A medical practice in the Reading area

3. Mr U complains about the care and treatment he received from the Practice between January 2020 and April 2021. Specifically, he complains that:

· the Practice stopped his diabetic medication, metformin, in January 2020 after it incorrectly concluded that his HbA1c levels were consistently low · the Practice did not appropriately monitor his diabetes from January 2020 to February 2021, despite Mr U’s rising HbA1c levels, and delayed restarting him on diabetic medication · the Practice did not act on his concerns about his deteriorating eyesight, considering his rising HbA1c levels, when he raised this between November 2020 and February 2021 · the Practice did not make timely arrangements for him to receive the COVID-19 vaccine, despite being a clinically extremely vulnerable individual · the original letter he wrote to his GP from the Practice on 20 December 2020 was not responded to.

4. Mr U says he was caused anxiety, poor health, and diabetes related damage from the Practice’s actions.

5. Mr U wants the Practice to make service improvements and to provide him with a financial remedy for the anxiety and damage to his health that it has caused.

6. Mr U was diagnosed with type 2 diabetes around five years prior to the events complained about. He was receiving metformin and regular assessments of his HbA1c levels to manage this, as part of his healthcare in prison. A glycated haemoglobin test (HbA1c) is a measure of your average blood glucose (sugar) levels for the last three months.

7. On 20 January 2020, Mr U was told by a GP working for the Practice that it would be stopping his metformin prescription as it was felt that his HbA1c readings were consistently below 40mmol/mol, and his diabetes was in remission. Mr U stated that he was concerned at the time that his diabetes would not be adequately controlled if this medication was removed.

8. Following the metformin being stopped, the Practice documented it would take another HbA1c reading from Mr U in eight weeks, and then review this decision. His next HbA1c levels were recorded as 36mmol/mol on 9 March.

9. On 15 April a review of diabetic notes took place, as there was limited face to face contact due to the COVID-19 pandemic. This noted that Mr U’s HbA1c level was within his target range.

10. Mr U’s next review took place on 30 June when his HbA1c level was recorded as 43mmol/mol. It was noted by the GP at the Practice that the result was ‘borderline’ and that it should be discussed with the diabetic nurse.

11. A telephone consultation between Mr U and his GP on 12 August discussed his past HbA1c levels, and his next test was arranged to be repeated in September. This was carried out on 14 September and produced a HbA1c result of 53mmol/mol. It was recorded by the GP that the result was ‘abnormal’ and should be raised with the nurse.

12. Mr U was next seen on 25 November by the diabetic nurse for an annual diabetes review. It was noted that Mr U’s HbA1c has ‘crept up’ over the year and the nurse recommended obtaining an up-to-date reading and, on review, consider restarting metformin. Mr U complained that he was not told about the September 2020 test result until this 25 November appointment. He says he was also told that the September 2020 test result ‘had not been flagged up’ with the diabetic nurse at the time.

13. The next HbA1c test took place on 17 December with a result of 100mmol/mol. The nurse’s review on 19 December recorded that Mr U had been restarted on metformin but Mr U informed us that he did not receive the medication until the end of the month. Mr U first wrote to his GP with his concerns about the management of his diabetes on 20 December.

14. Mr U did not receive a response to his original letter, so he contacted the Practice again on 7 February 2021, requesting to see a GP urgently. He informed the Practice that he was concerned his eyesight was deteriorating due to the previous lack of treatment for diabetes. Mr U was seen by the Practice on 12 February where his HbA1c level was 105mmol/mol.

15. In February 2021 Mr U became concerned that he was eligible for the COVID-19 vaccine, due to being clinically vulnerable, but he had not received it. He wrote to the Practice to complain about the delay. He received the COVID-19 vaccine on 16 March.

16. Mr U made further applications to speak to a GP about the management of his diabetes. He saw a GP from the Practice on 22 March. In this consultation it was noted that Mr U was concerned about changes to his eyesight, and it was agreed a referral would be made to an optician for further investigation.

