Regulator patient safety alerts
Lack of clear responsibility for regulators (e.g., CQC) to review decisions not to comply with patient safety alerts.
Strongest theme matches
Mixed across source types and ranked by classifier confidence plus text match strength.
Inquiry recommendation
100match
F41 - Use of information about compliance by regulator from: Patient safety alerts
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 alerts should continue following the transfer of the National Patient Safety Agency's functions in June 2012 to the...
Matched on
terms: alert, patient, regulator, safety
HSSIB recommendation
99match
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 of staff fatigue; considering organisational and individual factors that may have contributed to staff fatigue when making decisions...
Matched on
terms: patient, regulator, safety
Inquiry recommendation
90match
11 - Regulatory system patient safety priority
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.
Matched on
terms: patient, regulator, safety
Committee recommendation
90match
#8 - Set out impact of Patient Safety Alerts on private prescribing and enforcement measures.
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.
Matched on
terms: alert, patient, safety
Inquiry recommendation
86match
F100 - National Patient Safety Agency functions
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.
Matched on
terms: patient, regulator, safety
HSSIB recommendation
81match
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 effectiveness of barriers created by these actions, and provide appropriate advice for providers on implementation, include ongoing monitoring.
Matched on
terms: alert, patient, safety
HSSIB recommendation
81match
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 related information, including any involving concerns with pH or X-ray in the context of nasogastric tubes, are shared...
Matched on
terms: patient, regulator, safety
Inquiry recommendation
78match
BRIS-111 - Require National Patient Safety Agency to inform trusts and publish reports
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 also be required to publish regular reports on patterns of sentinel events and proposed remedial actions.
Matched on
terms: patient, safety
PFD report
77match
Patrick Moran
An insulin overdose occurred due to the common practice of using incorrect syringes, exacerbated by the removal of diabetes from mandatory training and the lack of a system to review compliance with safety alerts.
Matched on
terms: alert, safety
HSSIB recommendation
77match
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 to identify wrong prostheses prior to implantation. The Department of Health and Social Care commissions the development and...
Matched on
terms: alert, regulator, safety
HSSIB recommendation
77match
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 and ongoing monitoring.
Matched on
terms: alert, patient, safety
HSSIB recommendation
77match
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.
Matched on
terms: alert, patient, safety
HSSIB recommendation
77match
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 intention of this safety observation is to ensure there is clarity and consistency in the role and competencies...
Matched on
terms: patient, regulator, safety
HSSIB recommendation
77match
12-lead electrocardiograms (ECGs) in ambulance services: diagnosis of suspected ST elevation myocardial infarction (STEMI) — HSSIB
Ambulance services can improve patient safety by informing regulators and manufacturers of instances where the use of monitor/defibrillators has impacted on patient safety.
Matched on
terms: patient, regulator, safety
PFD report
69match
Venetia Pierce
An EMIS system failed to flag a nitrofurantoin safety alert because it only triggered for pre-existing conditions, alongside generally low clinician awareness of the drug's pulmonary risks in the elderly.
Matched on
terms: alert, safety
HSSIB recommendation
69match
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 the document or use other mechanisms to improve the implementation of Human Factors in the pre-market approval process....
Matched on
terms: regulator, safety
CQC action
69match
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.
Matched on
terms: alert, safety
HSSIB recommendation
69match
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 to electronic patient record system configuration and optimisation.
Matched on
terms: patient, safety
HSSIB recommendation
69match
Mental health inpatient settings: Creating conditions for learning from deaths in mental health inpatient services and when patients...
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 investigations and other patient safety investigation reports, as well as prevention of future death reports from inquests,...
Matched on
terms: patient, safety
Inquiry recommendation
68match
F32 - Interim measures
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 measures to ensure such protection while any investigation required to make a final determination is undertaken.
Matched on
terms: patient, regulator, safety
HSSIB recommendation
66match
Safety issues for people experiencing a mental health crisis who come into contact with urgent and emergency care...
HSSIB recommends that the Care Quality Commission works with stakeholders to produce a position statement on existing legal powers, and the expectations for support for staff, for the care of people experiencing a mental health crisis in emergency departments (including mental health emergency departments and mental health crisis assessment services), who are not detained under a formal legal...
Matched on
terms: safety
PFD report
65match
Roy Millar
Ward administrators in the Neurology Department were unaware of their responsibility to book follow-up appointments, leading to a large number of patients, including the deceased, not having appointments booked; a review revealed 146 patients did not have follow-up appointments booked.
Matched on
terms: patient
PFD report
65match
Aviva Otte, Oscar Barker and Yousef Al-Kharboush
A lack of clear reporting requirements for section 10 exempt entities regarding adverse events prevents crucial findings from being shared with regulatory bodies, other trusts, or the wider industry.
Matched on
terms: regulator
HSSIB recommendation
64match
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 recommendation is to increase awareness of and action on known risks related to the design of the medical...
Matched on
terms: regulator, safety
Inquiry recommendation
64match
F107 - Sharing concerns
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 or public safety, they should immediately inform all responsible commissioners, including the relevant regional office of the NHS...
Matched on
terms: patient, safety
PFD report
61match
Daniel Paylor
Ambulance services exhibit inadequate regulatory control, safeguards, and auditing for drugs compared to hospitals, lacking sufficient peer supervision and requiring only single-person authority for drug access.
