Dear Mr Potter,

RE: Regulation 28 Report to Prevent Future Deaths Patient: Brian John COLBY (Date of Death 16 September 2023)

I am writing in response to your letter dated 26th June 2024 and received into HCA Healthcare UK on 27th June 2024, informing me of the outcome of an inquest into the death of Mr Brian John Colby.

Firstly, on behalf of HCA Healthcare UK (HCA), I would like to personally extend my heartfelt and sincere condolences to the family of Mr Colby for their loss. I do acknowledge what a difficult time this must have been for the family and would like to assure you that HCA and The Princess Grace Hospital have taken the Regulation 28 Order extremely seriously. We have reviewed the findings of the inquest and have taken immediate action to make the required improvements in order to prevent these issues reoccurring in future.

Please now find below HCA’s response to the above order. As you had raised a number of concerns following Mr Colby’s inquest, I will respond to each one in turn below for clarity;

1. The concern is that there did not appear to be any, or any clear, protocol(s) in place for the escalation of a deteriorating patient. At or about 10:00 on 16th September 2023, Mr Colby’s vital signs and observations showed a drop in his Glasgow Coma Score from 15/15 (at 09:00) to 11/15, and a clinically significant rise in his blood pressure. I heard evidence that this change in his vital signs and observations was enough to warrant requesting a CT scan to ascertain the cause or causes of the change in clinical presentation. Despite this, I found that this was not escalated as a cause for concern at the time. I heard that the on-call consultant for the intensive care unit (ICU) was not made aware of any deterioration in Mr Colby’s presentation until 12:42 that afternoon. HCA fully recognises that timely escalation and intervention of appropriate clinical management is vital to minimise the likelihood of a patient experiencing a serious adverse event. HCA has a number of systems and protocols in place to recognise patients who are at risk of deterioration and for escalation of a deteriorating patient. We utilise the National Early Warning Score (NEWS) system, which was developed by The Royal College of Physicians in 2012, and updated to NEWS2 in 2017, to facilitate a standardised and nationally unified approach to alert clinical staff to any patient clinical deterioration. This is in line with The National Institute for Health and Clinical Excellence (NICE) guidance. The purpose of the Early Warning Score (EWS) is to reduce avoidable harm by undertaking timely observations and by escalating a patient’s deterioration appropriately. HCA’s electronic patient health record automatically calculates the EWS after a complete set of observations have been taken and documented within the system. All staff are trained on this system and our supporting policy documents follow the EWS tool escalation process in the time frame stated within the system; unless the Consultant responsible for the patient’s care has requested otherwise. Observations may also be taken manually at any point during the patient’s care and escalation may be required dependant on the results. This protocol is defined in the HCA policy “Early Warning Scores Escalated through Nervecentre” (HCAUK.NUR.ALL.POL1032 1.1). This policy is available on the HCA clinical policy library and accessible via an internal Intranet site, to which all of our staff have access. Additionally, the HCA protocol for managing medical emergencies is outlined in the HCA “Corporate Cardiopulmonary Resuscitation Policy” (HCAUK.CRI.RESUS.POL.1001 4.2) There is a clinical member of the Intensive Care Unit (ICU) team on each shift out of hours (at weekends and nights) who is responsible for undertaking the role of Critical Care Outreach. This role is responsible for facilitating admissions to the ICU by assessing deteriorating patients on the ward in a timely manner and providing advice and enabling discussions with the patient’s care team regarding on going management. Additionally, all HCA hospitals are serviced by a 24 hour cardiac arrest team who are activated via a 2222 call to respond to a medical emergency. Management of medical emergencies is in line with nationally recognised treatment algorithms. To provide further assurance, relevant clinical staff in all of our HCA hospitals receive training in both Immediate Life Support (ILS) and Advanced Life Support (ALS) and these programmes include; recognition of, escalation of and management of the deteriorating patient. Compliance with this training is monitored monthly by clinical Heads of Department and Facility Executive Leadership teams.

