Valerie Ellis

Coroner's concerns

AI summary

Inadequate discharge counselling for a vulnerable patient on medication, coupled with concerns about 111 health advisor training and imprecise algorithms. A call-back was prematurely closed and a joint investigation has not occurred.

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1) On discharge from the hospital the use of Apixaban in an elderly confused patient being cared for by a carer with hearing loss should have merited careful counselling by the clinicians the use of a warning card: Whilst the hospital is taking steps to assess this area, my understanding is that no policy has been adopted and | feel it should be made a matter of urgency:
2) KMSS 111 provides a valuable lifeline for many patients and although health advisors are trained to follow algorithms only have 4 weeks training followed by 2 weeks of sitting in with an experienced advisor. am concerned about the training schedule, particularly for those with Iittle or no background medical knowledge. Whilst reliant on algorithms advisors must be able_to recognise potentially fatal illnesses and Mrs The and and they deteriorating conditions as thousands of patients rely on this service for medical help. Clinical advisors on duty were not consulted in this complex case_ The senior manager for Quality and Clinical Governance at KMSS 111 expressed concern at the algorithm used in the case of Mrs Ellis . The clinical algorithm called NHS Pathways is owned by the Department of Health and was felt to be imprecise but despite representations to the Department of Health by KMSS 111 for changes and improvement there has been no positive communication since February.
3) A disposition from 111 was made to IC24 for a telephone consultation by an on call clinician. This was received and logged and a call was made within one hour. There was no response by the carer and a note was made to call back within 5 minutes_ Apparently the case was closed before this could occur; no explanation could be given as to why this happened. Training for clinical staff in the use of the computer system used by IC24 is essential but did not appear well organised and should be rectified.
4) The results of investigations by both KMSS and IC24 should result in a joint RCA_ This has not occurred as yet and no date has apparently been arranged.

Responses

3 respondents

South East Coast Ambulance Service NHS Trust NHS / Health Body

25 Jul 2016 PDF

Disputed

The Ambulance Service states it has met NHS Pathways training requirements and believes further algorithm concerns should be directed to the Department of Health. They are open to sharing their Serious Incident report with IC24. (AI summary)

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Dear Sir, write in response to the regulation 28 report issued following the proceedings exploring the events leading to the sad death of Mrs Valarie Ellis. The points of report have been duly noted and provide our Trust's response below in relation to section 5(2) and 5(4) respectively. Firstly and with regards to the NHS Pathways training KMSS 111 deliver; this is in line with requirements set out by the Department of Health who own the system. As commented during proceedings if three answers of 'unknown' are provided by the caller this would flag to pass the call to clinician in the room. This is considered the mechanism to provide a safe service , with call takers operating within the scope of the algorithm: Developments in training issued by Pathways are incorporated into KMSS 111 training packages and we can confirm the following levels of trainingldevelopments have taken place; As of July 2015 (which our KMSS 111 call taker received); 2 weeks (60 Hours) NHSP Core Module week (30 hours) Common learning week shadow shifts Developments introduced November 2015; 2 weeks supervised live support The Trust provides Pathways update training normally twice a year in the spring and autumn but in 2015 Pathways brought out only one update which was full days training face to face. Developments being or have been introduced in 2016; 3 hours face to face training thus far This will become 6 hours face to face training scheduled in October November 2016. Further; there are additional coaching modules, DoS modules, mental health modules, sexual abuse modules, domestic abuse workshop and audit levelling modules. Interim Chair: Sir Peter Dixon Interim Chief Executive: Geraint Davies Your Service, {our call Skipp said

South East Coast Ambulance Service [NHS] NHS Foundation Trust believe this demonstrates that training is incorporated as per NHS Pathways requirements and that further developments and implementation of training have already occurred post the KMSS 111 call regarding Mrs Ellis. concerns regarding the content and degree of training would consider be appropriately directed to the Department of Health as suggested during the proceedings as own the system, training and auditing requirements. Indeed as you note in your report, our Senior Manager for Quality and Clinical Governance had previously raised concerns to the Pathways team regarding the algorithm and impact regarding not only Mrs Ellis' case but anyone in a similar situation regarding anticoagulants. The principle areas of concern raised regarded the blood loss, clinical shock and anticoagulant questions: am therefore confident our Trust has already done all it can in relation to improving this algorithm by raising and following up on concerns through the appropriate governance channels: Unfortunately our Trust has not received a conclusion regarding these concerns from NHS Pathways. With these concerns appearing to directly correlate to the points of the regulation 28 report likewise consider these directed to the Department of Health Turning to the matter of a joint RCA, our Trust is always open to cross-NHS collaboration and review to strive to ensure safe patient care can be provided. However the regulation 28 report does not comment on what is expected to be achieved by a joint RCA and therefore it is difficult to respond: am aware that both our Trust and IC24 have completed Serious Incident (Sl) reports and are happy to share findings and if not already in place a date can be set: However our organisations are independent of each other and we do not receive communication from an out of hours provider following such a disposition being reached and a referral passed: In turn we have no further control in the matter unless we receive a further call either following up for an out of hours call or due to change in condition. In each case KMSS 111 is able to appropriately process the call. In summary believe the KMSS 111 service of our Trust has already done all it can in relation to implementing training in accordance with NHS Pathways requirements and residual concerns on the algorithm and training should be appropriately addressed to the Department of Health who own the system: We are willingly open to sharing the findings of our Sl report with IC24 and will seek to confirm a date to complete this trust this clarifies our response to the regulation 28 report;

