Mid Staffordshire NHS Foundation Trust Public Inquiry
CompletedMid Staffs Inquiry
Public inquiry into the serious failings in care at Mid Staffordshire NHS Foundation Trust between 2005-2009, where patients were routinely neglected and standards of care were appalling. The Francis Report made 290 recommendations for fundamental culture change to put patients first, including statutory duty of candour, enhanced CQC powers, nursing standards, and NHS leadership reforms.
Reports (5) Click to expand
| Title | Volume | Publication Date | Tracked recs | Links |
|---|---|---|---|---|
| Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry - Executive Summary | Executive Summary | 06 Feb 2013 | 0 290 published | |
| Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry | HC 947 | 06 Feb 2013 | 290 | |
| Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry - Volume 1 | Volume 1 | 06 Feb 2013 | 0 | |
| Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry - Volume 2 | Volume 2 | 06 Feb 2013 | 0 | |
| Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry - Volume 3 | Volume 3 | 06 Feb 2013 | 0 |
Timeline (3) Click to expand
Recommendations (201)
Implementing the recommendations
- The Department of Health published "Culture Change in the NHS" in February 2015, reporting progress across all 290 recommendations. A supporting annex tracked implementation actions by responsible organisations (Culture Change in the NHS, Department of Health, February 2015).
- The House of Commons Health Committee published its third report of session 2013-14, "After Francis: Making a Difference," examining organisational responses. The government responded in Cm 8755 (Government Response to the Health Committee, November 2013).
- No systematic published record of annual progress reporting by individual NHS organisations against Francis recommendations has been identified after the 2015 Culture Change report.
- No further published government-wide progress report on Francis implementation has been identified since February 2015.
Putting the patient first
- The NHS Constitution sets out seven core values: working together for patients, respect and dignity, commitment to quality of care, compassion, improving lives, and everyone counts (NHS Constitution for England, DHSC, 17 August 2023).
- The statutory duty of candour was introduced through Regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, requiring providers to be open and transparent with patients about failures in care (SI 2014/2936, in force from 27 November 2014).
- The NHS Staff Survey includes questions on organisational culture, and results are published annually by NHS England (NHS Staff Survey, NHS England, annual publication).
- No single published "cultural barometer" tool of the kind described in this recommendation, designed to measure the cultural health of all parts of the NHS system, has been identified in published sources.
Clarity of values and principles
The NHS Constitution should be the first reference point for all NHS patients and staff and should set out the system's common values, as well as the respective rights, legitimate expectations and obligations of patients.
- The NHS Constitution was revised in 2013, 2015, and most recently updated on 17 August 2023. The Handbook to the NHS Constitution was updated on 24 January 2025 (NHS Constitution for England, DHSC, 17 August 2023; Handbook, DHSC, 24 January 2025).
- The Constitution states it "establishes the principles and values of the NHS in England" and is described as "a document for patients, staff and the public" (NHS Constitution for England, DHSC, 17 August 2023).
- A 10-year review consultation was launched on 9 April 2024 but was discontinued following the July 2024 general election. The government stated it would develop a revised consultation aligned with the 10 Year Health Plan (NHS Constitution 10-year review, DHSC, 30 April 2024; government update 3 March 2025).
Clarity of values and principles
The core values expressed in the NHS Constitution should be given priority of place and the overriding value should be that patients are put first, and everything done by the NHS and everyone associated with it should be informed by this ethos.
- The seven core values were refreshed through a consultation process involving over 9,000 patients, staff and stakeholders, and incorporated into the revised Constitution published on 26 March 2013. They were retained in the 2015 and 2023 editions (NHS Constitution for England, DHSC, 17 August 2023).
- The Health Act 2009, section 1, requires the Secretary of State to publish a document setting out the constitution of the NHS in England, and section 2 imposes a duty to have regard to it (Health Act 2009, ss.1-2).
Clarity of values and principles
- The Constitution states staff should "follow all guidance, standards and codes relevant to your role, subject to any more specific requirements of your employers" (NHS Constitution for England, DHSC, 17 August 2023).
- The staff responsibilities section also states: "You have a duty to accept professional accountability and maintain the standards of professional practice as set by the appropriate regulatory body applicable to your profession or role" (NHS Constitution for England, DHSC, 17 August 2023).
- These staff expectations were incorporated into the revised Constitution published on 26 March 2013 and retained in subsequent editions (NHS Constitution for England, DHSC, 26 March 2013; 27 July 2015; 17 August 2023).
Clarity of values and principles
The handbook to the NHS Constitution should be revised to include a much more prominent reference to the NHS values and their significance.
- The Handbook was most recently updated on 24 January 2025. It provides context on "NHS values and the principles that guide the NHS" (Supplements to the NHS Constitution for England, DHSC, 24 January 2025).
- The Health Act 2009, section 5, requires the Secretary of State to publish and periodically review a handbook explaining the NHS Constitution (Health Act 2009, s.5).
Clarity of values and principles
- The NHS Standard Contract, used for commissioning NHS-funded services from all providers, includes provisions on quality standards and requires providers to comply with applicable legislation including the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (NHS Standard Contract, NHS England, 2025/26 edition).
- The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 apply to all registered providers regardless of sector, establishing fundamental standards that outsourced providers must meet (SI 2014/2936).
- No published evidence of a specific contractual clause requiring outsourced service staff to make an express personal commitment to NHS values, distinct from general regulatory compliance, has been identified.
Fundamental standards of behaviour
- NICE has continued to publish clinical guidelines, quality standards, and pathways covering a wide range of interventions and clinical areas. As of March 2026, NICE had published over 200 clinical guidelines and over 180 quality standards (NICE, www.nice.org.uk).
- The Getting It Right First Time (GIRFT) programme, established by NHS England, works with clinical teams to reduce unwarranted variation in clinical practice through specialty-level reviews (GIRFT programme, NHS England, established 2015).
- No published evidence of a single national requirement mandating that all healthcare professionals contribute to the development of standard procedures in their areas of work has been identified. Compliance with standard procedures remains primarily a matter for individual employer policies and professional regulation.
Fundamental standards of behaviour
- The Patient Safety Incident Response Framework (PSIRF), published by NHS England in August 2022 and mandatory from autumn 2023, replaced the Serious Incident Framework. PSIRF requires organisations to support staff in reporting patient safety events and to provide feedback on reports (Patient Safety Incident Response Framework, NHS England, August 2022).
- The Learn from Patient Safety Events (LFPSE) service, launched by NHS England in 2023-24 to replace the National Reporting and Learning System, provides a national platform for recording patient safety events (LFPSE, NHS England, 2023-24).
- The Freedom to Speak Up framework, established following the Sir Robert Francis "Freedom to Speak Up" review (February 2015), requires all NHS trusts to have a Freedom to Speak Up Guardian. NHS England reports that all trusts have appointed guardians (Freedom to Speak Up Review, Sir Robert Francis, February 2015; Freedom to Speak Up National Guardian's Office).
The nature of standards
- Regulation 22 of the 2014 Regulations created a criminal offence for providers who fail to provide care in a way that results in avoidable harm or a significant risk of harm (SI 2014/2936, Regulation 22).
- The three-tier standards framework recommended by Francis (fundamental, enhanced, developmental) was broadly reflected in the government's approach: fundamental standards enforced by CQC; quality standards set by NICE and monitored by commissioners; and aspirational standards in the NHS Outcomes Framework (Hard Truths Vol 2, Cm 8754, Department of Health, November 2013).
- The CQC describes its fundamental standards as "the standards below which your care must never fall," covering 14 areas of care quality (CQC, Fundamental Standards).
Responsibility for setting standards
- The regulations were developed following consultation with patients, providers and professional bodies, as described in the government response "Hard Truths" (Hard Truths Vol 2, Cm 8754, Department of Health, November 2013).
- The CQC has statutory powers to take enforcement action against providers who fail to meet fundamental standards, including warning notices, conditions on registration, and prosecution for serious failures (Health and Social Care Act 2008, Part 1; SI 2014/2936, Regulations 22-24).
Responsibility for setting standards
It is essential that professional bodies in which doctors and nurses have confidence are fully involved in the formulation of standards and in the means of measuring compliance.
- Royal colleges and professional bodies contribute to CQC's specialist advisory function, and CQC employs specialist professional advisers in its inspection teams (CQC inspection framework).
- The Academy of Medical Royal Colleges and individual royal colleges have published clinical standards and contributed to national quality improvement programmes including Getting It Right First Time (GIRFT) (Academy of Medical Royal Colleges; GIRFT programme, NHS England).
- Professional bodies including the Royal College of Nursing and royal medical colleges were consulted on the development of the 2014 fundamental standards regulations (Hard Truths Vol 2, Cm 8754, Department of Health, November 2013).
Responsibility for regulating and monitoring compliance
- NICE published safe staffing guideline SG1 in July 2014, covering nurse staffing in adult inpatient wards. However, NICE's safe staffing programme was subsequently discontinued, and no further safe staffing guidelines were published (NICE SG1, July 2014; programme discontinued 2015).
- NHS England published the Developing Workforce Safeguards framework in October 2018, requiring providers to use evidence-based tools for workforce planning including safe staffing assessments, but this is an NHS England framework rather than a NICE standard (Developing Workforce Safeguards, NHS Improvement/NHS England, October 2018).
- The NHS Staff Survey measures aspects of staff experience and organisational culture. CQC uses staff survey results as part of its intelligence model (NHS Staff Survey, annual publication; CQC Insight model).
- No single comprehensive NICE framework covering staff competence, organisational culture, and evidence-based staffing tools across all specialties has been published as described in this recommendation.
Responsibility for regulating and monitoring compliance
Compliance with regulatory fundamental standards must be capable so far as possible of being assessed by measures which are understood and accepted by the public and healthcare professionals.
- CQC ratings are published on its website and are required to be displayed by providers under Regulation 20A of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (SI 2014/2936, Regulation 20A).
- The CQC inspection model was developed with input from patients, professionals and stakeholders to ensure measures were meaningful and accessible (CQC, Chief Inspector of Hospitals programme, 2013-14).
- The NHS Outcomes Framework and NICE quality standards use outcome and process indicators designed to be measurable and publicly reportable (NHS Outcomes Framework; NICE quality standards).
Responsibility for regulating and monitoring compliance
- Individual royal colleges and specialty associations have developed outcome measures and clinical audit programmes in their areas. The National Clinical Audit and Patient Outcomes Programme (NCAPOP) funds over 30 national clinical audits across specialties (NCAPOP, Healthcare Quality Improvement Partnership).
- The Getting It Right First Time (GIRFT) programme, established by NHS England in 2015, works with clinical specialties to develop and apply outcome measures to reduce unwarranted variation (GIRFT programme, NHS England).
- No published evidence of a formal duty placed on all specialty professional bodies to develop outcome measures in coordination with NICE has been identified. Participation remains voluntary rather than mandated.
Responsibility for regulating and monitoring compliance
- CQC inspection teams include specialist advisers and use a combination of announced and unannounced inspections, with direct observation of practice on wards and in clinical areas (CQC inspection methodology).
- CQC retains the capacity to undertake in-depth investigations. Section 48 of the Health and Social Care Act 2008 gives CQC powers to conduct special reviews and investigations where concerns arise (Health and Social Care Act 2008, s.48).
- CQC has conducted themed reviews and investigations into specific areas of concern, including reviews of trusts in special measures and investigations triggered by intelligence about potential failures (CQC, various published investigation reports).
Responsibility for regulating and monitoring compliance
- CQC can issue warning notices requiring providers to improve within a specified period, and can impose urgent conditions on registration, suspend or cancel registration, and prosecute for offences under the Health and Social Care Act 2008 (Health and Social Care Act 2008; SI 2014/2936, Regulations 22-24).
- CQC uses a risk-based approach to regulation, with an intelligence model (CQC Insight) that monitors a range of indicators to identify providers at risk of failing to meet standards, enabling targeted inspection (CQC Insight model).
- The CQC ratings system is designed to highlight concerns: providers rated "Inadequate" overall are placed in special measures with a defined improvement trajectory (CQC special measures framework).
Sanctions and interventions for non-compliance
- The Criminal Justice and Courts Act 2015, sections 20-21, created separate offences of ill-treatment or wilful neglect by individual care workers (s.20) and by care provider organisations (s.21). These provisions came into force on 13 April 2015 (Criminal Justice and Courts Act 2015, c.2, ss.20-21).
- The statutory duty of candour (Regulation 20, SI 2014/2936) requires providers to notify patients of incidents causing harm or death. CQC can take enforcement action for failure to comply with the duty of candour (SI 2014/2936, Regulation 20).
