Regulator patient safety alerts
Lack of clear responsibility for regulators (e.g., CQC) to review decisions not to comply with patient safety alerts.
Source spread
Where this theme appears
This theme appears across 13 independent accountability sources, so the source mix matters as much as the headline total.
17 inquiry recs
32 PFD reports
33 committee recs
25 HSSIB recs
11 CQC actions
1 patient safety alert
1 Scottish FAI
2 DHR recs
1 CQC enforcement action
Browse by source
Source-grouped records are useful for tracing where a concern came from. Large sections show the 50 strongest matches for that source; counts still show the full theme total.
Inquiry recommendations(17)
MAI-121 — Consequences for breaching event healthcare standards
Recommendation: The Department of Health and Social Care together with the Care Quality Commission should consider what the consequences of breaching the appropriate standard should be. That should include consideration of whether the sanction should be criminal in nature.
Gov response: Partially accepted
Accepted in part
9 — Date for submitting Safety Cases
Recommendation: As regards existing installations the date for submission of the Safety Case should be laid down by regulation. There is an urgent need for the submission of Safety Cases, but the date should be selected by the regulatory body. The …
Unknown
8 — Safety Case before installation operates
Recommendation: No fixed installation should be established or maintained in controlled waters; and no mobile installation should be brought into those waters with a view to its being stationed there or maintained in those waters unless a Safety Case in respect …
Unknown
4 — Whole body monitoring as authorisation condition
Recommendation: The authorising departments should however consider whether provision of such facilities should be made a condition of authorisations to discharge (para 10.95).
Unknown
BRIS-111 — Require National Patient Safety Agency to inform trusts and publish reports
Recommendation: The National Patient Safety Agency, in the exercise of its function of surveillance of sentinel events, should be required to inform all trusts of the need for immediate action, in the light of occurrences reported to it. The Agency should …
Unknown
11 — Regulatory system patient safety priority
Recommendation: We recommend that the government should ensure that the current system of regulation and the collaboration of the regulators serves patient safety as the top priority, given the ineffectiveness of the system identified in this Inquiry.
Gov response: Accept System and professional regulators have an overarching statutory objective to protect, promote and maintain the health, safety and wellbeing of the public. The healthcare regulators referenced in the inquiry (GMC, NMC and CQC) exist …
Accepted
76 — Immediate analysis without waiting for legislation
Recommendation: The regulatory body should ask operators which have not already done so to undertake an evacuation, escape and rescue analysis forthwith, without waiting for legislation. The timetable for completion of this analysis should be agreed between the regulatory body and …
Unknown
IBI-7e — Implementing SHOT Reports
Recommendation: Implementing SHOT reports: That all NHS organisations across the UK have a mechanism in place for implementing recommendations of Serious Hazard of Transfusion (SHOT) reports, which should be professionally mandated, and for monitoring such implementation.
Gov response: Work is underway to develop governance practices for the implementation of SHOT recommendations, with careful consideration given to the needs for standardisations and the needs of local organisations. Accreditation for SHOT as an organisation for …
Accepted in part
F107 — Sharing concerns
Recommendation: If the Health Protection Agency or its successor, or the relevant local director of public health or equivalent official, becomes concerned that a provider's management of healthcare associated infections is or may be inadequate to provide sufficient protection of patients …
Gov response: Accepted. Public Health England is reviewing its governance framework which underpins its responsibilities (in partnership with local, regional and national partners) for sharing and escalating concerns. As part of this work and as new structures …
Accepted
F100 — National Patient Safety Agency functions
Recommendation: Individual reports of serious incidents which have not been otherwise reported should be shared with a regulator for investigation, as the receipt of such a report may be evidence that the mandatory system has not been complied with.
Gov response: Accepted in principle. All serious incidents involving severe harm and death reported by individuals to via the on-line e-form, or any route, are routinely shared with the Care Quality Commission on a weekly basis. The …
Accepted in part
F41 — Use of information about compliance by regulator from: Patient safety alerts
Recommendation: The Care Quality Commission should have a clear responsibility to review decisions not to comply with patient safety alerts and to oversee the effectiveness of any action required to implement them. Information-sharing with the Care Quality Commission regarding patient safety …
Gov response: Accepted in principle. The Care Quality Commission already monitors compliance with patient safety alerts, such as those issued by the Medicines and Healthcare products Regulatory Agency, and is able to investigate further where it identifies …
Accepted in part
F32 — Interim measures
Recommendation: Where patient safety is believed on reasonable grounds to be at risk, Monitor and any other regulator should be obliged to take whatever action within their powers is necessary to protect patient safety. Such action should include, where necessary, temporary …
Gov response: Accepted. As part of the overall single failure regime (see recommendation 19) it is important that where the Care Quality Commission, Monitor or the NHS Trust Development Authority identify breaches of fundamental standards that they …
Accepted
COVID-M5.5 — Emergency Healthcare Equipment Plan
Recommendation: UK regulators, including the Health and Safety Executive, the Health and Safety Executive for Northern Ireland, the Office for Product Safety and Standards and the Medicines and Healthcare products Regulatory Agency, should establish an emergency healthcare equipment cross-regulator plan for …
Gov response: No formal government response published. The Northern Ireland Executive had not published a response to the Module 5 report of 14 July 2026 when the Executive Office's publications list was checked on 25 September 2026.
No response yet
42 — Register external reviews with CQC
Recommendation: We further recommend that all external reviews of suspected service failures be registered with the Care Quality Commission and Monitor, and that the Care Quality Commission develops a system to collate learning from reviews and disseminate it to other Trusts. …
Gov response: 43. We accept these recommendations. A new national, Independent Patient Safety Investigation Service will improve local standards of investigation and openness. 44. During the 10-year period in which serious incidents were occurring at Morecambe Bay, …
Accepted
IBI-10a(v) — Yellow Card System Prominence
Recommendation: Steps be taken to give greater prominence to the online Yellow Card system to those receiving drugs or biological products, or who are being transfused with blood components.
