17. Before we decide if we should do a detailed investigation of a complaint, we look at whether there are signs the organisation has got something wrong. We do this by comparing what should have happened with what did happen. We have done this and have not seen any signs that something has gone wrong.
The GP Practice
18. Ms L says she visited her GP between October 2021 and January 2022 about her PMB. She explains the bleeding became worse over time despite seeing the gynaecology team at the Trust and being prescribed Provera. She says she experienced dizzy spells, breathlessness, leg swelling and heart palpitations.
19. Ms L visited the Trust’s A&E on 4 January 2022 and was admitted. Her haemoglobin level was below 100 and she was diagnosed with anaemia (low on iron).
20. Ms L says the GP Practice should have given her more treatment than Provera. She says it should have prescribed her with iron tablets as a precaution to avoid her becoming anaemic.
21. We asked our GP adviser whether the GP Practice’s treatment for PMB was in line with relevant standards and guidance.
22. Our GP adviser explained that while there is no specific national guidance for PMB treatment, it is recommended that there are local processes for investigation that should reflect local availability and expertise. We know there is local guidance for PMB treatment but it was not available between October 2021 and January 2022. We spoke to our adviser about other national guidance that might be relevant.
23. Our GP adviser explained that under BMA guidance a clinician who orders a test is responsible for getting and acting on the results when available. This may require direct action by the clinician or a transfer of responsibility, for example a consultant writing to the patient’s GP with details of results and any actions needed.
24. Our GP adviser also explained the GMC gives guidance for good medical practice. This advises doctors, ‘You must provide a good standard of practice and care. If you assess, diagnose or treat patients, you must:
• adequately assess the patient’s conditions, taking account of their history (including the symptoms and psychological, spiritual, social and cultural factors), their views and values; where necessary, examine the patient • promptly provide or arrange suitable advice, investigations or treatment where necessary • refer a patient to another practitioner when this serves the patient’s needs.
In providing clinical care you must: • prescribe drugs or treatment, including repeat prescriptions, only when you have adequate knowledge of the patient’s health and are satisfied that the drugs or treatment serve the patient’s needs • provide effective treatments based on the best available evidence.’
25. The GP records show that Ms L saw her GP on 15 October 2021 and reported a history of bleeding on and off for six years and she had been bleeding clots. She had an ultrasound when abroad and this showed a thickened endometrium (lining of the womb).
26. To investigate the bleeding, the records show the GP Practice referred Ms L to a gynaecology specialist. The GP Practice also ordered blood tests. The results came back on 26 October. The GP records show Ms L had more contact with the Practice by phone on 11 November, 10 and 24 December.
27. The specialist involvement was the first investigation of the PMB. In line with NICE guidance on gynaecological cancers Ms L was referred to the specialist to exclude uterine cancer (womb cancer) as the cause of the PMB. This guidance says:
‘Refer women using a suspected cancer pathway referral (for an appointment within 2 weeks) for endometrial cancer if they are aged 55 years and over with post-menopausal bleeding (unexplained vaginal bleeding more than 12 months after menstruation has stopped because of the menopause)’.
28. The results of the investigation showed that the PMB was not because of womb cancer. The Trust’s gynaecology team gave treatment and recommendations to manage the PMB. The GP Practice acted on the recommendations of the gynaecology team by continuing to prescribe Provera and offering a Mirena coil (part of hormone therapy treatment for menopause symptoms).
29. Based on the symptoms described (of PMB with associated bloating), the GP Practice’s actions were in line with the guidance. The evidence shows it took a full history, referred Ms L on for investigation and acted upon the recommendations of the specialist.
30. We also considered if the GP Practice should have given Ms L iron tablets.
31. Our adviser explained the NICE guidance on anaemia and iron deficiency is relevant here. There is also relevant information on the NHS website. This says iron deficiency anaemia is caused by lack of iron, often because of blood loss or pregnancy. It is treated with iron tablets and by eating iron rich foods.