- CQC has powers to cancel or suspend the registration of providers that are incapable of meeting fundamental standards, and to impose urgent conditions where there is a serious risk to life, health or wellbeing (Health and Social Care Act 2008, ss.17, 18, 31).
Sanctions and interventions for non-compliance
- The Criminal Justice and Courts Act 2015, section 20, created an offence of ill-treatment or wilful neglect by an individual care worker, carrying a maximum sentence of 5 years' imprisonment. Section 21 created a corresponding offence for care provider organisations (Criminal Justice and Courts Act 2015, c.2, ss.20-21, in force 13 April 2015).
- CQC can also issue warning notices under section 29 of the Health and Social Care Act 2008, and failure to comply with a warning notice can be relevant to prosecution decisions (Health and Social Care Act 2008, s.29).
Interim measures
- CQC can issue warning notices under section 29 of the Health and Social Care Act 2008, requiring improvement within a specified period (Health and Social Care Act 2008, s.29).
- NHS England (which absorbed Monitor's functions in July 2022) retains powers to give directions to NHS foundation trusts in the interests of patients under the licensing regime, including in urgent cases (Health and Care Act 2022, c.31; NHS provider licence conditions).
- These interim powers are exercisable on reasonable grounds in the public interest, without requiring a concluded investigation (Health and Social Care Act 2008, s.31).
Interim measures
- CQC maintains a risk-based intelligence model (CQC Insight) that continuously monitors indicators of risk across registered providers, enabling it to prioritise inspection and enforcement action (CQC Insight model).
- The Health and Care Act 2022 gave CQC a new duty to conduct reviews of integrated care systems (s.31), expanding its oversight beyond individual providers (Health and Care Act 2022, c.31, s.31).
- Memoranda of understanding exist between CQC, NHS England, and other regulators setting out arrangements for coordination and information sharing when concerns arise about patient safety (inter-regulator coordination arrangements).
Interim measures
- NHS England can issue enforcement undertakings and take regulatory action against NHS foundation trusts through the licensing regime where patient safety is at risk (NHS provider licence conditions; Health and Care Act 2022).
- CQC's special measures regime provides for intensive support and oversight of providers rated "Inadequate," with a defined period for improvement before further enforcement action including potential closure (CQC special measures framework).
- Temporary measures such as urgent conditions can be imposed while investigations are ongoing, without waiting for a final determination (Health and Social Care Act 2008, s.31).
Need to share information between regulators
- CQC's Insight model draws on a wide range of intelligence sources including NHS Staff Survey data, patient safety incidents, complaints data, mortality statistics, and information from other regulators and stakeholders (CQC Insight model).
- The Health and Care Act 2022, section 31, introduced a duty for CQC to conduct reviews of integrated care systems, requiring coordination with NHS England and other bodies including sharing of intelligence (Health and Care Act 2022, c.31, s.31).
- The National Quality Board, established in 2009, provides a forum for national health and care organisations to coordinate approaches to quality, including information sharing about system-wide concerns (National Quality Board).
Use of information for effective regulation
- NHS England publishes the Model Hospital portal, providing trusts and the public with benchmarking data across a range of clinical, operational and workforce indicators in near-real time (Model Hospital, NHS England).
- The Learn from Patient Safety Events (LFPSE) service, launched in 2023-24, provides a national platform for recording and analysing patient safety events, replacing the National Reporting and Learning System (LFPSE, NHS England, 2023-24).
- NHS Digital (now part of NHS England) publishes a range of performance data including Hospital Episode Statistics, SHMI, patient surveys, staff surveys, and quality indicators through the NHS Digital data catalogue (NHS England data services).
- The Secondary Uses Service and other NHS data systems provide near-real-time data feeds to support regulatory and commissioning decisions (NHS England data infrastructure).
Use of information about compliance by regulator from: Quality accounts
- Quality accounts must include information on areas where improvement is needed as well as areas of achievement. Providers are required to include statements from commissioners, local Healthwatch, and overview and scrutiny committees (SI 2010/279, as amended).
- The Health Act 2009, section 8, provides the statutory basis for quality accounts. External auditors provide limited assurance on specified quality account content (Health Act 2009, s.8).
- The government stated in Hard Truths (November 2013) that it would strengthen quality accounts requirements and explore making wilfully false statements a criminal offence. No separate criminal offence specifically for false quality account statements has been enacted, though Regulation 22 of SI 2014/2936 creates offences for breaches of Regulation 17(3) relating to accurate information (Hard Truths Vol 2, Cm 8754, Department of Health, November 2013; SI 2014/2936, Regulation 22).
- No published evidence has been identified that a specific criminal offence for wilfully or recklessly false quality account statements has been created in legislation.
Use of information about compliance by regulator from: Complaints
- CQC's inspection model, introduced from October 2014, examines complaints handling under the "Responsive" key question. Inspectors review complaints data, processes, and outcomes as part of routine inspections (CQC inspection framework).
- CQC's Insight model draws on complaints data from multiple sources to inform its risk-based approach to regulation and inspection targeting (CQC Insight model).
- The Clwyd-Hart review, "Putting Patients Back in the Picture" (October 2013), recommended improvements to NHS complaints handling. The government accepted its recommendations in Hard Truths (Clwyd-Hart Review, October 2013; Hard Truths Vol 1, Cm 8777, November 2013).
Use of information about compliance by regulator from: Complaints
It is important that greater attention is paid to the narrative contained in, for instance, complaints data, as well as to the numbers.
- The Clwyd-Hart review (October 2013) recommended that NHS organisations pay greater attention to the substance of complaints and use them as a source of learning. The government accepted this in Hard Truths (Clwyd-Hart Review, October 2013; Hard Truths Vol 1, Cm 8777, November 2013).
- The PHSO NHS Complaint Standards set expectations for how NHS organisations handle complaints, including learning from complaint narratives and themes (PHSO, NHS Complaint Standards).
- The Patient Safety Incident Response Framework (PSIRF), mandatory from autumn 2023, requires organisations to consider patient and family concerns, including complaints, as part of patient safety investigations (PSIRF, NHS England, August 2022).
Use of information about compliance by regulator from: Serious untoward incidents
Strategic Health Authorities/their successors should
- Providers are required to report serious incidents to their commissioners and to NHS England under the Patient Safety Incident Response Framework (PSIRF), which replaced the Serious Incident Framework from autumn 2023 (PSIRF, NHS England, August 2022).
- The Care Quality Commission (Registration) Regulations 2009, Regulations 16 and 18, require registered persons to notify CQC of deaths of service users and other serious incidents (SI 2009/3112, Regulations 16, 18).
- CQC's Insight model draws on serious incident data reported through national systems as part of its intelligence gathering (CQC Insight model).
Use of information about compliance by regulator from: Media
Those charged with oversight and regulatory roles in healthcare should monitor media reports about the organisations for which they have responsibility.
- CQC's Insight model draws on a range of intelligence sources to inform its risk-based approach. CQC has stated that it uses publicly available information as part of its monitoring, though the specific inclusion of systematic media monitoring is not detailed in published CQC methodology documents (CQC Insight model).
- NHS England's oversight arrangements include monitoring of provider performance through various intelligence sources (NHS Oversight Framework, NHS England).
- No published evidence has been identified of a specific, formalised requirement placed on all healthcare regulators to systematically monitor media reports about the organisations for which they have responsibility.
Use of information about compliance by regulator from: Quality and risk profiles
The Quality and Risk Profile should not be regarded as a potential substitute for active regulatory oversight by inspectors. It is important that this is explained carefully and clearly as and when the public are given access to the information.
- CQC has stated that its Insight data is used to inform inspection planning and prioritisation, not as a substitute for direct inspection. CQC's inspection model involves on-site inspections with direct observation, patient and staff interviews, and review of records (CQC inspection framework, from October 2014).
- CQC publishes provider ratings based on inspection findings, not solely on indicator data. The ratings system (Outstanding, Good, Requires Improvement, Inadequate) is based on inspection evidence (CQC ratings system).
- Information from the Insight model is available to CQC staff and is used to support, not replace, regulatory oversight through inspection (CQC methodology).
Use of information about compliance by regulator from: Foundation trust governors and scrutiny committees
The Care Quality Commission should expand its work with overview and scrutiny committees and foundation trust governors as a valuable information resource. For example, it should further develop its current 'sounding board events'.
- Local authorities' health overview and scrutiny committees have powers to review and scrutinise local NHS services. CQC can share information with scrutiny committees and has engaged with them as part of its local intelligence gathering (Local Authority (Public Health, Health and Wellbeing Boards and Health Scrutiny) Regulations 2013).
- NHS foundation trust governors are required to hold boards to account and can raise concerns with CQC. CQC has engaged with governors during inspections (Health and Social Care Act 2012; CQC inspection methodology).
- No published evidence has been identified of specific, formalised CQC "sounding board events" or equivalent structured engagement programmes with overview and scrutiny committees and foundation trust governors beyond what occurs during inspections.
Enhancement of monitoring and the importance of inspection
- CQC replaced its Quality and Risk Profile with "Intelligent Monitoring" reports from March 2014, which brought together over 150 indicators to identify risks and help prioritise inspections. This subsequently evolved into CQC's "Insight" model, which combines data indicators, feedback from service users, inspection knowledge, and partner intelligence at provider and core service level (CQC Insight: NHS trusts, CQC).
- CQC's inspection methodology from October 2014 draws on quality accounts data, reports from local Healthwatch, themed inspection programmes, and peer review through specialist advisers on inspection teams (CQC new inspection approach, CQC, September 2014).
- The Penny Dash review (October 2024) found that CQC's monitoring capacity had declined, with inspections falling from approximately 16,000 in 2019-20 to approximately 7,000 in 2023-24, and approximately one in five locations CQC has the power to inspect had never received a rating (Review into the operational effectiveness of the CQC, DHSC, October 2024).
Enhancement of monitoring and the importance of inspection
The Care Quality Commission should retain an emphasis on inspection as a central method of monitoring non-compliance.
- Professor Sir Mike Richards was appointed as the first Chief Inspector of Hospitals on 31 May 2013. CQC confirmed its new inspection and rating approach would roll out nationally from 1 October 2014, using larger and more specialist inspection teams assessing services against five key questions (Safe, Effective, Caring, Responsive, Well-led) with a four-tier rating system (CQC new inspection approach, CQC, September 2014).
- The Penny Dash review (October 2024) found that CQC's inspection volumes had fallen from approximately 16,000 in 2019-20 to approximately 7,000 in 2023-24, representing a decline of more than half. The review identified "significant failings in the internal workings of CQC" and concluded that operational performance needed to be "rapidly improved" (Review into the operational effectiveness of the CQC, DHSC, October 2024).
- The Richards review (October 2024) found that between December 2023 and September 2024, only 1,379 inspections had been conducted under the new single assessment framework, compared to approximately 15,800 in 2019-20 (Review of CQC's single assessment framework, CQC/Professor Sir Mike Richards, October 2024).
Enhancement of monitoring and the importance of inspection
- CQC's inspection teams for NHS trusts, from October 2014, are led by CQC inspection managers and include specialist professional advisers such as clinicians, pharmacists, nurses, doctors, psychiatrists, psychologists, social workers, GPs, and health service managers. Inspection teams also include Experts by Experience — people with recent personal experience of using or caring for someone who uses health or social care services (CQC inspection team: NHS trusts, CQC).
- CQC's Experts by Experience programme transitioned to a single national contract delivered by Choice Support from 1 April 2020. Experts by Experience conduct conversations with service users during inspections, make observations, and provide perspectives that might otherwise be overlooked (Experts by Experience programme, CQC).
- The Penny Dash review (October 2024) found that CQC had experienced a "loss of sector expertise and credibility due to restructuring" as part of its 2021 transformation programme. The review recommended that CQC "rebuild expertise and relationships with providers" (Review into the operational effectiveness of the CQC, DHSC, October 2024).
- CQC announced in October 2024 that it would appoint at least three chief inspectors for hospitals, primary care, and adult social care, potentially with a fourth for mental health, in response to the Dash and Richards reviews (CQC response to Dash and Richards reviews, CQC, October 2024).
Enhancement of monitoring and the importance of inspection
The Care Quality Commission should consider whether inspections could be conducted in collaboration with other agencies, or whether they can take advantage of any peer review arrangements available.
- CQC's inspection methodology uses specialist professional advisers including practising clinicians who serve as peer reviewers during inspections. Inspection teams routinely include nurses, doctors, pharmacists, and other professionals from the relevant sector alongside CQC staff (CQC inspection team: NHS trusts, CQC).
