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
Committee recommendation
81match
#19 - 4th Report - Homecare medicines services: an opportunity lost
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 taken against providers, even where avoidable harm has taken place, is feeble. There appears to be no appetite...
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
CQC action
81match
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.
Matched on
terms: alert, patient, safety
CQC action
81match
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.
Matched on
terms: alert, patient, 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
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
CQC action
77match
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.”
Matched on
terms: alert, patient, safety
PFD report
73match
Patrick Moran
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.
Matched on
terms: alert, safety
PFD report
69match
Roy Millar
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.
Matched on
terms: patient
PFD report
69match
Venetia Pierce
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.
Matched on
terms: alert, safety
PFD report
69match
Melanie Walker
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.
Matched on
terms: alert, patient
Inquiry recommendation
69match
9 - Date for submitting Safety Cases
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 regulatory body should have the power, in the event of the failure of an operator to submit an...
Matched on
terms: regulator, safety
Inquiry recommendation
69match
8 - Safety Case before installation operates
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 of that installation has been submitted to and accepted by the regulatory body (para 17.41).
Matched on
terms: regulator, 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
GIRFT recommendation
69match
Dermatology
Ensure the public, patients and clinicians have access to the latest research studies, information and support to implement national safety recommendations. a Improve awareness and support implementation of national actions related to: • risks of fire associated with use of skin creams and cosmetics containing any oil • risks of accidental ingestion of potassium permanganate antiseptic tablets and...
Matched on
terms: patient, 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
CQC enforcement action
68match
Warning Notice: Berkshire Healthcare NHS Foundation Trust
Following a review, the Care Quality Commission found that incidents concerning patient safety were not being reported quickly enough to the National Patient Safety Agency. The CQC required that the trust address this issue by 23 March, stating that if improvements were not made, next steps could include prosecution.
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
PFD report
65match
Aviva Otte, Oscar Barker and Yousef Al-Kharboush
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.
Matched on
terms: patient
Committee recommendation
65match
#20 - 4th Report - Homecare medicines services: an opportunity lost
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 with the skill and the breadth necessary to take necessary action against providers which are under-performing. These urgent...
Matched on
terms: regulator
CQC action
65match
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.
Matched on
terms: alert, 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
GIRFT recommendation
64match
Neurology
Support the Department of Health and Social Care co-ordinated response to implementation of the Independent Medicines and Medical Devices Safety Review relating to safe use of sodium valproate in women of child-bearing potential. Actions: a) Carry out an annual review for all women currently taking sodium valproate. b) Continue to follow guidance regarding prescribing of sodium valproate and...
Matched on
terms: patient, 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
James Hedge
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.
Matched on
terms: patient
PFD report
61match
Daniel Paylor
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.
Matched on
terms: regulator
PFD report
61match
Beryl Holland
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.
Matched on
terms: patient
PFD report
61match
Oli Hoque
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.
Matched on
terms: safety
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
60match
Ismaeel Islam
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.
Matched on
terms: patient, safety
PFD report
57match
Desmond Statton
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.
Matched on
terms: patient
PFD report
57match
Ozan Atasoy
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.
Matched on
terms: patient
PFD report
57match
George Stone
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.
Matched on
terms: patient
PFD report
57match
Pauline Taylor
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.
Matched on
terms: patient
PFD report
57match
Dominic Philip
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.
Matched on
terms: patient
GIRFT recommendation
57match
Cardiology
NHSX and the Department of Health and Social Care should work to ensure that there is clinical engagement with the procurement of cardiac devices and that all devices are subject to systematic surveillance to ensure their safety and efficacy. a) Improve awareness of costs and product utilisation across the NHS by providing cardiology supply chain analytics. b) Work...
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