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Showing results for tags 'Regulatory issue'.
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Content ArticleNow called Right support, right care, right culture, the guidance (published on 8 October 2020), outlines three key factors that CQC expects providers to consider if they are, or want to care for autistic people and/or people with a learning disability: Right support: The model of care and setting should maximise people's choice, control and independence Right care: Care should be person-centred and promote people's dignity, privacy and human rights Right culture: The ethos, values, attitudes and behaviours of leaders and care staff should ensure people using services lead confident, inclusive and empowered lives
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Content ArticleSummary of the four themes from the CQC: PEOPLE: We want to be an advocate for change, ensuring our regulation is driven by what people expect and need from services, rather than how providers want to deliver them. We want to regulate to improve people’s experience so they move easily between different services. SMART: We want to be smarter in how we regulate, with an ambition to provide an up-to-date, consistent, and accurate picture of the quality of care in a service and in a local area. SAFE: We want all services to promote strong safety cultures. This includes transparency and openness that takes learning seriously – both when things go right and when things go wrong, with an overall vision and philosophy of achieving zero avoidable harm. IMPROVE: We want to play a much more active role to ensure services improve. In our engagement over the next two months we’ll explore what each of these areas mean in detail as part of an open conversation about the future direction of CQC. Follow the link below to access the draft strategy (the section on safety begins on page 11) and to contribute your feedback.
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EventuntilThe Westminster Health Forum is a division of Westminster Forum Projects, an impartial and cross-party organisation which has no policy agenda of its own. Forums operated by Westminster Forum Projects enjoy considerable support from within Parliament and Government. The agenda: The impact of investigations in the NHS and the priorities of the Healthcare Safety Investigation Branch Progress of improving patient safety in the NHS Maintaining patient safety during COVID-19 - rapid learning to respond to the virus, continuity of care, and adapting care delivery practices Delivering safe care in the NHS - preventing errors, utilising data and technology, supporting the workforce, and promoting high quality leadership Learning from the voice of parents and families How to improve patient safety by reducing unwarranted variation and learning from clinical negligence claims The role of technology in reducing errors, enhancing care, and ensuring safety in remote healthcare and telemedicine Taking forward the National Patient Safety Syllabus and supporting the workforce to deliver care safely during the presence of COVID-19 Learning from harm, reducing the cost of litigation in the NHS, and the impact of COVID-19 Assessing findings from the Independent Medicines and Medical Devices Safety Review The role of the regulator in reducing avoidable harm and informing future practice Register
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Independent sector model ‘inherently risky’, says CQC
Patient Safety Learning posted a news article in News
The care model run by independent sector mental health and learning disability hospitals is ‘inherently risky’, a Care Quality Commission (CQC) chief inspector has warned. Speaking at the NHS Providers conference, Ted Baker, chief inspector of hospitals for the Care Quality Commission, unveiled the regulator’s plans to change how it inspects health and care services. When asked by HSJ how its new “streamlined” approach would be applied to inpatient units run by the independent sector for people with mental health and learning disability, Professor Baker said: ”One of the things we’ve been doing during the pandemic, and will continue in our transitional approach, is target risk. And one of the risks we have been targeting is exactly this, patients with learning disability and/or autism in some of these small units that have got closed cultures." “I think we do recognise that model of care is an inherently risky model of care and so we have been inspecting many of those under this risk driven model and taking action against many of them. But there is ongoing concern about that model of care and in a few weeks’ time we will be publishing a report on our assessment of that model of care and the importance of it being changed for the benefit of the people being looked after. The model of care needs to be improved but we need to make sure we are tackling the risk.” The chief’s comments come ahead of the regulator’s state of care report, which is due to be published next week. In its report published last year the CQC highlighted a concern regarding the quality and safety of independent learning disability and autism units. In particular it warned these were at a higher risk of developing closed cultures. Read full story (paywalled) Source: HSJ, 7 October 2020) -
