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Found 162 results
  1. Content Article
    Practical guidance on the application of human factors in the investigation process is presented. Nine principles for incorporating human factors into learning investigations are identified: 1. Be prepared to accept a broad range of types and standards of evidence. 2. Seek opportunities for learning beyond actual loss events. 3. Avoid searching for blame. 4. Adopt a systems approach. 5. Identify and understand both the situational and contextual factors associated with the event. 6. Recognise the potential for difference between the way work is imagined and the way work is actually done. 7. Accept that learning means changing. 8. Understand that learning will only be enduring if change is embedded in a culture of learning and continuous improvement. 9. Do not confuse recommendations with solutions.
  2. News Article
    In many ways it is wrong to talk about the NHS restarting non-coronavirus care. A lot of it never stopped — births, for instance, cannot be delayed because of a pandemic. However, exactly what that care looks like is likely to be very different from what came before. There are more video and telephone consultations and staff treat patients from behind masks and visors. That is likely to be the case for some time, experts have told The Times. Read full story (paywalled) Source: The Times, 6 June 2020
  3. Content Article
    The authors conducted a qualitative interview study with 22 accident investigators from different domains in Sweden. They found a wide range of factors that led investigations away from the ideal, most which more resembled factors involved in organisational accidents, rather than reflecting flawed thinking. One particular limitation of investigation was that many investigations stop the analysis at the level of “preventable causes”, the level where remedies that were currently practical to implement could be found. This could potentially limit the usefulness of using investigations to get a view on the “big picture” of causes of accidents as a basis for further remedial actions.
  4. Content Article
    Healthcare safety is complex every day – yet the emergence of the novel coronavirus has made holes in the Swiss cheese of the system more apparent. UK psychologist James Reason’s now famous “Swiss Cheese Model” serves as a metaphor for this month’s Letter from America. As more details on the coronavirus emerge, and time enables reflection on what has transpired, deeper analyses will no doubt materialise. Knowledge is developing in real time, helping us see gaps in our safety barriers and providing valuable insight to the challenge of reducing harm. The Swiss Cheese model illustrates how latent weaknesses in the protective barriers that systems build exist and become more apparent after failures occur – if we look for them. COVID-19 is just such a test; it is amplifying the holes in today’s healthcare system. A recent New Yorker essay highlights the known weaknesses in healthcare visible long before COVID-19 – racial inequities, bureaucratic inefficiencies, drug shortages, under resourced public health initiatives and fiscal prioritisation to the detriment of preparedness. Others are more specific to the pandemic: lack of access to personal protective equipment and medical devices, supply chain disruptions, hording behaviours, misinformation and patients not seeking chronic, emergency or preventive care. The essay suggests that we should not seek to return to this “normal”, but to learn, revise and improve. Holes in processes to keep patients and workers safe are also expanding as the cheese melts. Healthcare worker illness, psychological strain and suicide are revealing fractures across US healthcare delivery that undermine the ability of clinicians to provide care as they work to keep patients and themselves safe. The US National Academies of Medicine has outlined an approach to protect clinicians’ wellbeing. Through a focus on organisational and national priorities, it aims to help sideline the negative after-effects that first responders to the COVID-19 crisis may experience through a call for funding, epidemiology and real-time support for providers. Efforts to diagnose COVID-19 are thick slices of cheese with a myriad of holes that affect both clinical and policy responses. As summarised in a recent commentary, the system response is a fundamental challenge: measurement is a mess, data are inconclusive, testing processes are inconsistent and results in some cases unreliable. While this state of affairs is rapidly changing, foundational concerns are likely to remain. Economic support for organisations and States rests on the data that are apt to be skewed, ineffective and counterproductive. The international disease codes used to document COVID-19 cases are being imprecisely applied. The authors of the commentary provide suggestions to impove the use of the diagnostic codes and thus the quality of the data collected. Actions in this area are needed to inform the research so we can understand what has happened and fund and design public health initiatives and reopening strategies that enable containment, testing and equitable treatment. As time passes, suggestions for improvement informed by national and local experience appear. Communities are painfully aware of the situation COVID-19 places them in. Experts there are contextually situated to address local challenges such as population instability due to unemployment, homelessness and food insecurity. A Health Affairs blog calls for strengthening the community-based workforce to assist in propping up vulnerable populations after disaster of any kind strikes, including COVID-19. Community health workers, volunteers and nonprofit organisations are highlighted as