Western Sussex Hospital NHS Trust NHS / Health Body

10 Aug 2016 PDF

Action Taken

The Trust launched a NOAC alert card in October 2015 and introduced a Standard Operating Procedure for pharmacy staff. They will also place a NOAC card in the medication bag given to patients on discharge, document discussions with relatives, and are revising their anti-coagulants policy. (AI summary)

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Dear Dr RE: Regulation 28 Report Valerie ELLIS Thank you for your letter dated 16 June 2016 under cover of which you enclosed a formal copy of the Regulation 28 report to Prevent Future Deaths_ The Trust has welcomed the opportunity to build upon the work already in place to ensure that patients prescribed Apixiban receive the best information about the potential side-effects. Despite the absence of national guidance, the Trust has continued to strive to develop a system to ensure that both counselling and a warning card provide patients and their carers with a firm understanding of the risks, as well as the benefits, of this and other new oral anticoagulants (NOAC): As you will be aware, the Trust launched the NOAC alert card in October 2015 and introduced a Standard Operating Procedure to enable pharmacy staff to be fully appraised of the new system and to support the distribution of the warning card. In addition, daily reminders generated by the electronic prescribing software ensure that new patients are identified. It is hoped to strengthen the system still further by placing a further NOAC card in the medication bag given to patients on discharge and to ensure that all discussions with relatives and carers regarding the new are documented: The Trust has been extremely saddened by Mrs Ellis's death and is keen to ensure that the potential for both local and national learning can be fully maximized. While the prescription and risks associated with NOACs will continue to be monitored and discussed at Medical Clinical Governance and Thrombosis committee meetings, the Trust's Medication Safety Officer has initiated discussions with NHS England Medication Safety Division meeting co-ordinator to ensure that the matter is discussed and debated at both regional and national medication forums. Locally, the introduction of the generic NOAC information leaflet within Primary care has been submitted to the Coastal Clinical Commissioning Group for the benefit of all NOAC patients in the local area: Skipp Skipp very drug

The Patient First initiative sits at the very heart of the Western Sussex NHS Foundation Trust's vision of continuous improvement and provides a framework for reviewing each stage of a patient care process While the above actions seek to address the former inadequacies of the counselling process, it is intended to adopt this methodology to review the entire NOAC process. The standards are being captured in the revised policy for prescribing and administration of anti- coagulants. The policy includes that newly initiated patients are consented by the medical staff as treatment is initiated and receive written information and counselling during the stay and at discharge from nursing and pharmacy staff. Concurrently plans are underway for the establishment of a multi-disciplinary group to design and introduce mechanisms to ensure the policy is embedded in practice including actions to formalize electronic recording of counselling discussions, an initiation checklist for use by prescribers and patient leaflets to support the NOAC card: Mrs Ellis's family has been invited to be part of this group and we much hope that; in time, they will wish to be involved The Trust's incident reporting system will provide an invaluable tool to assist future audits to measure the effectiveness of these new initiatives_ We hope that the above provides sufficient assurance that the Trust continues to strive to ensure that patients prescribed Apixiban are carefully counselled and have the reassurance of a NOAC card t0 ensure timely help and advice can be obtained, as and when necessary:

Integrated Care 24 Limited

PDF

Action Taken

IC24 has implemented new Failed Contact Guidance and software to prevent premature call closure. They have reviewed their induction training program and specifically included information on accessing NHS 111 reports and sent an alert to out of hours GPs reminding them about accessing this information. (AI summary)

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Dear Dr Skipp Re: Inquest into the death of Valerie Margaret Ellis 21 April 2016 Thank you for your letter regarding the concluded inquest into the death of Valerie Ellis: We write to you in response to the Regulation 28 report and the matters of concern points 3 and the only matters of concern which relate to IC24.
3) A disposition from 111 was made to IC24 for telephone consultation by an on call clinician. This was received and logged and & call was made within one hour: There was no response by the carer and a note was made to call back within 5 minutes: Apparently the case was closed before this could occur; no explanation could be given as to why this happened. Training for clinician staff in the use of the computer system used by IC24 is essential but did not appear well organised and should be rectified IC24's own internal investigation found that the case was closed due to human error on the part of the GP concerned: The GP concerned could not why she had closed the case on the system and confirmed that training had been provided. At the time of this incident the software version in use at the time had one warning box that appeared before a case could be closed and would leave the active case list. The prompt was are you sure that no further action is required on this call, if not press save, if press complete' As explained in evidence at the inquest in evidence by since this case IC24 have introduced a new Failed Contact Guidance and a new software version which means that it is not possible to close a call before three attempts spread over the timeframes set out in the Guidance have been made This change has improved the process and software. All new users of the software are trained in this regard, and all established users have been informed of and reminded about the correct process Integrated Care 24 Limited 01233 505450 IC24 Lid Reglstered Office: Tle 012}; ',04052 Klmsto Mytise Tlie lol 8a518#+, (nbtalrall , Kingsfon House; Lotey Rarrow, Ahiart #ei TN?4GF Orbital Park, Asltord, W: wwvwIC24..k Cempany Reglstralton No {1041x2 Kent TN2A OGP inlof czAnhsuk being explain yes the