17. The Practice responded to Mr U’s complaint on 27 April. In this, the Practice acknowledged that there had been missed opportunities to discuss his HbA1c levels with him, and it apologised. It stated it was not aware of Mr U having raised concerns about his eyesight but would request an urgent optician referral. In relation to the complaint about the time taken to provide the vaccine, the Practice stated that the timing of vaccinations depended on the number of vaccines it received.

Decision to stop metformin in January 2020

21. Our decision is that there was not a failing by the Practice in stopping Mr U’s metformin prescription in January 2020. From the evidence we have seen, the Practice’s actions were in line with NICE guideline NG28.

22. Mr U described that though his previous HbA1c result in December 2019 was below 40mmol/mol, he considered that the Practice should have confirmed three successive readings below 40mmol/mol before concluding his HbA1c levels were controlled and withdrawing metformin.

23. We asked the Practice for any test results which were used in reaching its decision that Mr U’s diabetes were in remission. The Practice provided us with results from December 2019, where Mr U’s HbA1c was 34mmol/mol, and a full blood test taken in September 2019 where his HbA1c levels were 41mmol/mol.

24. Our adviser confirmed that the relevant clinical standard for this is the NICE guideline NG28. This guideline sets out the HbA1c target levels that a patient should be supported to maintain, which changes depending on the treatment the patient is currently receiving. For patients who have diagnosed type 2 diabetes, managed by diet, lifestyle and/or medication, and not associated with hypoglycaemia the target level is 48mmol/mol. This would be the target level that applied to Mr U. Hypoglycaemia is a condition where blood sugar levels drop too low.

25. NICE guideline NG28 does not make specific recommendations about stopping treatment but says that if a patient with diabetes achieves a HbA1c level lower than their treatment target, they should be encouraged to maintain it. The relevant guidance does not recommend repeating HbA1c levels when making treatment decisions, and Mr U’s HbA1c levels in September and December 2019 were well within his target level. So our decision is that there is no evidence of a failing by the Practice when it stopped prescribing metformin.

Practice’s monitoring of Mr U’s diabetes

26. Our decision is that the Practice failed to monitor and manage Mr U’s diabetes in line with the GMC’s Good Medical Practice. From the evidence we have seen, this failing did not cause Mr U’s diabetes related damage, as he has claimed, but we recognise that the possibility of this caused significant anxiety. As the Practice has not remedied this our decision is to uphold this part of his complaint.

27. NICE guideline NG28 describes that HbA1c levels should be measured every three to six months for type 2 diabetes patients where their HbA1c level is not yet stable on unchanging therapy. We saw from the Practice’s records, its actions were in line with the guideline as, following 20 January 2020, Mr U received HbA1c tests on 9 March, 30 June, and 14 September.

28. The results of Mr U’s HbA1c tests in March and June 2020 were 36 and 43mmol/mol respectively, which were below his treatment target level of 48mmol/mol. However, the test in September gave a HbA1c of 53mmol/mol, exceeding the treatment target level.

29. Though the GP noted this should be discussed with the diabetic nurse, from the evidence we have seen this discussion did not happen. The 25 November 2020 consultation with the diabetic nurse appears to have been Mr U’s annual diabetic review rather than an appointment prompted by the September HbA1c result. There is no evidence of any correspondence between the GP and diabetic nurse regarding the September 2020 HbA1c result. We have also seen no evidence that Mr U was informed of September HbA1c result at the time.

30. Section 32 of the GMC’s Good Medical Practice states that patients must be given the information they want or need to know in a way they can understand. As there is no evidence that Mr U was informed of the HbA1c result in September 2020 our decision is that this was a failing by the Practice.

31. The NICE guideline NG28 does not specify a timeline for reviewing a patient or starting medication following an HbA1c result. Despite this, our decision is that there is evidence of a failing by the Practice in the time it took to restart Mr U on diabetic medication. Section 15b of the GMC’s ‘Good Medical Practice’ describes doctors must ‘arrange prompt advice, investigations or treatment’ when assessing, diagnosing, and treating patients. In the context of Mr U having diagnosed type 2 diabetes, and having stopped diabetic medication earlier in the year, our consideration is that the Practice should have reviewed whether to restart Mr U on metformin shortly following the September 2020 HbA1c result. As such, our decision is that there was a period of around three months when Mr U’s diabetes was not appropriately monitored or controlled.