important players in testing and contact tracing strategy implementation, psychological support provision and establishment of the infrastructure communities need to face their specific challenges. It will take resources, tenacity and courage to facilitate and sustain community level COVID-19 response. Watching media coverage can be overwhelming but can also illustrate the complexity of addressing the disruptive tendencies of the coronavirus pandemic. Newspapers and healthcare media services can provide insight into the system-level complexity of the pandemic. These services are flagging and providing access to articles from the press or literature to provide a well-rounded collection of materials to track what is happening. It’s one way to remain keep abreast of the issues: who from racial, ethnic and socioeconomic groups are impacted, what programmes and industries are being altered, where specifically in the US the virus touches, when the threat emerged to affect a particular segment of the population or workforce and why the connections between them all are important to consider. This is highlighted in a recent commentary in the Lancet, which illustrated some of the interacting components in a society responding to the threat of COVID. Tools such as these can assist in keeping us informed to combat weaknesses in failure barriers that emerge due to bias from listening to one outlet or seeking only one point of view. No matter what slice of the COVID-19 Swiss cheese sits on the plate in front of us – its holes are apparent. Experts are calling for coordinated system-wide action to prevent further loss of life and economic hardships. Other challenges are likely to emerge the longer COVID-19 influences lives. We all need to learn from the lack of success during the current response manifestation and use those insights to inform actions to prepare for the next virus wave. It will help to navigate future choppy, uncharted waters. To prepare for the 'new normal', courage to see value in failure is paramount. We should also proactively apply learnings based on what went well to better prepare organisations, systems and governments to close holes in the global approach before the next wave.
  5. Content Article
    Patient Safety Learning works with experts on guidance around ventilator safety As part of the Government’s fast track approach to the development of ventilators, the Medicines & Healthcare products Regulatory Agency (MHRA) issued guidance for clinical requirements based on ‘minimally acceptable’ performance. [2] Patient Safety Learning approached a range of human factors/ergonomics experts, asking for their input on the procurement of these new ventilators due to the involvement of new manufacturers, flexing of established guidelines and ‘safety in use’ issues. We asked them what they believed the key issues were in ensuring that these ventilators are safe in use. Experts did express concerns, identifying several risks: By moving at speed and developing non-standard ventilators (with some manufacturers with no prior experience in this area), we may unintentionally be designing a system than has numerous points of failure, increasing risk for patients. How ventilators can be used safely, particularly for staff redeployed in the pandemic who may be inexperienced or untrained in using them. How safe will ventilators be to operate for staff wearing full Personal Protective Equipment (PPE)? Should patients die as a result of safety problems with ventilators, their deaths may not be identified as such, instead being attributed to Covid-19. There are already known safety issues relating to the use of ventilators. For example, there are currently multiple designs of machines used by the NHS, with different training requirements for different devices. We worked with this expert group, who provided detailed advice and guidance to address these risks. Patient Safety Learning then immediately developed proposals for urgent action to ensure that ventilators are safe for use with patients. We called for the healthcare system to work at a pace, together with manufacturers and experts in human factors/ergonomics, in order to minimise the usability safety risks. With our proposals, we provided details of what is required to ensure ventilator safety in use. Experts called for the MPV (Minimum Viable Product) specification to be revised to reflect ‘safety in use’ requirements with an immediate design, development and test sprint approach with human engineering user trials, task analysis and hazard analysis. NHS and Chartered Institute of Ergonomics and Human Factors (CIEHF) work quickly to design new guidance So, what happened next? Initially there was a swift response. NHS England and NHS Improvement asked the CIEHF to provide designers and manufacturers with guidance aiding the rapid production of new ventilators. CIEHF subsequently designed guidance, sending it to NHS England within 48 hours. The guide, Human Factors in the Design and Operation of Ventilators for Covid-19, was then to be sent to manufacturers of ventilators in the UK.[3] Soon after CIEHF also developed a ‘rapid and easy to use’ testing protocol to assist manufacturers with testing. CIEHF have developed overarching advice and guidance and testing protocol. To support this, a detailed set of user requirements has been developed by Dr Sue Whalley Lloyd and Karen Priestly. They have worked with, and adapted, Yorkshire Water’s general human factors guidance and have produced a detailed Engineering Specification: Ventilator HF Design guidance. We need to address the risk to patient safety We’ve seen an enormous amount of activity these past few weeks towards the design and production of new ventilators; something that would usually take months or even years. However, there are still serious concerns about the process to date and outstanding safety issues. It’s vital that we meet the urgent need for additional ventilators in the UK, however it cannot be at the cost of patient safety. Concerns about the Government’s response The Government has come under increasing pressure in recent weeks over its handling of this issue. This has been, in part, because it decided not to order ventilators through the EU’s procurement scheme. This has resulted in a more urgent need for scaling up production within the UK.