Madhumita Mandal

Dear Ms Lynch

**Regulation 29 Response further to the Regulation 28 Report to Prevent Future Deaths in respect of the Inquest touching the death of Mrs Madhumita Mandal**

We are providing this letter in response to the Coroner’s Regulation 28 report dated 8 December
2015.

By way of background, Virgin Care Wandle LLP (Virgin Care) was commissioned to provide the healthcare services within the Urgent Care Centre (UCC) based within Croydon University Hospital (CUH) Accident and Emergency Department in March 2012 by Croydon Primary Care Trust (succeeded on 1 April 2013 by the Clinical Commissioning Group) (the CCG).

We now address the specific concerns which the Coroner has required Virgin Care’s response to in respect of her Regulation 28 report. We note that there are three issues that the Coroner has identified as a matter of concern. We have listed the Coroner’s concerns and have responded to each of these as follows:

1. **Mrs Mandal was taken to Croydon University Hospital by her husband. Virgin Care was contracted by the Croydon Clinical Commissioning Group to provide urgent care services, and to stream adult patients arriving at the emergency department. A streaming model was followed by a receptionist who had no medical training and who performed no medical observations. This led to a delay of about an hour before Mrs Mandal was seen by any qualified healthcare professional, by which time her condition was critical.**

From April 2012 until November 2015, when a patient presented at the joint reception in the A&E department at CUH, in line with the contractual service specification from our healthcare commissioners, the receptionist completed a record with administrative details and, using the condition specific criteria, streamed the patient to await assessment at either the UCC or the Emergency Department (ED) which is operated by CUH staff (see Appendix 1 – Adult Streaming Operational Policy and Appendix 2 – Streaming Index). Adult patients streamed to the UCC waited in the joint reception area to be seen by an UCC clinician (employed or contracted by Virgin Care). Adult patients streamed to the ED waited in the joint reception area to be seen by the ED triage nurse (employed by CUH) on duty. Once an ED patient had been triaged, they could either be asked to move to ED or return to the joint reception area. In addition, both UCC and ED staff were jointly responsible for surveillance of the waiting room to identify potentially deteriorating patients.

Virgin Care w: www.virgincare.co.uk

Registered office: Virgin Care Wandle LLP, Lynton House 7-12 Tavistock Square, London WC1H 9LT Registered in England and Wales: Number 08338708 Date: 27/01/2016 v2.0

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Receptionists were instructed to speak to a clinician if they were unsure about a patient’s condition or if they had any concerns about a patient. Receptionists were trained to carry out the streaming process and a record of this is attached at Appendix 3 (One to One Training), which has been redacted appropriately to maintain confidentiality. The receptionist who booked in Mrs Mandal had received such training in October 2012.

In September 2013, (after Mrs Mandal’s death) the Vitalpac Early Warning Score (VIEWS) protocol was implemented as part of ongoing improvements discussed and agreed with our commissioner. After a patient has been streamed to the UCC, a Healthcare Assistant undertakes the VIEWS assessment within 20 minutes of arrival and this includes taking full observations. We attach the ‘VIEWS Algorithm’ at Appendix 4. Based on a number of physiological parameters the healthcare assistant inputs the observations into the clinical system and an automatic score is generated. This system aims to provide a clinically objective score and is an additional tool to determine the acuity of a patient’s presentation to help ensure the patient is seen by the most appropriate clinician as soon as possible.

From November 2015, interim changes have taken place to the way patients are directed to the UCC or ED while the redevelopment of UCC and ED is underway. This means that the ED is now providing ‘clinical streaming’ i.e. one nurse viewing all patients as they enter the department to determine presenting condition. This is not a triage system. This decision was made by the CCG, CUH and Virgin Care as the two departments are no longer co-located. Virgin Care is working closely with both the CCG and CUH to ensure patient safety is maintained during the redevelopment. It is anticipated that the redevelopment will last until March 2017 at the earliest. As a committed provider of safe care for our patients, we will continue to liaise and work closely with our commissioners and CUH in relation to the UCC and ED and any improvements that can be made to the services commissioned by our commissioners. We confirm that representatives from the UCC and the ED meet regularly for joint governance meetings where clinical issues and incidents are raised and discussed.