- CQC's "Shaping the future" strategy for 2016-2021 set out a "more targeted, responsive and collaborative" approach to regulation, including increased joint working with other regulators (Shaping the future: CQC strategy 2016-2021, CQC, May 2016).
- CQC shares intelligence with partner organisations including NHS England, Healthwatch England, and professional regulators (GMC, NMC) through the National Quality Board and bilateral information sharing agreements (CQC Insight model, CQC).
Care Quality Commission independence strategy and culture
Any change to the Care Quality Commission's role should be by evolution – any temptation to abolish this organisation and create a new one must be avoided.
- CQC has been retained as the independent regulator of health and social care in England throughout the period since the Francis Report. Its statutory basis under the Health and Social Care Act 2008 has been maintained. No legislation to abolish CQC has been introduced (Health and Social Care Act 2008, as amended).
- CQC has undergone successive evolutionary reforms: a new inspection approach from October 2014, "Shaping the future" strategy for 2016-2021, a further strategy from 2021, and the introduction of a single assessment framework from November 2023 (CQC strategy 2021, CQC).
- The Penny Dash review (October 2024) found significant operational failings at CQC, and the Health Secretary declared CQC "not fit for purpose." The government's response was to commission reforms and additional reviews, not to propose abolition (Government acts after report highlights failings at regulator, DHSC, July 2024).
Care Quality Commission independence strategy and culture
Where issues relating to regulatory action are discussed between the Care Quality Commission and other agencies, these should be properly recorded to avoid any suggestion of inappropriate interference in the Care Quality Commission's statutory role.
- CQC has formal memoranda of understanding and information sharing agreements with partner organisations including NHS England, Monitor/NHS Improvement, and professional regulators. The National Quality Board provides a forum for regulatory coordination (CQC annual report and accounts 2023-24, CQC).
- The Penny Dash review (October 2024) recommended that DHSC "strengthen sponsorship arrangements" with CQC, noting concerns about the clarity of the Department's relationship with CQC and the degree to which CQC's operational independence had been maintained during recent difficulties (Review into the operational effectiveness of the CQC, DHSC, October 2024).
- No published evidence has been identified of a specific publicly available protocol requiring formal recording of all discussions between CQC and other agencies relating to regulatory action, as distinct from existing memoranda of understanding and statutory information sharing provisions.
Care Quality Commission independence strategy and culture
The Care Quality Commission should review its processes as a whole to ensure that it is capable of delivering regulatory oversight and enforcement effectively, in accordance with the principles outlined in this report.
- CQC published successive strategies — "Raising standards, putting people first" (2013-16), "Shaping the future" (2016-2021), and a new strategy from 2021 — each reviewing and reforming its regulatory approach (Shaping the future, CQC, May 2016; CQC strategy 2021, CQC).
- CQC introduced a single assessment framework from November 2023 intended to provide a unified approach across all service types. The Richards review (October 2024) found that the transformation programme behind this framework had "failed to deliver the benefits that were intended." CQC staff reported "almost unanimously" that the single assessment framework did not account for major differences between service types (Review of CQC's single assessment framework, CQC/Professor Sir Mike Richards, October 2024).
- The Penny Dash review (October 2024) concluded that CQC's operational effectiveness had declined, recommending that CQC "rapidly improve operational performance" and "review the SAF to make it fit for purpose" (Review into the operational effectiveness of the CQC, DHSC, October 2024).
Care Quality Commission independence strategy and culture
The leadership of the Care Quality Commission should communicate clearly and persuasively its strategic direction to the public and to its staff, with a degree of clarity that may have been missing to date.
- CQC published "Shaping the future: CQC's strategy for 2016 to 2021" in May 2016, developed after a year-long consultation, setting out a "more targeted, responsive and collaborative" approach (Shaping the future: CQC strategy 2016-2021, CQC, May 2016).
- CQC published a further strategy in 2021, "A new strategy for the changing world of health and social care," organised around four themes: People and Communities, Smarter Regulation, Safety Through Learning, and Accelerating Improvement (CQC strategy 2021, CQC).
- The Penny Dash review (October 2024) found that CQC had experienced "a substantial loss of credibility" and that its 2021 transformation programme — involving a major organisational restructure, single assessment framework, and new IT system — had created significant internal disruption. The review recommended that CQC "rebuild expertise and relationships with providers" (Review into the operational effectiveness of the CQC, DHSC, October 2024).
- Ian Trenholm stepped down as CQC Chief Executive in June 2024. Sir Julian Hartley was appointed as new Chief Executive from 2 December 2024 (CQC announcement, June 2024; CQC response to reviews, October 2024).
Care Quality Commission independence strategy and culture
- CQC's Insight model, which replaced Intelligent Monitoring, brings together data indicators, inspection knowledge, feedback from service users, and partner intelligence to monitor services at provider and core service level and identify where risk to quality is greatest (CQC Insight: NHS trusts, CQC).
- CQC's new inspection methodology from October 2014 was explicitly designed to address the types of failures identified at Mid Staffordshire, including unannounced inspections, use of data-driven risk surveillance, and assessment against five key questions (CQC new inspection approach, CQC, September 2014).
- The Penny Dash review (October 2024) found that approximately one in five locations CQC has the power to inspect had never received a rating, and that inspection volumes had fallen by more than half since 2019-20 (Review into the operational effectiveness of the CQC, DHSC, October 2024).
- No published evidence has been identified of a specific formal evaluation by CQC, opened to public scrutiny, testing how its current systems would detect and act upon the specific warning signs and events described in the Francis Report and the first Mid Staffordshire inquiry report.
Care Quality Commission independence strategy and culture
- CQC's 2021 strategy is organised around a "People and Communities" theme, which aims to ensure that the experiences, needs and preferences of people who use services are central to CQC's work (CQC strategy 2021, CQC).
- CQC established a "People and Communities Advisory Group" and a "Service User Reference Panel" to advise on strategic issues and ensure the perspective of people who use services informs CQC's work (CQC annual report and accounts 2023-24, CQC).
- No published evidence has been identified of a specific formal "patients' consultative council" of the type described in this recommendation — a standing body with a structural role in CQC governance through which patient perspective could be obtained directly on issues under discussion.
Improved patient focus
For as long as it retains responsibility for the regulation of foundation trusts, Monitor should incorporate greater patient and public involvement into its own structures, to ensure this focus is always at the forefront of its work.
- NHS England has a statutory duty under section 13Q of the National Health Service Act 2006 to involve patients and the public in commissioning decisions. NHS England publishes guidance on working with people and communities and has a patient and public participation policy (NHS England, Working with people and communities guidance).
- Healthwatch England, established by the Health and Social Care Act 2012, provides an independent national voice for patients and service users. Local Healthwatch organisations operate in every local authority area (Health and Social Care Act 2012, Part 5).
- No published evidence has been identified of a specific patient and public involvement structure created within Monitor or NHS Improvement before their respective mergers, of the kind envisaged by this recommendation. Patient involvement functions are now distributed across NHS England, Healthwatch, and Integrated Care Boards rather than concentrated in a single regulator.
Improved transparency
Monitor should publish all side letters and any rating issued to trusts as part of their authorisation or licence.
- The NHS provider licence replaced foundation trusts' Terms of Authorisation from 1 April 2013. Standard licence conditions were published by Monitor. NHS England publishes enforcement undertakings: "a non-confidential version will be published shortly after the undertakings have been accepted" (NHS enforcement guidance, NHS England).
- The Single Oversight Framework, published by NHS Improvement in September 2016, introduced segmentation ratings (1-4) applied equally to NHS trusts and foundation trusts for the first time. Segmentation results are published and updated regularly by NHS England (NHS Oversight Framework, NHS England).
- No published evidence has been identified that all "side letters" — informal communications from Monitor to foundation trusts about concerns — were routinely published during the period Monitor operated.
Quality of care as a pre-condition for foundation trust applications
The NHS Trust Development Authority should develop a clear policy requiring proof of fitness for purpose in delivering the appropriate quality of care as a pre-condition to consideration for support for a foundation trust application.
- The foundation trust application pipeline was effectively closed by 2014, with most applications paused or deferred. The TDA's focus shifted from supporting foundation trust applications to performance oversight of NHS trusts.
- The Fit and Proper Person Requirement (Regulation 5 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014) came into force in November 2014, requiring providers to ensure directors meet fitness requirements. This applies to all registered providers, not specifically to foundation trust applicants (SI 2014/2936, Regulation 5).
- From 1 April 2023, all NHS trusts are required to hold a provider licence, including Condition FT4 (Governance) which requires systems and processes for escalating and resolving quality issues. Annual self-certification against this condition is required (NHS provider licence conditions, NHS England).
- No published evidence has been identified that the NTDA developed a specific policy requiring "proof of fitness for purpose in delivering the appropriate quality of care" as a pre-condition for foundation trust applications, as distinct from the general quality oversight framework it applied to all NHS trusts.
Improving contribution of stakeholder opinions
- The foundation trust application pipeline was effectively closed by 2014, with most applications paused or deferred. The Department of Health, the NHS Trust Development Authority, and Monitor did not conduct a published joint review of the stakeholder consultation process before the pipeline closed.
- The Health and Care Act 2022 significantly narrowed the distinction between NHS trusts and foundation trusts by bringing both under the same licensing regime. Strategic Health Authorities, referenced in this recommendation, were abolished on 1 April 2013 under the Health and Social Care Act 2012 (Health and Social Care Act 2012; Health and Care Act 2022).
- The Advanced Foundation Trust Programme, announced November 2025, includes a new application and assessment process. The published guide for applicants does not describe a specific public consultation requirement of the type envisaged in this recommendation (Advanced Foundation Trust Programme guide, NHS England, November 2025).
Focus on compliance with fundamental standards
- The foundation trust application pipeline was effectively closed by 2014, with most applications paused or deferred. No published evidence has been identified that the NTDA developed the specific rigorous assessment process for foundation trust applicants described in this recommendation before the pipeline closed.
- From 1 April 2023, all NHS trusts are required to hold a provider licence under the same conditions as foundation trusts, including Condition FT4 (Governance) requiring clear accountability for quality of care. The NHS Oversight Framework applies the same segmentation methodology (segments 1-4) to both NHS trusts and foundation trusts (NHS Oversight Framework 2025/26, NHS England).
- The Advanced Foundation Trust Programme, announced November 2025, includes a new assessment process where both NHS trusts and foundation trusts may apply. Assessment criteria include quality of care alongside financial sustainability (Advanced Foundation Trust Programme guide, NHS England, November 2025).
Focus on compliance with fundamental standards
- The foundation trust application pipeline was effectively closed by 2014, with most applications paused or deferred. The requirement that applicants demonstrate current compliance with fundamental standards before receiving support for an application became moot.
- The Fit and Proper Person Requirement (Regulation 5, SI 2014/2936) and the Fundamental Standards (Regulations 2014) established minimum quality and safety standards that all registered providers must meet, regardless of foundation trust status. CQC ratings — including whether a trust is rated "Inadequate" — are publicly available (SI 2014/2936; CQC ratings).
- The NHS Oversight Framework segments trusts 1-4 based on quality, finance, and leadership concerns. Trusts in segments 3 or 4 receive mandated support or intensive intervention. This provides a mechanism for identifying trusts that are not meeting fundamental standards, though it is not specific to foundation trust applications (NHS Oversight Framework 2025/26, NHS England).
Focus on compliance with fundamental standards
- 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).
Duty of utmost good faith
- Section 92 of the Care Act 2014 creates a criminal offence where a care provider supplies, publishes or otherwise makes available information that is "false or misleading in a material respect" where required by law to provide it. The maximum penalty is an unlimited fine in the magistrates' court or up to 2 years' imprisonment on indictment. A defence exists where the provider "took all reasonable steps and exercised all due diligence to prevent the provision of false or misleading information" (Care Act 2014, s.92).
- The False or Misleading Information (Specified Care Providers and Specified Information) Regulations 2015 specify that NHS trusts and NHS foundation trusts are covered by the offence. The Department of Health published official guidance on the operation of the offence in February 2015 (SI 2015/229; DHSC guidance on False or Misleading Information offence, February 2015).
- The NHS provider licence includes conditions requiring the provision of accurate information. NHS England's enforcement guidance sets out consequences for non-compliance (NHS enforcement guidance, NHS England).
Role of Secretary of State
- The Health and Social Care Act 2012 had already established a process requiring the Secretary of State to support NHS trust applications to Monitor before they could be assessed for foundation trust status (National Health Service Act 2006, as amended by the Health and Social Care Act 2012).
