National Patient Safety Agency functions
Reporting to the National Reporting and Learning System of all significant adverse incidents not amounting to serious untoward incidents but involving harm to patients should be mandatory on the part of trusts.
- The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 established a statutory duty of candour for NHS bodies (The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, SI 2014/2936).
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 Reviewed extent of implementation: Superseded. This recommendation precedes the Patient Safety Incident Response Framework (the NHS approach to developing and maintaining effective systems and processes for responding to patient safety incidents) and the Learn from Patient Safety Events (LFPSE) service (a national NHS system for the recording and analysis of patient safety events). LFPSE replaces the previous National Reporting and Learning System. In addition, the statutory Duty of Candour ensures that providers are open and transparent with people who use services (please see response to recommendation 21 for more information about this duty).
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.
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.
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.
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.