News ArticleExperts say robust legal protections are needed to inspire public confidence. The UK government has set out plans to amend drug regulations in case it decides that COVID-19 vaccines should be used before they are licensed, in a bid to roll them out more quickly. In a consultation on the proposals that ran from 28 August to 18 September the Department of Health and Social Care for England explained that if a suitable vaccine emerged with strong evidence of safety, quality, and efficacy the government would seek to license it through the usual route but could supply it in the meantime. The document added, “A COVID-19 vaccine would only be authorised in this way if the UK’s licensing authority was satisfied that there is sufficient evidence to demonstrate the safety, quality, and efficacy of the vaccine. ‘Unlicensed’ does not mean ‘untested.” The consultation, and the timeframe in which it was conducted, prompted some people to post their concerns on social media. However, the Human Medicine Regulations 2012 already allow the licensing authority to temporarily authorise the supply of an unlicensed product in response to certain public health threats, including the suspected spread of pathogens. The proposed change would allow conditions to be attached “to ensure product safety, quality, and efficacy” The 2012 regulations also give healthcare professionals and manufacturers immunity from being sued in the civil courts for the use of some unlicensed products recommended by the licensing authority in response to a public health threat. The new regulations would extend the immunity to drug companies that have not manufactured the product but placed it on the market with the approval of the licensing authority, and they clarify the consequences for a breach of conditions imposed by the authority. Social media posts play into existing concerns that many people might not accept the vaccine, as surveys indicate. Lawyers have told the Department for Health and Social Care that to inspire public confidence it must provide redress for the few people who might experience adverse effects. Bozena Michalowska, a partner specialising in product liability at the law firm Leigh Day, said, “I do not believe that people will want to play Russian roulette with their health by taking a vaccine which they know nothing about, especially when they know that the risks they take are just taken by them and not a shared risk and they will not have sufficient protection should things go wrong.” Read full story Source: The BMJ, 28 September 2020
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Community PostThe UK government is seeking views on proposed changes to the Human Medicine Regulations 2012 to help with the safe and efficient distribution of a COVID-19 vaccine and expanded flu vaccine programme in the UK, along with treatments for COVID-19 and any other diseases that become pandemic. Ministers say there will be no shortcut on safety or effectiveness, and that any vaccine will be approved for the UK only if it meets the highest standards. The deputy chief medical officer for England, Prof Jonathan Van-Tam, said: “If we develop effective vaccines, it’s important we make them available to patients as quickly as possible but only once strict safety standards have been met. The proposals consulted on today suggest ways to improve access and ensure as many people are protected from Covid-19 and flu as possible without sacrificing the absolute need to ensure that any vaccine used is both safe and effective.” What do you think? Are there patient safety concerns here? We'd love to hear your views. Comment below.
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Content ArticleThe consultation covers: authorising temporary supply of an unlicensed product civil liability and immunity expanding the workforce eligible to administer vaccinations promoting vaccines making provisions for wholesale dealing of vaccines. You can access the consultation documentation via the link below. Respond online
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News Article
Gene-edited babies: Current techniques not safe, say experts
Patient Safety Learning posted a news article in News
Current scientific techniques are not yet safe or effective enough to be used to create gene-edited babies, an international committee says. The technology could one day prevent parents from passing on heritable diseases to children, but the committee says much more research is needed. The world's first gene-edited babies were born in China in November 2018. The scientist responsible was jailed, amid a fierce global backlash. The committee was set up in response. Gene-editing could potentially help avoid a range of heritable diseases by deleting or changing troublesome coding in embryos. But experts worry that modifying the genome of an embryo could cause unintended harm, not only to the individual but also future generations that inherit these same changes. It made several recommendations, including: Extensive conversations in society before a country decides whether to permit this type of gene-editing. If proven to be safe and effective, initial uses should be limited to serious, life-shortening diseases which result from the mutation of one or both copies of a single gene, such as cystic fibrosis. Rigorous checks at every stage of the process to make sure there are no unintended consequences, including biopsies and regular screening of embryos. Pregnancies and any resulting children to be followed up closely. An international scientific advisory panel should be established to constantly assess evidence on safety and effectiveness, allowing people to report concerns about any research that deviates from guidelines. Read full story Source: BBC News, 4 September 2020 -
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Content ArticleMyths and misunderstandings about prevalent mechanisms to achieve excellence in healthcare.
