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Found 466 results
  1. News Article
    The Government is inviting views on how well GP practices and other NHS organisations are complying with their legal duty of candour when things go wrong. Patients and health professionals are being asked whether the statutory duty is well understood and adequately regulated by the CQC. Under the statutory duty of candour, introduced for all CQC-registered providers in 2015, GP practices must be open and honest with their patients when something goes wrong and has caused harm. In December, the Department of Health and Social Care (DHSC) announced a review into whether healthcare providers are following the duty of candour rules. This was in response to concerns that the duty is not always being met and that there is variation in how the rules are being applied. The DHSC has published its ‘call for evidence’ to gather views on how well the duty of candour obligation is working for both patients and health professionals. Patients have been asked whether GP practices and other providers ‘demonstrate meaningful and compassionate engagement’ with patients who have been affected by an incident. The call for evidence also asks for views on whether the criteria for triggering the duty are appropriate and well understood by staff. Read full story Source: Pulse, 16 April 2024
  2. News Article
    The UK’s data protection regulator has published new guidance for health and social care organisations it says will help them be more transparent about how personal information is being used. The Information Commissioner’s Office (ICO) said the new guidance would provide regulatory certainty to organisations on how they should keep people properly informed as technology is increasingly used to deliver care and carry out research. The regulator said focus on the issue was needed as the health and social care sector routinely handles sensitive information about the most intimate aspects of peoples’ health, and that under data protection law, people have a right to know what is happening to their personal information. Being transparent is essential to building public trust in health and social care services Anne Russell, head of regulatory policy projects at the ICO, said the ever-increasing use of technology meant personal data was more important than ever, and so therefore was more transparency. “Being transparent is essential to building public trust in health and social care services,” she said. “If people clearly understand how and why their personal information is being used, they are likely to feel empowered to share their health information to both access care and support initiatives such as medical research. “As new technologies are developed and deployed in the health sector, our personal information is becoming more important than ever to boost the efficiency and public benefit of these systems. “With this bespoke guidance, we want to support health and social care organisations by improving their understanding of effective transparency, ensuring that they are clear, open and honest with everyone whose personal information is being used.” Read full story Source: The Independent, 15 April 2024
  3. News Article
    A regulator overseeing 340,000 professionals breached a psychologist’s human rights by letting their fitness-to-practise case go on for a decade, amid widespread very long delays, it has emerged. A judgment from the Health and Care Professions Tribunal said the “lamentable” situation for the registrant was down to the “disgraceful… manner in which the Healthcare Professions Council dealt with their case”. The HCPC oversees professional standards for several groups including radiographers, paramedics, physiotherapists, occupational therapists, and operating department practitioners. If a complaint is made about a registrant, it can investigate and refer them to the tribunal, which can strike them off. The Society of Radiographers said the current speed of cases was “simply unacceptable” and its director of industrial strategy Dean Rogers added: “Our members spend too long working — and living — under the intense scrutiny of their regulator, often under the control of an interim order restricting or even preventing their practise while investigations drag on.” Read full story (paywalled) Source: HSJ, 17 April 2024
  4. Content Article
    Richard von Abendorff, an outgoing member of the Advisory Panel of the Healthcare Safety Investigation Branch (HSIB), has written an open letter to incoming Directors on what the new Health Services Safety Investigations Body (HSSIB) needs to address urgently and openly to become an exemplary investigatory safety learning service and, more vitally, how it must not contribute to compounded harm to patients and families. The full letter is attached at the end of this page.
  5. Content Article
    In this opinion piece, Partha Kar describes patient safety issues relating to a planned increase in the number of Physician Associates (PAs) working in the NHS in England. Highlighting safety concerns being raised by healthcare professionals and members of the public, he calls for a pause to the planned expansion to allow these issues to be investigated. He outlines the need for a clear scope of practice, standardised training, full regulation and clear communication with all stakeholders, including the public.
  6. Content Article
    Batches of some products made by Legency Remedies Pvt Ltd have been found to contain a bacteria called Ralstonia pickettii (R. pickettii). All potentially affected batches are being recalled following an MHRA investigation.