Simulated Emergency Scenarios (SIMS) of a deteriorating patient also take place regularly across all HCA hospitals. These simulations involve the whole clinical team including; Doctors, Nurses and ward administrative staff. The benefit of undertaking these scenarios is to ensure that all staff are competent in managing a response to a deteriorating patient and are able to follow the HCA policies and protocols for escalation. The focus of these simulations is on learning and outcomes are shared and discussed at the HCA Corporate Resuscitation Committee. HCA also subscribes to BMJ Best Practice for clinical guidelines, which includes treatment algorithms and escalation pathways for a wide range of clinical specialities including emergencies. BMJ best practice is integrated into HCA policy and protocols which are tested as part of the simulation exercises. SIMs form part of the HCA Clinical Operations long term strategy to ensure a continual cycle of shared learning and improvement. We have increased the provision of face to face training for all clinical teams on “Recognition of a Deteriorating Patient, and Escalation of a Deteriorating Patient”, to build confidence in our clinical teams to practice effective communication of patient safety concerns to Consultants, using role play and simulated activities within multidisciplinary teams. The training includes, specifically Resident Doctors escalating to Consultants, along with GCS and BP changes. Training compliance is monitored monthly to ensure all Resident Doctors have attended. This training is built into the HCA Annual Mandatory Training programme which will ensure that best practice is firmly embedded in the future. We also have a Daily (every shift) ward “Safety Huddle” in line with HCA policy. The huddle discusses every patient on the ward and highlights specifically those patients that are high risk for deterioration as well as steps that should be taken should a patient require escalation. We have reviewed and revised all HCA policies relating to the deteriorating patient and actions to be taken when a patient needs to be escalated. These policies have been circulated to all relevant members of the clinical team and are also available on the HCA policy library (iHCA) which is accessible by all staff. These policies will be reviewed and updated regularly, as required, to ensure continued best practice guidance is always provided to all relevant staff. The new Resident Doctors handbook also refers to Resident Doctor responsibilities when required to escalate a deteriorating patient. This handbook will be provided to every new Resident Doctor in future in order to ensure that they are aware of their responsibilities at the point of onboarding. As part of the core HCA Clinical Audit programme, management of the deteriorating patient is audited monthly in order to ensure adherence to policy. The results are analysed, discussed and actioned where required through regular governance meetings. This clinical audit forms part of the HCA Clinical Operations long term strategy to ensure a continual cycle of quality improvement.

Action taken Prior to and following Inquest

Date Status 1 An increase in the frequency of Simulated Emergency Scenarios (SIMS) and Simulated Emergency Training Sessions at all HCA hospitals on management and escalation of a deteriorating patient for clinical staff. Simulated Emergency Scenarios and Training Sessions are scheduled throughout 2024 and are routinely scheduled at the start of each year for the rest of the year. Any medium or high risk reports are actioned immediately. Bi monthly and on-going Completed

2 Implementation of a “Call 4 Concern” policy. This recent patient safety initiative is a process which allows patients’ loved ones and caregivers to call a dedicated telephone number within the hospital and request an additional clinical review if they are concerned that the healthcare team may have overlooked a change in their loved ones’ clinical condition. This initiative has been implemented following the National response to Martha’s Rule (Implemented across the NHS in April 2024). Each referral that is made through this process will have a clinical review by a senior clinician to understand the concerns that were raised and the management that was subsequently implemented. This initiative now forms part of the Clinical Operations long term strategy and referrals will be monitored going forward through relevant governance committees 14 May 2024 and on-going Completed

Action Taken Following Inquest

Date Status 1 Communications to all Resident Doctors as well as an Internal safety alert circulated reinforcing escalation protocols; when Resident Doctors are concerned about a deteriorating patient, these concerns must be escalated to the consultant responsible for the patient as soon as possible via a phone call or face to face conversation. We have ensured that all clinical departments have acknowledged the alert as being read and understood. 20 June 2024 10 July 2024 Completed