Gov response: The online Yellow Card system is UK wide and therefore this recommendation has been addressed on a UK wide basis. The Yellow Card system has provided vital feedback, but we agree with the inquiry that …
Accepted
25 — Duty to report external investigation findings
Recommendation: We recommend that a duty should be placed on all NHS Boards to report openly the findings of any external investigation into clinical services, governance or other aspects of the operation of the Trust, including prompt notification of relevant external …
Gov response: 43. We accept these recommendations. A new national, Independent Patient Safety Investigation Service will improve local standards of investigation and openness. 44. During the 10-year period in which serious incidents were occurring at Morecambe Bay, …
Accepted
ICL-2 — New LPG Safety Regime
Recommendation: A new safety regime should be put in place governing the installation, maintenance, monitoring and replacement of all LPG systems.
Gov response: A key theme that emerged from stakeholders was the view that the existing legislative framework already allows for Lord Gill’s objectives to be achieved providing that it is supported by improved guidance, compliance and enforcement …
Noted
Prevention of Future Deaths reports(32)
Lee Adams
Concerns: The coroner noted propranolol's high toxicity even at small doses and the lack of a specific antidote, requiring only supportive hospital treatment. There is a need for doctors, especially GPs, to be aware of these serious consequences.
Response (Medicines and Healthcare Products Regulatory Agency): • The Medicines and Healthcare Products Regulatory Agency (MHRA) noted that product information for healthcare professionals (Summary of Product Characteristics) and patients (Patient Information Leaflet) provides warnings about propranolol toxicity … (AI summary)
Responded
Desmond Statton
Concerns: Radiographers and clinicians at Derriford Hospital cannot access patient allergy information recorded on different computer systems within the hospital or from other hospitals. There is also insufficient awareness among nursing staff regarding Chlorhexidine as a cause of anaphylactic reactions.
Overdue
John Gwynfryn Morris
Concerns: The coroner identified concerns regarding the adequacy of security measures and supervision at the care home, as a resident with dementia and a history of wandering repeatedly left the premises despite previous incidents.
Response (CQC): • The CQC conducted a themed inspection project on the quality of care for people living with dementia between December 2013 and February 2014. • The CQC implemented Dementia Awareness … (AI summary)
Responded
Roy Frank Fletcher
Concerns: The coroner identified deficiencies in the Trust's post-incident review, noting it did not include interviews with a relevant service user nor explore whether other service users had left the hospital in similar circumstances.
Overdue
Russell James Felstead
Concerns: Doctors did not access and read all relevant information, including nursing notes, leading to a delay in actioning critical information that was available in Mr Felstead's medical records.
Overdue
Ozan Atasoy
Concerns: The coroner noted repeated instances of a detained patient absconding from the hospital's smoking area, often while escorted by nursing staff. Concerns were also raised about the patient's ability to leave the ward by following an informal patient.
Response (CQC): • The CQC published its intentions for a more specialised approach to inspecting mental health services. • The CQC developed a new inspection methodology, including standard key lines of enquiry … (AI summary)
Responded
George Stone
Concerns: National guidelines for warnings given to patients prescribed certain antidepressants do not currently include the risk of severe seizures, a known potential side effect of these medications.
Overdue
James Hedge
Concerns: The coroner notes that advice and guidance for insulin pumps do not adequately highlight dangers of misuse, and diabetic patient education lacks focus on the rapid life-threatening nature of unmanaged hyperglycaemia.
Response (Roche Diabetes Care Limited): • Roche Diabetes Care Limited issued a Field Safety Notice in May 2016 to reinforce existing advice on correct insulin pump cartridge insertion and emphasize related risks. • The company … (AI summary)
Response (NHS England): • NHS England will consider issues related to the risks from incorrect use of insulin pumps and the management of hyperglycaemia as part of a review into supporting structured education. (AI summary)
Response (Welsh Government): • The Welsh Government noted that the Medicines and Healthcare Products Regulatory Agency (MHRA) issued a Medical Device Alert concerning incorrect cartridge insertion and under-delivery of insulin. • The Welsh … (AI summary)
Response (Medicine and Healthcare Products Regulatory Agency): • The Medicine and Healthcare Products Regulatory Agency (MHRA) published a Medical Device Alert (MDA) on 15 August 2016 to inform healthcare providers of new instructions for changing insulin cartridges … (AI summary)
Responded
Roy Millar
Concerns: The coroner noted a lack of clear responsibility for booking follow-up appointments for discharged neurology patients, resulting in many patients, including Mr Millar, not receiving scheduled post-discharge care for over two years.
Overdue
Daniel Paylor
Concerns: The coroner identified insufficient regulatory control, safeguards, and auditing for drugs in secondary employment settings, particularly noting a lack of peer supervision and double authorisation for accessing safes.
Overdue
Helen Millard
Concerns: The coroner highlighted an incongruity in the 'traffic light' classification of ligature points in psychiatric facilities, where ligatures one metre or less are 'amber' despite posing an extreme risk. It was suggested all such points should be classified as 'red' for urgent elimination.
Overdue
Pauline Taylor
Concerns: The coroner raised concerns about the fire hazard of emollient creams with low paraffin content, citing inadequate warnings on packaging and insufficient awareness of these risks. Locala also did not update risk assessments after significant patient changes.
Response (PAGB): • PAGB is developing new warning statements for product packaging and patient information leaflets, which will undergo user-testing to ensure clarity. • PAGB will work with the MHRA and other … (AI summary)
Response (Medicines and Healthcare Products Regulatory Agency): • The MHRA is undertaking an in-depth review of instructions for use and reported adverse incidents, aiming to complete it by the end of 2017 and consider publishing additional safety … (AI summary)
Response (Locala): • Locala disseminated updated guidance on paraffin-containing skin products and their fire risk to all business units and staff. • Training was updated, and risk assessment processes were revised to … (AI summary)
Response (NHS England): • The NHS Patient Safety Team undertook work with the Medicines and Healthcare Regulatory Agency and other organisations regarding the concerns. • Actions taken were detailed in the Patient safety … (AI summary)
Response (United Kingdom Home Care Association): • The United Kingdom Homecare Association published a fact sheet, 'UKHCA Guidance; Emollient Products Guidance for homecare providers,' in January 2018. • The United Kingdom Homecare Association published an article, … (AI summary)
Overdue
Patrick Moran
Concerns: The anaesthetic department commonly used non-insulin syringes for insulin administration, despite a national alert. Additionally, doctors lack mandatory training on insulin devices, and no process exists to check compliance with safety alerts.