- The Health and Care Act 2022 brought NHS trusts and foundation trusts under the same licensing and oversight regime, significantly narrowing the practical distinction between the two. From 1 April 2023, NHS trusts hold provider licences with the same governance conditions as foundation trusts (Health and Care Act 2022, ss.61-62).
- The Advanced Foundation Trust Programme, announced November 2025, introduces a new application process. The programme guide states that applicants must demonstrate they are delivering safe, high-quality care. Assessment criteria include CQC ratings, NHS Oversight Framework segmentation, and financial sustainability (Advanced Foundation Trust Programme guide, NHS England, November 2025).
Assessment process for authorisation
- CQC's inspection regime from October 2014 includes physical inspections of wards and clinical areas as a core element. Comprehensive inspections of NHS acute trusts involve multi-day site visits with inspectors observing care on wards, in emergency departments, theatres, and outpatient areas (CQC new inspection approach, CQC, September 2014).
- CQC ratings are publicly available and provide an independent assessment of whether a trust meets fundamental safety and quality standards. CQC inspections apply to all NHS trusts and foundation trusts, regardless of their application status (CQC ratings).
- The Advanced Foundation Trust Programme, announced November 2025, includes CQC ratings as one of the assessment criteria for applicants. The programme guide states that trusts rated "Inadequate" overall by CQC would not be eligible (Advanced Foundation Trust Programme guide, NHS England, November 2025).
Need for constructive working with other parts of the system
- Monitor merged into NHS Improvement (April 2016) and then into NHS England (July 2022). DHSC published a framework agreement with NHS Improvement setting out the terms of their accountability relationship (DHSC-NHS Improvement framework agreement).
- The Penny Dash review of CQC (October 2024) found that "DHSC could do more to ensure that CQC is sponsored effectively, in line with the government's Arm's length body sponsorship code of good practice." The review recommended "more regular performance review conversations" between DHSC and CQC, including monthly meetings at director general level (Review into the operational effectiveness of the CQC, DHSC, October 2024).
- The Dash review's finding that DHSC sponsorship of CQC needed strengthening suggests that the regular performance reviews envisaged by this recommendation were not conducted with sufficient rigour in the period before the review.
Enhancement of role of governors
- NHS England published an addendum to the guide on 27 October 2022, explaining how the duties of foundation trust councils of governors support system working and collaboration, with examples of good practice. The addendum supplements the original guide (Addendum to Your Statutory Duties, NHS England, October 2022).
- Monitor also published "NHS Foundation Trust Governors: A Brief Guide to Your Duties" as a shorter companion document (Brief Guide to Your Duties, Monitor/GOV.UK).
- NHS Providers (formerly the Foundation Trust Network) operates the GovernWell programme, established in 2013, which provides national training and support for NHS foundation trust governors. The programme includes modules on member and public engagement (GovernWell, NHS Providers).
Enhancement of role of governors
Arrangements must be made to ensure that governors are accountable not just to the immediate membership but to the public at large – it is important that regular and constructive contact between governors and the public is maintained.
- Monitor published guidance on governors' statutory duties including their obligation to represent the interests of members and the public (Your Statutory Duties, Monitor, August 2013).
- Foundation trust governors include elected public governors who represent the public constituency for their area. Foundation trust constitutions set out how public governors are elected and how they engage with the public they represent (National Health Service Act 2006, Schedule 7).
- No published evidence has been identified of specific arrangements requiring governors to maintain regular and constructive contact with the wider public beyond the immediate membership, as distinct from general expectations about public governor engagement set out in the statutory duties guide and foundation trust constitutions.
Enhancement of role of governors
- NHS Providers also provides governor support including the annual Governor Focus conference, Governor Focus e-newsletter, pre-induction materials, an induction toolkit, guidance documents, and an email/telephone helpline (Governor support, NHS Providers).
- Monitor published "Your Statutory Duties: A Reference Guide for NHS Foundation Trust Governors" (August 2013, updated November 2013). NHS England published an addendum in October 2022 (Your Statutory Duties, Monitor, August 2013; Addendum, NHS England, October 2022).
- The Health and Social Care Act 2012 strengthened governor powers to hold non-executive directors to account, creating a stronger basis for governor training to focus on quality scrutiny and challenge (Health and Social Care Act 2012, s.151).
Enhancement of role of governors
- Monitor published guidance on the dispute resolution process and the role of the Lead Governor in liaison between the council of governors and Monitor. NHS England, as Monitor's successor, retains these functions (Your Statutory Duties, Monitor, August 2013).
- CQC's inspection programme assesses compliance with healthcare standards independently of the licensing regime. Governors can raise concerns about quality of care directly with CQC. However, no published evidence has been identified of a specific advisory facility created jointly by CQC and Monitor (or their successors) to provide governors with advice on healthcare standards compliance, parallel to the licensing dispute facility under section 39A.
- NHS Providers' GovernWell programme and helpline provide governors with access to advice and support, but this is a membership body service rather than a regulatory advisory facility (GovernWell, NHS Providers).
Accountability of providers' directors
Consideration should be given to including in the criteria for fitness a minimum level of experience and/or training, while giving appropriate latitude for recognition of equivalence.
- The Kark review (February 2019) recommended (Recommendation 1) that all directors should meet specified standards of competence to sit on an NHS board. The Secretary of State accepted this recommendation (Kark review, DHSC, February 2019).
- NHS England published a Leadership Competency Framework for board members on 28 February 2024, with six domains of competency. Organisations must incorporate the competencies into board member role descriptions and recruitment from 1 April 2024. The framework sets expectations about the competencies required for board-level roles, while "giving appropriate latitude for recognition of equivalence" as Francis recommended, by not mandating specific qualifications or years of experience (Leadership Competency Framework for board members, NHS England, February 2024).
- The Kark review found that the existing FPPT was "essentially a self-certification exercise" and that "poor managers were moving around the system from high-profile job to high-profile job." The updated FPPT Framework (September 2023) requires documented assessments of competence at appointment and annually thereafter, strengthening the assessment process beyond self-certification (FPPT Framework, NHS England, August 2023; Kark review, DHSC, February 2019).
Accountability of providers' directors
- No published evidence has been identified that CQC has exercised its power under Regulation 5 to require the removal of a director. A parliamentary written question (PQ 48409, October 2016) addressed enforcement of the FPPT; the response indicated that CQC does not maintain a record of directors found not fit and proper, as the requirement is for providers to determine fitness (PQ 48409, 12 October 2016).
- The Kark review (February 2019) recommended (Recommendation 5) a power to disbar individuals from board positions for serious misconduct, independent of whether the trust is in breach of its licence or registration conditions. The Secretary of State did not accept this recommendation at the time (Kark review, DHSC, February 2019).
- The government consultation response of July 2025 confirmed that secondary legislation will be brought forward to implement a statutory barring system for senior NHS leaders, to be operated by the Health and Care Professions Council. This would create a mechanism for regulatory removal of individuals found guilty of serious misconduct, independent of the trust's overall regulatory status. Parliamentary debate is anticipated in the second half of 2026 (Leading the NHS: proposals to regulate NHS managers, DHSC, consultation response, July 2025).
Accountability of providers' directors
- Monitor, which merged into NHS Improvement (April 2016) and subsequently NHS England (July 2022), did not publish separate guidance on the exercise of FPPT removal or disqualification powers, as Regulation 5 was implemented through CQC rather than Monitor as Francis had envisaged.
- NHS England published the updated FPPT Framework (effective September 2023) with detailed guidance for chairs on implementation, including the procedures for FPPT assessment, the circumstances in which directors may be found unfit, and the Board Member Reference system for departing directors. Annual reporting to NHS England regional directors on FPPT outcomes for each board member is required, with written records of mitigations for any adverse findings (Guidance for chairs on FPPT implementation, NHS England, September 2023).
- The Kark review (February 2019) found that the FPPT as originally implemented was "essentially a self-certification exercise." The consultation response on regulating NHS managers (July 2025) confirmed that the Health and Care Professions Council will operate a statutory barring list, which will require guidance on the principles, procedures and due process for disbarment (Kark review, DHSC, February 2019; Leading the NHS consultation response, DHSC, July 2025).
Accountability of providers' directors
- The National Audit Office published a report on confidentiality clauses and special severance payments in June 2013, finding that 88% of compromise agreements sampled contained a confidentiality clause. The Public Accounts Committee subsequently found "shocking examples of using taxpayers' money to pay-off individuals who have flagged up concerns about patient safety and care" (NAO, Confidentiality clauses and special severance payments, June 2013; Public Accounts Committee 36th Report, 2013-14).
- NHS Employers published guidance on the use of settlement agreements and confidentiality clauses (most recently updated May 2024), requiring that all NHS providers include an express carve-out clause making clear a worker cannot waive their rights to make protected disclosures. The Public Interest Disclosure Act 1998 (as amended) renders unenforceable any contractual provision that purports to prevent a protected disclosure, but there is no outright statutory prohibition on confidentiality clauses in settlement agreements (NHS Employers, The use of settlement agreements and confidentiality clauses, May 2024).
- NHS England published guidance on processes for making severance payments (originally 2014, updated 2021), and the Cabinet Office published guidance on settlement agreements and confidentiality clauses applicable to the civil service. The NHS England FPPT Framework (September 2023) introduced mandatory Board Member References on departure, which must include information about investigations relevant to serious misconduct (NHSE severance payments guidance, 2021; FPPT Framework, NHS England, August 2023).
Requirement of training of directors
A requirement should be imposed on foundation trusts to have in place an adequate programme for the training and continued development of directors.
- NHS England published a directory of board-level learning and development opportunities listing 58 programmes across multiple providers including the NHS Leadership Academy, NHS Providers, The King's Fund, and NHS Confederation (Directory of board level learning and development opportunities, NHS England).
- The NHS England Leadership Competency Framework (February 2024) sets expectations about competencies required for board-level roles across six domains. Organisations must incorporate these into role descriptions and recruitment from 1 April 2024. The FPPT Framework requires annual assessment of directors' competence, which implicitly creates an expectation of ongoing development to maintain fitness (Leadership Competency Framework, NHS England, February 2024; FPPT Framework, NHS England, August 2023).
- No published evidence has been identified of a specific regulatory requirement that all foundation trusts must have in place a formal programme for the training and continued development of directors, as distinct from the extensive voluntary programmes available and the implicit expectation created by annual FPPT assessment. Director development remains a matter of individual trust governance rather than a mandated regulatory requirement.
Assistance in deciding on prosecutions
- CQC employs specialist professional advisors (SPAs) across a range of clinical disciplines who provide expert advice during inspections and enforcement activities. CQC's enforcement policy (updated November 2023) sets out the approach to using specialist advice in cases involving potential criminal prosecution for ill-treatment or wilful neglect under sections 20-21 of the Criminal Justice and Courts Act 2015 (CQC enforcement policy, November 2023).
- The Crown Prosecution Service published legal guidance on the prosecution of offences of ill-treatment or wilful neglect (sections 20-21, Criminal Justice and Courts Act 2015), including guidance on evidential requirements and the use of expert evidence in healthcare cases (CPS legal guidance on ill-treatment and wilful neglect).
- HSE and CQC's memorandum of understanding provides for cooperation in cases that may engage both health and safety at work legislation and healthcare regulatory requirements, including arrangements for sharing expert advice (HSE/CQC MoU, 2014).
NHS Litigation Authority Improvement of risk management
The financial incentives at levels below level 3 should be adjusted to maximise the motivation to reach level 3.
- NHS Resolution discontinued the three-level CRMS assessment programme. The maternity incentive scheme (MIS), introduced in 2018, replaced the previous broad risk management assessment approach for maternity services with a specific set of ten safety actions that trusts must demonstrate compliance with to qualify for a contribution rebate. Year 6 of the MIS (2024-25) provides financial incentives linked to meeting specific safety standards (CNST Maternity Incentive Scheme Year 6, NHS Resolution).
- NHS Resolution's Safety and Learning team publishes thematic reviews, scorecards and claims data analysis to support trusts in improving patient safety. The organisation's annual report (2023-24) states its strategy is to focus on "incentivising a reduction in harm" through learning and early resolution rather than through the previous three-tiered risk management assessment system (NHS Resolution annual report 2023-24).
- No published evidence has been identified that the specific three-level financial incentive structure was adjusted as recommended before the scheme was discontinued.
Evidence-based assessment
- NHS Resolution publishes annual claims scorecards for individual trusts, providing each organisation with analysis of its claims profile including volumes, costs, specialties, and trends over time. These scorecards are available to trusts to support learning from claims (NHS Resolution claims scorecards).
