) which could be colorectal or gynaecological in origin, although there was no histological evidence of either. Histological evidence refers to the microscopic examination of tissue samples.

46. It is not possible to determine where Mrs C’s cancer originally started, nor when it would have been visible on a CT scan or in surgery. We understand from our oncology adviser that, based on the evidence available to us, the diagnosis of a borderline serious cystadenofiroma in the ovary (which is a growth that is not cancer, but has some abnormal cells) was likely correct and that the cancer Mrs C sadly died of was a separate condition. They explained that stomach and pancreatic cancers have the tendency to grow rapidly and result in the patient’s death soon afterwards, as happened to Mrs C.

47. Having discussed this with our oncology adviser, we understand that given the aggressive nature of this cancer it would have been very unlikely that the Trust could have identified it at a time when it would have been curable, and it is also unlikely that it would have responded well to treatment. As such, we have not seen anything to indicate an earlier CT scan would likely have resulted in a better prognosis or clinical outcome for Mrs C.

48. However, we can see Miss A will be left with the uncertainty of not knowing what might have been different for her sister, and this will undoubtedly be a source of ongoing distress to her. In our view, this is an injustice that has not yet been put right and so we make recommendations for remedy later in this report.

Structured Judgement Case Note Review (SJCR)

49. Miss A said that the SJCR carried out into her sister’s care was not fit for purpose. She said that, rather than it considering all the care Mrs C received from November 2020 onwards, it had wrongly focused only on the last days of Mrs C’s life. Miss A stressed that she felt Mrs C had been let down prior to her admission to intensive care and so the review should have considered a longer period of care.

50. She also said that the Trust had apologised for the lack of communication between ICU team and the gynaecological department but had not acknowledged what had gone wrong throughout the period of care. She said that the family does not feel that the Trust has learnt anything from Mrs C’s death.

51. An SJCR forms part of the review process when a person dies in hospital. It uses a systematic method to assess the quality of care provided to patients during their admission. Its goal is to identify strengths, weakness, and any gaps in care. This enables organisations to learn from what happened.

52. The Trust provided a copy of the SJCR and its own guidance, which is based on the NQB’s ‘National Guidance on Learning from Deaths’. Point 18 of this guidance says, ‘The judgement of whether a problem may have contributed to a death requires careful review of the care that was provided against the care that would have been expected at the time of death’. The guidance does not specify if other periods of care or admissions should be considered as contributing factors to a patient’s death.

53. The SJCR completed by the Trust explains that Mrs C’s case was referred for an SCJR by the medical examiner, who was responsible for certifying Mrs C’s death. The Medical Examiner’s ME-1 form (completed to help the medical examiner to certify death) says that Mrs C did not know that she had cancer and thought that the operation in November 2020 was curative. A referral was completed based on this, as there was an indication that learning could be identified which would improve the Trust’s quality improvement work and based on the fact that Mrs C’s death was unexpected.

54. The SJCR considers six phases of care: Admission and initial 24 hours; ongoing care; care during a procedure’ perioperative/procedure care; end of life care; and assessment of overall care. These areas are scored 1 (very poor care) to 5 (excellent care).

55. The reviewer in Mrs C’s case scored each area as 4 (good care) and listed the reasons as to how they had reached that score.

56. Our Principles of Good Administration say that in order to be open and accountable, public bodies should be open and truthful when accounting for their decision making and give reasons for their decisions.

57. After reviewing the SJCR alongside both the Trust’s own guidance and the national guidance, we have not seen anything to suggest that the Trust acted outside of those standards. It completed a review of the period of care it had identified as being relevant, reached a decision and explained that decision with reference to the evidence available.

58. We appreciate the family’s concern that the Trust did not more widely review Mrs C’s care and treatment from the time she had the hysterectomy. In its response to Miss A, the Trust explained it carried out its review of the care Mrs C received from October 2020 up to her death, not only the last few days of her life, as Miss A fears. It said a review can be undertaken for a number of reasons, such as when a patient dies and the family have raised a significant concern about the care, when the death was unexpected, or it is felt significant learning can be gained.

59. The Trust offered its reassurance to Miss A its review covered Mrs C’s medical records, care and treatment plans and the clinical decisions it made. The evidence we have seen supports the Trust’s explanation that it considered the full period of care from October 2020 in taking forward its SJCR. As such, we have not seen any indications here that it failed to act in line with the relevant SJCR guidance.

1. Miss A complains that the Trust failed to investigate suspicious findings at the time of her sister, Mrs C’s, hysterectomy in November 2020 and failed to provide follow up treatment despite those suspicious findings. She said this resulted in Mrs C’s sad death 12 weeks later. We understand from Miss A’s correspondence and our conversations that Mrs C’s condition deteriorated quickly, despite a successful operation. We were sorry to hear of Mrs C’s death and we thank Miss A for openly sharing her and her family’s experience with us.

2. Miss A tells us these events distressed the family, particularly as Mrs C had been told she required no further treatment. She says the Trust could have identified the primary source of cancer which caused Mrs C’s death if it had done what it should have.

3. After considering the evidence available to us, we have found a failing in the way the Trust investigated Mrs C’s symptoms, in particular the failure to provide a CT scan around the time of the surgery. We cannot now reach any view as to whether signs of the cancer from which Mrs C died would have been present at the time.

4. We have therefore not seen anything to indicate that this was a missed opportunity to prevent Mrs C’s death. The evidence available to us shows it is likely Mrs C died of a separate, very aggressive cancer and not the ovarian condition for which she had the hysterectomy. This means we have not seen anything to indicate this sad outcome could have been avoided. We have seen that the failing we have identified means Miss A will be left with uncertainty around whether the cancer may have been identified sooner, which may have left the family better prepared for what was to come. This will likely be a source of ongoing distress to her.

5. Miss A also complained that, rather than review the whole period of care in its structured judgement case review (SJCR) after her death, the Trust only reviewed the clinical records of Mrs C’s final admission. We appreciate Miss A’s concerns here and we can see the Trust has acknowledged poor communication between the intensive care and gynaecological team.

6. After reviewing both national and Trust guidance about SJCRs following the death of a patient, we have not seen any evidence that the Trust departed from this guidance by not commenting on the entire period of care in its overall assessment of Mrs C’s final admission to the Trust. We have therefore not found a failing in this aspect of Miss A’s complaint.

7. We partly uphold this complaint. We hope our findings will be of some benefit to Miss A and her family.

60. 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. In this case, we can see that failing to carry out an earlier CT scan has led to avoidable uncertainty and distress for Mrs C’s family. We have therefore considered what the Trust should do to put things right.

61. Our Principles say that public organisations should look for continuous improvement and should use the lessons learnt from complaints to make sure they do not repeat maladministration or poor service. In line with this, we recommend the Trust:

• Acknowledge and apologise that it failed to complete a pre- or post-operative CT scan at the time of Mrs C’s hysterectomy. This should be provided to Miss A with a copy to us within one month of the date of this report.

• Produce an action plan which sets out how it will improve its services to ensure that patients will receive CT scans at the right time, in line with the applicable guidance. This should be completed in three months of the date of this report. A copy of this should be sent to Miss A, us, the Care Quality Commission (CQC) and NHS Improvement.

62. This concludes our report. We would like to thank Miss A for sharing the details of her and her family’s experience with us, as we know this has been an extremely difficult time for them. We hope our independent view and the recommendations we have made are helpful to them.