Overdue
Margaret Clark
Concerns: The coroner raised concerns that Ecolab Ultracover sheaths, used for Transoesophageal Echocardiograms (TOEs), may be linked to multiple fatal oesophageal tears. A review of these sheaths is recommended, considering their replacement with Probetection sheaths across all hospitals and Trusts.
Response (Medicines and Healthcare Products Regulatory Agency): • The MHRA requested and received complaint details from the manufacturer of Ecolab sheaths. • The MHRA reviewed its adverse incident database for reports concerning Ecolab sheaths. • The MHRA … (AI summary)
Responded
Mary Nelson
Concerns: The coroner raised concerns about Fluoxetine accumulating to dangerous levels that could trigger cardiac rhythm disturbance, questioning if dosage guidance needs revision or in-life drug level testing. Additionally, the death was not reported via the Yellow Card system.
Overdue
Beryl Holland
Concerns: The coroner noted a lack of national guidance for managing pressure ulcer risks in Emergency Departments. This can result in inadequate Trust policies, particularly for vulnerable patients experiencing prolonged stays in the ED awaiting ward transfer.
Response (National Institute for Health and Care Excellence): • NICE stated that its existing guideline (CG179) provides advice on managing and reducing pressure ulcer risks in emergency department settings. • NICE indicated that no further action was required … (AI summary)
Response (the Department for Health and Social Care): • The Department for Health and Social Care stated that the National Institute for Health and Care Excellence (NICE) provides a clinical guideline for the prevention and management of pressure … (AI summary)
Responded
Jon James
Concerns: The coroner notes the absence of national NICE guidance for Acute Behavioural Disturbance (ABD). Experts believe such guidance would prevent future deaths and provide practical support for medical professionals, police, and other responders.
Response (National Institute for Health and Care Excellence): • NICE has published a guideline (NG10) on violence and aggression, which includes a recommendation for staff training to distinguish between excited delirium states and other conditions. • NICE stated … (AI summary)
Responded
Van Tuyen
Concerns: The coroner noted the continued occurrence of deaths from misplaced nasogastric tubes, which are 'never events', and identified a lack of a unified approach across NHS Trusts to prevent these avoidable incidents.
Response (Department of Health and Social Care): • NHS England supported local implementation of nasogastric tube safety guidance, including funding eLearning for x-ray interpretation and developing easy reference safety checks. • The Healthcare Safety Investigation Branch (HSIB) … (AI summary)
Responded
Oli Hoque
Concerns: The coroner raised concerns that the MHRA lacks the power to compel timely production of relevant clinical data, which affects its ability to conduct robust safety investigations.
Response (Department of Health and Social Care): • The Medicines and Healthcare products Regulatory Agency (MHRA) is working with the NHS to enable interoperability and connectivity of reporting systems, including the new Learning from Patient Safety Events … (AI summary)
Responded
Robert Stevenson
Concerns: The coroner raises concerns that current guidelines for Ciprofloxacin and Quinolone antibiotics do not sufficiently emphasise a potential rare link to suicide behaviour, noting that prescribing doctors may lack full awareness of this side effect.
Overdue
Anita Graves
Concerns: The coroner identifies risks of inadvertent overdose due to the visual similarity of different strength carbimazole tablets and their resemblance to aspirin. The community dispensing process for carbimazole does not adequately mitigate this risk.
Response (Medicines and Healthcare Products Regulatory Agency): • The Medicines and Healthcare Products Regulatory Agency (MHRA) conducted a review of authorised carbimazole products and their labelling. • The MHRA has published and updated guidelines for the pharmaceutical … (AI summary)
Responded
Dumile Thompson
Concerns: Insufficient national guidance and training on angioedema types meant clinicians lacked awareness of ACE Inhibitor angioedema complexity and treatment pathways. The BNF also lacked information on racial disparities and alternative medications.
Overdue
Adrian Green
Concerns: The coroner noted a lack of local authority review into policies ensuring independent providers fulfil contractual duties for vulnerable individuals, and a lack of response from the Disclosure and Barring Service to a safeguarding referral.
Response (Torbay and Devon NHS): • The Trust implemented a new Provider Quality Support Protocol in February 2024 to formalise responses to concerns about care standards across all adult social services. • A Market Management … (AI summary)
Overdue
Aviva Otte, Oscar Barker and Yousef Al-Kharboush
Concerns: The coroner raises concerns about the absence of a requirement for section 10 exempt entities to report adverse event findings to the MHRA, other Trusts, or the wider industry. This lack of clear and mandatory reporting hinders wider learning and risk assessment for improving medication provision to vulnerable patients.
Response (NHS England): • NHS England published new guidance in March 2023, establishing clearer reporting structures and routine quarterly reporting for section 10 exempt units. • NHS England will review and update its … (AI summary)
Response (CQC): • NHS England published guidance in 2023 to clarify reporting requirements for aseptic preparation of medicines. • CQC received access to a digital iQAAPS dashboard in 2024 to review audits … (AI summary)
Response (Medicines and Healthcare Products Regulatory Agency): • The MHRA will communicate its expectation to Section 10 exempt facilities regarding the reporting of serious incidents. • The MHRA will work with NHS England to review guidance and … (AI summary)
Response (Department of Health and Social Care): • NHS England will review, update, and strengthen its 2023 guidance to provide further direction on reporting thresholds and escalation of concerns. • CQC and NHS England will implement a … (AI summary)
Responded
June Liddell
Concerns: Concerns were raised regarding the device's Instructions for Use, which omitted a critical error message and the significance of disappearing control icons. Additionally, the unique alarm function was unknown to users, and manufacturer maintenance lacked a wear-and-tear identification process.
