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Showing results for tags 'Regulatory issue'.
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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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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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Consent to treatment: Overview
Claire Cox posted an article in Consent issues
This link below, leads to an NHS web page that covers: the definition of consent how consent is given consent from children and young people when consent is not needed consent and life support how to complain if you think consent was not given. -
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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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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.
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Content ArticleThis page includes: an animation explaining the role of the NMC their values and mission their strategy their corporate plans their role in midwifery regulation.
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