Derby and Derbyshire Integrated Care Board

3.Miss A complains about the actions of the Practice during November 2022 – January 2023. Miss A says the Practice failed to get a diagnosis for her father, Mr A, before he died. Specifically, she says:

• the Practice should have referred Mr A on the urgent two-week pathway sooner, without a FIT sample, due to his symptoms of anaemia, weight loss, change in bowel habits, burning sensations and vomiting • the Practice did not manage Mr A’s FIT sample correctly and failed to ensure this had been delivered to the laboratory.

4.Miss A says her father passed away in February 2023 without a diagnosis, which meant he did not receive palliative care or medication to ease his symptoms. She says staff in the ED did not know the cause of death due to the lack of diagnosis. Miss A adds that her father could not say goodbye to his family, and the events caused her significant emotional distress.

5.Miss A would like the Practice to acknowledge any failings and make service improvements.

6.Mr A was 90 years old during the time of the events. In November 2022, Mr and Miss A had a consultation at the Practice regarding Mr A’s condition. Mr A reported a three-week history of intermittent diarrhoea/constipation and had been vomiting. Miss A also explained to the GP that Mr A had been losing weight. The GP arranged for blood tests and a Faecal Immunochemical Test (FIT).

7.In Mid-December, the hospital laboratory notified the Practice that it had not received the completed FIT sample, which was expected within 14 days. Following this, the GP spoke with Miss A and arranged for another FIT to be sent out for Mr A. Miss A dropped the FIT sample off directly at the Practice due to postal strikes that were in place at the time. In January 2023, the hospital laboratory again notified the Practice that the FIT sample had not been received.

8.In late January, the GP had a consultation with Miss A who explained Mr A was suffering with profuse diarrhoea. During this conversation the GP agreed to refer Mr A on the two-week pathway for suspected cancer without a completed FIT due to the delays and issues with the laboratory receiving it.

9.In February, Mr A was sent to the ED in hospital and sadly died. A postmortem confirmed the cause of death was complications from metastatic colon cancer. There was later an addendum to the postmortem report which confirmed the cause of death was complications from colon cancer.

Urgent pathway referral

13.Before we decide if we should conduct 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 found any indications that something has gone wrong.

14.Miss A is unhappy the Practice requested a FIT sample before referring her father on the urgent two-week pathway for suspected cancer. She says the Practice should have referred Mr A without requesting a FIT sample based on his symptoms and says she could not see anywhere in relevant guidance that a FIT sample was a pre-requisite for a referral. She explained that ultimately the Practice did refer Mr A without a FIT sample and feels it should have done this sooner.

15.Miss A says her father died without knowing he had colon cancer meaning he was denied his right to patient centred care and did not receive palliative care. We can understand the significant distress the events caused Miss A and her father, and we appreciate this was an extremely difficult time.

16.In its complaint response, the Practice said that throughout Derbyshire, the colorectal/lower gastrointestinal criteria for referral state that a FIT must be carried out to instigate a referral as the results help to determine the need and urgency of the referral. The Practice also explained that it was following the relevant NICE guidance when it requested the FIT sample.

17.The Practice said the GP’s understanding was that a referral would not be accepted without a FIT result and explained the local pathways insist a FIT result is required before a referral is made.

18.The relevant NICE guidance says:

‘Offer quantitative faecal immunochemical testing (FIT) using HM‑JACKarc or OC‑Sensor to guide referral for suspected colorectal cancer in adults:

• with an abdominal mass or

• with a change in bowel habit or

• with iron-deficiency anaemia or

• aged 40 and over with unexplained weight loss and abdominal pain or

• aged under 50 with rectal bleeding and either of the following unexplained symptoms:

• abdominal pain

• weight loss or

• aged 50 and over with any of the following unexplained symptoms:

• rectal bleeding

• abdominal pain

• weight loss or

• aged 60 and over with anaemia even in the absence of iron deficiency.

FIT should be offered even if the person has previously had a negative FIT result through the NHS bowel cancer screening programme. People with a rectal mass, an unexplained anal mass or unexplained anal ulceration do not need to be offered FIT before referral is considered.’

19.During Mr A’s consultation in November 2022 with an advanced nurse practitioner, it was noted he had symptoms including a change in bowel habit and weight loss. Both symptoms are highlighted in the above quoted guidance as reason to arrange a FIT.

20.Our adviser said in this case, it is clear Mr A needed a FIT based on the symptoms he presented with. We consider the actions of the Practice regarding its decision to offer a FIT to be appropriate and in line with guidance.

21.Our adviser said many NHS Trusts require a FIT result before a two-week urgent referral is made. The local ICS cancer alliance rapid diagnostic pathway says:

‘FIT is now integral to the assessment of patients with symptoms and signs suggestive of possible bowel cancer. All should have a FIT test as part of their assessment as the result will inform the clinical decision to refer or to direct the patient to other investigations or pathways.’

‘The FIT result MUST be included in the referral as this will directly affect the management (both the secondary care pathway and the prioritisation) of your patient.’

22.Our adviser said there could be some exceptions to refer a patient without a FIT result if the sample genuinely could not be done, but there has to be some attempt to obtain one first. The evidence shows the Practice attempted to obtain a FIT sample on two separate occasions, which we consider to be reasonable.