Response (LivaNova): • LivaNova stated that the error message and the disappearance of icons are clear indicators to trained perfusionists, and no additional explanation in the Instructions for Use is necessary. • … (AI summary)
Response (Medicines and Healthcare Products Regulatory Agency): • The Medicines and Healthcare Products Regulatory Agency (MHRA) conducted an investigation into the LivaNova S5 heart lung machine. • The MHRA recommended that the manufacturer update the Instructions for … (AI summary)
Responded
Venetia Pierce
Concerns: An MHRA drug safety alert regarding nitrofurantoin's pulmonary risks did not appear on the prescribing system because it only triggers for pre-existing conditions. Awareness of potential pulmonary damage from nitrofurantoin in the elderly may also be low among GPs and hospital clinicians.
Response (EMIS): • EMIS undertook an internal review of its EMIS Web system in response to the report. • The review found that the system displayed multiple warnings related to nitrofurantoin for … (AI summary)
Overdue
Melanie Walker
Concerns: The coroner raises concerns that heart monitors in other hospital trusts may not re-alert staff if a lead remains disconnected after an initial acknowledgment, creating a risk that cardiac events could go undetected. This deficiency means patients may not be appropriately monitored until equipment is reconfigured and staff are trained.
Response (Philips Electronics UK Ltd): • Philips reset the "ECG Leads Off" technical alarm to the factory default configuration for the hospital involved. • Philips stated it does not propose further action to the default … (AI summary)
Response (NHS England): • Learning from the Patient Safety Incident Investigation was shared via Speciality and Divisional Governance structures and Trust Governance structures. • Heart monitors were reconfigured so that if an 'ECG … (AI summary)
Response (Department for Health and Social Care): • The Medical and Healthcare products Regulatory Agency (MHRA) published a Field Safety Notice from Philips on its gov.uk platform. • The MHRA is assessing the notice, which includes a … (AI summary)
Responded
Dominic Philip
Concerns: The coroner raises concerns about the absence of pre-screening for contrast medium allergies in patients who have not previously had it, and the unexplained presence of Lidocaine in the deceased's system despite a known allergy and no documented administration.
Response (Medicines Healthcare Products Regulatory Agency): • The Medicines Healthcare Products Regulatory Agency (MHRA) will continue to monitor and review adverse event reporting for contrast media as part of its pharmacovigilance activities. • The MHRA will … (AI summary)
Response (The Royal College of Radiologists): • The Royal College of Radiologists (RCR) has established a working party to develop guidance on the administration of iodinated contrast medium (ICM) and gadolinium. • The RCR anticipates this … (AI summary)
Response (University Hospitals of Northamptonshire NHS Group): • The trust stated that routine allergy testing prior to CT contrast studies is not considered viable, citing low incidence of severe reactions, lack of reliable tests, and significant resource … (AI summary)
Response (Department for Health and Social Care): • The Department for Health and Social Care indicated that other agencies were best placed to respond directly to the issues raised. • The Department for Health and Social Care … (AI summary)
Responded
Amelia Nasiadka
Response (National Institute for Health and Care Excellence): NICE will work with clinical experts to determine if its fetal monitoring guideline should be amended to emphasize that poor quality CTG may mask fetal bradycardia, distress, or demise, and … (AI summary)
Response (The Royal College of Obstetricians and gynaecologists): The RCOG acknowledges concerns about loss of CTG contact and explains that its national Avoiding Brain injury in Childbirth (ABC) programme's intrapartum toolkit advises urgent escalation for difficulty obtaining a … (AI summary)
Responded
John Philips
Concerns: The SystmOne electronic patient record system can deactivate a patient's active record when a previous organisation accesses it, removing current care plans and risking unsafe clinical care. A national technological solution is preferable.
Response (NHS England): • NHS England stated it would share the findings of its review with regional commissioning teams, the Welsh Health Board, and HMP Parc. • It indicated it would highlight to … (AI summary)
Responded
Ismaeel Islam
Concerns: The coroner raises concerns that the monitor manufacturer has not yet made a decision regarding the hospital's request to lock or default alarm volumes to maximum, which could enhance patient safety.
Response (Masimo UK): • Masimo stated that the Rad-97® monitor is shipped with the SpO₂ Alarm Volume setting at its maximum default. • Masimo confirmed that the device is equipped with an Alarm … (AI summary)
Responded
Muluembet Yohanes
Concerns: The coroner identified gaps in the NHS 111 Pathways system, noting the absence of a dedicated category for neurosurgery patients and that call handlers did not ask about post-surgical 'red flag' discharge advice.
Response (NHS England): • The NHS Pathways team will review training on the 'Predetermined management plans' route to enhance clarity for health advisors. • The 'Predetermined management plans' route and its associated training … (AI summary)
Responded
Select committee recommendations(33)
#20 —
Recommendation: The Secretary of State should review the regulatory regime for homecare medicines services, considering in particular the lack of enforcement action taken by the CQC against homecare providers where avoidable harm has occurred. The review should identify a lead regulator …
Response attribution not verified
#19 —
Recommendation: The regulatory model for homecare is failing to ensure the safety and quality of patient care. The regulators appear to have a limited understanding of the sector and there appears to be no appetite to find more information. Enforcement action …
Response attribution not verified
#20 — Groceries Code Adjudicator lacks sufficient powers for Welsh agricultural sector
Recommendation: We recognise that there is some dissatisfaction among stakeholders concerning the effectiveness and scope of the Groceries Code Adjudicator. There remain concerns about whether the Groceries Code Adjudicator has sufficient powers to address the full spectrum of challenges facing the …
Response attribution not verified
#20 — Committee to continue monitoring veterinary medicine access and scheme effectiveness in Northern Ireland
Recommendation: We will continue to monitor access to veterinary medicines in Northern Ireland and scrutinise the effectiveness of both the Veterinary Medicines Internal Market Scheme and the Veterinary Medicines Health Situations Scheme. (Conclusion, Paragraph 59)
Response attribution not verified
#4 — Collect data on supplier performance in advising indebted consumers for use in Ofgem's review.
Recommendation: The Department and Ofgem are not doing enough to ensure people falling into debt with their energy bills receive the advice and support they need from their energy supplier. At the same time as energy prices have risen significantly so …
Response attribution not verified
#8 — Set out impact of Patient Safety Alerts on private prescribing and enforcement measures.
Recommendation: In their response to this report, the Government should set out what impact it believes National Patient Safety Alerts have on private prescribing and what scrutiny and enforcement measures are in place to ensure private prescribers adhere to these alerts.
