Dear Mr Moore Re: Regulation 28 following Inquest into the Death of Annette Hill write further to the Regulation 28, dated 21 September 2018, issued as a result of the inquest into the death of Mrs Annette Hill: At the read only inquest understand you noted specific concerns regarding the unresolved tension between the Sepsis Six guidelines and the BTS COPD care bundle for the management of patients with advanced respiratory disease_ Firstly , would Iike to apologise as it transpires that the wording in the RCA may have misled you regarding the potential conflict To allow me to provide context to the RCA and the investigation we have completed, have set out the difference between the two documents and the potential impact each may have on the Trust's patients Background Information By way of a brief synopsis, it is important to note that a care bundle allows practice to be standardised and is a structured way of improving the process of care_ It reduces the variation in treatment and intends to improve patient outcomes, by providing a set of interventions. Alternatively, clinical guidelines are evidenced based recommendations of how healthcare professionals should care for people with a specific condition: NICE Guidelines set out the care and services suitable for most people with a specific condition or need. Below is more specific detail regarding the two documents considered in the RCA. A Universily of Bristol Teaching Trust A University of the West of England Teaching Trust AA 12 ('

COPD Care Bundle The NBT COPD admission care bundle is based on the BTS COPD admission care bundle, implementing the same care pathway, steps and timeframes_ This care bundle aims to improve care and reduce readmissions for patients admitted with acute exacerbation of COPD (AECOPD): The first stage of the NBT care bundle is to establish a correct diagnosis of AECOPD as soon as possible at the of hospital admission, and that the diagnosis should be supported by an ECG and chest X-ray. The BTS and NBT COPD care bundle recommend that this is done within 4 hours of admission_ The BTS Pilot Care Bundle Project, A Care Bundles- Based Approach to Improving Standards of Care in COPD and Community Acquired Pneumonia (2014), evidenced that when the bundle was implemented patients were almost twice as to be seen by the specialist respiratory team and those patients were more likely to have received all appropriate treatments within 48 hours of their admission. This care bundle focuses on ensuring patients receive the correct diagnosis and standardised investigations during their admission to hospital whilst under review of respiratory physicians. Sepsis Six Pathway UK Sepsis Trust developed the concept of the 'Sepsis Six' a set of six tasks to be instituted within one hour by non-specialist practitioners at the front line. The UK Sepsis Trust and The College of Emergency Medicine's Toolkit for Emergency Departments highlight that in the most severe cases, septic shock for every hour that appropriate antibiotic administration is delayed there is an 8% increase in mortality. It is for this reason that sepsis is regarded as a time critical condition and the Sepsis Six guidelines are nationally mandated by NHS England and CQUINs were set up with the purpose f providing the correct treatment for sepsis asap. The NBT Sepsis Screening & Action Tool implements tasks identified in the UK Sepsis Trust 'EDIAMU Sepsis Screening & Action Tool' . The NBT Sepsis Six guideline identifies the importance of recognising, diagnosing and early management of sepsis, with the importance of early identification of treatment stemming: The NICE Guidelines recommend that patients only need to be suspected of having sepsis in acute hospital settings, show at least 1 of the criteria indicating high risk of severe illness or death, to have the first dose of IV antibiotics and a review by a senior clinical decision maker: The Guidelines recommend that this is done within 1 hour of the patient being suspected of being at risk of sepsis. The criteria provided by the NICE Guidelines are intentionally wide to reduce the risks of missing patients who do have sepsis. However; North Bristol NHS Trust tries to reduce the number of patients receiving antibiotics unnecessarily by ensuring that identified patients are reviewed by a senior clinician before antibiotics are A University of Bristol Teaching Trust University of the West of England Teaching Trust point likely

prescribed. We also aim to do this within hour of the patient being suspected of being at risk of sepsis. The need for time critical preventative treatment against suspected sepsis means that the Sepsis Six guidelines are implemented immediately and each patients risk of sepsis is considered once they attend the ED. Investigation would Iike to reassure you that before the Trust introduces policy/guidelines/care bundle, the implications are considered by the relevant division. If there are departmental concerns regarding the implementation of a policylguidelines this would be escalated through the Trusts Clinical Governance structure to ensure that decision can be made based on the best interests of our patients. If the Trust considers that harm may be caused through implementation this would be escalated for regional consideration before NHS England, NHS Improvement or NICE Given the volume of guidance available, conflicts between guidance is however, the Trust takes appropriate measures to identify and implement approaches which will be of greater benefit for its patients and take steps to reduce the risk as much as reasonably possible_ The RCA identified the possible conflict between the British Thoracic Society COPD care bundle and the Sepsis 6 guidelines in relation to the prescription of antibiotics in patients with undiagnosed exacerbation of airways disease. It was recommended that the potential conflict be reviewed at the Sepsis Group meeting: This group convened on 16 October 2018 and was of the opinion there was no conflict with the COPD care bundle Furthermore they did not feel that the Trust's current approach to sepsis needed to change. They highlighted that there will always be patients who overlap clinical guidelines (sometimes several) and it is important to recognise the guidelines are there to assist clinicians, but clinical judgment must always be used which is why a senior clinician reviews each patient before antibiotics are administered to those at risk of sepsis_ Since the inquest and receipt of your Regulation report, the concerns raised have been explored with the RCA author Consultant Emergency Physician) and contributor Consultant Respiratory Physician) who have both confirmed they do not consider that the Sepsis Six pathway and the BTS COPD care bundle actually conflict Furthermore, it was established that approximately 2 out of 3 of patients that attend the Trust with exacerbated COPD have a definitive infective component therefore the majority of patients attending with exacerbated COPD are also likely to benefit from the administration of antibiotics in any event; University of Bristol Teaching Trust University of the Wost of England Teaching Trust likely,

North Bristol NHS Trust's approach is to adopt the Sepsis Six guidelines but we do not routinely follow the BTS COPD care bundle_ The Sepsis Six guidelines are implemented for each patient that attends the ED, whereas the BTS COPD care bundle is only intended for use for those diagnosed with AECOPD. As a Trust; we are satisfied that it is in the patients' best interests to implement the Sepsis Six guidelines before the BTS COPD care bundle, as the former addresses an immediate risk to a patient's welfare This approach is supported by the fact there is no national guidance that says that Sepsis Six should not apply to patients with COPD; the majority of patients suffering with exacerbated COPD have an infective cause and are therefore likely to benefit from antibiotics; furthermore NICE estimate that 20 deaths from anaphylaxis are reported each year in the UK, compared to 37,000 sepsis related deaths in the UK am satisfied with the findings of the Trust's Sepsis Group meeting in that a great number of patients will overlap clinical guidelines and that on the evidence available it is correct to prioritise the Sepsis Six Guidelines before the COPD care bundle with the additional safety net of a review by a senior clinician before antibiotics are administered. In doing so this is likely to be of benefit for the greater population of our patients_ hope the above addresses your concerns surrounding the potential conflict in the RCA and reassures you that we have a clear approach to sepsis and why this approach is taken.