- NHS Resolution's Safety and Learning team publishes thematic reviews drawing on claims data analysis. Reports have included Early Notification Scheme reports (maternity), and thematic reviews of claims in specific clinical areas such as surgical never events and medication errors (NHS Resolution thematic reviews).
- The NHS Resolution data strategy states the organisation's aim to make "better use of data and intelligence from claims to identify patient safety risks, support providers, and inform system-wide improvement" (NHS Resolution corporate strategy).
Information sharing
- CQC's Insight intelligence model draws on data from multiple sources to assess provider risk. CQC confirmed that it uses NHS Resolution claims data as one of its data sources for monitoring and risk assessment (CQC Insight model documentation).
- NHS Resolution's Early Notification Scheme (maternity), introduced in April 2017, specifically requires early reporting of potentially negligent maternity incidents. Relevant information is shared with CQC and the Healthcare Safety Investigation Branch (now HSSIB) where safety concerns are identified (NHS Resolution Early Notification Scheme).
- The Health and Care Act 2022 (section 97) introduced a duty of candour enforcement provision, and Regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 already requires providers to be open and transparent with patients when things go wrong. Claims information can be relevant to CQC's assessment of compliance with the duty of candour (SI 2014/2936, Regulation 20).
Information sharing
The NHS Litigation Authority should make more prominent in its publicity an explanation comprehensible to the general public of the limitations of its standards assessments and of the reliance which can be placed on them.
- NHS Resolution's website and annual reports describe the organisation's role as managing clinical and non-clinical claims on behalf of NHS bodies and operating incentive schemes such as the maternity incentive scheme. The website includes a description of the organisation's purpose and scope of its schemes (NHS Resolution website).
- No published evidence has been identified of a specific public-facing explanation of the limitations of the former CRMS standards assessments, as the programme was discontinued rather than continued with improved public explanation.
- NHS Resolution's maternity incentive scheme (MIS) publishes detailed criteria for each of the ten safety actions that trusts must meet, and the results of compliance assessments are published, providing a degree of public transparency about what the standards measure and their limitations (CNST Maternity Incentive Scheme, NHS Resolution).
National Patient Safety Agency functions
- Getting It Right First Time (GIRFT), established in 2014 and expanded as a national NHS England programme, provides clinically-led peer review across more than 40 surgical and medical specialties. GIRFT uses clinician reviewers who visit trusts to compare clinical practice and outcomes against national benchmarks, providing a form of mutual peer review of clinical services (GIRFT programme, NHS England).
- The Patient-Led Assessments of the Care Environment (PLACE) programme replaced the Patient Environment Action Team (PEAT) assessments in 2013. PLACE assessments include representatives from outside the organisation being assessed, including patient assessors, and cover cleanliness, food, privacy and dignity, and condition of buildings (PLACE assessments, NHS England).
- CQC's well-led framework inspection methodology includes the use of specialist professional advisors and Expert by Experience inspectors (people who have used health or social care services) who participate in inspections alongside CQC inspectors. This provides external scrutiny from outside the organisation being inspected (CQC inspection methodology).
- The Health Services Safety Investigations Body (HSSIB), operational from October 2023, conducts independent safety investigations that involve clinical expert review of incidents and can examine the systems and processes within trusts (Health and Care Act 2022, Part 4).
Transparency use and sharing of information
Data held by the National Patient Safety Agency or its successor should be open to analysis for a particular purpose, or others facilitated in that task.
- NHS England publishes patient safety incident data and analysis from the reporting system. Data is available for analysis by trusts, researchers and other organisations for patient safety improvement purposes. Published reports have included analysis of never events, medication incidents, and other categories of patient safety events (NHS England patient safety data).
- The LFPSE service was designed to provide enhanced data analysis capabilities compared to the NRLS. NHS England stated that LFPSE would enable "richer and more insightful data to support patient safety improvement at local, regional and national levels" through improved data structure, categorisation and search functionality (LFPSE service, NHS England).
- The Healthcare Safety Investigation Branch (HSIB, now HSSIB from October 2023) has published thematic investigations drawing on patient safety incident data, demonstrating the use of reporting system data for specific analytical purposes including its reports on maternity, mental health, and surgical safety (HSSIB investigation reports).
Transparency use and sharing of information
The National Patient Safety Agency or its successor should regularly share information with Monitor.
- As both functions now sit within NHS England, the sharing of patient safety information between the former NPSA function and the former Monitor function is an internal matter within a single organisation. NHS England's System Oversight Framework (SOF) uses patient safety indicators alongside financial, operational, and quality metrics to assess and segment NHS providers (NHS System Oversight Framework, NHS England).
- NHS England's Regional Teams, which carry out the oversight functions previously performed by Monitor and NHS Trust Development Authority, have access to patient safety incident data from LFPSE as part of their provider oversight role (NHS England operating framework).
- The Learn from Patient Safety Events (LFPSE) service data is available to NHS England teams across all functions, removing the organisational boundary that existed when the NPSA/NHS England patient safety team and Monitor were separate bodies (LFPSE, NHS England).
Transparency use and sharing of information
- NHS England and CQC published a joint working agreement setting out how they share information and coordinate their respective roles in relation to provider oversight and regulation. This includes sharing patient safety incident data and intelligence about providers of concern (NHS England/CQC joint working).
- The Learn from Patient Safety Events (LFPSE) service, which replaced the NRLS (decommissioned June 2024), was designed with inter-organisational data sharing in mind. NHS England stated that the data would be accessible to support patient safety improvement at local, regional and national levels, including for regulatory purposes (LFPSE, NHS England).
- CQC's regulatory approach includes the use of statistical outlier analysis of patient safety indicators to identify trusts that may be under-reporting or where reporting patterns suggest potential safety concerns (CQC regulatory methodology).
Transparency use and sharing of information
Consideration should be given to whether information from incident reports involving deaths in hospital could enhance consideration of the hospital standardised mortality ratio.
- SHMI is calculated using Hospital Episode Statistics (HES) data linked to ONS death registrations. It uses a statistical model to compare observed deaths against expected deaths based on case-mix adjustment. The methodology has been developed and refined since its introduction in October 2011 to incorporate additional data sources and improve risk adjustment (SHMI methodology, NHS England).
- The Care Quality Commission uses SHMI as one of its mortality indicators in its Insight intelligence model. Trusts identified as statistical outliers on SHMI may trigger further investigation by CQC (CQC Insight model).
- Patient safety incident reports from LFPSE (and previously NRLS) record incidents resulting in death. NHS England publishes analysis of these reports alongside SHMI data. However, the direct linkage of individual incident reports to SHMI calculations at a case level has not been implemented as a formal methodology — the two data systems remain operationally separate, though both are used in combination for mortality surveillance purposes (NHS England patient safety data; SHMI publication).
Health Protection Agency Coordination and publication of providers' information on healthcare associated infections
- UKHSA operates the mandatory surveillance programme for healthcare associated infections (HCAI), publishing data on each NHS trust's performance in relation to MRSA bacteraemia, Clostridioides difficile infection, Escherichia coli bacteraemia, Klebsiella species bacteraemia, and Pseudomonas aeruginosa bacteraemia. Data is published at trust level and is publicly accessible (UKHSA HCAI mandatory surveillance, GOV.UK).
- The Health and Social Care Information Centre (now part of NHS England) collaborated with PHE (now UKHSA) on the publication and dissemination of HCAI data. HCAI data is published through the UKHSA data dashboard and Fingertips public health data tool, providing trust-level, ICB-level, and national-level analysis (UKHSA Fingertips, GOV.UK).
- NHS England includes HCAI reduction objectives in the NHS Standard Contract. Trusts are required to have infection prevention and control programmes and to report HCAI data through mandatory surveillance. CQC monitors compliance with Regulation 12 (safe care and treatment) which includes infection control requirements (NHS Standard Contract; SI 2014/2936, Regulation 12).
Sharing concerns
- UKHSA publishes the mandatory surveillance data on healthcare associated infections (HCAI) at trust level. Where a trust's HCAI performance is a statistical outlier or shows a concerning trend, UKHSA regional teams work with NHS England regional teams, CQC, and ICBs to share intelligence and coordinate responses. UKHSA issues enhanced surveillance letters to trusts that exceed infection thresholds (UKHSA HCAI surveillance programme, GOV.UK).
- NHS England's System Oversight Framework (SOF) includes infection control indicators among the metrics used to assess and segment providers. Providers in SOF segments 3 or 4 (mandated or enhanced oversight) receive increased scrutiny from NHS England regional teams, with information shared with CQC and ICBs (NHS System Oversight Framework, NHS England).
- CQC's Regulation 12 (safe care and treatment) includes infection prevention and control requirements. CQC uses HCAI data from UKHSA as part of its Insight intelligence model for monitoring providers. Where CQC identifies concerns about infection control at a provider, it can take enforcement action including warning notices, conditions of registration, or prosecution (SI 2014/2936, Regulation 12; CQC enforcement policy).
Support for other agencies
Public Health England should review the support and training that health protection staff can offer to local authorities and other agencies in relation to local oversight of healthcare providers' infection control arrangements.
- UKHSA provides training and support to local authorities and NHS organisations on infection prevention and control (IPC). The UKHSA IPC team publishes guidance on the management of healthcare associated infections and provides specialist advice to local health protection teams who support NHS providers and local authorities (UKHSA IPC guidance, GOV.UK).
- UKHSA regional health protection teams (formerly PHE centres) provide local expert advice and support to Directors of Public Health, local authorities, and NHS providers on infection prevention and control, outbreak management, and surveillance. This includes training on the investigation and management of HCAI outbreaks (UKHSA health protection team functions).
- The Health and Care Act 2022 placed UKHSA's health protection functions on a statutory footing. Directors of Public Health in local authorities have a statutory duty to protect the health of the local population (under the NHS Act 2006 as amended by the Health and Social Care Act 2012), and UKHSA provides the specialist support and training to enable them to discharge this function in relation to healthcare providers' infection control arrangements (NHS Act 2006, s.73A as inserted by HSCA 2012).
Effective complaints handling
- The NHS Constitution (revised 2023) includes the right to have any complaint about NHS services acknowledged within three working days and properly investigated, and the right to discuss the manner in which the complaint is to be handled. It also includes the right to have the complaint dealt with efficiently and investigated properly (NHS Constitution, DHSC, January 2021 with 2023 updates).
- The Parliamentary and Health Service Ombudsman (PHSO) published the NHS Complaint Standards in July 2022, setting out expectations for how NHS organisations should handle complaints. The standards include requirements for accessible complaints processes with multiple routes for providing feedback, and for organisations to make it "as easy as possible for people to raise concerns and make complaints" (NHS Complaint Standards, PHSO, July 2022).
- NHS England published complaint handling guidance requiring providers to offer multiple channels for complaints including in person, by telephone, in writing, by email, and through online forms. The Patient Advice and Liaison Services (PALS) provide an additional gateway for patients to raise concerns during and after treatment (NHS complaints guidance, NHS England).
Lowering barriers
- The PHSO's NHS Complaint Standards (July 2022) state that organisations should not refuse to investigate a complaint solely because the complainant has indicated an intention to take legal action. The standards provide that complaints and legal processes serve different purposes and should be treated separately (NHS Complaint Standards, PHSO, July 2022).
- The Clwyd-Hart Review ("A Review of the NHS Hospitals Complaints System: Putting Patients Back in the Picture"), commissioned by the Secretary of State and published in October 2013, recommended that trusts should not use the possibility of litigation as a reason to refuse to investigate complaints. The review found evidence that some trusts were routinely declining to investigate complaints where litigation was mentioned (Clwyd-Hart Review, October 2013).
- NHS Resolution published guidance on the interaction between complaints and claims, advising NHS bodies that the complaints process should continue to operate where a claimant or potential claimant has also made a complaint, and that early resolution of complaints can reduce the likelihood of litigation (NHS Resolution guidance).
Lowering barriers
- The PHSO's NHS Complaint Standards (July 2022) require organisations to create an environment where "people feel comfortable providing feedback and making complaints." Standard 1 (Complaint handling) states that organisations should actively encourage feedback and make it clear that complaints are welcome and will be used to improve services (NHS Complaint Standards, PHSO, July 2022).
- CQC assesses complaint handling as part of its inspection of the "responsive" key question. The inspection framework examines whether services encourage feedback, make it easy for people to give feedback or raise concerns, and whether they investigate and take action on complaints. Poor complaint handling can contribute to a "requires improvement" or "inadequate" rating (CQC inspection framework).
- The Friends and Family Test (FFT), mandatory for NHS trusts since 2013, provides a continuous mechanism for patients to give real-time feedback on their experience of care. FFT data is published monthly at trust level by NHS England (Friends and Family Test, NHS England).