  7. News Article
    The General Medical Council (GMC) has relaxed its fitness to practise (FTP) processes for doctors so that ‘minor’ concerns such as ‘pushing a colleague’ are not taken to tribunal. In an update to its guidance, the regulator has given FTP decision makers and case examiners ‘more discretion’ to throw out complaints if they represent a lower risk to public protection. Concerns which are ‘minor in nature and did not impact patient care’ will fall under this guidance. This is part of the GMC’s efforts to carry out ‘more efficient and proportionate investigations’ and to ‘minimise’ stress for doctors during the FTP process. Two examples of concerns which will no longer need to be investigated, if there are ‘no aggravating factors’, are: A doctor giving false details to a market research company, in order qualify for free products. A doctor pushing a colleague out the way following a heated argument. The regulator has said: "Decision makers will now be able to weigh the full circumstances of a concern earlier in the fitness to practise process to assess the overall risk to public protection including to public confidence in the profession– meaning some concerns may not need to be investigated or referred to a tribunal." However, the guidance, which covers concerns relating to violence and dishonesty, emphasises that allegations which raise a risk to public protection will continue to be investigated. Read full story Source: Pulse, 4 April 2024
  8. Content Article
    Letter Patient Safety Commissioner, Henrietta Hughes, wrote to Amanda Pritchard, NHS England, on the implementation of Martha's Rule.
  9. Content Article
    In December 2024, the General Medical Council (GMC) will start regulating physician associates (PAs) and anaesthesia associates (AAs). The GMC have developed proposed rules, standards and guidance setting out how they will regulate these professions. They have also developed draft principles that will inform the content of decision-making guidance that will apply to doctors as well as to PAs and AAs from December 2024. This consultation is about those rules, standards and guidance and those principles. It is not about who should regulate PAs and AAs. This consultation asks for your comments on the General Medical Council's proposed rules, standards and guidance that set out how they will regulate anaesthesia associates (AAs) and physician associates (PAs). The consultation is open from 26 March to 11.59pm on 20 May 2024. 
  10. Content Article
    Central to the Patient Safety Incident Response Framework (PSIRF) is the requirement for healthcare organisations to be proactive in how they respond to and learn from patient safety incidents. This article from legal firm Kennedys considers the implications of PSIRF on healthcare organisations’ legal and governance teams. In particular, considering practical steps that may be adopted, as an example, in the context of preparing for an inquest.
  11. News Article
    Trust chiefs have collectively called for the Care Quality Commission (CQC) to review its use of single-word inspection ratings, following MPs’ calls for an overhaul of Ofsted ratings for schools. In a report containing a series of recommendations for CQC reform, shared with HSJ, NHS Providers urges the regulator to re-evaluate the success of its single-word ratings, asking it to consider adding a narrative verdict as part of its new provider assessment reports. The recommendation is made “in the context of the Ofsted inquiry findings” following the death of headteacher Ruth Perry by suicide, which a coroner ruled was contributed to by an Ofsted inspection. It prompted MPs on the Commons’ education committee to call for a ban on single-word Ofsted ratings. The NHSP report said the inquiry’s concerns around inspectors’ behaviour, the complaints process, and single ratings can also be applied to CQC. The report adds: “While we recognise the differences between the two regulators’ approaches, we believe now is the right time to take stock… for example, CQC may need to consider the value of its single-word ratings, modelled upon Ofsted’s rating system. “As suggested by the Nuffield Trust and many trust leaders, a single-word rating will inevitably oversimplify what happens in a very complex organisation". Read full story (paywalled) Source: HSJ, 21 March 2024
  12. Content Article
    The Regulation and Quality Improvement Authority (RQIA) are an independent health and social care regulator in Northern Ireland. RQIA aim to assure public confidence in health and social care through their independent, proportionate and responsible regulation. Through inspections, reviews and audits, RQIA provides assurance about the quality of care, challenges poor practice, promotes improvement and safeguards the rights of service users. RQIA informs the public of their findings through the publication of reports. They are committed to working closely with service providers so that they can deliver improved care and are dedicated to hearing and acting on the experiences of patients, clients, families and carers. This leaflet provides more information about RQIA.