The Coroner has stated that there was “a delay of about an hour before Mrs Mandal was seen by any qualified healthcare professional, by which time her condition was critical”. We note that during the Inquest hearing, this was not confirmed by any of the witnesses on the day including the expert, Dr Soni. He stated that “At 8.20 she is in extremis and has got a prominent problem, the nature of which was uncertain at that point in time, so I think it is likely she was already in extremis at 7.20”. Dr Soni also went on to say “the probabilities say that it is more likely that she would have died despite the best efforts”. We are therefore concerned that a conclusion has been drawn by the Coroner that as a result of the actions by the receptionist, Mrs Mandal’s condition was rendered or became critical, despite the lack of evidence at the inquest on that point. We respectfully invite the Coroner to re-consider this statement.

2. **The streaming model had been approved and commissioned in the contract as recommended by an NHS body called the Emergency Care Intensive Support Team. The system at Croydon has changed since Mrs Mandal’s death but concerns remain about the level of qualification for assessment of patients, and there may be lessons for other Trusts who contract out the provision of urgent care.**

As the learned Coroner has correctly identified, the “streaming model” followed by Virgin Care has been approved and commissioned in our contract by the CCG as recommended by the

Virgin Care w: www.virgincare.co.uk

Registered office: Virgin Care Wandle LLP, Lynton House 7-12 Tavistock Square, London WC1H 9LT Registered in England and Wales: Number 08338708 Date: 27/01/2016 v2.0

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Emergency Care Intensive Support Team (ECIST), an NHS body, affiliated with NHS Interim Management And Support.

When the services commenced in April 2012, the UCC was required, under the contract and conditions of the commission, to assess patients using a process based on the Manchester Triage System (MTS). Due to the nature of patient flows within the services, the MTS process resulted in delays in treatment for both the UCC and the CUH ED. Delays were resulting in four hour breaches in the ED and prolonged waits in patients being seen by a clinician in both services, which was an agreed significant patient safety cause for concern by both services. At busy times clinical staff were taken from treatment duties to assist with the MTS. This meant there were fewer clinicians treating people which in turn added to delays. The UCC had already identified triage as a bottleneck and had strengthened the process by replacing nurses with General Practitioners (GP) to carry out the MTS.

The Emergency Care Intensive Support Team (ECIST) was invited by Virgin Care to review the processes between the UCC and CUH. We attach at Appendix 5 a letter dated 15 August 2012 to Jacqui Smart, previous Head of Operations at the UCC, from ECIST, which outlined their recommendations and reasoning (‘ECIST Report’).

The ECIST recommendations challenged the concept that triage provided a clinical safety net for patients with serious injuries or illnesses. ECIST stated that non-clinical reception staff could be trained to “identify red flag conditions” and have those patients seen by a clinician immediately. They also pointed out that the delays caused by triage were “inherently dangerous”. Our understanding is that long delays for triage had occurred in the ED in the past.

Virgin Care adopted most of the recommendations of the ECIST review after consultation with CUH and the PCT (now the CCG). ‘Streaming and See and Treat’ was commissioned and introduced on 9 October 2012 in order to replace the MTS triage. The process specified non- clinical receptionists streaming adult patients to the UCC or ED in accordance with strict criteria.

The development of the streaming model involved senior staff and clinicians from Virgin Care, CUH ED (including Dr Kathryn Channing, Clinical Lead) and the PCT. We attach at Appendix 6 a copy of the ‘Emergency Recovery Board Meeting Minutes’ of 4 October 2012 which confirm that both clinical teams were “very happy” with the proposed model of care which they had “worked up together” at the request and with the involvement of the commissioner.

The condition specific criteria for streaming decisions (the ‘Adult Streaming Operational Policy’ and the ‘Streaming index’ as attached at Appendix 1 and 2) were all jointly agreed by Lorraine Walton, ED Operations Manager at CUH and Caroline Bampton, Service Manager at Virgin Care and their teams. These processes and policies were jointly signed by CUH and Virgin Care.

Receptionists were trained to carry out the streaming process and a record of this is attached at Appendix 3 (One to One Training). Receptionists were instructed to speak to a clinician if they were unsure about a patient’s condition or if they had any concerns about a patient. The receptionist who booked in Mrs Mandal had received such training.

Virgin Care w: www.virgincare.co.uk

Registered office: Virgin Care Wandle LLP, Lynton House 7-12 Tavistock Square, London WC1H 9LT Registered in England and Wales: Number 08338708 Date: 27/01/2016 v2.0

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3. **Mrs Mandal’s death also raises questions about the use of ambulance services. A difference in assessment of patients based upon their mode of transport to the emergency department may encourage patients to err on the side of calling an ambulance.**

There is a process for patients brought to CUH via ambulance services to be seen and treated within the UCC similar to those walking into the UCC. Patients are not assessed differently based upon their mode of arrival, except in the case of blue light ambulances where this group of patients would be seen immediately by an ED clinician due to the serious nature of the clinical condition.