Response attribution not verified
#10 — Legislative changes necessary to address remediation barriers and strengthen freeholder enforcement.
Recommendation: Addressing some of these barriers will require legislative changes, for example, creating new obligations on landlords to remediate, and new enforcement powers for regulators to compel remediation or impose penalties. The Plan did not mention other barriers to pace highlighted …
Response attribution not verified
#9 —
Recommendation: We recommend that a single set of stretching safety training targets should be established by the Maternity Transformation Programme board, working in conjunction with the Royal Colleges and the Care Quality Commission. Those targets should be enforced by NHSE&I’s Maternity …
Response attribution not verified
#18 —
Recommendation: An outcomes-focused approach, however, can present a challenge for regulators and policymakers in measuring the influence or impact of regulation and the level of compliance by industry. A regulator’s influence over the industry it regulates—for example, how well businesses comply …
Response attribution not verified
#17 —
Recommendation: An outcomes-focused regulatory approach is one characterised by setting overall outcomes or principles expected of the regulated industry, rather than specifying rules. This has the benefit of often being more responsive to change because the regulatory objective or outcome remains …
Response attribution not verified
#9 —
Recommendation: Rapid technological development is altering traditional business and commerce, the climate emergency is driving changes in business and consumer behaviour, and changing social attitudes are shifting citizens’ expectations of regulators. The UK’s exit from the EU has also created both …
Response attribution not verified
#8 —
Recommendation: The Department told us that the UK is ranked highly in terms of regulatory policy and competitiveness by international bodies such as the OECD, the World Bank and the World Economic Forum (WEF). We heard that the Department seeks to …
Response attribution not verified
#7 —
Recommendation: The Government’s 2019 White Paper ‘Regulation for the 4th Industrial Revolution’ found that only 29% of businesses believed that “government’s approach to regulation facilitates innovative products and services being efficiently brought to market”.9 The Department explained that enabling innovation and …
Response attribution not verified
#6 —
Recommendation: We asked the Department how lessons from the regulatory response to the pandemic, including effective cooperation between regulators, could be embedded in the regulatory system. It told us that encouraging dialogue between regulators and with ministers was important, and highlighted …
Response attribution not verified
#5 —
Recommendation: Outcomes-based regulation comes with benefits, but also presents challenges for regulators in measuring their influence and compliance by industry. In general, setting goals and facilitating business to meet them can be both a more effective and a less burdensome approach …
Response attribution not verified
#3 —
Recommendation: Regulators may fail to protect citizens, businesses and the environment if they do not successfully adapt to major changes in their sectors. To remain effective, 6 Principles of effective regulation regulators must adapt and respond to change. Rapid technological development …
Response attribution not verified
#21 —
Recommendation: Local authority Trading Standards services have experienced significant resourcing challenges, including a 39% real-terms reduction in funding in the past 10 years. The OPSS told us that services’ funding varies enormously throughout the UK, as some Trading Standards are very …
Response attribution not verified
#20 —
Recommendation: The OPSS is still quite a new regulator with only a £14 million budget for product safety operations. The Department told us that it is providing additional funding for goods checking at the border, while the OPSS noted that additional …
Response attribution not verified
#2 —
Recommendation: The OPSS has struggled to reach some businesses and consumers to prevent harm being caused by unsafe products. Businesses are responsible for ensuring that the products they make and sell are safe. The OPSS and local regulators therefore rely on …
Response attribution not verified
#12 —
Recommendation: More significantly, we are concerned by the Government’s apparent lack of understanding of the extensive failings of the regulator and the consequences that this would have on the market in the event of any demand or supply-side shocks. 76 Energy …
Response attribution not verified
#11 —
Recommendation: We expect Ofgem, as the independent regulator, to clearly outline to Ministers and Parliament the risks and consequences associated with the delivery of Government objectives. We do not believe that Ofgem properly raised the risks to Government, or Parliament, that …
Response attribution not verified
#20 — Ofgem's proposed energy debt relief scheme faces significant delay until winter 2025
Recommendation: The Department recognised this as a serious issue. It made clear that, because in the first instance consumers facing energy debts should contact their energy supplier, the regulatory regime should that require suppliers to offer “good, accurate and helpful advice” …
Response attribution not verified
#27 —
Recommendation: We acknowledge that a large part of the success to date into the development of covid-19 vaccines and therapeutics can be credited to lessons learned from previous outbreaks and efforts made to prepare for future crises. As further promising vaccine …
Response attribution not verified
#26 —
Recommendation: The development of vaccines and therapeutics is a policy area in which it is right that science must lead the way, so that there may be a high level of confidence that a rigorous approach has been taken towards safety …
Response attribution not verified
#17 —
Recommendation: We are aware that the Medicines and Healthcare products Regulatory Agency (MHRA), the government’s regulatory body which approves medical devices, approved 51 https://www.gov.uk/government/news/staggered-rollout-of-coronavirus-testing-for-secondary-schools- and-colleges; https://www.gov.uk/government/publications/coronavirus-covid-19-asymptomatic-testing-in- schools-and-colleges/coronavirus-covid-19-asymptomatic-testing-in-schools-and-colleges; https://www.gov.uk/ government/news/all-students-offered-testing-on-return-to-university 52 Qq 13, 16–17, 118 53 C&AG’s Report paras 1.28–1.29 54 Q …
Response attribution not verified
#16 —
Recommendation: A number of significant commentators, including the British Medical Association and British Medical Journal, have raised concerns about the effectiveness and risks of mass testing with LFD tests.55 A particular issue raised is the relative accuracy of LFD tests compared …
Response attribution not verified
#1 —
Recommendation: On the basis of a report by the National Audit Office, we took evidence from the Department for Business, Energy and Industrial Strategy (the Department), and from the Environment Agency, the Health and Safety Executive (HSE) and the Office of …
Response attribution not verified
#25 —
Recommendation: The Government should assess whether outlets in the UK that are recruiting patients for medical treatment overseas should be brought into a regulatory regime and be subject to investigation and, where necessary, sanction. (Recommendation, Paragraph 97) Body image
Response status not verified
#24 —