2 We have increased the provision of face to face training for all clinical teams on “Recognition of a Deteriorating Patient, and Escalation of a Deteriorating Patient” to build confidence in our clinical teams to practice effective communication of patient safety concerns to Consultants using role play and simulated activities within multidisciplinary teams. The training includes, but is not limited to; GCS and BP changes. This training started on 29 July 2024 HCA Wide with 2 further training sessions on 5 and 12 August 2024. This training is built into the HCA Annual Mandatory Training programme which will ensure that best practice is firmly embedded across HCA for the future. 29 July 2024 and on-going Completed 3 We have reinforced to clinical teams hospital wide that any unwell patient must be discussed at each ward Daily (shift) “Safety Huddle” in line with HCA policy (Corporate Safety Huddles in Clinical Practice Policy) (HCAUK.NUR.ALL.POL.1042) and have reminded all clinical staff that should the team have concerns relating to a patient’s clinical condition they must escalate to the Senior Clinical Leadership team immediately. Full handover is given to any member of staff who was not present at the Safety Huddle. We have also increased the frequency of Matron and Chief Nursing Officer patient and staff rounding. The effectiveness of Safety Huddles will continue to be monitored regularly as part of the HCA Quality Assurance programme to ensure consistently high standards. 18 July 2024 and on-going Completed 4 Roll out of Resident Doctors Workshops; These training workshops ran over 3 sessions throughout July 2024 for all Resident Doctors and included learning from Mr Colby’s inquest as well as a reiteration of all HCA protocols and policies relating to escalation and responding to the deteriorating patient. We have also reiterated the importance of escalating to a Consultant as soon as possible when a patient is noted to be deteriorating. 29 July 2024 Completed 5 Within the ICU environment, we have emphasised to the Nurses-in-Charge the importance of escalating concerns from the bedside to Resident Doctors. It has also been reinforced to Nurses-in-Charge to ensure that Resident Doctors are supported to escalate as soon as possible all deteriorating patients to the Consultant. The Nurse -in -Charge is also empowered to escalate directly to the Consultant if required. 29 July 2024 and on-going Completed

Senior Chief Nurse Rounding is now firmly embedded into HCA practice in order to support the Nurse-in-Charge and to ensure that best practice is being adhered to. 6 We have formalised the identification of specific patients of concern on the ICU at the start of each shift and on ward rounds, to ensure that these particularly patients are monitored more closely throughout the shift. This practice has now been integrated into HCA policy and disseminated to all relevant staff. Adherence to policy will be monitored regularly as part of the HCA regulatory Quality Assurance programme. The Quality Assurance programme continually reviews and monitors adherence to best practice and regulatory standards across every HCA facility throughout each year. 29 July 2024 and on-going Completed 7 We have reinforced through the HCA Hospitals Medical Advisory Committee, the expectation that all communication related to urgent clinical matters is undertaken Consultant to Consultant, either face to face or via telephone. This has also been made specific within the Consultant Practicing Privileges policy which is provided to all Consultants to ensure that this practice remains embedded across HCA. All new Consultants are provided with this policy as part of their onboarding process and are required to adhere to this policy as part of their practice with HCA. 25 June 2024 and on-going Completed

2. Notwithstanding the clearly significant ongoing investment in new record keeping software, my concern is not about record keeping per se, it is about communication between clinical staff and expectations in terms of plans of care etc. Both points (1) and (2) involve ineffective communication of clinicians at many levels.

In addition, while I accept that clinical staff may not always be able to complete contemporaneous records and may have to write some records in retrospect, there is no clear procedure or expectation in relation to record keeping, particularly in relation to urgent clinical matters, or alternatively, any procedures or expectations are not always followed.

