Dear Dr Cummings Regulation 28: Report to Prevent Future Deaths I write in response to the Regulation 28 report you issued on 06 September, following on from the Inquest you held into the death of Mrs Glenda May Logsdail (on 23 August
2020) which concluded on 06 July 2021. This report was issued to me, along with . It is a matter of profound regret that this incident occurred in this organisation, and it is a seminal event for us. Our thoughts remain with Mrs Logsdail's family and friends. I had hoped that we had been able to assure you at the Inquest of the steps we are taking locally to reduce the chance that an incident ofthis nature might recur in Milton Keynes (through the evidence of Trust employees and updates on progress against the actions articulated in the root cause analysis - RCA - report). I will not duplicate the detailed content of our RCA action plan here other than to remind you that our actions fall into the following categories:
1. At the practitioner level we have managed, and continue to manage, the individuals involved in the incident in association with relevant regulators and Practitioner Performance Advice (NHS Resolution). Our primary emphasis is on patient safety, and appropriate levels of supervision and support are in place.
2. In relation to systems and processes, we have shared resources in relation to 'no trace, wrong place' widely within the organisation, we have implemented the Association of Anaesthetists Quick Reference Handbook in our theatres, and we have ensured (as covered at Inquest) that monitor configuration across theatres is standardised. q .. Mtoctun o ho:.p 1rat \A"f ~anduc:t • c:h,co1oon nnd re54K1rch 10 1rnoro-w hMc Uhcota lur o ur

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3. In relation to wider environment and culture we continue with an extensive programme of simulation training and human factors work, both in our state-of­ the-art skills laboratory and in-situ. This work is a mixture of in-house and collaborative - we have commissioned a bespoke theatre human factors programme with Cranfield University. We continue to work with all staff ­ including the multi-professional theatres team - on teamwork, raising concerns and flattening hierarchy. This work involves optimising team communication, advocating the freedom to speak up route, and a novel programme of 'appreciative inquiry' - a strengths-based change management methodology which engages staff in the workplace. Working with experts, this work is being implemented across maternity, ED and theatres.
4. Regarding wider learning, you have shared the Regulation 28 report with the Chief Medical Officer and the President of the Royal College of Anaesthetists (RCoA). You noted that the penetration ofthe 'no trace, wrong place' message (the campaign as opposed to the science/ physiology) was incomplete. In our view, the effectiveness of this campaign is an area for RCoA to evaluate and optimise, rather than drawing conclusions specific to this organisation. You will recall from our RCA report and associated evidence that we attempted to refer this case to HSIB for further work. Whilst HSIB has not progressed the referral, we continue to believe that this would be the optimal approach. I hope that will consider making additional representations to HSIB. We are in touch with the Association of Anaesthetists and remain committed to working with the association - and all other relevant organisations - to reduce the likelihood of a recurrence both here and elsewhere in healthcare. We would be happy to share our RCA action plan with you again should that be helpful. I hope that this response is helpful.

Dear Dr Cummings,

Re: Regulation 28: Report to Prevent Future Deaths in the matter of Mrs Glenda May Logsdail

Thank you for giving the Royal College of Anaesthetists (RCoA) the opportunity to respond to your Regulation 28 Report highlighting your concerns regarding the tragic death of Mrs Logsdail. The RCoA has collaborated with the Association of Anaesthetists and the Difficult Airway Society (DAS) in the preparation of this response and action plan. It is of great concern to the RCoA, the Association and DAS that an avoidable death resulting from failure to identify and appropriately manage a misplaced tracheal tube has happened, despite the previous work of the speciality to try to ensure that oesophageal intubations are swiftly recognised and corrected.

We will seek to address the issues highlighted by Mrs Logsdail’s case through a coordinated campaign to disseminate and embed the lessons to be learned into practice. Key aspects of the campaign are described below.