Recommendation: We welcome Government action on educating the public on the risks of travelling abroad for cosmetic procedures and providing guidance on how to do so as safely as possible and its use of social media channels to do so. With …
Response status not verified
#23 —
Recommendation: The Government should review the need for the NHS to systematically record data on complications arising from cosmetic procedures performed abroad. Publishing such data in an annual release would enable a comprehensive assessment of the financial impact on the NHS …
Response status not verified
#22 —
Recommendation: The increasing number of cases requiring medical treatment after cosmetic surgery abroad raises serious concerns for patient safety and places additional financial strain on the NHS. However, the true extent will remain unknown until comprehensive data is collected. (Conclusion, Paragraph …
Response status not verified
#21 —
Recommendation: The Government should work with the devolved administrations to ensure regulatory alignment across all UK nations on legislation governing non- surgical cosmetic procedures. (Recommendation, Paragraph 82) Cosmetic tourism
Response status not verified
#20 —
Recommendation: While Scotland has taken steps to introduce a licensing scheme for non-surgical cosmetic procedures, Wales and Northern Ireland have yet to announce similar plans. This lack of regulatory alignment across the UK creates significant risks, including inconsistent safety standards and …
Response status not verified
HSSIB safety recommendations(25)
Implantation of wrong prostheses during joint replacement surgery
The Department of Health and Social Care expands the remit of the working group consisting of Derby Teaching Hospitals NHS Foundation Trust’s Scan4Safety Programme, the National Joint Registry (NJR), and the Medicines & Healthcare products Regulatory Agency to include alerts …
Safety Recommendation
Design and safe use of portable oxygen systems
It is recommended that the Medicines and Healthcare products Regulatory Agency evaluate how its Human Factors guidance document is used in practice by manufacturers and by Notified Bodies. Based on the review, the MHRA should make any changes necessary to …
Safety Recommendation
Piped supply of medical air and oxygen
The National Patient Safety Alert Committee should set standards for all issuers of patient safety alerts that require an assessment for unintended consequences, the effectiveness of barriers in the alert, and the advice the alert issuers give providers on implementation …
Safety Recommendation
Inadvertent administration of an oral liquid into a vein
It is recommended that NHS Improvement, through the National Patient Safety Alert Committee, set standards for all issuers of patient safety alerts which make clear that alert issuers should assess for unintended consequences of the actions in the alert, the …
Safety Recommendation
Procurement, usability and adoption of ‘smart’ infusion pumps
Medicines and Healthcare products Regulatory Agency (MHRA)
Learning Prompt
Placement of nasogastric tubes
It may be beneficial if national organisations including the Medicines and Healthcare products Regulatory Agency, NHS Supply Chain and NHS England and NHS Improvement review arrangements for ensuring all medical device related incidents, Yellow Card reports, or other device safety …
Safety Observation
Oxygen issues during the COVID-19 pandemic
All national Central Alerting System issuing organisations and teams will be accredited to issue national patient safety alerts from mid-2021.
Safety Action
Oxygen issues during the COVID-19 pandemic
It may be beneficial if the principles of user-centred design were adopted to help ensure that updates to the Central Alerting System assist users to interpret information.
Safety Observation
Administering high-strength insulin from a pen device in hospital
It may be beneficial for systems to support regulators in identifying when large volumes of unlicensed medication are regularly being prescribed to patients. Regulators can then engage in dialogue with the manufacturer about applying for a UK product licence. The …
Safety Observation
12-lead electrocardiograms (ECGs) in ambulance services: diagnosis of suspected ST elevation myocardial infarction (STEMI) — …
Ambulance services can improve patient safety by informing regulators and manufacturers of instances where the use of monitor/defibrillators has impacted on patient safety.
Safety Observation
12-lead electrocardiograms (ECGs) in ambulance services: diagnosis of suspected ST elevation myocardial infarction (STEMI) — …
Regulatory bodies can improve patient safety by supporting standardisation across manufacturers in how information from ECG traces is displayed.
Safety Observation
The impact of staff fatigue on patient safety
Healthcare regulators and professional bodies can improve patient safety by: considering how they can contribute to driving improvement in the understanding and awareness of staff fatigue; considering how they can support and share best practice on mitigations for the risk …
Safety Observation
The use of an appropriate flush fluid with arterial lines
HSIB recommends that the Medicines and Healthcare products Regulatory Agency communicates to all relevant stakeholders and acts on the available evidence concerning the management of the risks associated with arterial transducer line sets. The intention of this safety recommendation is …
Safety Recommendation
The use of an appropriate flush fluid with arterial lines
HSIB recommends that the Medicines and Healthcare products Regulatory Agency reviews and acts on the available evidence to regulate for the use of pressure infusion bags that allow fluid labels to be read when inflated. The intention of this safety …
Safety Recommendation
Failures in communication or follow-up of unexpected significant radiological findings
It is recommended that the Care Quality Commission amends all appropriate core service frameworks to include risk controls identified in this report, to mitigate the risk of significant abnormal findings not being followed up.
Safety Recommendation
The diagnosis of ectopic pregnancy
It is recommended that the Care Quality Commission Services Framework for Gynaecology and Termination Services includes an assessment of early pregnancy services, using as a reference the National Institute for Health and Care Excellence Guideline 126, Ectopic pregnancy and miscarriage: …
Safety Recommendation
Placement of nasogastric tubes
(previously shared in interim bulletin): It is important that organisations are aware that there is not a standard scale/colour scheme across the different manufacturers of CE marked enteral testing strips and they vary in scale (pH of 1-12, 0-6, 2-9 …
Safety Observation
Placement of nasogastric tubes
It is recommended that NHS Supply Chain and the British Standards Institution work together (engaging other system leaders as appropriate, such as the Medicines and Healthcare products Regulatory Agency and NHS England and NHS Improvement), to develop and publish an …
Safety Recommendation
Administering high-strength insulin from a pen device in hospital
It may be beneficial if national work was undertaken to review the robustness of the strategies to prevent administration errors with high-strength insulin and update accordingly. The intention of this safety observation is to ensure that the medication regulator becomes …
Safety Observation
The use of an appropriate flush fluid with arterial lines
It may be beneficial if regulatory bodies remain alert to and encourage the adoption of alternative approaches to continuous glucose monitoring.