Lowering barriers
- The Patient Advice and Liaison Services (PALS), which operate in NHS trusts, provide a route for patients to raise concerns informally. PALS are intended to provide on-the-spot help and to resolve concerns quickly without the need for a formal complaint, but where concerns suggest patient safety issues, PALS should escalate to the formal complaints or incident reporting process (NHS PALS guidance).
- CQC's inspection of the "responsive" key question examines whether providers take account of all feedback, including informal comments and concerns, and whether they investigate and respond to all expressions of dissatisfaction regardless of the channel through which they are raised (CQC inspection framework).
- The Patient Safety Incident Response Framework (PSIRF, mandatory from autumn 2023) requires trusts to consider patient and family concerns as potential indicators of patient safety incidents, creating a pathway from informal feedback to formal investigation where safety concerns are identified (PSIRF, NHS England, August 2022).
Complaints handling
The recommendations and standards suggested in the Patients Association's peer review into complaints at the Mid Staffordshire NHS Foundation Trust should be reviewed and implemented in the NHS.
- The Clwyd-Hart Review ("A Review of the NHS Hospitals Complaints System: Putting Patients Back in the Picture"), published in October 2013, conducted a comprehensive review of NHS complaints handling and made recommendations covering many of the same areas as the Patients Association review. The Clwyd-Hart Review was commissioned directly in response to the Francis Report and effectively superseded the Patients Association recommendations as the basis for national policy reform (Clwyd-Hart Review, DHSC, October 2013).
- The PHSO published the NHS Complaint Standards in July 2022, establishing a national framework for complaint handling across the NHS. The standards cover expectations for timeliness, investigation quality, communication with complainants, learning from complaints, and staff training — addressing many of the themes raised in the Patients Association's original peer review (NHS Complaint Standards, PHSO, July 2022).
- No published evidence has been identified of a specific review and implementation programme directed at the Patients Association's peer review recommendations as a distinct exercise, though the substantive issues raised were addressed through the Clwyd-Hart Review and subsequent PHSO standards.
Complaints handling
Comments or complaints which describe events amounting to an adverse or serious untoward incident should trigger an investigation.
- The PHSO's NHS Complaint Standards (July 2022) state that where a complaint describes events that amount to a patient safety incident, the organisation should ensure the matter is investigated under the appropriate patient safety processes as well as the complaints process. The standards require organisations to have clear processes for identifying and escalating safety concerns arising from complaints (NHS Complaint Standards, PHSO, July 2022).
- CQC's fundamental standards include Regulation 12 (safe care and treatment) which requires providers to have systems for identifying and responding to safety risks. CQC assesses whether providers use complaint data to identify safety concerns during inspections (SI 2014/2936, Regulation 12).
- The NHS Standard Contract 2024/25 requires providers to have arrangements for linking complaints data with incident reporting data to ensure that patient safety concerns identified through complaints are investigated through the appropriate safety processes (NHS Standard Contract, NHS England).
Support for complainants
Where meetings are held between complainants and trust representatives or investigators as part of the complaints process, advocates and advice should be readily available to all complainants who want those forms of support.
- The NHS Constitution (revised 2023) includes the right "to receive appropriate support throughout the handling of a complaint" and the right to advocacy support. The Constitution states that the NHS pledges to ensure complainants "receive appropriate support" (NHS Constitution, DHSC).
- The PHSO's NHS Complaint Standards (July 2022) state that organisations should inform complainants about the availability of advocacy and support services, including independent NHS complaints advocacy. The standards state that "people should be told about the support available to them" when they raise concerns or make complaints (NHS Complaint Standards, PHSO, July 2022).
- Healthwatch England published guidance on NHS complaints advocacy, setting out the role of local Healthwatch organisations and independent advocates in supporting complainants through the complaints process, including attendance at meetings with trust representatives (Healthwatch England advocacy guidance).
Learning and information from complaints
Overview and scrutiny committees and Local Healthwatch should have access to detailed information about complaints, although respect needs to be paid in this instance to the requirement of patient confidentiality.
- Health Overview and Scrutiny Committees (HOSCs) have powers under the Local Authority (Public Health, Health and Wellbeing Boards and Health Scrutiny) Regulations 2013 to require NHS bodies to provide information, including information about complaints. HOSCs can require NHS commissioners and providers to attend and answer questions, and can access information necessary to carry out their scrutiny function (SI 2013/218).
- The PHSO's NHS Complaint Standards (July 2022) state that organisations should share learning from complaints with relevant partners and stakeholders. Complaints data, appropriately anonymised, should be available to support local scrutiny and accountability (NHS Complaint Standards, PHSO, July 2022).
- CQC publishes information about complaints it receives and how they inform regulatory action. Local Healthwatch organisations can share intelligence about complaints trends with CQC through established information-sharing arrangements (CQC/Healthwatch information sharing).
Learning and information from complaints
The Care Quality Commission should have a means of ready access to information about the most serious complaints. Their local inspectors should be charged with informing themselves of such complaints and the detail underlying them.
- CQC's inspection methodology includes examining complaint handling as part of the "responsive" key question. CQC inspectors review complaints data, complaint handling processes, and how organisations learn from complaints during inspections. Inspectors can request access to complaint files and records of complaint investigations (CQC inspection framework).
- The Health and Social Care Act 2008 (Registration) Regulations 2009 (as amended) require registered providers to notify CQC of certain categories of events, including serious incidents. CQC can also request information from providers at any time under its information-gathering powers (Health and Social Care Act 2008, s.64).
- PHSO shares data with CQC on complaints it receives and investigates about NHS providers. A memorandum of understanding between PHSO and CQC provides for information sharing where complaints raise concerns about the quality and safety of care (PHSO/CQC information sharing agreement).
Responsibility for monitoring delivery of standards and quality
- The GP contract (GMS/PMS) does not include a specific contractual obligation for GPs to monitor the quality of acute hospital services received by their patients or to maintain systematic records of outcomes following referral. The Quality and Outcomes Framework (QOF) incentivises clinical indicators within primary care but does not include indicators related to monitoring secondary care outcomes for referred patients (NHS GP contract, NHS England).
- NHS England's Referral Support System and e-Referral Service (e-RS) provide a mechanism for GPs to refer patients to hospital services, but the system does not include structured feedback to GPs on outcomes of referred patients. Discharge summaries are sent to GPs following hospital episodes, providing information on treatment and outcomes, but there is no systematic requirement for GPs to aggregate this information to identify patterns of concern about provider quality (e-RS, NHS England).
- The CQC inspection of GP practices under the "effective" key question examines whether practices make appropriate referrals and follow up on referrals, but does not assess whether GPs systematically monitor the quality of hospital services to which they refer patients (CQC GP inspection framework).
Responsibility for requiring and monitoring delivery of enhanced standards
- The NHS Standard Contract includes provisions for commissioners to set enhanced quality requirements beyond fundamental standards, with associated performance metrics and remedial mechanisms. Best Practice Tariffs (BPTs) provide additional financial incentives for providers to meet evidence-based standards of care in specific clinical areas (NHS Standard Contract; NHS Payment System, NHS England).
- NHS England publishes the NHS Outcomes Framework, which sets out high-level outcome indicators across five domains (preventing premature death, enhancing quality of life, recovering from episodes of ill health, patient experience, and treating in a safe environment). These indicators inform commissioning priorities and provide benchmarks for improvement above minimum standards (NHS Outcomes Framework, NHS England).
- Getting It Right First Time (GIRFT) provides nationally benchmarked clinical data to trusts and commissioners, enabling identification of unwarranted variation and opportunities for improvement beyond minimum compliance (GIRFT, NHS England).
Preserving corporate memory
- NHS England published guidance on ICB establishment and transition, including requirements for due diligence during the transfer of commissioning responsibilities from CCGs to ICBs. The guidance covered the transfer of contracts, data, staff, and organisational knowledge (NHS England ICB establishment guidance, 2022).
- No published evidence has been identified of a specific national "code of practice for managing organisational transitions" as Francis recommended, applicable to all types of organisational change across commissioners and providers. NHS England published transaction guidance for organisational mergers, acquisitions, and reconfigurations (updated periodically), covering provider-side transactions, but this is transactional guidance rather than a comprehensive code covering information candour and completeness during all organisational transitions (NHS England transactions guidance).
- NHS England's provider licence (condition FT4) requires foundation trusts to have systems for effective governance, but does not contain specific requirements about the quality of information conveyed during organisational transitions.
Resources for scrutiny
- NHS England provides support to ICBs through regional teams, including quality assurance, financial oversight, and performance management. The System Oversight Framework (SOF) provides the mechanism through which NHS England monitors and supports ICBs and their providers (NHS System Oversight Framework, NHS England).
- ICBs have the legal power to commission services and enter into contracts with providers. The NHS Standard Contract provides a comprehensive template for commissioning contracts, including quality schedules, performance monitoring requirements, and information requirements. ICBs can access specialist commissioning support through NHS England's regional teams and through collaborative commissioning arrangements with other ICBs (NHS Standard Contract, NHS England).
- NHS England published guidance on ICB governance and accountability, setting out expectations for the infrastructure, staffing, and expertise required for effective commissioning. ICBs must publish annual reports including assessments of the quality of services they commission (NHS England ICB governance guidance).
Expert support
- NHS England regional teams provide specialist commissioning support to ICBs, including clinical advice, procurement expertise, and quality assurance. NHS England directly commissions specialised services (approximately £20 billion annually) through its specialised commissioning function, using clinical reference groups comprising specialist clinicians (NHS England specialised commissioning).
- ICBs can collaborate with other ICBs through joint commissioning arrangements where individual ICBs lack the scale or expertise to commission effectively alone. The Health and Care Act 2022 enables ICBs to enter into joint commissioning arrangements and to delegate functions to other ICBs or to NHS England (Health and Care Act 2022, s.14Z50).
- NHS England published procurement guidance for ICBs (the Provider Selection Regime, introduced January 2024 under the Health Care Services (Provider Selection Regime) Regulations 2023), setting out processes for selecting providers including requirements for clinical expertise in procurement decisions (Provider Selection Regime, NHS England; SI 2023/1348).
Ensuring assessment and enforcement of fundamental standards through contracts
- NHS England publishes guidance on quality in commissioning, emphasising that commissioners should engage patients and the public in defining quality priorities and selecting indicators for monitoring. The NHS Constitution requires ICBs to involve patients and the public in decisions about the services they commission (NHS Constitution, DHSC; NHS England commissioning guidance).
- The Commissioning for Quality and Innovation (CQUIN) indicators are developed with clinical input and are intended to focus on areas where quality improvement will have the greatest impact on patient safety and outcomes. The selection of CQUIN indicators involves consultation with clinical experts and patient representatives (CQUIN, NHS England).
- Healthwatch England and local Healthwatch organisations provide patient and public perspectives to commissioners. ICBs are required under the Health and Care Act 2022 to have regard to the views of Healthwatch when exercising their commissioning functions (Health and Care Act 2022, s.14Z36).
Relative position of commissioner and provider
- The Provider Selection Regime (PSR), introduced in January 2024 under the Health Care Services (Provider Selection Regime) Regulations 2023 (SI 2023/1348), replaced the previous NHS procurement rules. The PSR gives commissioners decision-making authority over which providers to contract with, while requiring them to consider quality, innovation, and value in their decisions. Commissioners can use the competitive process, the most suitable provider process, or the direct award process depending on the circumstances (Provider Selection Regime, NHS England).
- The NHS Standard Contract is issued by NHS England and must be used for all NHS-funded secondary care services. Commissioners agree local quality schedules and activity plans with providers within the national contract framework, giving commissioners the ability to specify what they want to be provided (NHS Standard Contract, NHS England).
- NHS England's commissioning guidance emphasises that commissioning is "not simply procurement" but involves needs assessment, service design, market shaping, and quality assurance, with commissioners taking the lead in determining what services are required for their populations (NHS England commissioning guidance).
Development of alternative sources of provision
- The Health and Care Act 2022 enables ICBs to enter into joint commissioning arrangements with other ICBs and with NHS England, providing the "negotiating weight" that Francis identified as necessary. ICBs can collaborate on commissioning to achieve economies of scale and to access a wider range of potential providers (Health and Care Act 2022, s.14Z50).
- NHS England directly commissions specialised services on a national basis, ensuring that commissioning of highly specialised services has sufficient scale and expertise. The specialised commissioning function was integrated into NHS England from April 2013 and uses national contracts with providers (NHS England specialised commissioning).
- The independent sector has been an increasingly significant provider of NHS-funded services. NHS England data shows that independent sector providers deliver a growing proportion of elective care, providing commissioners with alternative sources of provision (NHS England elective recovery programme).