Your report highlights the critical importance of human factors in safe anaesthetic practice. Multidisciplinary team training has an important role to play in rehearsing emergency drills, embedding non-technical skills in practice and allowing teams to learn how to function well as a whole within a flattened hierarchy. Regular, multidisciplinary team training is one of the standards for our Anaesthesia Clinical Services Accreditation (ACSA) scheme. However, in practice, it is a standard that many departments find difficult to meet to an adequate level due to the pressure on theatre time. To support this, we will:

• Develop resources for multidisciplinary team training on the subject of unrecognised oesophageal intubation, including short scenarios to limit the need for theatre downtime
• Ask Clinical Directors in every UK anaesthetic department to confirm how they have used these resources, via an evaluation form
• Work with stakeholders to highlight the importance of theatre teams having sufficient time to undertake essential emergency drills training.

In situ multidisciplinary team training for emergency scenarios can also highlight systemic issues that can affect a team’s response in an emergency. Your report highlights the variable configurations of monitors across the hospital as one such issue. We will work with the Association of Anaesthetic and Respiratory Device Suppliers (Barema) to support the development of

engineered solutions to the issue of variable and different configurations of the displays and alarms notifications of monitors.

It is disappointing that both the anaesthetist involved in the case and the author of the incident investigation report were not aware of the “Capnography in Cardiac Arrest: No Trace = Wrong Place” video. This was published in 2018 and was widely promoted through the RCoA’s, the Association’s and DAS’s communication channels. We recognise that much of this promotional activity was concentrated in a relatively short period of time. We plan for the following coordinated actions to take place over the next year. We will:

• Spread the key lessons to be learned through RCoA, Association and DAS journals, newsletters and social media
• Present the lessons to be learned at key educational events including the DAS Annual Conference, the Safe Anaesthesia Liaison Group Annual Conference, the RCoA Winter Symposium and the Association’s Winter Scientific Meeting
• Work with stakeholders such as the College of Operating Department Practitioners and the Association for Perioperative Practice to ensure that the key messages are heard by the whole theatre team
• Work with other Royal Colleges to ensure that the key messages are shared with all medical professionals who undertake intubation.

We hope that these proposed actions will satisfy you that we are taking appropriate steps to ensure that anaesthetists and the wider theatre team are aware of these issues and, most importantly, that these steps make future, similar tragedies less likely to occur.

We would be happy to respond to any questions that you might have.

Dear Dr Cummings, Thank you for your letter of 6 September 2021 to , Chief Medical Officer for England, about the death of Glenda May Logsdail. I am replying as Minister with portfolio responsibility for patient safety and I am grateful for the additional time in which to do so. Firstly, I would like to say how deeply shocked and saddened I was to read of the circumstances of Mrs Logsdail’s death and I offer my heartfelt condolences to Mrs Logsdail’s family and loved ones. That Mrs Logsdail’s death was avoidable must be particularly distressing and it is essential we do all we can to ensure such failings in care do not occur again. I expect the Milton Keynes University Hospital NHS Foundation Trust and the Royal College of Anaesthetists (RCA) respectively, to address your concerns about the specific circumstances and failings described, and awareness of the Royal College’s campaign on capnography in cardiac arrest (‘No Trace, Wrong Place’). My response will comment on the national level aspects in relation to your concerns, in particular, training in relation to multi-disciplinary team working in an emergency situation, and display configurations on anaesthetic machines and multiparameter monitors. In preparing this response, my officials have taken advice from Health Education England (HEE); NHS England and NHS Improvement (NHSEI); and the Medicines and Healthcare products Regulatory Agency (MHRA). Multi-disciplinary team working and training for an emergency situation In relation to your concerns about multi-disciplinary team working in an emergency situation, you may wish to note that specific simulation-based training for emergency skills and team-based drills in specialised areas of clinical practice, such as the operating theatre, is the responsibility of, and delivered by, individual NHS trusts, based on the

availability of appropriate simulation resources and time for clinical trainers to support this practice.

