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 NHS Commissioning Board.
- Every National Patient Safety Alert explicitly states that failure to take required actions may lead to regulatory action by the Care Quality Commission (DHSC and NHS England implementation update to the Thirlwall Inquiry, April 2025).
- The Learn from Patient Safety Events (LFPSE) service replaced the National Reporting and Learning System on 30 June 2024 to improve trend identification (NHS England LFPSE announcement, June 2024).
- The Health Services Safety Investigations Body (HSSIB) was established as an independent statutory body in October 2023 to conduct system-focused patient safety investigations (Health and Care Act 2022).
How was this evidence gathered?
Response
Accepted in Part
Response
Accepted in PartThe 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" in March 2013. Key reforms included a new Chief Inspector of Hospitals, strengthened Care Quality Commission inspection regime, a statutory duty of candour, and the fit and proper person test for NHS directors. Volume 2 (Cm 8754) contains the government's detailed responses to each of the 290 recommendations. See: https://assets.publishing.service.gov.uk/media/5a7cd486ed915d63cc65d167/34658_Cm_8777_Vol_1_accessible.pdf
Progress Timeline
DHSC and NHS England implementation update provided to the Thirlwall Inquiry (April 2025). This is the government's own account of progress, submitted to the inquiry. Reviewed extent of implementation: Superseded. Led by NHS England, there is now a redesigned system for National Patient Safety Alerts. Each alert includes reference to the fact that failure to take the actions required may lead to CQC taking regulatory action. CQC uses indicators on declared compliance with alerts in their assessments. See the response to recommendation 35 for information on how regulators work together, and the current regulatory landscape. Patient safety alerting NHS England currently issues alerts as 'National Patient Safety Alerts' and is accredited by the National Patient Safety Alerting Committee (NaPSAC). All National Patient Safety Alerts are required to meet NaPSAC's thresholds and standards, which include working with patients, frontline staff and experts to ensure alerts provide clear, effective actions to reduce the risk of death or disability. NaPSAC requires healthcare providers to introduce new systems for planning and coordinating the actions required by any National Patient Safety Alert across their organisation, and must include executive oversight. Each NatPSA includes reference to the fact that failure to take the actions required under any National Patient Safety Alert may lead to CQC taking regulatory action. CQC uses indicators on declared compliance with alerts in their assessments. The Learn from Patient Safety Events (LFPSE) service is a national NHS system for the recording and analysis of patient safety events that occur in healthcare. This replaced the National Reporting and Learning System.
Published Evidence
Published assessments of progress from inspectorates, select committees, official progress reports, and other sources. Source type badge indicates whether each assessment is independent or government self-reported.
Penny Dash Review (commissioned May 2024) found significant failings at CQC. Health Secretary declared CQC "not fit for purpose". Key findings: one in five services never rated; inspection levels well below pre-pandemic levels; lack of specialist inspector expertise; 5,000 notification-of-concern backlog. CQC consulting on resetting its approach from October 2025.
Learn from Patient Safety Events (LFPSE) service replaced the National Reporting and Learning System (NRLS). NRLS fully decommissioned 30 June 2024. LFPSE has broader coverage including primary care, uses machine learning for analysis and improved trend identification.
Patient Safety Incident Response Framework (PSIRF) replaced the Serious Incident Framework from Autumn 2023. Shifts from individual blame to system-based learning approaches. Mandatory for all NHS-funded secondary care providers. Part of NHS Patient Safety Strategy (July 2019).
HSSIB formally launched 1 October 2023 as independent statutory body under Health and Care Act 2022. Replaced HSIB (non-statutory, established 2016). Has statutory "safe space" protections, powers of entry, inspection and seizure. Conducts system-focused patient safety investigations.
Research published 2023 marking ten years since the Francis Report found mixed results. Structural and legislative changes largely delivered (duty of candour, FPPR, CQC overhaul, revalidation, Freedom to Speak Up Guardians). However, cultural change not fully embedded; understaffing, fear of speaking up, and poor complaint handling persist in parts of the NHS.
First Patient Safety Commissioner Dr Henrietta Hughes OBE appointed 12 September 2022 under Medicines and Medical Devices Act 2021. Independent champion for patient safety regarding medicines and medical devices.
Clinical Commissioning Groups replaced by 42 Integrated Care Boards from 1 July 2022 under Health and Care Act 2022. ICBs have broader responsibilities for population health, bringing together NHS organisations, local authorities and partners. Implements some Francis recommendations on commissioning integration.
Government published "Culture Change in the NHS" (Cm 9009) reporting progress on all 290 recommendations. Key achievements: 19 hospitals placed in special measures; those trusts recruited 109 additional doctors and 1,805 additional nurses; 129 board-level changes made; excess avoidable deaths fell by 450 in less than a year.
New "Fundamental Standards" replaced previous CQC registration requirements from 7 November 2014. Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 introduced clearer minimum standards including: person-centred care (Reg 9), dignity (Reg 10), safe care (Reg 12), staffing (Reg 18), good governance (Reg 17), fit and proper persons (Reg 5), duty of candour (Reg 20).
CQC overhauled its inspection regime in response to Francis. Professor Sir Mike Richards appointed as first Chief Inspector of Hospitals (July 2013). New methodology based on five key questions (Safe, Effective, Caring, Responsive, Well-led) rolled out nationally October 2014. Four-tier ratings introduced (Outstanding/Good/Requires Improvement/Inadequate). Specialist expert-led inspection teams replaced generalist compliance model.
Government published "Hard Truths: The Journey to Putting Patients First" (Cm 8777) in two volumes. Vol 1 set out new actions; Vol 2 provided detailed response to each of the 290 recommendations. Approximately 204 of 290 recommendations were fully accepted.