Monitoring tools
- CQC monitors compliance with fundamental standards through its inspection and regulatory regime, enabling commissioners to focus their monitoring activity on enhanced standards and contractual requirements beyond the CQC baseline. CQC and commissioners share intelligence about provider performance through established information-sharing arrangements (CQC regulatory approach).
- The System Oversight Framework provides an overarching structure for monitoring provider performance, with NHS England regional teams working alongside commissioners to assess and intervene where providers are underperforming. SOF metrics cover quality, finance, operational performance, and workforce indicators (NHS System Oversight Framework, NHS England).
- NHS England publishes a wide range of provider performance data including waiting times, cancer performance, A&E performance, mortality indicators, and patient experience data, which commissioners use to monitor the performance of their commissioned services (NHS England statistical publications).
Role of commissioners in provision of support for complainants
Consideration should be given to whether commissioners should be given responsibility for commissioning patients' advocates and support services for complaints against providers.
- The government's response to the Francis Report in "Hard Truths" (Cm 8777, November 2013) considered whether commissioners should be given responsibility for commissioning complaints advocacy, as Francis recommended. The government decided that local authorities were the appropriate bodies to commission advocacy services, as they are independent of both NHS providers and commissioners, and can integrate health complaints advocacy with other advocacy services (Hard Truths, DHSC, November 2013).
- Local Healthwatch organisations, funded by local authorities, also provide signposting and support for people wishing to make NHS complaints. Local Healthwatch has a statutory role under the Health and Social Care Act 2012 in providing information and advice to the public about health and social care services, including the complaints process (Health and Social Care Act 2012, ss.221-227).
- The consideration Francis recommended was given — the decision was that local authorities rather than NHS commissioners should commission advocacy, to preserve independence from the NHS commissioning and providing organisations that might be the subject of complaints.
Public accountability of commissioners and public engagement
- ICBs are required to publish annual reports and accounts, hold meetings in public, maintain websites with information about their activities and decisions, and engage with their local populations. These transparency requirements establish ICBs as recognisable public bodies (Health and Care Act 2022; NHS England ICB governance guidance).
- NHS England provides support to ICBs through regional teams, including quality assurance, financial oversight, and workforce support. ICBs can access specialist technical support through NHS England and through collaborative arrangements with other ICBs (NHS System Oversight Framework, NHS England).
- Local Healthwatch organisations provide an independent patient and public voice in the local health and care system, working alongside ICBs to ensure that commissioning decisions reflect the needs and experiences of local people (Health and Social Care Act 2012, ss.221-227).
Local scrutiny
Commissioners should have contingency plans with regard to the protection of patients from harm, where it is found that they are at risk from substandard or unsafe services.
- The Health and Care Act 2022 includes provisions for the continuation of NHS services where a provider is unable to provide them. NHS England has powers to direct alternative providers to deliver services and to make emergency commissioning arrangements (Health and Care Act 2022).
- The NHS Standard Contract includes provisions for service continuity in the event of provider failure. The contract requires providers to have business continuity plans and to cooperate with commissioners in contingency planning. The contract also includes provisions for the orderly transfer of services to alternative providers where necessary (NHS Standard Contract, NHS England).
- CQC's enforcement powers include the ability to impose urgent conditions on or cancel a provider's registration where there is a serious risk to patients. Where CQC takes such action, commissioners are responsible for ensuring continuity of services for affected patients (CQC enforcement policy; Health and Social Care Act 2008).
The need to put patients first at all times
- CQC's fundamental standards, set out in the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, establish minimum safety and quality requirements that all registered providers must meet. Regulation 12 (safe care and treatment) requires providers to assess risks to health and safety of service users and to do all that is reasonably practicable to mitigate such risks. CQC can take enforcement action where fundamental standards are not met, including prosecution for breaches causing harm (SI 2014/2936).
- The Patient Safety Incident Response Framework (PSIRF), mandatory for all NHS-funded providers from autumn 2023, requires organisations to prioritise patient safety through structured incident investigation and learning. PSIRF replaces the Serious Incident Framework and emphasises system-based approaches to identifying and addressing safety risks (PSIRF, NHS England, August 2022).
- The Learn from Patient Safety Events (LFPSE) service, which replaced the National Reporting and Learning System (NRLS, fully decommissioned 30 June 2024), provides a national repository of patient safety incident data. LFPSE enables identification of trends, outliers, and emerging safety concerns across the NHS, with data available to regulators and commissioners (LFPSE, NHS England).
Performance managers working constructively with regulators
- The System Oversight Framework (SOF) requires NHS England regional teams to coordinate with CQC in the oversight of providers. Where providers are placed in SOF segment 3 (enhanced oversight) or segment 4 (mandated support), a multi-agency support group is established including CQC, NHS England, and other relevant bodies to coordinate their response (NHS System Oversight Framework, NHS England).
- The National Quality Board (NQB), which brings together NHS England, CQC, NICE, HSSIB, and other system leaders, provides a forum for aligning quality oversight across organisations. NQB's "Shared Commitment to Quality" framework (March 2021) sets out expectations for how system organisations should share intelligence and coordinate their responses to quality concerns (National Quality Board, Shared Commitment to Quality, NHS England).
- The Health and Care Act 2022 places a duty on ICBs and NHS England to cooperate with CQC in the exercise of their respective functions. CQC is required to share relevant information with commissioners and NHS England where it identifies concerns about the quality or safety of services (Health and Care Act 2022).
Clear lines of responsibility supported by good information flows
For an organisation to be effective in performance management, there must exist unambiguous lines of referral and information flows, so that the performance manager is not in ignorance of the reality.
- NHS England's System Oversight Framework establishes defined information flows from providers to ICBs and from ICBs to NHS England regional teams. SOF metrics are collected routinely through national data submissions, with defined escalation triggers when metrics indicate potential quality concerns. Regional quality teams triangulate multiple data sources including CQC ratings, patient safety incidents, complaints, mortality data, and workforce indicators (NHS System Oversight Framework, NHS England).
- The NHS Standard Contract 2024/25 specifies detailed information requirements that providers must comply with, including submission of quality and performance data at defined intervals, notification of serious incidents, cooperation with information requests from commissioners, and provision of access to premises and records for audit purposes (NHS Standard Contract, NHS England).
- NHS England's Data, Insight and Intelligence programme publishes provider-level performance data across a wide range of metrics through the Model Health System and the National Quality Dashboard, enabling commissioners and NHS England to identify performance concerns through routine data monitoring (NHS England statistical publications).
Clear metrics on quality
- The Summary Hospital-level Mortality Indicator (SHMI) is published quarterly by NHS England, providing a standardised measure of in-hospital and 30-day post-discharge mortality at trust level. SHMI enables identification of trusts with mortality rates significantly above expected levels, with trusts flagged as "higher than expected" subject to further scrutiny (SHMI, NHS England Digital).
- Getting It Right First Time (GIRFT) publishes nationally benchmarked clinical data by specialty, enabling identification of unwarranted variation in clinical outcomes, processes, and resource use across trusts. GIRFT data is used by trust boards, commissioners, and NHS England to identify areas for improvement and to compare performance against peer providers (GIRFT, NHS England).
- The Clinical Quality Indicators (CQIs) and quality metrics within the System Oversight Framework provide a suite of metrics covering patient safety, clinical effectiveness, and patient experience. These metrics are published at provider level and are used to identify organisations requiring enhanced oversight or support (NHS System Oversight Framework, NHS England).
Need for ownership of quality metrics at a strategic level
The NHS Commissioning Board should ensure the development of metrics on quality and outcomes of care for use by commissioners in managing the performance of providers, and retain oversight of these through its regional offices, if appropriate.
- NHS England's System Oversight Framework includes a defined set of quality and performance metrics that NHS England regional teams use to oversee ICBs and providers. These metrics cover operational performance (waiting times, A&E performance, cancer standards), quality (mortality, infection rates, patient safety incidents), and workforce indicators. The metrics enable NHS England to monitor commissioner and provider performance and to identify organisations requiring support (NHS System Oversight Framework, NHS England).
- ICBs are required to produce annual quality accounts and to report against a range of quality metrics to NHS England. NHS England publishes ICB-level performance data through the NHS England website and statistical publications, enabling comparison of commissioner performance across the country (NHS England statistical publications).
- The Model Health System, maintained by NHS England, provides trusts and commissioners with benchmarking data across a wide range of clinical, operational, and workforce metrics, enabling identification of variation and opportunities for improvement (Model Health System, NHS England).
Coordination of local public scrutiny bodies
Guidance should be given to promote the coordination and cooperation between Local Healthwatch, Health and Wellbeing Boards, and local government scrutiny committees.
- The Local Authority (Public Health, Health and Wellbeing Boards and Health Scrutiny) Regulations 2013 (SI 2013/218) set out the governance arrangements for Health and Wellbeing Boards and health scrutiny committees, providing a regulatory framework for their operation and interaction with other local health and care bodies (SI 2013/218).
- Local Healthwatch organisations have a statutory right to a seat on their local Health and Wellbeing Board under the Health and Social Care Act 2012 (section 194). This ensures that the patient and public voice represented by Local Healthwatch is directly integrated into the strategic health and care planning carried out by HWBs (Health and Social Care Act 2012, s.194).
- The Centre for Governance and Scrutiny (CfGS) has published guidance on health scrutiny, including advice on how scrutiny committees should coordinate with Local Healthwatch and Health and Wellbeing Boards. CfGS guidance is referenced in DHSC's statutory guidance on health scrutiny (CfGS health scrutiny guidance).
Training
The complexities of the health service are such that proper training must be available to the leadership of Local Healthwatch as well as, when the occasion arises, expert advice.
- The government's response to the Francis Report in "Hard Truths" (Cm 8777, November 2013) acknowledged the need for Local Healthwatch to have access to training and expert advice. The government stated that Healthwatch England would have a role in supporting the development of Local Healthwatch capacity and capability (Hard Truths, DHSC, November 2013).
- Healthwatch England has reported that Local Healthwatch organisations face challenges in securing specialist training and expert advice, particularly in areas such as understanding complex healthcare commissioning, clinical quality indicators, and regulatory frameworks. Healthwatch England's annual reports have noted that smaller Local Healthwatch organisations with limited budgets face particular challenges in accessing training (Healthwatch England annual reports).
- No published evidence has been identified of a dedicated national training programme specifically designed for Local Healthwatch leaders covering the complexities of the health service, as distinct from the general support and guidance provided by Healthwatch England through its network support function.
Expert assistance
Scrutiny committees should be provided with appropriate support to enable them to carry out their scrutiny role, including easily accessible guidance and benchmarks.
- The Department of Health and Social Care published statutory guidance on health scrutiny in June 2014 ("Local authority health scrutiny: guidance to support local authorities and their partners to deliver effective health scrutiny"), setting out best practice for the conduct of health scrutiny and the relationship between scrutiny committees and NHS bodies (DHSC health scrutiny guidance, June 2014).
- The Centre for Governance and Scrutiny (CfGS) has published guidance and resources for health scrutiny committees, including benchmarking tools and practical advice on questioning techniques, evidence gathering, and report writing. CfGS provides a training and development programme for scrutiny members and officers (CfGS health scrutiny resources).
- The Local Government Association (LGA) has published guidance on health scrutiny, including a councillor handbook on health scrutiny. However, Local Healthwatch England's evidence to parliamentary committees and Healthwatch England's annual reports have noted that the level of support available to health scrutiny committees varies significantly between local authorities, and that many scrutiny committees lack dedicated officer support and access to independent expert advice (LGA health scrutiny resources).
Medical training
- CQC's inspection methodology includes assessment of the quality of medical education and training environments within healthcare providers. CQC inspectors review whether providers have adequate training supervision and whether the training environment supports patient safety. CQC shares concerns identified during inspections with the GMC and other training regulators through established information-sharing agreements (CQC inspection framework).
- The government's response to the Francis Report in "Hard Truths" (Cm 8777, November 2013) stated that the duty to cooperate under the Health and Social Care Act 2012 would be used to ensure that organisations share information about training concerns with the relevant training regulator. The government committed to strengthening information-sharing arrangements between CQC, NHS England, and the GMC (Hard Truths, DHSC, November 2013).
- The National Quality Board (NQB), bringing together NHS England, CQC, GMC, and other bodies, provides a forum for coordinating quality oversight including the identification and referral of concerns about training providers (National Quality Board, NHS England).
Medical training
- CQC's inspection methodology for NHS trusts includes assessment of the training environment, supervision arrangements, and the relationship between training quality and patient safety. CQC inspectors can identify concerns about training provision and share these with the GMC through established channels (CQC inspection framework).