  13. Event
    The overall objective of this masterclass is to build good governance commitment, capacity, and resilience in the face of severe resource constraints and complex staff, patient, political and regulatory expectations. The programme is interactive, developmental, based on best practice and focused on achievable improvement of practice, behaviours and outcomes. The course includes online access to the relevant CQG e-learning module for 12 months and a discount code to purchase additional modules. This masterclass is one of a series that will help enhance your understanding and application of governance in healthcare, this module recognises the mechanisms and drivers for improvement available to the board, including creating a culture for effective analysis and reporting of outcome measures and benchmarking internally. We clarify the role of the board in organisational scrutiny and challenge. We also look at the ways the board can add value and ensure exemplar organisational effectiveness by developing its own culture of improvement. Each masterclass has its own set of learning objectives, the final one of each is to be able to apply the learning to the participant’s own organisation using the provided CQG Maturity Matrix. The matrix can be used to set strategic objectives and consider progress over coming months. At the completion of this module, the participants will be able to: • Understand the mechanisms and drivers for improvement available to the board. • Clarify the role of board scrutiny and challenge. • Assist the board in adding value and ensuring organisational effectiveness by developing its own culture of improvement. • Apply the learning to the participant’s own organisation using the CQG Maturity Matrix. Register
  14. Content Article
    The Government is in the process of reforming the way that health and care professionals are regulated. It is planning to change the legislation for 9 out of the 10 healthcare professional regulators that the Professional Standards Authority (PSA) oversees, giving them a range of new powers and allowing them to operate in a very different way. The changes the Government intends to roll out will give regulators greater freedom to decide how they operate, including introducing the flexibility to set and amend their own rules. There will also be changes to regulators’ powers and governance arrangements. The changes will also create an entirely new process for handling fitness to practise (the process by which concerns about healthcare professionals are dealt with). The PSA support the reforms to healthcare professional regulation but have also identified certain risks that may arise from the new ways of working. PSA has developed guidance that they are now consulting on. The presentation slides attached are from a recent PSA roundtable and give further information on the changes, PSA guidance and the consultation. PSA are seeking views from everybody with an interest in healthcare professional regulation, including patients, the public, registrants, regulators, professional bodies and employers. The consultation is open until 5.00 pm on Monday 15 April 2024.
  15. News Article
    A doctor working at a women’s health clinic in Melbourne has been suspended as a regulator revealed it was aware of concerns about other practitioners there. The facility’s boss claims it is a “witch hunt”. It follows the death of 30-year-old mother Harjit Kaur, who died in January at the Hampton Park Women’s Clinic after what was described as a “minor procedure”. It was later identified as a pregnancy termination. The Australian Health Practitioner Regulation Agency (Ahpra) has confirmed Dr Rudolph Lopes’ registration had been suspended but did not reveal the reason behind the decision. His registration details show he was reprimanded in 2021 for failing to respond to the regulator’s inquiries. “[The regulator] has received a range of concerns about a number of practitioners associated with the Hampton Park Women’s Clinic,” Ahpra said in a statement. “[The regulator] has established a specialist team to lead a co-ordinated examination of these issues which involve multiple practitioners across a number of professions and across a number of practice locations.” Ahpra chief executive, Martin Fletcher, said he was “gravely concerned by the picture that is emerging.” “We have taken strong action to protect the public while our investigations continue,” Fletcher said. “National boards stand ready to take any further regulatory action needed to keep patients safe. “While the coroner continues to examine the tragic death of a patient, our inquiries are focusing on a wider range of issues that our investigations bring to light.” Read more Source: The Guardian, 15 March 2024
  16. News Article
    A fertility clinic in London has had its licence to operate suspended because of “significant concerns” about the unit, the regulator has said. The Homerton Fertility Centre has been ordered by the Human Fertilisation and Embryology Authority (HFEA) to halt any new procedures while investigations continue. The clinic in east London said there had been three separate incidents highlighting errors in some freezing processes. This resulted in the “tragic loss of a small number of embryos” that either did not survive or became “undetectable”, which means an embryo stored in frozen liquid solution in a container cannot be found during subsequent thawing. The clinic has informed the patients affected and apologised for any distress caused. Homerton Healthcare NHS foundation trust said it began an investigation in late 2023 and immediately made regulators fully aware of it. The HFEA is now conducting its own investigation alongside the trust. In a statement, the clinic said that while the investigators had not been able to find any direct cause of the errors, it had made changes in the unit to prevent the recurrence of such incidents. All staff now work in pairs to ensure all clinical activities are checked by two healthcare professionals, competencies of staff within the unit have been rechecked, and security at the unit has been increased. Read full story Source: The Guardian, 8 March 2024
  17. News Article