32. In terms of the impact on Mr U, he was seen by an optician on 29 April 2021 where it was noted that no diabetic retinopathy was seen in either eye. Mr U also underwent a diabetic eye screening in August 2021, by the local diabetic screening eye programme, which confirmed that his test results showed no signs of diabetic eye disease.

33. From the Practice’s records we have seen, Mr U likely experienced some temporary symptoms (such as excessive urination and temporary blurring of vision from varying blood sugar levels) that could have been avoided or mitigated if his diabetic mediation had been restarted sooner. However, our decision is that there is no evidence that Mr U experienced permanent diabetes related damage to his eyesight.

34. Despite this, we consider the three-month period when Mr U’s diabetes was not controlled meant the Practice did not act promptly, and the possibility of diabetes related damage would have caused him significant anxiety.

35. From what we have seen, we consider Mr U potentially experienced significant anxiety from when he first became aware of his raised HbA1c on 25 November 2020 until the optician’s review on 29 April 2021. His anxiety may have also reasonably persisted until he was confirmed as having no signs of diabetic eye disease by the screening programme, in its letter dated 2 September 2021. In our work at detailed investigation, it is our view Mr U experienced anxiety over an approximately nine-month period due to the Practice’s failings, which it has not remedied. Our decision is therefore to uphold this part of the complaint and we have set out at the end of this report what we consider the Practice should do to remedy this.

Practice’s response to Mr U’s concern about deteriorating eyesight

36. Our decision is that the Practice did not act in line with our Principles of Good Administration it is response to Mr U’s concerns about his eyesight worsening because of his diabetes. As the Practice has not remedied this, our decision is to uphold this part of his complaint.

37. From the records, we cannot see that Mr U raised concerns about his eyesight worsening in November 2020. However, from the documents he provided, we can see that he explicitly raised this in an application to see a GP on 7 February 2021. In this application he asked to see a GP urgently about concerns over his lack of treatment for diabetes and that he believed his ‘eyesight is being affected and deteriorating, presumably due to the diabetes’.

38. From the records available, there is no evidence that the Practice responded to this at the time. Though the Practice’s records state that a referral was sent for retinal eye screening, there is no indication that Mr U was then updated and informed of this action, or any further action was then taken. The agreement to refer Mr U to an optician only happened following a further GP appointment on 22 March, after Mr U applied again to see a GP on 24 February.

39. Our adviser stated that there is no specific timescale from the GMC’s Good Medical Practice about how quickly an appointment should be offered. As there are no clinical standards to refer to, we have considered what should have happened against our Principles of Good Administration.

40. From what we have seen, there is no evidence that the Practice acknowledged Mr U’s concern about his eyesight for around six weeks. We cannot say whether Mr U would have received an optician appointment sooner due to the ongoing effects of the COVID-19 pandemic. However, in line with the requirement of ‘being customer focused’ in our Principles of Good Administration, we would have expected the Practice to tell Mr U promptly what it was intending to do to address his concern, and to respond flexibly to the circumstances of his case and individual needs.

41. The advice given to patients from the diabetic eye screening programme is not to just wait for the next test, but to contact their GP or optometrist if the patient has concerns about their eyesight. As we have seen no evidence that the Practice gave Mr U any information about his concern for six weeks, and only initially referred him back to the diabetic eye screening programme, our decision is that the Practice did not act in line with our Principles of Good Administration.

42. Our Principles are intended to promote a shared understanding of what is meant by good administration and to help public bodies provide a first-class public service to their customers.