32. The website says symptoms of iron deficiency can include:
• tiredness and lack of energy • shortness of breath • noticeable heartbeats (heart palpitations) • paler than usual skin • headaches.
33. The NICE guidance says it would consider a female patient to have anaemia if their haemoglobin blood level was below 120 g/L. It goes on to say that iron tablets are prescribed to replace the iron that is missing from the body. We understand from this guidance that clinicians would prescribe iron tablets if a patient was showing signs of anaemia. There is no requirement in the guidance for iron tablets to be prescribed as a preventative step to avoid anaemia developing.
34. We have considered all the evidence. Ms L was experiencing heavy bleeding when she returned to the UK in October 2021. The medical records from that time show that Ms L was also feeling bloated. Records of the blood test from 26 October show she had a haemoglobin level of 141 g/L.
35. Later entries in the medical records say she had leg swelling in November 2021 and there was no shortness of breath.
36. Overall, there were no clinical signs from her symptoms or blood test results that she had iron deficient anaemia.
37. This means there was no clinical need for Ms L to have iron tablets between October and December 2021. We think the GP Practice acted in line with the relevant guidance when it did not prescribe iron tablets.
38. We are sorry to hear that Ms L developed anaemia and we understand the effect this had on her life. We have not seen any signs of a failing so we are not investigating this part of the complaint further.
The Trust
39. In October 2021 Ms L was referred to the Trust with PMB. She had three different appointments for different tests including an ultrasound and a hysteroscopy. Ms L says there was no plan to monitor her blood levels or prescribe iron tablets, although she had significant and heavy PMB. She also says the Trust should have done more than providing hormone therapy.
40. On 4 January 2022 Ms L was having heart palpitations, breathlessness and dizzy spells and she was near to collapse. Ms L called NHS 111 who advised her to attend A&E.
41. Ms L attended the Trust’s A&E that day and blood tests showed her haemoglobin level had dropped to 98 g/L (a low level) since the last blood test six weeks ago. Ms L says the Trust were even considering a blood transfusion.
42. Ms L says the Trust should have prescribed her iron tablets as a precaution during October to December 2021. Ms L says this would have meant she would have not become anaemic and had ongoing problems.
43. We asked our gynaecology adviser whether the Trust’s care and treatment received was in line with relevant guidance. Our adviser explained the recommendations in the NICE NG88 guidance apply here. These say: • ‘treatments for women with no identified pathology: consider an LNG-IUS [a levonorgestrel releasing intrauterine system. This is a form of progesterone treatment where a coil is inserted into the womb]. If a woman with heavy menstrual bleeding declines an LNG-IUS or it is unsuitable, consider the following pharmacological treatments: non hormonal (tranexamic acid, non-steroidal anti-inflammatory drugs); hormonal (combined hormonal contraception, cyclical oral progestogens) • If treatment is unsuccessful, the woman declines pharmacological treatment or symptoms are severe consider referral to specialist care for alternative treatment choices including pharmacological options not already tried and/or surgical options.’
44. The GP Practice referred Ms L for suspected cancer on 15 October 2021. The Trust saw her on 21 October. The medical records show the Trust did standard investigations for cancer at first. These included a scan and a biopsy (testing tissue from the womb lining). After cancer was excluded, records show the Trust offered hormonal treatments in the form of an LNG-IUS, which Ms L declined. The Trust then offered oral progestogens (steroid hormones).
45. The evidence shows the Trust acted in line with the first part of the guidance with the treatments it offered to Ms L. We note the second part of that guidance recommends considering a referral to specialist care for alternative treatment in certain circumstances.
46. We have considered this and the relevant evidence, including discussing it with our gynaecology adviser. We do not think the evidence suggests that these circumstances were met. The Trust provided treatment in October and did not have information at that time to say it was unsuccessful. We do not think her symptoms at this point were so severe to require referral for specialist care for surgery.
47. Overall, we think the Trust acted in line with the above guidance and we have not seen signs of a failing here.
48. We also considered whether the Trust should have prescribed iron tablets as a precaution. We spoke to our gynaecology adviser about this.