23.The GP referred Mr A in late January 2023. This was done without a FIT result because of the difficulties with the laboratory receiving the sample. Informed by our adviser’s comments, we do consider this to be appropriate given that there were multiple attempts to obtain a FIT result and bearing in mind Mr A’s ongoing symptoms.

24.In summary, we acknowledge there were some delays with the FIT sample being received in the laboratory (our full consideration of which is below), which subsequently caused a slight delay in Mr A being referred on the two-week pathway. We are very sorry to learn how this impacted Mr A. We consider the actions of the GP, specifically in requesting a FIT sample before referral, to be appropriate and in line with guidance. We have not seen any evidence to suggest the GP should have referred Mr A without first requesting a FIT sample. We have therefore found no indications of any failings, and we will not consider this issue further.

Handling of FIT sample

25.Miss A is unhappy with the way the Practice handled Mr A’s FIT sample after she dropped it off at the Practice. She explained the laboratory never received the sample and says the Practice should have ensured the sample was received at the laboratory.

26.Miss A explains this contributed to the delays with Mr A’s urgent two-week referral and lack of diagnosis before he died. We are very sorry to learn of the issues regarding the FIT sample and can understand the distress and frustration this caused.

27.The Practice arranged for two FIT’s to be sent out to Mr A – one in November 2022 and a further one in December 2022. We understand the first FIT that was sent out was not returned as Mr A was unable to provide a stool sample due to suffering from constipation.

28.When Miss A received the second FIT in December 2022, Mr A was able to provide a stool sample. We understand the normal process for returning a FIT sample is for the patient to post it directly to the relevant laboratory. During the time of these events, there was a postal strike in effect. The letter Miss A received with the second FIT clearly outlined that she could take the sample straight to the Practice because of the ongoing postal strikes. The Practice documented that Miss A dropped two stool samples off at the Practice reception (the FIT sample and a Helicobacter Pylori stool test).

29.In January 2023, the laboratory contacted the Practice and said it had not received the FIT sample as expected. In its complaint response, the Practice said that the Royal Mail is intended to return the FIT sample to a specific laboratory. The Practice explained that the sample was sent to Royal Derby Hospital along with the Helicobacter Pylori stool test via the daily courier service. It said that it could not investigate what happened after the sample was sent via the daily courier service.

30.We asked the Practice if there was any evidence that the FIT sample was sent via the courier service with the Royal Mail. The Practice confirmed the usual process is for patients to post the samples themselves and the Practice do not make a log of what is sent by its daily courier service. The laboratory did receive the Helicobacter Pylori stool test. Therefore, on balance, we consider it is more likely than not that the FIT sample was posted along with the Helicobacter Pylori stool test via the daily courier service.

31.There is no specific guidance on organisations such as the Practice sending samples to a laboratory. Our Principles of Good Administration state organisations must act in accordance with recognised quality standards, established good practice or both when delivering clinical care. Therefore, in this situation, we will use the professional judgement of our adviser which is based on established good practice.

32.Our adviser said that in general, it would be reasonable to assume it would be the Practice’s responsibility to send the sample safely to the laboratory, given Miss A handed the sample to the Practice because of the ongoing postal strikes. Our adviser said that overall, the responsibility to ensure the FIT sample was successfully delivered to the laboratory is with the Practice, however there were some mitigating circumstances.

33.The postal strike in place during the time of the events meant the FIT sample could not be sent to the laboratory via the usual method. The Practice sent the samples it received from Miss A via its daily courier service however only one sample was received and processed by the laboratory. The Practice had no control over this.

34.We will never definitively know what happened to the FIT sample. What we do know is that the laboratory did not receive it which caused a slight delay in Mr A’s pathway, and we are sorry that this happened. This was not directly the Practice’s fault however there could have been a more robust follow-up with the FIT sample to ensure this had been received, especially considering there had already been a delay with obtaining a FIT sample from Mr A.

35.Whilst we acknowledge that the Practice could have potentially done more in terms of checking with the laboratory if it had received the sample, given the unusual situation, we do not consider that this amounts to maladministration. Assuming the Practice sent the sample (and unfortunately, we can never know this for certain), it was out of its control.

36.To summarise, we are very sorry to learn that the laboratory did not receive the FIT sample sent by the Practice and we acknowledge this caused further delay in Mr A’s diagnostic/treatment pathway. We can understand the distress these events caused both Mr and Miss A. Given the mitigating circumstance of the postal strike and the fact we cannot be sure of what happened to the sample, we do not consider there to be any indications of failings in how the FIT sample was handled by the Practice. Once it was apparent the laboratory did not receive the sample, we consider the actions of the Practice to be appropriate in terms of actioning the referral for Mr A without the FIT sample/result. For these reasons, we shall not consider this complaint further. We are sorry if this decision causes Miss A any further distress.

1. We have carefully considered Miss A’s complaint about a GP Practice in the Derbyshire area (the Practice). We are sorry to learn of the events which led Miss A to complain, and we recognise the impact the events had on her. We understand the importance of Miss A’s complaint, and we acknowledge this has been a difficult experience.

2.We have looked at what Miss A has told us and evidence we have received from enquiries with the Practice. We have investigated the complaint into the Practice’s care and management of Miss A’s father, Mr A. We have seen no indication the Practice was incorrect to request a Faecal Immunochemical Test (FIT) sample before referring Mr A on the urgent two-week pathway. We have also seen no indication the Practice did anything wrong regarding the FIT sample it sent to the laboratory.