Social Enterprise Gld Mc IC inlegrated care IC24 take the training of those providing its services seriously. At the inquest there was concern expressed by you regarding training on accessing information from the NHS Pathways NHS 111 report The GP concerned did not appear to have the level of awareness regarding the accessing of the information from 111 that IC24 would have wished, Whilst there was no evidence that the failure to access the information from 111 had an impact on the outcome for Mrs Ellis, IC24 have reviewed the induction training programme and have specifically included the access of this information from NHS 111 pathway as specific topic_ A copy of the induction training programme is attached. IC24 have also sent in alert to existing out of hours GP reminding them about accessing this information:
4) The results of investigations by both KMSS and IC24 should result in & joint RCA This has not occurred as and no date has apparently been arranged The SUI noted that there would be a joint RCA between KMSS and IC24 A Joint meeting took place between IC24 and KMSS NHS 111 on 31 December 2015. At this meeting learning across the organisations was discussed and in particular Mrs Ellis case was reviewed: The note of that meeting is attached to this letter for your ease of reference. andi have discussed the merits of a further joint SI and RCA investigation:. the joint working that has already occurred and that will continue, and the new processes regarding call closure instituted within IC24 and other actions taken have concluded that a further RCA would not produce any new learning or actions. If you would Iike any further details regarding these matters please do not hesitate to contact me

Report sections

Investigation and inquest

On 14th September 2015 an investigation into the death of Valerie Margaret Ellis was commenced The investigation concluded at the end of the inquest on 21 April 2016. The conclusion, in narrative form, stated: Mrs Ellis died on 6"h September 2015 at home as a consequence of prescribed blood thinning agent, Apixaban: Counse as to the side effects of the was not given by the hospital and this, with non-compliance call handling by 111 and inexplicable premature closure of the case within IC24 may have contributed to death. The pathologist gave cause of death as: 1a Massive Gastrointestinal Bleed due to 1b Apixaban 2 Ischaemic Heart Disease

Circumstances of the death

Mrs Ellis was an 83 year old woman who had been treated in hospital for a fractured hip and discharged on the 14th August 2015. On August she was readmitted with a cardiac arrhythmia stabilised by a combination of drugs along with Apixaban, a blood thinning agent: She was discharged from hospital on 29th August to her home with medication and a post hospital District Nurse visit on the 2nd September did not identify any unexpected problems no further nursing needs were identified. On 6th September Mrs Ellis developed a nose bleed and at 18.31 hours her husband phoned NHS 111 for advice_ He was informed that he would receive a call from a clinician within 1 hour but; although apparently a call was made who has an acknowledged hearing disability, did not either hear or respond. At 21.07 a further call was made to NHS111 and as a result it was suggested at 21.21 taking lling drug 24th _ and that Mrs Ellis be taken to hospital. Circumstances meant that it was not possible for Ito undertake this action and he phoned 999 at approximately 21.34 The initial Category C rated call was change to Red 2 and an ambulance attended at 22:10 but the patient was deceased. During the inquest there appeared to be missed opportunities which may have had an impact on Mrs Ellis' end of life. 1 . On discharge from hospital on 29th August; althoughe was given a list of drugs that his wife was to take, there was no information or counselling given as to the nature of Apixaban, a novel anticoagulant. Details of side effects and the identification of bleeding complications were not given. Ellis was exhibiting signs of confusion and had loss of high frequency tones but his evidence was unequivocal as to lack of counselling: The community nurse did not identify any nursing needs.
3. The first call to 111 was difficult as a result of communication problems between the caller and the health advisor algorithm used by the health advisor did not make clear the appropriate pathway for Mrs Ellis' symptoms vital information about the medication she was taking was not elicited, particularly the blood thinning agent: A referral was made to IC24 for a clinician to speak tol This was undertaken but in view of lack of response a note was made to phone in 5 minutes The file, however, was lost from the system in IC24 and the return call was not made. No explanation could be given as to the fact that the case was closed prematurely without further contact withll
5.A second call to 111 was made as Mrs Ellis' condition deteriorated. All the information had to be repeated and again there were communication problems. In neither call to 111 was advice sought from available clinicians by the health advisors was asked to take his wife to A & E after the second call. He agreed although with no means to get his wife out of the house due to her bleeding and poor mobility he eventually resorted to dialling 999 gave information to the 999 operator that his wife's problem was a severe nose bleed The call was therefore rated as category C and only when phoned again to say that his wife was not breathing was the category raised to the highest category:

Action should be taken

In my opinion action should be taken to prevent future deaths and believe your organisation the power to take such action:

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