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Ehi Iden, Chief Executive Officer of the Occupational Health and Safety Managers, shares with the hub his blog 'Safety of the patients and correlation with the safety of the healthcare workers' (see attachment below). He also share the interview he did for TVC News Nigeria on World Patient Safety Day. Images from the day

In our recent blog Analysing the Cumberlege Review; Who should join the dots for patient safety? we identified a number of key patient safety issues which were reflected in the Review’s findings. One theme running throughout the Review was a failure to engage patients in their care, most noticeably around the issue of informed consent. What is informed consent? The NHS definition of informed consent is that “the person must be given all of the information about what the treatment involves, including the benefits and risks, whether there are reasonable alternative treatments, and what will happen if treatment does not go ahead”.[1] The landmark UK Supreme Court judgement Montgomery v Lanarkshire Health Board case in 2015 reaffirmed this principle in law, setting out the legal duty of doctors to disclose information to patients regarding risks.[2] Review findings Patients being unable to make decisions on the basis of informed consent was a recurring theme in the review, manifesting itself in several ways: Patients’ consent not being sought - the Review heard from patients where consent was not given for the procedure carried out, particularly in cases for implanting pelvic mesh. The authors of the Review state that they were “appalled by the numbers of women who have come forward to say they never knew they had had mesh inserted, or where they gave consent for ‘tape’ insertion they did not know they were being implanted with polypropylene mesh”.[3] Patients lacking information – this was a consistent issue concerning patients regarding the three interventions considered by the Review: hormone pregnancy tests, sodium valproate and pelvic mesh implants. One specific example of this is the case of pregnant women taking sodium valproate as an epilepsy treatment without knowing that doing so could harm their unborn child. Despite efforts to make patients aware of this, it remains an issue, with women who are taking sodium valproate as a epilepsy treatment “still becoming pregnant without any knowledge of the risks”, lacking the information to make the decision about whether to continue with this medication.[4] Patients not being involved in decision making – the Review also heard from patients who raised concerns about the failure of informed consent as a result of doctors choosing not to share relevant information with patients for their decision-making. They refer to cases where doctors did not discuss the risks with women taking sodium valproate prior to pregnancies and “gave advice based on their own assumptions, without involving patients in the decision-making process”.[5] Concerns around the absence of informed consent go beyond the procedures focused on in the Review. On the hub, we have featured community discussions and patient accounts of these issues in relation to hysteroscopy procedures, while earlier in the year the Paterson Inquiry highlighted concerns about this, recommending that a short period should be introduced into surgical procedures to allow for patients to provide their consent.[6] How can we ensure informed consent is gained? The Cumberlege Review notes that, since the Montgomery ruling in 2015, there has been a significant increase in patient safety leaflets sharing information on risks of specific treatments, but that the sheer variety of these and differing consent forms can be “bewildering and a major source of confusion”.[7] The Review is supportive of an approach where information is conveyed in a clear and direct way, and where patient decision aids are used in complex conversations to support the consent process.[8] At Patient Safety Learning, we believe it is important that patients are not simply treated as passive participants in the process of their care. Informed consent is vital to respecting the rights of the patient, maintaining trust in the patient-clinician relationship and ensuring safe care. We have identified three calls for action which we believe are needed to tackle the failure of informed consent: All patient information should be co-produced with patients to ensure that it meets patient needs for decision-making. Repositories of information and good practice are put in place so that organisations don’t have to re-invent the wheel but instead can learn from experience. Patient information for medication and medical devices should be reviewed and signed off by the NHS to ensure that it is not solely the responsibility of manufacturers. What are your thoughts on this issue? Have you had an experience where you feel that you have not given informed consent before receiving medical care? Are you a healthcare professional who can share resources for good practice? Let us know in the comments below to ensure our calls for action are informed by your experience and insights. References NHS England, Consent to treatment, Last Accessed 16 July 2020. https://www.nhs.uk/conditions/consent-to-treatment/ UK Supreme Court, Montgomery v Lanarkshire Health Board, 2015. https://www.supremecourt.uk/cases/docs/uksc-2013-0136-judgment.pdf; Lee, Albert. “'Bolam' to 'Montgomery' is result of evolutionary change of medical practice towards 'patient-centred care'.” Postgraduate medical journal vol. 93,1095 (2017): 46-50. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5256237/#R3 The Independent Medicines and Medical Devices Safety Review, First Do No Harm, 8 July 2020. https://www.immdsreview.org.uk/downloads/IMMDSReview_Web.pdf Ibid. Ibid. Campaign Against Painful Hysteroscopy, Patients Stories Essay, September 2018. https://www.hysteroscopyaction.org.uk/wp-content/uploads/2018/10/sept-2018.pdf; The Right Reverend Graham Jones, Report of the Independent Inquiry into the Issues raised by Paterson, 2020. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/863211/issues -raised-by-paterson-independent-inquiry-report-web-accessible.pdf The Independent Medicines and Medical Devices Safety Review, First Do No Harm, 8 July 2020. https://www.immdsreview.org.uk/downloads/IMMDSReview_Web.pdf Ibid.