Safety Observation
Electronic patient record (EPR) systems – thematic review
National bodies responsible for providing digital advice and guidance to NHS organisations can improve patient safety by clarifying consistent definitions for design-related IT terms – such as usability and functionality – and sharing guidance on how to apply design principles …
Safety Observation
Management of chronic health conditions in prisons
It is recommended that the Care Quality Commission amends its inspection criteria to ensure that interprison transfer processes are fully encapsulated within the inspection schedule to assure the provision of care throughout.
Safety Recommendation
Detection of retained vaginal swabs and tampons following childbirth
It is recommended that NHS England/Improvement carries out its intention to commission and publish an independent evaluation of its alternative design for swabs and tampons. The evaluation should also consider other solutions or technologies and include usability, cost/benefit analysis and …
Safety Recommendation
The use of an appropriate flush fluid with arterial lines
HSIB recommends that the Medicines and Healthcare products Regulatory Agency engages with other national regulators and relevant stakeholders to develop design guidance on labelling and packaging specific to fluids to reduce selection errors.
Safety Recommendation
Mental health inpatient settings: Creating conditions for learning from deaths in mental health inpatient services …
HSSIB recommends that the Department of Health and Social Care creates a national oversight mechanism that supports co-ordination, prioritisation and oversight of safety recommendations to implementation across the system. This is to ensure that recommendations from public inquiries, independent patient …
Safety Recommendation
NCEPOD recommendations(1)
CQC inspection actions(11)
The York Hospital
The service must ensure ED staff review national patient safety alerts for relevant learning and ensure measures taken around historical alerts are maintained.
Must Do
Scarborough Hospital
The service must ensure ED staff review national patient safety alerts for relevant learning and ensure measures taken around historical alerts are maintained.
Must Do
Liverpool Walk in Centre
Review the system in place for disseminating safety alerts to all member to ensure there is evidence and monitoring in place that actions when required have been completed.
Should Do
St Michael's Hospital
The trust should ensure their new peri-operative documentations are implemented across all the surgical Care Groups immediately to include the patient safety alert, “confirming removal or flushing of lines and cannula after procedures 9 November 2017.”
Should Do
St Lawrence Road Surgery
Update processes for acting on Medicines and Healthcare products Regulatory Agency (MHRA) alerts to include a recall system or background searches for historic MHRA alerts.
Should Do
Reside at Southwood
The registered persons must notify CQC of all incidents.
Must Do
Oak Tree Manor
However, we could not be sure that we had been informed the CQC of significant events in a timely way which meant we could check that appropriate action had been taken. This was an area that required monitoring.
Should Do
Woodland Care Home
Services that provide health and social care to people are required to inform the CQC of deaths and other important events that happen in the service in the form of a 'notification'.
Must Do
Reside at Southwood
The registered provider had not notified us of all incidents.
Must Do
Park Cottages
CQC had not been notified of all incidents in line with regulatory requirements.
Must Do
Holly House Residential Care Home
The provider must inform the Care Quality Commission (CQC) of important events that happen in the service in a timely way.
Must Do
National patient safety alerts(1)
Health investigations(14)
Assurance Review: Recommendations for commissioners, NHS England, advisors and regulators — Rec 72
NHS England and NHS Improvement should share the findings from the testicular implant recall exercise with relevant bodies and agree the next steps at a local or national level.
University Hospitals of Morecambe Bay NHS Foundation Trust
north_west
This Independent Investigation into concerns and issues raised relating to … — Rec 39
The Care Quality Commission (CQC) should review its processes for receiving and acting upon identifiable information relating to patient safety concerns, particularly in cases where anonymity is requested, to ensure that such information can be effectively used to trigger timely and appropriate regulatory action.
University Hospitals of Morecambe Bay NHS Foundation Trust
north_west
An independent review into the independent sector provider One to … — Rec 4
The Care Quality Commission should consider how they publicly share information about actions taken to address any issues from previous regulation activity, ensuring this is easy to understand, accessible and provides evidence of how they have held organisations to account for people’s care.
north_west
Independent investigation: Philip Slater, Silsden (2017) — Rec 8
NHS England should report the findings of this report that relates to the dispensing error to the Royal Pharmaceutical Society and the General Pharmaceutical Council.
north_east_yorkshire
Assurance Review: Trust recommendations — Rec 49
Trust Management of Royal College reports • The Trust should inform regulators (CQC and NHS England and NHS Improvement) and commissioners of any plans for external reviews for quality and safety concerns, including Royal College Invited Service Reviews as soon as they are confirmed. This will ensure that regulators and …
north_west
An independent review into the care and treatment of Mr … — Rec 7
Canterbury and Coastal CCG should seek to assure itself, as a priority, that it is signing off Trust SI reports in line with CCG policy and the NHSE SI framework, and that Trust action plans are appropriately tested, monitored and reviewed.
south_east
An independent investigation into the care and treatment of a … — Rec Recommendation 4
Kernow Clinical Commissioning Group must ensure that the policy covering the management of serious incidents includes a requirement for oversight of provider investigation action plans, and appropriate and documented dialogue between the commissioner and relevant provider/s.