49. NICE guidance NG12 and NG88 both set out steps to be taken for investigation and then treatment of PMB. Neither set of guidance says that iron tablets should be prescribed as a precaution.
50. As we explained earlier, the NICE guidance on anaemia also does not include recommendations for iron tablets as a precaution to prevent anaemia.
51. We have seen in the medical records that Ms L had a healthy haemoglobin level at October 2021. We have also seen the reported symptoms in October until the Trust discharge on 30 November were unexplained PMB with associated bloatedness.
52. Ms L had been referred to the Trust for investigations to exclude cancer and then for treatment for PMB. There was nothing clinically to suggest that anything more than these investigations and treatment were needed. There were no clinical signs that her iron levels needed treatment. This was until Ms L returned to the Trust’s A&E in January 2022 and had anaemia. At that point the Trust treated the anaemia.
53. We have seen evidence to show that the Trust followed the relevant guidance when it did not prescribe iron tablets to Ms L.
54. We are sorry to hear that Ms L later developed anaemia and we understand how this affected her life. We are not investigating this further because we have not seen any signs of a failing.
The Trust: discharge on 6 January 2022
55. Ms L says she was discharged too early because she still had ongoing symptoms. This led to her having to stay in a hotel for a few days because she could not manage the stairs at her son’s or her parents’ homes.
56. Ms L says after she attended A&E and was admitted, the gynaecology team at the Trust prescribed iron tablets and inserted a Mirena coil. She was discharged on 6 January 2022.
57. She says the Trust discharged her without having any proper plan for how she would cope. She says she could not climb stairs, she could not walk far and needed to be near a toilet. We are sorry to hear about the difficult experience she had.
58. The DHSC guidance says doctors should review all people in acute beds to decide who no longer meets the clinical criteria to stay in inpatient care and who should be discharged. It also says people should be discharged when clinically ready, in a safe and timely way.
59. Ms L’s medical records have these entries:
5 January 2022: Mrs L reported PMB with clots, swollen legs, feeling exhausted with fatigue and shortness of breath. Haemoglobin levels were tested by the Trust and noted as 94 and symptoms of anaemia noted despite this level. Treatment options discussed including significant risk of hysterectomy given her raised body mass index (BMI). Plan to start iron tablets, continue with tranexamic acid (medication for blood loss), start cerezette mini pill (a proestrogen only pill to thicken the mucus of the cervix) after stopping Provera and fit a Mirena coil. Ms L may be discharged as the clinicians see fit.
6 January 2022: Ms L was discharged.
60. We discussed with our gynaecology adviser whether the discharge was in line with relevant guidance and standards. There are records that Ms L’s haemoglobin levels were 98 on 4 January. This suggests iron deficiency anaemia. But, our adviser said it is not a particularly severe deficiency.
61. As we explained earlier, the care the Trust gave to Ms L is in line with guidance.
62. The evidence in the medical records shows the Trust felt Ms L was clinically ready for discharge. Part of that decision making seems to have been a medical review of Ms L’s chest symptoms, which is in the medical records. This did not find any significant concerns.
63. We recognise Ms L disagrees and we have listened to what she said. The Trust seems to have considered what treatment it could have provided, like hysterectomy (surgery to remove the womb), but it did not feel that it was in her interests. Our adviser said hysterectomy would have been very high risk for Ms L.
64. While we recognise there is a difference of opinion, overall we think the Trust acted in line with the guidance because it felt Ms L was fit for discharge. The Trust also seems to have recorded the plan for her ongoing care.
65. We are sorry to hear that Ms L’s symptoms continued after being given iron tablets and having a Mirena coil inserted. We cannot see a sign of a failing here because the Trust acted in line with standard practice. For this reason we are not investigating this part of the complaint further.
66. We appreciate the impact this experience had on Ms L and we are glad to hear she is getting ongoing help and advice from her GP for her current symptoms. We hope Ms L is reassured that we have seen no signs of failings in the areas she is concerned about.