During the debate there were contributions from a range of parliamentarians reflecting on the First Do No Harm report and the implementation of its recommendations in Scotland. Some points of interest from the debate included: Jeane Freeman MSP indicated the intention of the Scottish Government to implement the recommendations of the First Do No Harm report which fall within its remit and powers. Their discussion about the report's recommendation that specialist centres should be set up to provide comprehensive treatment, care and advice for those affected by implanted mesh. While Jeane Freeman noted that a National Mesh Removal Service had been established in Glasgow last year, Neil Findlay MSP expressed concerns that the levels of coproduction involved in the design and delivery of this service were inadequate. Alison Johnstone MSP highlighted the particular impact of these issues on women and noted nthat the findings reflected the ways in which women are disadvantaged in accessed health and social care services. In her closing remarks Clare Haughey MSP, Minister for Mental Health, noted the intention to begin a consultation on the Scottish Government's proposal to introduce a Patient Safety Commissioner. Follow the link below for the full transcript.

I have included this poignant video as a matter of public interest. This is an issue which goes beyond party politics. I use Robbie's story in all of my teaching on ethics and clinical governance.

Allow me to start this essay with a real personal story: more than a decade ago, while I was doing my Transplant & Hepato-Biliary Surgery fellowship in the USA, I had to have elective orthopaedic surgery. The good news was the hospital where I was about to have the surgery was the number one in the US News Ranking for Orthopedics that year. The bad news was that I was literally ‘terrified’ while I was in the pre-op holding area, just before I was wheeled into the operating room! How could that be? Me: the surgeon, terrified of having a straightforward orthopaedic procedure in the number one orthopaedic surgery hospital in the US? The answer was yes. It was precisely for this reason – that I am a surgeon who knew what could go wrong in a clinical unit like the OR and that I was terrified of becoming just another casualty of a medical error! Back in 2016, in their book 'Safer Healthcare', Charles Vincent and Rene Amalberti beautifully articulated the safety levels in hospitals where they classified five levels of care: Level 1: The care envisaged by standards. Level 2: Compliance with standards / ordinary care with imperfections. Level 3: Unreliable care / poor quality, but the patient escapes harm. Level 4: Poor care with probable minor harm but overall benefits. Level 5: Care where harm undermines any benefit obtained. As a practicing healthcare professional (a surgeon), I can, unfortunately, say that the majority of clinical units in hospitals are performing around Level 3 (unreliable care / poor quality, but the patient escapes harm) with fluctuations towards Level 4 (poor care with probable minor harm but overall benefits) for below-average performers or Level 2 (compliance with standards / ordinary care with imperfections) for a very few leading medical centres... sometimes! Patient safety was defined as the absence of harm. I believe it is time to define patient safety using a patient-centric approach where patient safety can be defined as the absence of harm for each patient, by the right person(s), at the right time(s) and the right place(s). Such definition would help us think about a systemic and individual framework to safety, where safety is customised to every patient, all the time, in the backdrop of a safe clinical unit. Last year marked the 20th anniversary of the landmark paper 'To Err is Human'. Although the past 20 years have seen much progress in the understanding of the healthcare safety which helped bridge the knowledge gap in this significant field, we still have a significant implementation and structural gap, which continues to contribute to the ongoing inherently weak safety conditions for patients. The main reason for writing