Matched on
terms: regulator
PFD report
61match
Pauline Taylor
Emollient creams with paraffin pose an unrecognised fire hazard due to inadequate warnings and lack of awareness, alongside insufficient patient risk assessments.
Matched on
terms: patient
PFD report
61match
Beryl Holland
Inconsistent hospital policies and a lack of national guidance for managing pressure ulcer risks in Emergency Departments led to prolonged waits and inadequate care for vulnerable patients.
Matched on
terms: patient
PFD report
61match
Robert Stevenson
Prescribing doctors may be unaware of a rare potential link between Ciprofloxacin/Quinolone antibiotics and suicidal behaviour, especially in depressed patients. Guidelines should be reviewed to increase awareness and mitigate this risk.
Matched on
terms: patient
PFD report
61match
Dominic Philip
The hospital lacked pre-screening for contrast allergies, and Lidocaine was inexplicably present in an allergic patient, raising concerns about medication contamination or poor stock control.
Matched on
terms: patient
Committee recommendation
60match
#9 - Fourth Report - The safety of maternity services in England
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 Transformation Programme, the Royal College of Midwives, the Royal College of Obstetricians and Gynaecologists and the Care Quality...
Matched on
terms: patient, safety
PFD report
57match
Russell James Felstead
Doctors failed to access and read vital medical information within nursing notes, resulting in a four-day delay in ordering an urgent CT scan for the patient.
Matched on
terms: patient
PFD report
57match
Ozan Atasoy
A detained patient repeatedly absconded from a psychiatric unit's smoking area, often while escorted, indicating insufficient supervision and inadequate security protocols.
Matched on
terms: patient
PFD report
57match
George Stone
National guidelines for antidepressant warnings, specifically for Venlafaxine, fail to include the rare but severe risk of seizures, potentially leaving patients uninformed about a critical side effect.
Matched on
terms: patient
PFD report
57match
James Hedge
Insulin pump guidance inadequately highlights misuse dangers from incorrect cartridge insertion, and patient education fails to emphasize the rapid life-threatening nature of hyperglycaemia.
Matched on
terms: patient
PFD report
57match
Oli Hoque
The MHRA's inability to compel timely clinical data hinders robust safety investigations into potential vaccine adverse events, impacting public interest in drug safety.
Matched on
terms: safety
Committee recommendation
56match
#10 - Legislative changes necessary to address remediation barriers and strengthen freeholder enforcement.
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 by the NAO, such as the affordability of paying for defects that do not relate to cladding and...
Matched on
terms: regulator, safety
Inquiry recommendation
55match
COVID-M5.5 - Emergency Healthcare Equipment Plan
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 future pandemics. The plan must include arrangements for: coordination of written guidance from regulators to ensure that it...
Matched on
terms: regulator, safety
Committee recommendation
55match
#2 - Nineteenth Report - Protecting consumers from unsafe products
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 influencing businesses to ensure they comply with the rules. Despite issuing guidance and advice, the OPSS has found...
Matched on
terms: regulator, safety
PFD report
53match
Roy Frank Fletcher
The Trust's post-incident review was inadequate, failing to interview a key witness or assess if similar events were persistent issues, thus hindering learning and preventing future deaths.
Matched on
classifier match
HSSIB recommendation
53match
Procurement, usability and adoption of ‘smart’ infusion pumps
Medicines and Healthcare products Regulatory Agency (MHRA)
Matched on
terms: regulator
CQC action
52match
Park Cottages
CQC had not been notified of all incidents in line with regulatory requirements.
Matched on
terms: regulator
Scottish FAI
52match
Guy Henderson and John McCreanor
Safety Recommendation 2006-101: The European Aviation Safety Agency and Joint Aviation Authorities should review the UK Civil Aviation Authority’s proposal to mandate the fitment of upper torso restraints on all seats of existing Transport Category (Passenger) aeroplanes below 5700kg being operated for public transport and consider creating regulation to implement the intent of the proposal. Safety Recommendation 2006-102:...
Matched on
terms: safety
Committee recommendation
51match
#21 - Nineteenth Report - Protecting consumers from unsafe products
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 well resourced to tackle product safety risks while others do not have the funding to deal with the...
Matched on
terms: regulator, safety
Committee recommendation
51match
#20 - Nineteenth Report - Protecting consumers from unsafe products
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 resources and tools would be needed to effectively regulate the scale of products now sold online.36 The OPSS...
Matched on
terms: regulator, safety
Committee recommendation
51match
#20 - 11th Report – Cosmetic procedures
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 the potential for ‘cosmetic tourism’ within the UK, where individuals seek treatments in jurisdictions with weaker protections. (Conclusion,...
Matched on
terms: regulator, safety
PFD report
49match
Lee Adams
Doctors, particularly GPs, require greater awareness of propranolol's high toxicity at small doses and the lack of a specific antidote for overdose.
Matched on
classifier match
PFD report
49match
Margaret Clark
A change to new TOE probe sheaths (Ecolab) was linked to multiple fatal oesophageal tears, and these potentially unsafe sheaths may still be in use in other hospitals despite safer alternatives existing.
Matched on
classifier match
PFD report
49match
Adrian Green
The local authority failed to review independent care providers' contractual duties for vulnerable individuals, and a Disclosure and Barring Service referral regarding actions of a former manager received no response.
Matched on
classifier match
Committee recommendation
47match
#18 - Sixteenth Report - Principles of effective regulation
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 with standards—can be difficult to measure, particularly if there are not specific rules that can be easily monitored.38...
Matched on
terms: regulator