[4] There have also been questions raised around the number of ventilators required. Initial estimates of 30,000 have since been cut down by more than a third to 18,000. [5] [6] [7] Efforts to engage more UK manufacturers in the production of new ventilators have also proved to be complicated, with only one new model to date, Penlon’s ESO2 device, receiving approval from the MHRA.[8] While this covers a provisional order for 5,000 ventilators, there are a significant number of other applications still waiting the regulatory clearance that will be needed to meet the revised 18,000 target. Meanwhile, another provisional order has been forced to withdraw, as a model from the Renault and Red Bull Formula 1 teams was found to not be suitable for treating patients with Covid-19. [9] “Don’t bother, you’re wasting your time” There has been increasing clinical concern about the Government’s decision to move away from standard specification and known manufacturers. Some of these concerns have related to the minimum specification for the ventilator programme set out by the MHRA, suggesting that it will not lead to the production of machines that are suitable for treating Covid-19 patients. Dr Alison Pittard, Dean of the Faculty of Intensive Care Medicine, has raised concerns about the minimum specifications.[10] The MHRA guidance states that “it is proposed these ventilators would be for short-term stabilisation for a few hours”.[11] Dr Pittard has said that the group of medical professionals that advised the Government on this in March suggested that these machines should be capable of working for the a patient’s full time in intensive care.[12] She noted that: “If we had been told that that was the case, that the ventilators were only to treat a patient for a few hours, we’d have said: “don’t bother, you’re wasting your time. That’s of no use whatsoever.”[13] Compounding this issue, the standards that currently exist in this area are not formal regulatory requirements. The MHRA state that: “They are not formal regulatory requirements, but many are harmonised against regulatory requirements. Consider them as helpful advisory standards for now. MHRA will lead an exercise to define which can be ‘safely’ relaxed for this emergency situation.”[14] This is not simply a technical issue. If we can’t ensure ventilators are being produced to the right standards, to deliver the right care and to be used safely, then it will inevitably result in errors and could ultimately cost lives. Critical safety questions for the Government Considering these concerns, Patient Safety Learning believes that it is vital that the Government responds to the following critical ventilator safety questions: Safety standards Are the standards for ventilators issued to manufacturers fit for purpose? Are MHRA ensuring that these standards are being applied? These standards are not currently formal regulatory requirements. Should they be? Utilising expertise Has the expert guidance on ventilator safety in use, developed by CIEHF and others, been issued to manufacturers by NHS England and NHS Improvement or the MHRA? If yes, are manufacturers required to apply this guidance? Is it advisory or is it mandatory? Are manufacturers who comply with the guidance and usability protocols given an advantage in the procurement process? Are regulators signing off new ventilators against this guidance? Delivery, communication and timescales Currently only one of the manufacturers of new ventilators has received approval. What is the timescale for delivery of the new ventilators and how does this match estimated demand? How are the NHS and MHRA communicating with patients, staff and the public to assure them that the new ventilators will be safe in use? Monitoring performance How will ventilator ‘safety in use’ be monitored and reported on? Are NHS providers and clinicians being asked to strengthen their incident reporting, particularly where manufacturers have developed novel approaches? References Gov.uk, Call for business to help make NHS ventilators, Last Accessed 15 April 2020. Medicines & Healthcare products Regulatory Agency, Rapidly Manufactured Ventilator System, 10 April 2020. Chartered Institute of Ergonomics & Human Factors, Human Factors in the Design and Operation of Ventilators for Covid-19, Last Accessed 1 April 2020. The Guardian, UK missed three chances to join EU scheme to bulk-buy PPE, 13 April 2020. The Guardian, How the UK plans to source 30,000 ventilators for the NHS, 26 March 2020. The Guardian, How close is the NHS to getting the 18,000 ventilators it needs? 14 April 2020. Health Service Journal, NHS needs a third fewer ventilators than forecast, says Hancock, 5 April 2020. Gov.uk, Regulator approves first Ventilator Challenge device, 16 April 2020. The Guardian, UK scraps plans to buy thousands of ventilators from Formula One group, 14 April 2020. Financial Times, Ventilator standards set out for UK makers ‘of no use’ to Covid patients, 15 April 2020. Medicines & Healthcare products Regulatory Agency, Rapidly Manufactured Ventilator System, 10 April 2020. Financial Times, Ventilator standards set out for UK makers ‘of no use’ to Covid patients, 15 April 2020. Ibid. Medicines & Healthcare products Regulatory Agency, Rapidly Manufactured CPAP System (RMCPAPS), 29 March 2020.