At a national level, HEE is taking a number of proactive steps to strengthen multi- professional supervision, with a view to delivering consistent quality standards across the system and breaking down silos between clinical professions.

HEE, via its Technology Enhanced Learning (TEL) programme is currently implementing a specialty training recovery project that is seeking to enhance the use of simulation-based training across all postgraduate specialties. One specific theme within this work, is developing professional capabilities that support team-based practice in complex or life- threatening situations. These capabilities will be based on individual specialty curricula and the national patient safety syllabus. They will include clinical leadership, decision making, and developing effective teamworking skills and behaviours.

As part of TEL, HEE is also seeking to develop standards in simulation-based education and training that will help ensure high quality practice across different providers. This includes a national development programme that can be accessed by educators and practitioners from all specialities and professions. Specific learning outcomes within this programme will include transferrable skills of observing and supervising performance and debriefing clinical colleagues and multi-professional teams in the clinical setting. These attributes are fundamental when creating trust and respect within teams and hence critical to delivering safe, effective team-based care in life threatening situations.

HEE is also piloting a unique simulation and competency assessment methodology that is applicable to multi-professional team training for high risk clinical settings. This will offer the opportunity to create personalised development plans for individual participants and local teams. This will also provide more objective assurance of meeting these needs for clinical service leaders.

You may wish to note that in May 2020, the Academy of Medical Royal Colleges (AoMRC) published guidance on developing professional identity within multi-professional teams. The principles outlined in the AoMRC document shape the work of specialty schools and faculties in developing training environments. Specific elements of this training are offered to multi-professional participants and address team-based skills and behaviours that are important in responding to acute medical emergencies.

Variable configurations in relation to the displays on ventilators used in operating theatres, anaesthetic rooms and intensive treatment units

The MHRA is the regulator for medical devices in the UK. The MHRA has reviewed your report and has noted that it does not suggest a device failure or widespread user error.

By way of background, the MHRA has explained that during anaesthesia, capnography is typically displayed in two places: the screen of the anaesthetic machine itself; and, the screen of the multiparameter monitor. The anaesthetic machine delivers oxygen, air and gaseous anaesthetic drugs to the patient and these can be delivered under the manual control of the anaesthetist or using various methods of mechanical ventilation. The screen of these devices typically displays the measurements of gasses inhaled and exhaled by

the patient. This can include capnography labelled ‘end tidal CO2’ or ‘ETCO2’. The layout of this display is bespoke to the manufacturers design. However, this is usually consistent across that manufacturers range.

It should be noted that anaesthetic machines are very different from intensive care ventilators, which serve a different purpose. Therefore, the display of an anaesthetic machine is very different to that of a ventilator, though there are some similarities in the information that is given.

A multiparameter monitoring system is a medical device designed to monitor a number of different aspects of the patient’s physiology. This can include oxygen saturation, non- invasive and invasive blood pressure, electrocardiogram (ECG) and inhaled and exhaled gasses. The information displayed and layout of the screen of these devices can be customised, within certain parameters, by the user according to their specific need. This is an important feature of this device as they are used in many settings throughout a hospital such as high-dependency and intensive care units. These devices can also be integrated into anaesthetic machines to provide the monitoring needed during anaesthesia.

ISO standard, ISO 80601-2-13:2011 A2:2019, states that it is not compulsory for an anaesthetic machine to have built in CO2 monitoring equipment. Therefore, it should not be assumed that this information will be displayed on the screen of the anaesthetic machine itself.

The standard dictates that if the anaesthetic machine does not contain built in CO2 monitoring, a statement to users informing them of the need to equip such a monitoring device to the machine before putting it into use should be placed in the devices instructions for use.

This highlights the importance of users familiarising themselves with the instructions and function of medical devices before attempting to use them.

If CO2 monitoring equipment is installed on the device, then the information displayed should be clearly labelled and easy to recognise.