At or about 11:00 on 16th September 2023, Mr Colby was routinely reviewed by a medical consultant (i.e. the review did not take place because Mr Colby’s condition had been escalated). The medical consultant was immediately concerned by the apparent deterioration in Mr Colby’s condition and, as part of a wider plan, the medical consultant requested that a CT head scan should be carried out urgently or as soon as possible. This request was misunderstood and therefore not acted upon by the ICU fellow. The medical consultant did

not record his assessment of, and plan for Mr Colby until approximately 20:00 that evening. This meant that the entire plan was not available for others to refer back to, if required. I heard that the record keeping system is currently a hybrid system, comprising some manuscript and some computerised records. I also heard that HCA Healthcare is currently mid-way through commissioning a new patient records system at significant cost. HCA recognises that maintenance of the Medical Record is vital to patient care. In HCA’s Intensive Care Unit, an electronic clinical information system is utilised to record patient’s care and treatment, which is in line with the Faculty of Intensive Care Medicine, “Guidelines for the Provision of Intensive Care Services” (July
2022). There are daily verbal and written handovers of care and regular “safety huddles” in order to discuss any changes in a patient’s condition, which is attended by all clinicians involved in the patient’s care. HCA sets standards for all clinical staff and Consultants in terms of the management of health records and record keeping. This includes both paper and electronic records. These standards are set out in the HCA, “Corporate Health Records Management Policy” (HCAUK.INF.RM.POL.1000 2.0) and in the HCA “Practising Privileges Policy”, (HCAUK.GOV.SM.POL.1006 15.14). These policies are explicit in terms of the requirements for clinicians to document all care plans, treatments and decisions as soon as reasonably practical following the review of a patient. Following implementation of an integrated Healthcare record, which is currently being developed within HCA, we will be exploring the use of more advanced automated surveillance and alerting algorithms in the software, in order to rapidly identify patients who are deteriorating.

Action Taken Following Inquest

Date Status 1 We have reinforced through the HCA Hospitals Medical Advisory Committee, the expectation that all communication related to urgent clinical matters is undertaken Consultant to Consultant, either face to face or via telephone call. We have also reinforced the expectation that Consultant documentation is completed contemporaneously, or as soon as reasonably practical. This has also been made specific within the Consultant Practicing Privileges policy which is provided to all Consultants to ensure that this practice remains embedded across HCA. All new Consultants are provided with this policy as part of their onboarding process and are required to adhere to this policy as part of their practice with HCA. 25 June 2024 and on-going Completed 2 We have sent a directive communication to all consultants to reiterate the requirement to document patient’s care plans in the medical records as soon as possible following a patient review. We have also taken the opportunity to 26 July 2024 and on-going Completed

remind all Consultants of the expectations regarding good record keeping as set out in the GMC guidance 'Good medical practice' (2024). Good record keeping will be monitored regularly as part of the HCA regulatory Quality Assurance programme and action will be taken where improvements are required. 3 We have revised and strengthened the Standard Operating Procedures for;
• Staffing and delivery of medical care in critical care
• Care of the Deteriorating Patient to make it explicitly clear on roles and responsibilities for; escalation, record keeping, and communication. This document has been shared with our Consultants, Resident Doctors and all members of the Critical Care nursing team. These procedures will be reviewed and updated regularly, as required, to ensure continued best practice guidance is provided to all relevant staff. 22 July 2024 and on-going Completed 4 We have implemented a “Situation, Background, Assessment, Recommendation” (SBAR) communication tool across all clinical areas to assist staff in framing effective communications when escalating critical information. An audit has been implemented to monitor the use and effectiveness of the tool, the results of which will be reviewed and monitored via a weekly clinical incident review meeting attended by clinicians and senior Executives. 19 July 2024 and on-going Completed

3. There was clearly a delay in Mr Colby being sent for a scan as a result, albeit there were other delays for different reasons. I am not assured that the additional training in this regard, is having the desired effect and consider the risk may well remain.

On 16th September 2023, the ICU fellow did not arrange a CT scan their self for Mr Colby. I heard that this was because the ICU fellow was working under the mistaken belief that only a consultant could order a CT scan in the private sector. Other evidence confirmed that this was clearly not the case. I heard evidence that, “the authority of resident doctors to commence the scan ordering process in advance of a consultant discussion has now been re-emphasised across the Resident Doctor Training Group.” However, when I heard evidence from the ICU fellow, on 22 May 2024, that clinician remained of the view that they did not have the authority to authorise/commence a CT scan.

