F184 Accepted

Enforcement by the Care Quality Commission

Mid Staffs Inquiry · Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry · Issued 6 February 2013 · Addressed to: CQC

Source — verbatim from the inquiry

Inquiry recommendation

Observance of the duty should be policed by the Care Quality Commission, which should have powers in the last resort to prosecute in cases of serial non-compliance or serious and wilful deception. The Care Quality Commission should be supported by monitoring undertaken by commissioners and others.

Mid Staffs Inquiry, Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry · 6 Feb 2013 Source PDF →

Published evidence summary

Publicly available evidence relating to this recommendation:

- CQC has statutory responsibility for monitoring and enforcing compliance with the duty of candour under Regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. CQC assesses compliance with the duty of candour as part of its inspection programme, primarily under the "well-led" and "safe" key questions. Where providers fail to meet the duty of candour, CQC can issue requirement notices, impose conditions on registration, and in serious cases prosecute for breach of regulatory requirements (SI 2014/2936, Regulation 20; CQC enforcement policy).
- CQC has powers under the Health and Social Care Act 2008 to prosecute registered persons for breaches of regulations including the duty of candour. CQC can also prosecute under section 91 of the Act for the provision of false or misleading information. These powers provide the "last resort" prosecution capability that Francis recommended (Health and Social Care Act 2008; CQC enforcement policy).
- DHSC's call for evidence on the duty of candour (November 2024) found that 52% of respondents considered that CQC had not adequately monitored compliance with the duty of candour. The Penny Dash Review of CQC (October 2024) identified significant failings in CQC's regulatory performance, including reduced inspection activity and inconsistent enforcement, raising questions about the effectiveness of CQC's policing of the duty of candour in practice (DHSC Duty of Candour Call for Evidence, November 2024; Penny Dash Review, October 2024).
- Commissioners support CQC's monitoring through the NHS Standard Contract, which requires providers to comply with the duty of candour and to report notifiable safety incidents to commissioners. Commissioners can take contractual action where providers fail to comply with candour requirements (NHS Standard Contract, NHS England).

Response — verbatim from government

Department of Health and Social Care

The 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

Department of Health and Social Care · 19 Nov 2013 Written response →

Evidence trail — what's actually happened since

  • 26 Nov 2024 · DHSC - Duty of Candour Review DHSC published findings of call for evidence on statutory duty of candour. 261 responses received. Key finding: 52% of respondents said CQC had not adequately enforced the duty. Many reported it had become a "tick-box exercise". Only 40% thought the purpose was clear and well understood. Final government response still pending. View source → Reasonable Progress
  • 15 Oct 2024 · DHSC - Penny Dash Review of CQC 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. View source → limited_progress
  • 6 Feb 2023 · Academic Review - Ten Years After Francis 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. View source → Reasonable Progress
  • 1 Jul 2022 · Legislation - Integrated Care Boards (Health and Care Act 2022) 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. View source → Confirmed Completed
  • 1 Apr 2016 · Legislation - Health and Social Care Act 2012 (Monitor reformed) 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. View source → Confirmed Completed
  • 11 Feb 2015 · UK Government - Culture Change in 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. View source → Good Progress
  • 27 Nov 2014 · Legislation - Duty of Candour (Regulation 20) Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, Regulation 20: statutory duty of candour came into force for NHS trusts November 2014, extended to all CQC-registered providers April 2015. Requires providers to notify patients/families of notifiable safety incidents and apologise. View source → Confirmed Completed
  • 7 Nov 2014 · Legislation - CQC Fundamental Standards 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). View source → Confirmed Completed
  • 1 Oct 2014 · CQC - New Inspection Regime 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. View source → Confirmed Completed
  • 19 Nov 2013 · UK Government - Hard Truths Vol 1 & 2 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. View source → Good Progress

Each entry above links to a primary source — gov.uk written statement, consultation response document, or inspection report. The Index does not characterise government intent; it tracks what has been published.

How this page is built

Source and Response are verbatim from primary documents. The Evidence trail records published activity since — written statements, consultation outcomes, inspection findings, parliamentary references. The Index does not paraphrase or characterise intent; it tracks what has been published. Where the evidence is the absence of action (a missed deadline, a slipped timetable), that absence is documented from primary sources rather than inferred.

This recommendation's data is verified periodically against primary sources. The Index is monitored for staleness weekly.