End tidal capnography readings are distinctive and anaesthetists will be taught to recognise these as part of their training. The display and alarm settings for all gas readings for these devices should conform, or be equivalent to, ISO 80601-2-55:2018, which dictates the basic safety and essential performance of respiratory gas monitors.

The displays of the multiparameter monitors used during anaesthesia have to be customisable so they can accommodate the different types of monitoring devices, which may be required for different types of anaesthesia and surgery being undertaken. This is necessary because the needs of the patient vary according to the complexity of the surgery being undertaken. If there was standardisation, this would either remove this flexibility or require unnecessary monitoring parameters where they are not essential. This in turn would have unintended impacts on patient safety.

Any gas readings measured and displayed by this device should also conform, or be equivalent to, ISO 80601-2-55:2018. If an anaesthetic machine does not have built in CO2

monitoring, then the multiparameter monitor would be the most logical place to integrate this type of monitoring. This can be achieved by the addition of an attachable module.

The MHRA’s document on Managing Medical Devices1, contains guidance for first time users of a device. This includes confirming that the user has received adequate training on the use of the device, as well as the user ensuring they have read the manufacturers and any local instructions for use.

Training for anaesthetists and intensivists in complex anaesthesia for complicated surgical procedures, should include methods that enable anaesthetists and intensivists to check the patient’s physical condition to verify the readings on any monitors. This would include actions such as observing the patient’s chest to ensure equal rise and fall as well as auscultation of the lungs for air ingress. These actions, among others, if undertaken should provide adequate risk mitigation for any malfunctions or misinterpretation of CO2 monitoring, as well as ensuring that a patient was being ventilated.

The MHRA recognises the complexity of some device’s instructions for use. The Managing Medical Devices document advises that NHS trusts can produce their own local instructions for use for devices and are encouraged to do so when multiple devices are used together in one system. However, it is advised that these instructions are checked with the manufacturer to ensure accuracy.

The Managing Medical Devices document also contains advice for NHS trusts on the purchasing of equipment and attempting to assure, where possible, that there is uniformity to the equipment purchased to avoid user confusion.

Anaesthetists should know the importance of being entirely familiar with the monitoring they use within their own institution, and if they are unfamiliar, should not start an episode of patient care until they are, or receive the appropriate help.

All monitors have alarms and setting them should be routine practice for any clinician using monitoring devices. This should be done in accordance with The Association of Anaesthetists specialty guidance2.

Conclusion

I hope this response is helpful and provides the necessary information to address your concerns.

It is essential that the Milton Keynes University Hospital NHS Foundation Trust takes the action necessary to ensure the safety of its patients and the quality of the care it provides, and I am aware that it has provided detail to you on the actions it has taken as a result of Mrs Logsdail’s sad death.

1 Safeguarding public health (publishing.service.gov.uk)

2 Recommendations for standards of monitoring during anaesthesia and recovery 2021 (anaesthetists.org)

My officials have brought your report to the attention of the Care Quality Commission (CQC), the independent regulator for care quality, and I am advised that the CQC has sought and received assurances from the Trust on the actions it has taken following Mrs Logsdail’s death.

Finally, I am aware that the Trust referred this incident to the Healthcare Safety Investigations Branch (HSIB) to consider if it met its criteria for national investigation. I am informed that HSIB determined that this was not suitable for investigation. However, the information is helpful to HSIB’s intelligence monitoring processes and can be used to inform any future work that might take place in this area.

Thank you for bringing your concerns to my attention.

MARIA CAULFIELD MP PARLIAMENTARY UNDER SECRETARY OF STATE FOR PRIMARY CARE

Dear Dr Cummings,

Re: Regulation 28: Report to Prevent Future Deaths in the matter of Mrs Glenda May Logsdail

On 27 October 2021, we responded to your Regulation 28 Report highlighting your concerns regarding the tragic death of Mrs Logsdail. The Royal College of Anaesthetists (RCoA), in collaboration with the Association of Anaesthetists and the Difficult Airway Society (DAS), committed to an action plan in this response and this letter is to update you on the progress that has been made over the past year.

