National Patient Safety Agency functions
The National Patient Safety Agency's resources need to be well protected and defined. Consideration should be given to the transfer of this valuable function to a systems regulator.
- The Health and Care Act 2022 (Part 4) established the Health Services Safety Investigations Body (HSSIB) as an independent statutory body, which commenced operations on 1 October 2023. HSSIB replaced the Healthcare Safety Investigation Branch (HSIB), which had operated since April 2017 as a non-statutory body within NHS England. HSSIB conducts independent investigations into patient safety incidents of national significance and has statutory powers to protect information disclosed during investigations (Health and Care Act 2022, ss.94-121).
- The Patient Safety Commissioner, Dr Henrietta Hughes, was appointed in September 2022 under the Medicines and Medical Devices Act 2021 (section 11). The Commissioner's role is to promote the safety of patients and the interests of patients in relation to the safety of medicines and medical devices (Medicines and Medical Devices Act 2021, s.11).
- NHS England's National Patient Safety Team leads system-wide patient safety improvement work, including managing the Learn from Patient Safety Events (LFPSE) service which replaced the NRLS (decommissioned June 2024), and the Patient Safety Incident Response Framework (PSIRF), mandatory from autumn 2023 (NHS England patient safety).
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
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.
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.