Candour about incidents
Guidance and policies should be reviewed to ensure that they will lead to compliance with Being Open, the guidance published by the National Patient Safety Agency.
- The Patient Safety Incident Response Framework (PSIRF), mandatory for all NHS-funded providers from autumn 2023, replaced both the Serious Incident Framework and effectively superseded the "Being Open" guidance. PSIRF includes requirements for open and transparent communication with patients and families as a core element of the patient safety incident response process (PSIRF, NHS England).
- CQC assesses compliance with the duty of candour as part of its inspection framework, particularly under the "well-led" and "safe" key questions. CQC can take enforcement action where providers fail to comply with Regulation 20, including issuing requirement notices, imposing conditions on registration, and prosecution for serious or persistent non-compliance (CQC enforcement policy).
- DHSC's call for evidence on the duty of candour (November 2024) reviewed whether the existing framework — which replaced "Being Open" — is working effectively. The review found support for the principle of the statutory duty but identified concerns about inconsistent implementation and enforcement (DHSC Duty of Candour Call for Evidence, November 2024).
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.
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.
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.
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.
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.