We launched a coordinated campaign to disseminate the key learning points from Mrs Logsdail’s case to our specialty. This included the following actions:
• We launched a dedicated webpage www.rcoa.ac.uk/safety-standards-quality/patient- safety/prevention-future-deaths, which has been viewed over 12,000 times. This webpage also repromoted the original “No trace, wrong place” video, which has been viewed over 7,500 times since November 2021.
• There have been educational talks at more than ten events across the year to over 5,000 delegates. Of particular note is the session that we devoted to Mrs Logsdail’s case at the RCoA’s Winter Symposium 2021. This was carried out in the presence of representatives of Mrs Logsdail’s family. We have made key talks freely available online on our webpage.
• Multiple articles across the year have been published in the RCoA’s, the Association’s and the Difficult Airway Society’s members’ magazines and newsletters, which are distributed directly to all our members.
• Articles and editorials have also been published in the speciality’s most popular peer- reviewed journals the “British Journal of Anaesthesia” and “Anaesthesia”.
• We have promoted the campaign on social media platforms as well. As an example, one Twitter thread on the topic of Mrs Logsdail’s death had over 375,000 impressions.

To help embed the key messages of the campaign into practice, and recognising the critical importance of human factors in safe anaesthetic practice, we developed resources for multidisciplinary team training on the subject of oesophageal intubation. One of these resources were a set of flashcards, short scenarios that could be delivered with no need for theatre downtime. The flashcards have been downloaded over 2,000 times. Colleagues at the Royal United Hospital Bath developed a package of “tea trolley” training on the subject of oesophageal intubation, which has also been made freely available on our webpage.

At the end of 2021, we wrote to all Clinical Directors of departments of anaesthesia in the UK and asked them to promote the campaign and trial the use of the flashcards in their departments. Despite this period coinciding with another wave of the covid-19 pandemic, we received responses from 55% of departments. In those that responded, 80% had used multidisciplinary team training to disseminate the key messages to prevent unrecognised oesophageal intubation. We continue to promote the need for theatre teams to have sufficient time to train together through all of our guidance and quality improvement work.

Your report highlighted the variable configurations of monitors across the hospital as a systemic human factors issue. We continue to work with the Association of Anaesthetic and Respiratory Device Suppliers (Barema) to support the development of engineered solutions to the issue of variable and different configurations of the displays and alarms notifications of monitors.

Unrecognised oesophageal intubation is an issue that affects not just anaesthesia in the UK and we have shared the lessons to be learned from Mrs Logsdail’s death with colleagues abroad as well through educational talks to organisations such as the European Airway Management Society, the Australian Safe Airway Society and to the International Anaesthesia and Acute Care Conference in the United Arab Emirates.

We have worked to ensure that other professionals involved in intubation are made aware of the key messages of the campaign. We wrote articles for the Faculty of Intensive Care Medicine’s member magazine, the College of Operating Department Practitioners’ newsletter and the National Freedom to Speak Up Guardian blog. We have also shared our resources with colleagues in intensive care and emergency medicine.

We recognise that there is still more that can be done:
• We will continue to regularly disseminate the key messages about preventing unrecognised oesophageal intubation to our members.
• In January 2022, the Association and the Difficult Airway Society launch their Human Factors guidance for Anaesthesia. We will work together to promote and embed the recommendations from this guidance in practice.
• We will develop more resources for multidisciplinary team training through the RCoA’s simulation workstream.
• We will maintain our work to prevent unrecognised oesophageal intubation through the Safe Anaesthesia Liaison Group, which is a collaborative project between the Association of Anaesthetists, the Royal College of Anaesthetists and NHS England.

We hope that you can agree that we are taking appropriate steps to ensure that anaesthetists and the wider theatre team are aware of these issues and, most importantly, that these steps make future, similar tragedies less likely to occur.

We would be happy to respond to any questions that you might have.