    Physician associates should never see ‘undifferentiated’ patients in a GP setting, the BMA has declared in new ‘first of its kind’ guidance. Today, the union has published a national scope of practice laying out how physician associates (PAs) and anaesthesia associates (AA) should work safely in GP practices and secondary care. According to the BMA, the guidance is different from what it describes as the current ‘piecemeal or fragmented approach’ whereby individual organisations set their own guidelines for how PAs should be supervised. In general practice, the guidance said a GP ‘should first triage’ all patients and ‘decide which ones a PA can see’, suggesting annual health checks as an appropriate contact. The union is also clear that PAs ‘must not make independent management decisions for patients’ and must be clear in all their communications that ‘they are not doctors’. Read full story Source: Pulse, 7 March 2024
  18. Content Article
    Landmark national guidance outlining how MAPs (medical associate professionals) can work safely and effectively in the NHS, has been published by the British Medical Association (BMA). The association has unveiled its report Safe Scope of Practice, which sets out in highly detailed terms the responsibilities of MAPs including PAs (physician associates) and AA (anaesthesia associates). Described as a ‘first of its kind’ the report uses a traffic light-style system to illustrate what clinical duties MAPs should be able to carry out, as well as those responsibilities from which they should be prohibited.  The guidance also sets out six general principles for how MAPs should be deployed in primary and secondary-care settings. The guidance comes as the Government continues to press ahead with its plans to have PAs regulated by the GMC despite intense opposition to such a move from the BMA.
  19. News Article
    Medical leaders support a planned increase in the number of physician associates (PA) in the NHS. But the British Medical Association (BMA) is concerned about a new law allowing the General Medical Council (GMC) to regulate PAs, who must be supervised by a fully qualified doctor. The doctors' union says it blurs the lines between doctors and PAs and could risk patient safety. Two families whose relatives were seen by PAs want the roles defined. The NHS has 3,286 PAs, who assist healthcare teams and are not authorised to prescribe or request scans. PAs and anaesthetic associates (AA) qualify after a funded two-year master's degree. They often have a science undergraduate degree, but that is not a prerequisite. Their role includes taking medical histories, conducting physical examinations and developing treatment plans. Like PAs, AAs are healthcare professionals who work as part of a multidisciplinary team with supervision from a named senior doctor. The Academy of Medical Royal Colleges said on Tuesday that it welcomes a push to increase the number of PAs in the NHS, but that it is "vital" that there are clear guidelines on how they are deployed. Read full story Source: BBC News, 5 March 2024
  20. News Article
    Harry Miller was a popular teenager, appreciated for his sharp humour, ability to get on with anyone and eagerness “for the next adventure”. In the autumn of 2017, he was struggling with difficult thoughts and feelings of anger. Harry, who was 14 and lived in south-west London, confided his inner turmoil to friends and family. “I’m just having these anger rages,” he told his mother one day. “It’s like I just go crazy suddenly and I can’t control it. I don’t know what’s going on.” Two years previously, Harry had been prescribed the drug montelukast for his asthma. Unbeknown to his parents, a range of psychiatric reactions had been reported in association with montelukast treatment, including aggression, depression and suicidal thoughts. Harry’s parents, Graham and Alison Miller were not properly warned of the potential side effects. Their son was referred to the NHS child and adolescent mental health services in January 2018, but he missed an appointment because it was sent to the wrong person. On 11 February 2018, Harry was found dead in the family home, with an inquest later recording a verdict of suicide. He was described in a tribute by friends at St Cecilia’s Church of England school in Southfields, south-west London, as a “super star burning brightly”. Two years after his death, his father read an online warning about the adverse reactions involving montelukast by the Medicines and Healthcare Products Regulatory Agency (MHRA). It said these could very rarely include suicidal behaviour. Graham Miller said: “It is an absolute outrage that parents are being given psychoactive substances to give to their children without proper warning of the risk.” This weekend, the MHRA has confirmed that the drug is under review. A montelukast UK action group is calling for more prominent warnings of the drug’s possible side effects. Read full story Source: BBC News, 3 March 2024
  21. News Article
    The medical regulator failed to sound the alarm over Covid vaccine side effects and should be investigated, MPs have said. The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for approving drugs and devices and monitors side effects caused by treatments. But the all-party parliamentary group (APPG) on pandemic response and recovery, an influential group of MPs, has raised “serious patient safety concerns”. It has claimed that “far from protecting patients” the regulator operates in a way that “puts them at serious risk”. Some 25 MPs across four parties have written to the health select committee asking for an urgent investigation. In reply, Steve Brine, the health committee chairman, has said an inquiry into patient safety is “very likely”. In a letter to Mr Brine, the APPG said that there was reason to believe that the MHRA had been aware of post-vaccination heart and clotting issues as early as February 2021, but did not highlight the problems for several months. Read full story (paywalled) Source: The Telegraph, 27 February 2024 Related reading on the hub: Interview with Charlet Crichton, founder of UKCVFamily
  22. Content Article
    On 8 February 2024, Ombudsman, Rob Behrens and Patient Safety Commissioner, Henrietta Hughes, wrote a joint letter to government. Both have regulatory roles to play in improving patient safety and both are struggling to gain headway with the recalcitrant NHS. Supposedly independent of government, this correspondence shows they are in fact totally dependent on government, due to their limited powers writes Della Reynolds in this blog.