this essay is to say that 20 years after To Err is Human, the majority of hospitals are treading around Level 3 (mediocre patient safety conditions to use layman’s terms!). Such a situation is entirely unacceptable for high-reliability industries like aviation, nuclear, and oil and gas. Fifty to sixty years ago, these industries were not as safe as they are today but reached their watershed moments (tipping point) and had to transform their safety practices. This essay is a call for action to highlight the following: Healthcare continues to be structurally weak when it comes to the safety conditions. This lack of resilience leads to ongoing medical errors and harm to patients. There is an urgent need for us to have a paradigm shift in the way we think about patient safety and how we implement it while providing healthcare. As healthcare systems are complex adaptive systems, the only way to do that is to build resilience in the system. Here are my practical solutions: Adopting co-production principles: co-design, co-delivery and co-assessment. Introducing complementary checklists for both patients and healthcare professionals throughout the patient journey. Safety reconciliation: transition of care or any patient transfer carries potential patient harm – e.g., fall, tubes or IV dislodgement, communication failure with new staff members, such as radiology department technicians, etc. Hence, it is vital that a safety reconciliation is performed by both the patient/families and healthcare professionals (co-production) using checklists. Leveraging implementation science: by introducing safety principles into the day to day clinical practices at the bedside (undergraduate, postgraduate, and board-certified practitioners). Human Factors Engineering (HFE): introducing HFE principles into bedside clinical practice – e.g., effective communication, situational awareness, flat hierarchy and team-based simulated learning – will introduce resilience into the system and help reduce potential harm to patients.

Hazardous Hospitals: Cultures of Safety in NHS General Hospitals, c.1960-Present is a three-year research project at the University of Warwick, funded by the Wellcome Trust. It is being conducted by Dr Christopher Sirrs. The publication of the Francis Report into healthcare failures at Mid Staffordshire NHS Foundation Trust in 2013 dramatically refocused public and political attention on issues of ‘safety’ in the National Health Service. ‘Safety’ has increasingly occupied the attention of policy makers in recent decades, with hospital managers establishing various systems and processes to protect patients and staff from harm. These include learning and reporting systems, policies about patient consultation, and campaigns for preventing harms such as falls and healthcare-associated infections. However, little is understood about how and why these ideas and practices around ‘safety’ in the NHS evolved. This three-year project explores the history of safety in the NHS, highlighting how hospitals have promoted ‘safety cultures’: ideas, values and behaviours which support safety. Drawing upon a rich seam of archival material, as well as a distinctive methodology, it makes timely contribution to historical understandings of the NHS. The project asks the following key questions: 1. What defines the ‘safety culture’ of NHS hospitals? How can these ‘safety cultures’ vary? 2. How was safety in hospitals assessed, and in what ways did it come to the attention of NHS managers and policymakers after 1960? 3. How did NHS managers promote safety among their staff? 4. What role did groups such as patient organisations, safety campaigners and the press play in depicting, challenging and promoting reform of hospital ‘safety cultures’? The project will directly engage individuals and organisations involved in promoting or campaigning for safety in the NHS. Interviews will also be conducted with a wide range of individuals. If you are interested in participating in the project, please see the ‘Participate‘ page for more information. You can follow the project via @hazardhospitals or, for more information follow the link below.