43. As with the previous complaint part we have not seen any evidence that Mr U experienced any diabetic eye damage. However, we consider that the delay in responding to his concern would have added to his anxiety and the Practice has not remedied this. Our decision is therefore to uphold this part of the complaint and we have set out at the end of this report what we consider the Practice should do to remedy this.

Time taken to provide Mr U with the COVID-19 vaccine

44. Our decision is that there was a delay in providing Mr U with a COVID-19 vaccine considering his underlying health condition. As we have not received any explanation of this delay from the Practice, our decision is to uphold this part of the complaint.

45. In its response to Mr U’s complaint, the Practice outlined when it received authorisation to begin providing COVID-19 vaccines: · 11 February cohorts 2-4: all people over 70 years of age and ‘clinically extremely vulnerable individuals’ · 18 February cohorts 2-6: all people over 65 years of age and those aged 16-64 with ‘underlying health conditions which put them at higher risk of serious disease and mortality’ · 11 March cohorts 2-8: all people over 55 years of age

46. Mr U received the COVID-19 vaccine on 16 March, five days after he became eligible to receive it based on his age.

47. The Practice did not address what cohort it considered Mr U to be in, and only stated that the number of patients booked was dependant on vaccinations available. Our adviser confirmed that, though Mr U was not a ‘clinically extremely vulnerable individual’, due to his diabetes, he should have been part of priority group 6 as he was in a known ‘at-risk’ group. In line with the UK Health Security Agency: ‘COVID-19: the green book, chapter 14a’ Mr U should have been vaccinated when local arrangements enabled priority group 6 to be vaccinated.

48. We asked the Practice for information about the vaccines it received for the prison where Mr U is detained. It is described that doses of the vaccine were delivered to the prison on 17 February 2021, the day before the Practice received authorisation to vaccinate cohorts 2-6. Following this though, the records describe that the prison did not receive any further doses until 8 April. Given that Mr U received his vaccine on 16 March, we consider that this was from the batch received on 17 February.

49. As part of our detailed investigation, we asked for details of when cohorts 4 and 6 at the prison were able to receive COVID-19 vaccines. We have not received an explanation from the Practice to describe why Mr U, or other cohort 6 prisoners, were not given the vaccine for almost a month after the Practice was authorised to vaccinate this priority group, on 18 February.

50. Furthermore, as explained above in its response to Mr U’s complaint, the Practice only referred to the supply of vaccines to explain the 16 March date of his vaccine. Given that there was an availability of vaccines, and an unexplained delay in administering them, our decision is that there was a failing by the Practice, when considered against the UK Health Security Agency: ‘COVID-19: the green book, chapter 14a’.

51. In terms of the impact, Mr U confirmed that he was not aware of any medical impact to him from the delay in receiving the vaccine. But he was caused anxiety about the possibility of contracting COVID-19 during this time, and the effect this could have due to his underlying health condition. He also said the delay impacted his role as a support worker within the prison, as his lack of vaccination limited his ability to look after medically vulnerable prisoners. Our decision is that it is understandable Mr U would have been caused some anxiety by this, and it may have affected his day-to-day activity (for around a month), from not wanting to risk exposure to COVID-19 or passing this to other at-risk prisoners.

52. Our own Principles for Remedy state we would expect to see a public body restore the complainant to the position they would have been in if the maladministration or poor service had not occurred. Based on this, we cannot see the Practice has remedied this complaint. As such, our decision is to uphold this part of the complaint and we have set out at the end of this report what we consider the Practice should do to remedy this.

53. Our own policy, our Service Model Guidance, states it is for the Ombudsman to consider what actions are required to resolve a complaint. Unlike the other parts of the complaint that we are upholding, we do not consider it would be proportionate to recommend service improvements. This is because the national response to the COVID-19 pandemic has developed since February-March 2021. This means any service improvements we would recommend to the Practice would be unlikely to still be relevant or have ongoing benefit to other patients. In addition, the PHSO has conducted precedent checks and has no record of receiving other similar complaints regarding COVID-19 vaccinations about the Practice. If PHSO did, this might suggest this was a systemic issue that required an organisation wide improvement.