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Clinical Risk Management Training
HannahMcCann posted an article in NHS Digital
There are two types of training – Foundation and Community of Interest (previously known as Revalidation). Originally the foundation training spanned over two days but we recognised that this took up a lot of time and resource, especially given a large proportion of our delegates are practising clinicians. With this in mind, we condensed one of the days learning objectives into an e-learning session, followed up with the one-day classroom course. There are a number of ‘open’ foundation courses. Usually located in Leeds and London. Anyone can sign on to these courses once they have completed the e-learning. Open courses allow for a good mix of colleagues from both the health organisations and the manufacturing companies. Venues are decided and hosted by NHS Digital and the course fee is £475 for NHS colleagues and £625 for others. Completion of the e-learning and the classroom course are worth a total of 14 Continuing Professional Development (CPD) points. For those with more than one colleague wishing to participate on the course, we can arrange a ‘closed’ course at your venue. Price is negotiable but we ask for a minimum of 12 delegates. The foundation course covers all the principles of Clinical Risk Management and helps put the theory and technique learned on the e-learning, into practise. The Clinical Safety Community of Interest Course (CSCOI), previously known as the Revalidation Course, contains: a stronger emphasis on sharing best practice and networking case studies presented by members of the clinical safety community recent developments in health IT, including a key speaker where possible. There will also be a recap of the key requirements outlined in DCB0129 and DCB0160. This course is for both clinicians and non-clinicians. Clinicians attending this course will be issued with 6.5 CPD points. Cost for CSCOI is £225 for NHS and £325 for others. Booking can be made online -
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Content ArticleMEs are a key element of the death certification reforms, which, once in place, will deliver a more comprehensive system of assurances for all non-coronial deaths, regardless of whether the deceased is buried or cremated. MEs will be employed in the NHS system, ensuring lines of accountability are separate from NHS Acute Trusts but allowing for access to information in the sensitive and urgent timescales to register a death. This case study outlines the approach of South Tees Hospitals NHS Foundation Trust as one of the early adopter sites. To date, the following learning points have been identified and explored: End of Life Care, ceilings of care and avoidable admissions Some investigations have highlighted cases where the End of Life Care pathway could have either been established or fully implemented, where this would have been of benefit to patients and their families. Some patients may not have been cared for in the right location, and some admissions could have been avoided if the End of Life Care pathway had been suitably established and followed. Early detection and response to physiological deterioration, and effective communication Response stretched by implementation of National Early Warning Score (NEWS) but still learning around effective communication of escalation. The use of standardised communication tools is essential. Record keeping and organisation of medical records Some learning was identified in relation to the accuracy and completeness of medical records. It was evident that not all records are reflective of the clinical picture. Discussion with specialty teams is vital to support the investigation An independent review by the ME should be further supported by speciality ‘experts’, and if possible, peer review from other trusts can be sought to allow for full independent review. Seeking speciality opinion from those not directly involved with the case within STHFT has also been shown to be effective. Pathways for links to wider clinical governance processes have been strengthened.
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Content ArticleWhat will I learn? The process for investigating gross negligence manslaughter Reflective practice of healthcare professionals The regulation of healthcare professionals
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News Article
Somerset care home failed to notify health watchdog of deaths
Patient Safety Learning posted a news article in News
A residential care home failed to notify the health watchdog about the deaths of people they were providing a service to, its report has found. Kingdom House, in Norton Fitzwarren, run by Butterfields Home Services, was rated "requires improvement". The home cares for people with conditions such as autism. The Care Quality Commission (CQC) said the registered manager and provider lacked knowledge of regulations and how to meet them. Inspectors found the provider failed to notify the CQC about the deaths of people which occurred in the home, as required by Regulation 16 of the Health and Social Care Act 2008. The report also found people were at "increased risk" because the provider had not ensured staff had the qualifications, competence, skills and experience to provide people with safe care and treatment. Inspectors did, however, praise the "positive culture" at the home, that is "person-centred", and noted the provider was "passionate about their service and the people they cared for". Read full story Source: BBC News, 2 January 2020 -
Content ArticleThe Learning Disability Mortality Review (LeDeR) programme was commissioned to improve the standard and quality of care for people with a learning disability. The third annual report, published in May 2019, provides a welcome update on the learning emerging from this vital work. This NHS England and NHS Improvement report will outline some of the extensive activity that is taking place locally and nationally in response to the learning from LeDeR reviews.
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NHS Resolution: Christine's story
Claire Cox posted an article in NHS Resolution
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Bawa-Garba - Implications and the BMA's response (April 2018)
Claire Cox posted an article in Systems
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Content ArticleThis mapping revealed over 126 organisations who exert some regulatory influence on NHS provider organisations in addition to 211 Clinical Commissioning Groups. The majority of these organisations set standards and collect data from provider organisations and a considerable number carry out investigations. The variability in approach and overlapping functions suggest that there is no overall integrated regulatory approach.
