Sangeerth Girirathan

Dear Mr Osborne I am writing to formally respond to the Regulation 28 report to prevent future deaths you made following the conclusion of the inquest into the death of Sangeerth Girirathan on 6 May 2022. You also wrote to me on 19 May 2022 on two matters raised during this inquest, but which did not form part of the Regulation 28 report; namely the disclosure of notes in a paginated and indexed format; and the storage of data on monitoring units in the hospital, particularly the ICU. I will address these matters within this letter. Regulation 28 Report The Regulation 28 report reads as follows: During the inquest it became apparent that in the ICU the alarms that are operating on the monitors had been disengaged. This resulted in the staff not being alerted when the patient's saturations fell below an acceptable level and he went into cardiac arrest. My understanding is that if a patient is being monitored at all then it is essential that the alarms remain operational. I believe that all staff should be reminded of the need for the alarms to be active so that future deaths in similar circumstances do not arise Response There is no national guidance regarding frequency of observations on ICU and patients vary from those who are acutely unwell to those who are well and waiting for a ward bed and on occasions direct discharge home. Observations (frequency and type) are decided by ongoing dynamic risk assessments from the nurse looking after the patient with input from the medical team as required. As a teach ing hosp ital. \Ne conduct education and rvs.klrch to improvo heotfhcora for our Chief E xecutive:

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TheMK ,~1:;1 CAR COMMUNICATE. Milton Keynes CC CONTRIBUTE. University Hospital NHS Foundation Trust Alarm fatigue is a recognised detrimental consequence of intensive, continuous monitoring. As part of the wider learning from this incident, the importance of proportionate and appropriate use of alarms and alarm limits will be emphasised to all critical care staff. A reference is included at Appendix 1. All registered nurses and consultant intensivists have been communicated to regarding the recommendations contained within the Regulation 28 report. The communication has reiterated that nursing staff must position themselves to have visibility of the monitor and when monitoring is deemed appropriate, the audible alarms set should reflect and augment the parameters monitored. If monitoring - intermittent or continuous but more important for the continuous - is deemed necessary then the alarms will not be disabled but parameters ­ highs and lows - may be altered to alert us a different points for different patients to avoid 'overuse' of the audible alarms. The senior nursing team and consultant intensivists are doing point prevalence surveys to support and education staff as to safe and effective monitoring. The ability to store data on monitoring devices following an incident that may have caused harm Response The ICU has a monitoring system provided by Spacelabs. There are several options to retain information/data from this monitoring system. Some of these options are longer term and require input from IT and all methods have risks associated with them that might result in failure to capture the appropriate data. In the short term, all registered nurses, medical trainees, and consultant intensivists have been informed that in clinical situations where death may have been prevented or an incident may have resulted in serious harm, that the monitor should be quarantined and data preserved. As an interim solution, monitor data should be transferred into the monitor modules, uploaded into a Spacelabs transport monitor and preserved until the clinical engineering team has access to that monitor to download the data. The patient should not be unlinked from the monitor (i.e. 'discharged' or disassociated from the monitor) unless absolutely necessary (in the case of the monitor being required urgently for another patient). Registered nurses have received refresher training and have been competency assessed to ensure they can transfer data as above. In the medium term, with training there is also an opportunity to draw across additional observations that have not yet been saved to eCare. In a situation where harm or death has occurred and the patient has not been discharged from the monitor, additional time points As o teaching h ospltol. we conduct oducotion ond research to lmprOYllil hoolfhcore ror our Chief E xecutive:

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r.!1:kj CARE. COMMUNICATE. Milton Keynes COUABO CONTRIBUTE. University Hospital NHS Foundation Trust can be added to assessments that will pull through observations at that time point. The downside to this will be that observations will not be corroborated in real time and some readings may be artefactual if monitoring is not correctly attached at the time (dampened arterial line trace, sats probe that is incorrectly positioned etc) leading to inaccurate data. In the longer term, Spacelabs lntesys Clinical Suite held in the central station should be able to store 72 hours of data for a patient who has been on a monitor in ICU (or elsewhere in the hospital) and has since been discharged from that monitor. 72 hours of data can be accessed from the moment a patient is discharged. However, the amount of data available reduces over that time frame as it's not designed as a data repository. A business case is being produced to draw up a contract between Spacelabs and IT to further consider this option. An action plan detailing ongoing work is included at Appendix 2. Pagination and Indexing of Notes for Court Disclosure Response There is a meeting between your team and the MKUH Director of Corporate Affairs,

and Head of Clinical Governance and Risk, Tina Worth, on 19 July to discuss potential options and agree next steps to ensure disclosures to the Court are made appropriately, coherently and accessibly. I trust that this response is satisfactory and as always, please do contact me if you would like any further information or assurance on any of the areas above.