Cornwall Partnership NHS Foundation Trust
south_west
An independent review into the independent sector provider One to … — Rec 3
The Care Quality Commission should review its approach to consider the impact that financial instability might have on a small company’s ability to provide safe care.
north_west
Independent investigation: Angela Titley, Private Psych hospital, Redhill, Surrey (2004) — Rec R10
We recommend to PCTs, Trusts and Social Services that the process of monitoring a patient’s placement in an “out-of-area” hospital should always include active consideration of whether the hospital in question is providing a service of an acceptable standard. A starting point for any such consideration ought to be a …
south_east
Joint Domestic Homicide Review and independent mental health homicide investigation … — Rec 20
NHS England should gain assurance about the quality of private PICU provision following the principles of host commissioning arrangements. This is to ensure that the local CCG/ICS monitors and has quality oversight for providers in their locality. Quality issues should be raised via the quality system oversight groups.
north_west
Joint Domestic Homicide Review and independent mental health homicide investigation … — Rec 17
Cygnet Health Care must ensure that serious incident investigations are carried out at the appropriate levels, within expected timescales and that they meet expected NHS England national standards.
north_west
An Independent Review into the care and treatment provided by … — Rec 10
The organisations with responsibility for regulation, oversight and support to GMMH must review their current systems of quality assurance. They must also review how they work together collectively to identify concerns in a provider at an early stage to prevent tragedies like those seen at Edenfield from reoccurring. Where learning …
Greater Manchester Mental Health NHS Foundation Trust
north_west
Themes and lessons learnt from NHS investigations into matters relating … — Rec R14
Monitor and the Trust Development Authority should exercise their powers to ensure that NHS hospital trusts comply with recommendation 12.
national
Accepted
Themes and lessons learnt from NHS investigations into matters relating … — Rec R13
Monitor, the Trust Development Authority, the Care Quality Commission and NHS England should exercise their powers to ensure that NHS hospital trusts, (and where applicable, independent hospital and care organisations), comply with recommendations 1, 2, 4, 5, 7, 9, 10 and 11.
national
Accepted
Independent reviews(15)
Keogh Cosmetic Interventions Review — Rec 22
The Director of Patient Safety for NHS England should develop a framework to encourage and support the reporting of suspected device failures to the MHRA.
Health & Social Care
Keogh Cosmetic Interventions Review — Rec 20
A system should be developed by the MHRA to link the Unique Device Identifier for all implants to the patient's electronic record, enabling routine collection through Hospital Episode Statistic (HES) data. This information would enable assessment of implant performance, and the tracking and tracing of patients in case of a …
Health & Social Care
Francis Inquiry (Mid Staffs 2010) — Rec 2
The Secretary of State for Health should consider whether he ought to request that Monitor – under the provisions of the Health Act 2009 – exercise its power of de-authorisation over the Mid Staffordshire NHS Foundation Trust. In the event of his deciding that continuation of foundation trust status is …
Health & Social Care
Cumberlege Review — Rec 6
The Medicines and Healthcare products Regulatory Agency (MHRA) needs substantial revision particularly in relation to adverse event reporting and medical device regulation. It needs to ensure that it engages more with patients and their outcomes. It needs to raise awareness of its public protection roles and to ensure that patients …
Health & Social Care
Review of patient safety across the health and care landscape — Rec 4
The original function of the Patient Safety Commissioner - to promote the safety of and enable the user voice to feed back on adverse impacts of medicines and medical products - should be hosted by MHRA , which has direct responsibility to monitor medicines and medical devices. This move would: …
Health & Social Care
Review of patient safety across the health and care landscape — Rec 2
CQC should remain the independent regulator and oversight body across the health and care system. However, it needs to adopt tailored approaches to assessments by sector and within sectors, taking into account the structure of commissioners (including private health insurers) and providers, as described in more detail in the previous …
Health & Social Care
Dash Patient Safety Review — Rec 4
Transfer the hosting arrangement of the Patient Safety Commissioner to MHRA, and broader patient safety work to a new directorate for patient experience within NHS England, transferring to the new proposed structure within DHSC. The original function of the Patient Safety Commissioner — to promote the safety of and enable …
Health & Social Care
Accepted
Dash Patient Safety Review — Rec 2
Continue to rebuild the Care Quality Commission with a clear remit and responsibility. CQC should remain the principal independent regulator responsible for oversight of the health and care system. It should develop sector-specific approaches to registration and assessment, set standards for the quality of health and care in co-ordination with …
Health & Social Care
Accepted
Goldacre Review — Rec Open 12
The Medicines and Healthcare products Regulatory Agency should address code sharing and device regulation It is not practical or useful that there should be conflict - or perceived conflict - between code sharing and medical device regulations. The Medicines and Healthcare products Regulatory Agency (MHRA) should deliver absolute clarity to …
Health & Social Care
Francis Inquiry (Mid Staffs 2010) — Rec 16
The Department of Health should consider instigating an independent examination of the operation of commissioning, supervisory and regulatory bodies in relation to their monitoring role at Stafford hospital with the objective of learning lessons about how failing hospitals are identified.
Health & Social Care
Shaw Review of Network Rail — Rec 2
Recommendation 2: Focus on the customer through deeper route devolution, supported by independent regulation. Building on the current Network Rail move to greater devolution to its routes, there should be a step-change in the degree of autonomy of these routes to deliver more flexibly and responsively for their customers, passengers …
Other
Wessely Review — Rec 151
The role of the CQC in monitoring the use of the MHA should be extended to cover all organisations that commission or provide services under the Act with due consideration given to the roles of other national bodies.
Health & Social Care
Accepted
Independent review of the physician associate and anaesthesia associate roles: … — Rec 15
The General Medical Council requirements for regulation and reaccreditation of physician assistants and physician assistants in anaesthesia in Good medical practice should be presented separately to reinforce and clarify the differences in roles from those of doctors.
Health & Social Care
Keogh Cosmetic Interventions Review — Rec 19
Manufacturers should inform the MHRA when bringing a new product to the UK market and the MHRA should publish a list of the cosmetic devices available in the UK.
Health & Social Care
Mental Health Taskforce 2016 — Rec 53
Within its strategy for 2016–2020, the CQC should set out how it will strengthen its approach to regulating and inspecting NHS-funded services to include mental health as part of its planned approach to assessing the quality of care along pathways and in population groups.
Health & Social Care
Domestic Homicide Reviews(2)
Swindon — recommendation 10
1. Develop locality Safety Alert highlighting this incident and the expected standards of record keeping in progress notes. 2. Disseminate locality Safety Alert and ensure all teams respond to state that the Safety Alert has been shared and understood 3. Monitor quality of progress notes on monthly basis in team …
Avon and Wiltshire Mental Health Partnership …
Avon and Wiltshire NHS …
West Berkshire — recommendation 6.12
A response to these recommendations should reflect the guidance provided in the Department of Health publication 292071 “Improving safety, reducing harm, a practical toolkit for front-line practitioners” published in 2009.
NHS Berkshire West
NHS Buckinghamshire, Oxfordshire and …