We trust the information we have provided is of assistance to the learned Coroner when making her recommendations and the Coroner is satisfied that relevant actions have been taken and no further actions are necessary.

Dear Ms Lynch Re: Madhumita Mandal (Deceased) I write to you in my capacity as Chief Executive for Croydon Health Services NHS Trust (“the Trust”). This response is made on behalf of the Trust. This response follows a Prevention of Future Death Report (“the Report”) commissioned by you, dated 08 December 2015. The Report was commissioned in relation to the inquest into the death of Ms Madhumita Mandal who died on 11 September 2013. The inquest into Ms Mandal‟s death concluded on 23 September 2015. Thank you for sharing the Report with the Trust and I note that the subject matter of this Report, as set out at paragraph 4, relates to the events in the Urgent Care Centre on 7 September 2015. I understand that the Report has been sent to the Trust, Virgin Care Wandle LLP and the Croydon Clinical Commissioning Group. Your concerns The Trust is mindful that consideration must be given to this report and any response. In considering this report I have consulted with the clinical lead in the Trust‟s emergency department and the Trust‟s Medical Director. The Trust’s relationship with the Urgent Care Centre (“UCC”) I understand from paragraph 5 of your Report that your concerns relate to the „streaming' of adult patients arriving at the Trust‟s emergency department through the Urgent Care Centre (“UCC”). The Croydon Clinical Commissioning Group (“CCG”) awarded the contract for delivery of urgent care services to Virgin Care Wandle LLP. Virgin Care Wandle LLP controlled the steaming of adult patients who arrived in the Trust‟s Emergency Department at the time of the incident. The functionality and review of the streaming model at the time of the incident is accordingly the responsibility of Virgin Care Wandle LLP. The Trust respectfully submits that it is therefore not in a position to comment on the streaming model implemented by Virgin Care Wandle LLP nor the appropriateness of the triage assessment undertaken by the urgent care receptionist. The Trust does not consider it is in a position to Chairman: Michael Bell Chief Executive: John Goulston

[Page 2] comment on any actions or proposed timescales for any actions by Virgin Care Wandle LLP arising as a result of this inquest, save for those that relate to the working relationship between the UCC and the emergency department. Actions taken on behalf of the Trust As set out above, the Trust considers that the subject matter focus of your report will require a response from Virgin Care Wandle LLP or their insurers given the venue of your concerns. However, I note the contents of paragraph 3 of your Report and as a Trust we recognise the need for continual review and improvement of our health care services. Having consulted with the emergency department‟s clinical lead and the Medical Director, I can confirm that since September 2013 there have been changes made to the interface between the UCC and the Trust‟s own emergency department.
1. Medical observation reviews in UCC The streaming model currently in place between the UCC and the Trust‟s emergency department is now delivered by band 6/7 (senior) emergency department nurses.
2. Formalisation of the handover process from the UCC to the emergency department Patients received by the resuscitation team are received and assessed by an emergency department consultant or registrar. It is now standard practice for the Consultant in charge of the department on each shift to undertake a formal handover from the resuscitation area before starting the ward round, as opposed to relying on verbal feedback; this change was implemented immediately after Ms Mandal‟s death. The „handover‟ process in which patients are transferred from a UCC practitioner to the emergency department has been formalised in that on acceptance of a patient to the emergency department, both clinicians involved in the handover must sign and time-stamp a document to ensure the exact timing and approval of the handover are documented This helps to ensure that an appropriate care/treatment plan is devised and reviewed by more senior medical staff, and assists in the timely delivery of treatment.
3. Fortnightly governance review meeting There is now a fortnightly review of governance and process issues between the UCC and the emergency department; this has allowed us to work more closely with our UCC colleagues and recognise and deal with potential problems more quickly. We have used the forums to refine the streaming and handover processes thus ensuring patients get to the correct clinicians in a safe and timely fashion.
4. More emergency care nurses /paramedic practitioners in resus area We now have a well-established team of Emergency Care Nurses and paramedic Practitioners within the resus area who all have extended skills. This team has dramatically improved the quality and consistency of care we offer patients in the resuscitation room. They offer great support to the doctors but are also empowered to make autonomous decisions to escalate to more senior staff when the need is required. Conclusion Following the changes to the practice both in the UCC/Trust‟s emergency department interface and in the Trust‟s Emergency Department, I note there have been no similar incidents since Ms Mandal‟s death. The new streaming model between the UCC and the Trust‟s emergency department is more suitable in terms of patient safety and I understand this is the same model that most UCC‟s and emergency departments use across the country. Ms Mandal‟s sad passing has highlighted the importance of team work and communication and I firmly believe the changes we as a Trust have implemented has demonstrated that we have learned from the incident and have taken steps to ensure the health and wellbeing of our patients is upheld.