  23. News Article
    The House of Lords is being urged to throw out plans for non-doctor associate roles to be licensed by the same body as doctors. Under a planned new law, physician associates (PAs) will be regulated by the General Medical Council (GMC). The British Medical Association (BMA) believes this could lead to patients confusing the different roles, which it says could have "tragic consequences". There are about 3,200 PAs working in GP surgeries and hospitals in England, with 10,000 more planned in the next decade or so. They were introduced to help doctors with their work - examining and diagnosing patients and discussing treatments with them - although PAs are currently unregulated. Unlike doctors, they do not have to hold a medical degree, but they usually have a degree in a life science and have to undertake a two-year training course. The BMA, the union representing doctors in the UK, believes that regulation by the GMC could lead to a "blurring of the lines" between PAs and doctors. In an open letter to the House of Lords ahead of a debate on Monday, the BMA's chairman Prof Phil Banfield said: "PAs are not doctors. They do not hold a medical degree and are not medically trained, despite misleading statements made by some. "We know that patients are already confused about telling the difference between PAs and doctors, and this legislation will make this problem worse. "Keeping the GMC as the regulator exclusively of doctors would mean we retain the clear distinction between doctors and PAs." Read full story Source: BBC News, 25 February 2024
  24. Content Article
    The Government plans to expand physician associate (PA) and anaesthesia associate (AA) roles and to establish the General Medical Council (GMC) as their statutory regulator. There has been concerted opposition to the plans by groups including the Doctors’ Association UK (DAUK) and the British Medical Association (BMA). Earlier this month, the House of Lords sent the draft legislation to the main chamber for proper scrutiny, stating that this was the procedure when an issue "is politically or legally important or gives rise to issues of public policy". In this Medscape article, Dr Sheena Meredith outlines the Government's proposals and why the issue has become so contentious.
  25. Content Article
    In this letter to Health Secretary Steve Brine MP, members of the All Party Parliamentary Group (APPG) on Pandemic Response and Recovery raise serious concerns about the approach of the Medicines and Healthcare Products Regulatory Agency (MHRA) to patient safety. They outline problems within the MHRA that continue to put patients at serious risk of harm. The letter also highlights the role of the Independent Medicines and Medical Devices Safety Review (IMMDS), in its thorough investigation of Primodos, sodium valproate and pelvic mesh in bringing some of these concerns to the fore. It points to recent evidence presented to the APPG that indicates that the MHRA is at the heart of wider endemic failings, with issues uncovered so far being "the tip of a sizeable iceberg of failure." The letter outlines concerns about the following areas: The Yellow Card Scheme Conflicts of interest and transparency History of regulatory failures in the MHRA It calls on the Health and Social Care Select Committee to investigate these issues and make recommendations to the government on: legislative changes as to who is obligated to report adverse drug reactions. funding changes to the MHRA. separation of regulatory approval duties from post marketing pharmacovigilance. more inclusion of patients. greater transparency across the board. proper enforcement of Part 14 of the Human Medicines Regulations 2012.
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