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.
- PSIRF (mandatory from autumn 2023) requires trusts to have systems for staff to report patient safety incidents and to ensure a supportive culture for reporting. The framework explicitly states that "all patient safety incidents and the concerns of patients, families and staff must be recorded" regardless of severity (PSIRF, NHS England, August 2022).
- CQC uses patient safety incident reporting data from LFPSE (and previously NRLS) as part of its Insight intelligence model for monitoring providers. Anomalies in reporting rates — including unusually low reporting — may be used as an indicator of potential concern about safety culture or compliance with reporting requirements (CQC Insight model).
- The Health Services Safety Investigations Body (HSSIB), established as an independent statutory body on 1 October 2023 under the Health and Care Act 2022, can receive referrals about patient safety concerns and can initiate investigations into incidents of national significance. HSSIB has statutory safe space protections for information disclosed during investigations (Health and Care Act 2022, Part 4).
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.
Over 1,400 Freedom to Speak Up Guardians across healthcare organisations in England. 38,000+ cases raised in 2024-25, cumulative total exceeds 142,000 since inception. However, NHS Staff Survey 2024 shows only 71.5% of staff feel secure raising concerns about unsafe practice (stagnant for years), and only 57% are confident their organisation would address concerns.
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.
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.
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).
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.
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.
Sir Robert Francis published Freedom to Speak Up Review on 11 February 2015 with 20 principles and actions. Led to: Freedom to Speak Up Guardians mandatory in all NHS trusts from October 2016; National Guardian's Office established January 2016.
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.