[Page 3] I understand a copy of this response will be sent to the Chief Coroner. If you have any other concerns or queries arising out of this response, please do not hesitate to contact me.

Dear Ms Lynch Regulation 28 – Madhumita Mandal Thank you for sharing a copy of the above report with us for our response. May we first of all offer our sincere condolences to Madhumita’s family and assure you of our desire to continue to improve the services that we commission. I will now deal with the concerns that you have raised around the see and treat model that you refer to. The protocol for the model in use at the time of the incident was agreed with clinical sign up and I have attached this for your reference. The streaming model was implemented originally to ensure swift streaming to reduce waits and improve safety and recognising the high level of primary care patients using the UCC. Until early November 2015 the Virgin UCC reception team were responsible for streaming all adult patients who walk into the department irrespective of whether they required ED or UCC type services. Patients were then streamed depending on their presenting condition in accordance with an agreed streaming protocol.

[Page 2] By way of back ground the service was initially implemented using the Manchester Triaging model, which required the triaging of all patients (primary care and otherwise). As a consequence there was a significant impact on performance due to the delays this introduced into patient flows. The national Emergency Intensive Support Team (ECIST) supported a local review of the model, which led to a joint agreement by ED consultants, urgent care and CCG GP clinicians and implementation of the current streaming model and a joint standard operating policy agreed and implemented on the 9th October 2012. The model was based on trained receptionist streaming patients to either the UCC or ED depending on their presenting complaint, with the aid of the streaming protocol. Since the streaming protocol was introduced to replace triage, increased numbers of patients were streamed into ED (circa a 5-10% increase), which reflects the risk adverse nature of the protocol. Patients streamed into the UCC were initially assessed within 20 minutes or are seen and treated. Patients streamed into ED are triaged by ED staff. Since the model was introduced there were further workshops to review patient flows between the UCC and ED, over the summer of 2013, facilitated by Prof Derek Bell and his team as part of the local health economy response to the March 2013 risk summit and development of a local health economy wide demand and capacity plan. Workshops also looked at the model, patient flow and interface issues. Following the CQC in 2013 the CQC reported that the 20 minute initial assessment commissioned for the UCC was not always met and were concerned that there was no clinical eye-eye review of patients as part of this assessment. The CQC were not confident initially in the use of a non-clinical streaming model. This issue was reviewed in a workshop with CHS, UCC and commissioner clinicians and executives where it was agreed that a modification would be made to the streaming model on a pilot basis, which has continued, whereby patients streamed to UCC would be given basic observations by a HCA. All observations would be scored using the Vital – Pac Early Warning System (VIEWS). Any patient scoring 4 and below would be asked to remain in the UCC; a score of 5 and above would indicate that the patient was inappropriately streamed and would be sent to ED or referred directly to a specialist. The VIEWS assessment not only gives assurance to the Trust about when patients are handed over but it is also compliant with guidance from the London Standards. The model has evidenced that less than 1 % of patients initially streamed to the UCC are transferred to ED following the observations review. Please see the attached protocol which commenced on Wednesday 13th November and was phased in over several days, moving to a 24 hour process from the 17th November 2013. Since the 8th November 2015 due to the changed layout resulting from the A&E Decant, and redevelopment of the ED department, which means the UCC is now located further away

[Page 3] from the ED Department, clinical streaming has now been introduced at the front end of A&E. We are currently commencing re-pocurement of urgent care services in Croydon and the specification for the new service will continue to require that effective streaming process are in place. The VIEWS process however continues to be used in the UCC. I am not clear from your report the significance of the issue around the mode of transport to A&E. Clearly the aim has to be to ensure that patients entering the UCC whether by ambulance or as walk in are effectively streamed. We would have been happy to clarify the model at the time of the inquest but I hope that the above will give you some assurance about the processes we had in place at the time and that we have in place now.