Regulator patient safety alerts
33 items
2 sources
Lack of clear responsibility for regulators (e.g., CQC) to review decisions not to comply with patient safety alerts.
Cross-Source Insight
Regulator patient safety alerts has been flagged across 2 independent accountability sources:
12 inquiry recs
21 PFD reports
This issue has been identified by multiple independent accountability bodies, suggesting it is a recurring systemic concern.
Inquiry Recommendations (12)
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: Accepted. Government is strengthening regulatory collaboration. CQC and GMC have improved information sharing arrangements. The Professional Standards Authority oversees healthcare regulators. Regulatory reform programme underway to ensure patient safety is paramount. Health and Care Act …
Accepted
No update 2+ yrs
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
In progress
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: UK Government 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 …
Accepted in Part
In progress
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: The Home Secretary made a written statement to Parliament on 3 November 2022 following publication of Volume 2, acknowledging the findings on emergency response failures and stating the government would work with emergency services to …
Accepted in Part
In progress
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: The government published "Hard Truths: the Journey to Putting Patients First" (Cm 8777) on 19 November 2013, responding to all 290 recommendations of the Francis Report. This followed an initial response "Patients First and Foremost" …
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: The government published "Hard Truths: the Journey to Putting Patients First" (Cm 8777) on 19 November 2013, responding to all 290 recommendations of the Francis Report. This followed an initial response "Patients First and Foremost" …
Accepted
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: The government published "Hard Truths: the Journey to Putting Patients First" (Cm 8777) on 19 November 2013, responding to all 290 recommendations of the Francis Report. This followed an initial response "Patients First and Foremost" …
Accepted
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: The government published "Hard Truths: the Journey to Putting Patients First" (Cm 8777) on 19 November 2013, responding to all 290 recommendations of the Francis Report. This followed an initial response "Patients First and Foremost" …
Accepted in Part
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
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
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. …
Accepted
Delivered
PFD Reports (21)
Melanie Walker
Concerns: Heart monitors have a critical design flaw where disconnected leads do not continuously re-alarm after initial acknowledgement, risking unobserved and fatal cardiac events in other hospitals.
Response: Philips reset the 'ECG Leads Off' alarm at the specific hospital to its factory default medium priority. However, Philips disputes the need for wider changes to their product's default settings, …
Response: The Greater Manchester ICB has reconfigured heart monitor alarms so that 'ECG leads off' alerts will visually flash and re-alarm audibly every three minutes if not reconnected, whereas previously they …
Response: The Department noted that Philips has already issued a Field Safety Notice for its IntelliVue Patient Monitors, clarifying that alarm functions are user-reconfigurable and must be confirmed as 'alarm on'. …
Responded
Venetia Pierce
Concerns: 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.
Overdue
June Liddell
Concerns: Critical error messages and equipment defect indicators are not documented in user instructions or known to staff. Machine maintenance procedures also fail to identify component wear and tear.
Responded
Aviva Otte, Oscar Barker and Yousef Al-Kharboush
Concerns: 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.
Responded
Adrian Green
Concerns: 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.
Overdue
Dumile Thompson
Concerns: Insufficient national guidance and training on angioedema types, risk factors (including ethnicity), and diverging treatments, alongside poor medical record sharing between Trusts, hindered appropriate emergency care.
Overdue
Anita Graves
Concerns: The visual similarity of carbimazole tablets of varying strengths, and to aspirin, creates an overdose risk. The community dispensing process fails to mitigate this danger, potentially exacerbating the risk.
Responded
Robert Stevenson
Concerns: 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.
Overdue
Oli Hoque
Concerns: The MHRA's inability to compel timely clinical data hinders robust safety investigations into potential vaccine adverse events, impacting public interest in drug safety.
Responded
Van Tuyen
Concerns: Misplaced nasogastric tubes continue to cause avoidable deaths, despite being a 'never event', with no unified national approach to prevent recurrences across NHS Trusts.
Responded
Beryl Holland
Concerns: 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.
Responded
Mary Nelson
Concerns: Dangerous fluoxetine accumulation suggests a need to revise dosage guidance, especially for the elderly, and consider in-life drug testing. This death was also not reported to the Yellow Card system.
Overdue
Jon James
Concerns: There is no national NICE guidance on Acute Behavioural Disturbance, which is vital for emergency services and police, contributing to a rising number of related deaths.
Responded
Margaret Clark
Concerns: 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.
Responded
Patrick Moran
Concerns: 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.
Overdue
Pauline Taylor
Concerns: Emollient creams with paraffin pose an unrecognised fire hazard due to inadequate warnings and lack of awareness, alongside insufficient patient risk assessments.
Overdue
Helen Millard
Concerns: The "traffic light" ligature risk classification system in psychiatric facilities is flawed; all ligature points, regardless of height, pose an extreme risk and should be categorized as "red" for urgent elimination.
Overdue
James Hedge
Concerns: Insulin pump guidance inadequately highlights misuse dangers from incorrect cartridge insertion, and patient education fails to emphasize the rapid life-threatening nature of hyperglycaemia.
Responded
Daniel Paylor
Concerns: 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.
Overdue
George Stone
Concerns: 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.
Overdue
Dominic Philip
Concerns: 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.
Responded