  6. Content Article
    Part I illustrates why improving safety is so difficult and complex, and why current approaches need to change. Part II looks at some of the work being done to improve safety and offers examples and insights to support practical improvements in patient safety. Part III explains why the system needs to think differently about safety, giving policymakers an insight into how their actions can create an environment where continuous safety improvement will flourish, as well as how they can help to tackle system-wide problems that hinder local improvement.
  7. Content Article
    From the 5365 operations, 188 adverse events were recorded. Of these, 106 adverse events (56.4%) were due to human error, of which cognitive error accounted for 99 of 192 human performance deficiencies (51.6%). These data provide a framework and impetus for new quality improvement initiatives incorporating cognitive training to mitigate human error in surgery.
  8. Content Article
    The findings of this paper show that safety lapses in primary and ambulatory care are common. About half of the global burden of patient harm originates in primary and ambulatory care, and estimates suggest that nearly four out of ten patients experience safety issue(s) in their interaction with this setting. Safety lapses in primary and ambulatory care most often result in an increased need for care or hospitalisations. Available evidence estimates the direct costs of safety lapses – the additional tests, treatments and health care – in primary and ambulatory care to be around 2.5% of total health expenditure. Safety lapses resulting in hospitalisations each year may count 6% of total hospital bed days and more than 7 million admissions in the OECD.
  9. Content Article
    What will I learn? The process for investigating gross negligence manslaughter Reflective practice of healthcare professionals The regulation of healthcare professionals
  10. News Article
    The NHS 111 helpline for urgent medical care is facing calls for an investigation after poor decision-making was linked to more than 20 deaths. Experts say that inexperienced call handlers and the software used to highlight life-threatening emergencies may not always be safe for young children. At least five have died in potentially avoidable incidents. Professor Carrie MacEwen, Chairwoman of the Academy of Medical Royal Colleges, said: “These distressing reports suggest that existing processes did not safeguard the needs of the children in these instances.” Since 2014 coroners have written 15 reports involving NHS 111 to try to prevent further deaths. There have been five other cases where inquests heard of missed chances to save lives by NHS 111 staff; two other cases are continuing and one was subject to an NHS England investigation. Read full story (paywalled) Source: The Times, 5 January 2020
  11. Content Article
    Building on its successful predecessors, the third edition of The Field Guide to Understanding ‘Human Error’ will help you understand a new way of dealing with a perceived 'human error' problem in your organisation. It will help you trace how your organisation juggles inherent trade-offs between safety and other pressures and expectations, suggesting that you are not the custodian of an already safe system. It will encourage you to start looking more closely at the performance that others may still call 'human error', allowing you to discover how your people create safety through practice, at all levels of your organisation, mostly successfully, under the pressure of resource constraints and multiple conflicting goals. The Field Guide to Understanding 'Human Error' will help you understand: how to move beyond 'human error' how to understand accidents how to do better investigations how to understand and improve your safety work. You will be invited to think creatively and differently about the safety issues you and your organisation face. In each, you will find possibilities for a new language, for different concepts, and for new leverage points to influence your own thinking and practice, as well as that of your colleagues and organisation.
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