Focus on compliance with fundamental standards
The assessment criteria for authorisation should include a requirement that applicants demonstrate their ability to consistently meet fundamental patient safety and quality standards at the same time as complying with the financial and corporate governance requirements of a foundation trust.
- The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 established Fundamental Standards that all registered providers must meet, including safe care and treatment (Regulation 12), good governance (Regulation 17), and staffing (Regulation 18). CQC assesses compliance with these standards through its inspection and rating programme (SI 2014/2936).
- From 1 April 2023, all NHS trusts are required to hold a provider licence under the same conditions as foundation trusts, meaning the quality and governance requirements apply equally across both trust types (Health and Care Act 2022, s.61).
- The NHS Oversight Framework assesses trusts against quality of care, finance, and use of resources, operational performance, strategic change, and leadership and improvement capability. Trusts are segmented 1-4, with quality concerns triggering mandated support or intervention (NHS Oversight Framework 2025/26, NHS England).
How was this evidence gathered?
Response
Accepted
Response
AcceptedThe 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.
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.
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.
Monitor merged with the Trust Development Authority to form NHS Improvement from 1 April 2016. NHS Improvement then merged with NHS England from 1 July 2022 under Health and Care Act 2022. Francis recommended incremental merger of system regulatory functions between Monitor and CQC; this was partially achieved through structural reorganisation.
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.
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.