HCA employs Resident Doctors who all attend a full induction during the onboarding process, part of which is to set out their responsibilities which include; medical care of inpatients, carrying out daily ward rounds, clerking new and unplanned patient admissions and responding to medical emergencies, including responding to the deteriorating patient. I would like to confirm that Resident Doctors are authorised to deliver medical procedures and order diagnostic tests as required and as requested by the consultant.

Action Taken Following Inquest

Date Status 1 Resident Doctor Workshops; These training workshops as detailed in point 1 above incorporated a reminder of the roles and responsibilities of Resident Doctors, including reiterating that Resident Doctors are authorised to order diagnostic tests, including CT scans and X Ray’s as required. 10 July 2024 Completed 2 Communications to all Resident Doctors as well as an Internal safety alert circulated as detailed in point 1 above, reiterated the importance of Resident Doctors ordering appropriate tests or scans to expedite diagnosis. 20 June 2024 10 July 2024 Completed 3 Implementation of a 6 weekly Resident Doctors peer group meeting, Chaired by the Head of Resident Doctors, in order to share learning and discuss best practices. This meeting has now been integrated into the HCA Governance structure. We are intending to include the circumstances of this case as part of on- going training for Resident Doctors. 29 July 2024 9 September 2024 and on-going Completed

4. My concerns relate to the efficacy of, or possible the adherence to, any procedure or protocols for the escalation of deteriorating patients. When an ICU fellow formed the view that Mr Colby’s clinical deterioration did warrant escalation to the on- call ICU consultant, this was done by way of sending the consultant a text message at 12:42 on 16 September
2023. Is seems to me that the sending of a text message is not likely to be the most effective way of escalating serious (and presumably urgent) concerns about patients. It carries inherent risks of the message not being delivered and/or not being seen by the recipient in a timely manner. As mentioned in point 1, we have revised all policies relating to the deterioration and escalation of patients within HCA. As part of the core HCA Clinical Audit programme, management of the deteriorating patient is audited monthly in order to ensure to ensure adherence to policy. The results are analysed, discussed and actioned where required through regular governance meetings.

Action Taken Following Inquest Date Status 1 We have updated the new Resident Doctor Induction Handbook to make it explicitly clear that escalation of a deteriorating patient must be undertaken via telephone call or face to face and that escalation via text message is not an appropriate form of communication to escalate urgent clinical concerns. This updated Handbook has been provided to all current Resident Doctors and will be provided to all new Resident Doctors in future. The Handbook will be regularly reviewed and updated going forward as required. 31 July 2024 and on-going Completed 2 The Internal safety alert circulated to Resident Doctors as detailed in point 1 above, reiterated the importance of escalating urgent clinical concerns via telephone or face to face and to not use text messaging as a form of urgent communication. 10 July 2024 Completed

5. This raises further concern in relation to communication and escalation of deteriorating patients. The effective instruction to send Mr Colby for an urgent CT scan was at 13:19 on 16 September 2023, over two hours after an instruction for an urgent or as soon as possible CT head scan was given by a medical consultant) albeit it, this instruction was misunderstood) and over three hours after a CT head scan was first clinically indicated. In response to this aspect of the Coroner’s concerns, we have detailed the actions above that we have taken to ensure effective communication and escalation of deteriorating patients across HCA hospitals. We have reiterated the importance of escalating to a Consultant as soon as possible when a patient is noted to be deteriorating. HCA have also shared widely the learning from Mr Colby’s inquest. We will ensure that the changes we have implemented as referenced above will be reviewed and monitored regularly through our HCA Quality Assurance programme, in order to confirm that all clinical staff remain aware, proactive and compliant with best practice standards. HCA has made long term improvements as a result of this case which have been firmly embedded in both current service delivery and clinical operations strategy for the future. I hope that this provides assurance that we have taken the Coroner’s concerns seriously and that we will continue to monitor these actions regularly through internal established governance processes. Should you require any further information, please do not hesitate to contact me.