Lack of response to Mr U’s original complaint

54. Our decision is the actions taken by the Practice, in response to Mr U’s letter dated 20 December 2020, were not in line with our Principles of Good Complaint Handling. These state that complaint handling should be customer focused and deal with complaints promptly. As such, our decision is to uphold this part of the complaint.

55. From the Practice’s complaint file, we can see that Mr U wrote to a GP at the Practice on 20 December. The Practice have marked this as being received the following day and reviewed by the GP on 23 December.

56. As set out previously, Mr U states he did not receive a response to the letter. From the Practice’s complaint file there is a letter to Mr U from the GP dated 1 March 2021. In this the GP states that they did not reply to his letter in December 2020 as they booked an appointment with Mr U on 20 January 2021. The GP acknowledges that the prison did not facilitate this appointment and is looking further into why this happened. No further explanation was given for the lack of response.

57. The Practice records show there are no entries between 19 December 2020 and Mr U’s later complaint on 9 February 2021. By contrast, later complaints Mr U made about his diabetes management (February and March 2021) are recorded on receipt in the Practice’s records, with details of any actions taken. As such, from the evidence available we do not see any information which supports that a plan was made to review Mr U’s concerns on 20 January 2021.

58. Considering our Principles of Good Complaint Handling, our decision is that there is evidence of a failing here, as the Practice was not customer focused and did not deal with his complaint promptly. Though the Practice received the complaint, it did not acknowledge it or tell Mr U how long he could expect to wait to receive a response. While the GP said that the plan was to see Mr U to discuss his concerns, there is no evidence of this in the records. As such, Mr U’s complaint went unacknowledged for two months until he wrote to complain again.

59. In terms of the impact, Mr U explained in his original letter that he was of the view that he was receiving poor treatment for his diabetes which could cause him long-term health damage. Our decision is that it is understandable that a two-month delay in acknowledging this complaint would cause him a degree of distress or anxiety, even without long-term health damage. Though the Practice has acknowledged this delay happened, it has not acknowledged the impact this had on him or remedied this. As such, our decision is to uphold this part of the complaint and we have set out at the end of this report what we consider the Practice should do to remedy this.

1. We have seen that the decision of a medical practice in the Reading area (the Practice) to stop Mr U’s metformin was made in line with the relevant National Institute for Health and Care Excellence (NICE) guideline. However, our decision is that there were failings by the Practice in how it monitored his diabetes and acted on his concerns about his treatment. We have also seen that there was an unexplained month-long delay in giving Mr U the COVID-19 vaccine.

2. Though we have not seen that the Practice’s failings permanently affected Mr U’s physical health, we recognise they caused him significant anxiety. We have partly upheld this complaint and recommended the Practice pays him a financial remedy for the anxiety caused. We also recommend it makes service improvements to limit the possibility of similar failings occurring.

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.

61. Our principles say that public organisations should look for continuous improvement and should use the lessons learned from complaints to make sure they do not repeat maladministration or poor service. In line with this we recommend that, within three months of receiving this report, the Practice provides us with an action plan detailing what actions it has or will take to improve its monitoring of, and communication with, diabetic patients. This action plan should also address how the Practice will improve its complaint handling regarding how it acknowledges and responds to patients’ complaints.

62. Our principles state that public organisations should put things right and, if possible, return the person affected to the position they would have been in if the poor service had not occurred. If that is not possible, they should compensate them appropriately.

63. To decide on a level of financial remedy, we review similar cases where the person has experienced similar injustice, along with our severity of injustice scale. Following this review, within one month of this final report, the Practice should write to Mr U to apologise for the failings identified and pay him the following financial remedy in recognition of the impact this had on him:

· £500 for the nine months’ anxiety Mr U experienced from the period where his diabetes was not appropriately monitored, and the delay in acting on his concern about his eyesight · £300 for the month of anxiety and impact on his day-to-day activity caused by the delay in giving Mr U a COVID-19 vaccine · £100 for the two-month delay in acknowledging his initial complaint.