- The GMC's quality assurance framework for medical education and training, "Promoting Excellence: Standards for Medical Education and Training" (published 2015, replacing "Tomorrow's Doctors" and "The Trainee Doctor"), sets out standards that education and training providers must meet. The GMC conducts quality assurance visits to education providers and shares findings with CQC and NHS England where relevant to patient safety (GMC, Promoting Excellence, 2015).
- The Health and Care Act 2022 transferred HEE's functions to NHS England, meaning that the commissioning and oversight of medical training and the oversight of healthcare providers now sit within the same organisation, simplifying coordination of oversight (Health and Care Act 2022, s.96).
Medical training
- The GMC conducts a programme of quality assurance visits to medical schools and local education providers. The GMC's quality assurance framework includes scheduled visits, triggered visits where concerns are identified, and enhanced monitoring where standards are not being met. The postgraduate dean is responsible for managing the quality assurance process at regional level (GMC quality assurance of medical education and training).
- The GMC's National Training Survey (NTS), conducted annually, provides data on the quality of training at individual placement level, enabling identification of training environments where standards are not being met. NTS data is used to trigger quality assurance visits and to inform the GMC's risk-based approach to monitoring training providers (GMC National Training Survey).
- The government's response in "Hard Truths" (Cm 8777, November 2013) stated that the GMC should strengthen its quality assurance of training, including through more systematic use of routine visits and enhanced engagement of Royal Colleges in the visit process (Hard Truths, DHSC, November 2013).
Medical training
The system for approving and accrediting training placement providers and programmes should be configured to apply the principles set out above.
- The GMC's quality assurance framework includes a structured process for approving and monitoring training programme providers and local education providers. Approval is based on evidence of compliance with standards, including evidence from the National Training Survey, quality assurance visits, and data on patient safety outcomes. Where providers fail to meet standards, the GMC can impose conditions on approval or withdraw approval (GMC quality assurance of medical education and training).
- The Health and Care Act 2022 transferred HEE's functions to NHS England from 1 April 2023. The postgraduate deans, who manage the approval and monitoring of training placements at regional level, now operate within NHS England's Workforce, Training and Education directorate, enabling closer integration of training quality assurance with NHS England's broader quality oversight functions (Health and Care Act 2022, s.96).
- The government's response in "Hard Truths" confirmed that the system for approving training placements should prioritise patient safety and that the GMC's quality assurance framework would be strengthened accordingly (Hard Truths, DHSC, November 2013).
Matters to be reported to the General Medical Council
- Postgraduate deans are required to provide annual reports to the GMC on the quality of training in their region, including data from quality assurance visits, National Training Survey results, and any concerns identified about training environments or patient safety. These reports cover all relevant activity and findings, not limited to exceptional matters (GMC quality assurance framework).
- The Freedom to Speak Up Review (Sir Robert Francis QC, February 2015) established principles and actions for protecting whistleblowers in the NHS, including trainees. Freedom to Speak Up Guardians, mandatory in all NHS trusts from October 2016, provide a confidential route for trainees and other staff to raise concerns. Over 1,400 Guardians are now in post across healthcare organisations (Freedom to Speak Up Review, February 2015; National Guardian's Office).
- The GMC's confidential helpline for doctors and medical students provides a direct route for individuals to raise concerns about patient safety or training quality without going through local reporting channels (GMC confidential helpline).
Training and training establishments as a source of safety information
- The GMC's quality assurance of undergraduate medical education includes regular reviews of medical schools, at which student feedback on clinical placement quality — including patient safety concerns — is a core source of evidence. The GMC requires medical schools to demonstrate how they collect, analyse, and act on student feedback about placement providers (GMC quality assurance of undergraduate medical education).
- The GMC conducts annual Medical Students Survey as part of its quality assurance programme, collecting data on student experiences of clinical placements including perceptions of patient safety and quality of care. Survey results are used to identify placements where standards may not be met and to trigger further investigation (GMC Medical Students Survey).
- The government's response in "Hard Truths" (Cm 8777, November 2013) supported the principle that feedback from students and trainees about patient safety should be actively sought and acted upon (Hard Truths, DHSC, November 2013).
Training and training establishments as a source of safety information
- The GMC shares NTS results with CQC and other healthcare regulators through established information-sharing arrangements. CQC uses NTS data as part of its intelligence gathering for inspections, with poor NTS results at specific trusts informing the timing and focus of CQC inspections (CQC and GMC information-sharing arrangements).
- The NTS was redesigned following the Francis Report to enhance its value as a source of intelligence on patient safety. Questions on patient safety, bullying and undermining, and the quality of clinical supervision were strengthened in subsequent iterations of the survey (GMC National Training Survey methodology).
- The government's response in "Hard Truths" (Cm 8777, November 2013) stated that the GMC should develop its surveys of medical students and trainees to optimise them as a source of intelligence about patient safety and should routinely share information with healthcare regulators (Hard Truths, DHSC, November 2013).
Training and training establishments as a source of safety information
Proactive steps need to be taken to encourage openness on the part of trainees and to protect them from any adverse consequences in relation to raising concerns.
- Freedom to Speak Up Guardians have been mandatory in all NHS trusts since October 2016. The National Guardian's Office reported that over 38,000 cases were raised with Guardians in 2024-25, with cumulative total exceeding 142,000 since inception. Guardians provide a confidential route for all staff, including trainees, to raise concerns about patient safety or workplace culture (National Guardian's Office, Annual Data 2024-25).
- The GMC's "Promoting Excellence" standards (2015) include requirements that education and training providers must have a culture that allows and encourages learners to raise concerns about patient safety without fear of adverse consequences. The standards require that trainees are informed about how to raise concerns and that providers can demonstrate that concerns raised by trainees are investigated and acted upon (GMC, Promoting Excellence, 2015).
- The Employment Rights Act 1996 (as amended by the Public Interest Disclosure Act 1998 and the Enterprise and Regulatory Reform Act 2013) provides legal protection for workers, including trainees, who make qualifying disclosures about wrongdoing in the public interest. The 2013 amendments removed the requirement for disclosures to be made "in good faith" for the purpose of protection from detriment (Employment Rights Act 1996, Part IVA).
Training and training establishments as a source of safety information
- The GMC's quality assurance framework includes a programme of visits to medical schools and postgraduate training environments. Visits include observation of clinical areas, meetings with trainees away from supervisors, meetings with educational supervisors, and review of documentation. Visits can be scheduled, triggered by concerns, or part of enhanced monitoring arrangements (GMC quality assurance of medical education and training).
- Postgraduate deans conduct quality visits to training placements as part of their regional quality management function. These visits include direct observation of the training environment and are not limited to gathering information from trainees. Visits also provide the opportunity to observe patient care and identify any concerns about patient safety alongside training quality (postgraduate dean quality management).
- The government's response in "Hard Truths" (Cm 8777, November 2013) stated that training visits should make an important contribution to the protection of patients and should include direct observation of the training environment (Hard Truths, DHSC, November 2013).
Training and training establishments as a source of safety information
- The GMC's quality assurance framework provides for the withdrawal of approval for training placements where fundamental patient safety and quality standards are not met. Where the GMC identifies that a training environment poses a risk to patient safety, it can require the removal of trainees from that environment, impose conditions on continued approval, or withdraw approval entirely (GMC quality assurance framework).
- CQC's fundamental standards (the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014) set minimum safety and quality requirements that all registered providers must meet, including those that host clinical placements for medical students and trainees. Providers that do not meet fundamental standards are subject to CQC enforcement action, and the GMC takes CQC findings into account when assessing the suitability of training environments (SI 2014/2936).
- The government's response in "Hard Truths" (Cm 8777, November 2013) stated that the GMC should ensure that providers of clinical placements are unable to take on students or trainees in areas that do not comply with fundamental patient safety and quality standards (Hard Truths, DHSC, November 2013).
Safe staff numbers and skills
- The GMC's quality assurance process includes assessment of staffing levels and skills as part of its review of training environments. National Training Survey data on supervision quality, workload intensity, and access to training opportunities provides indirect evidence of staffing adequacy in training environments (GMC quality assurance framework; GMC National Training Survey).
- NICE published safe staffing guidance (SG1, July 2014) setting out an evidence-based framework for determining safe nurse staffing levels in acute adult inpatient wards. While focused on nursing rather than medical staffing specifically, the guidance established the principle that staffing levels should be determined by patient acuity and dependency rather than arbitrary ratios (NICE SG1, July 2014).
- The government's response in "Hard Truths" (Cm 8777, November 2013) stated that the GMC's quality assurance must include review of the sufficiency of staff numbers and skills for safe training delivery (Hard Truths, DHSC, November 2013).
Health Education England
Health Education England should have a medically qualified director of medical education and a lay patient representative on its board.
- HEE was abolished as a separate body by the Health and Care Act 2022 (section 96), with its functions transferred to NHS England from 1 April 2023. The education and training functions are now exercised by NHS England's Workforce, Training and Education (WT&E) directorate (Health and Care Act 2022, s.96).
- Following the transfer to NHS England, the former HEE board no longer exists as a separate governance entity. NHS England's board oversees all NHS England functions including workforce education and training. NHS England's board includes a chief nursing officer and national medical director, but the specific governance arrangements for the WT&E directorate within NHS England are internal management arrangements rather than a separate board with dedicated medical education and patient representation (NHS England governance).
- No published evidence has been identified confirming whether the WT&E directorate within NHS England has the specific dedicated medical director and lay patient representative roles on its governance body that Francis recommended for HEE's board.
Deans
All Local Education and Training Boards should have a post of medically qualified postgraduate dean responsible for all aspects of postgraduate medical education.
- Following the abolition of HEE and the transfer of its functions to NHS England from 1 April 2023 under the Health and Care Act 2022 (section 96), the postgraduate dean function has been maintained within NHS England's Workforce, Training and Education directorate. Postgraduate deans continue to exercise their responsibilities for postgraduate medical education at regional level within the NHS England structure (Health and Care Act 2022, s.96; NHS England WT&E).
- The GMC's quality assurance framework requires each region to have a postgraduate dean responsible for the management and quality assurance of postgraduate medical training. The postgraduate dean is the GMC's primary point of contact for quality assurance at regional level and is responsible for routine quality management, triggered visits, and escalation of concerns about training environments (GMC quality assurance framework).
- The government's response in "Hard Truths" (Cm 8777, November 2013) confirmed that all LETBs should have a medically qualified postgraduate dean responsible for all aspects of postgraduate medical education (Hard Truths, DHSC, November 2013).
Proficiency in the English language
- The GMC requires all doctors applying for registration to demonstrate their knowledge of English. For doctors who qualified outside the UK, the GMC accepts evidence including IELTS Academic (minimum score 7.5 overall, minimum 7.0 in each component) or OET (minimum grade B in each component). The GMC can also assess English language proficiency at any point during a doctor's career if concerns arise (GMC registration requirements).
- The European Union (Withdrawal) Act 2018 and subsequent regulations removed the constraints that EU law had previously placed on the GMC's ability to require English language testing from EEA-qualified doctors. Prior to Brexit, EU Directive 2005/36/EC on mutual recognition of professional qualifications limited the circumstances in which member states could impose language tests on EU-qualified professionals. Following the UK's departure from the EU, the GMC can apply its English language requirements equally to all internationally qualified doctors (EU (Withdrawal) Act 2018).
- The government's response in "Hard Truths" (Cm 8777, November 2013) stated that the government would introduce legislation to strengthen English language proficiency requirements for healthcare professionals. This was implemented through SI 2014/1887 (Hard Truths, DHSC, November 2013).
Principles of openness transparency and candour
- The NHS Constitution was updated in July 2015 to incorporate the duty of candour principles. The Constitution states that patients have "a right to be told if a patient safety incident has occurred during their treatment which, in the opinion of a healthcare professional, has or could have caused harm" and that NHS organisations have a duty to be open and honest (NHS Constitution, DHSC, revised 2023).
- Professional regulators have incorporated candour requirements into their professional standards. The GMC's "Good Medical Practice" (updated 2024) requires doctors to be open and honest with patients when things go wrong. The NMC's Code (2015) includes Standard 14: "Be open and candid with all service users about all aspects of care and treatment, including when any mistakes or harm have taken place" (GMC Good Medical Practice; NMC Code 2015).
- DHSC published findings of a call for evidence on the statutory duty of candour on 26 November 2024. Of 261 respondents, 52% said CQC had not adequately monitored compliance with the duty of candour. The review found that while the statutory framework exists, implementation and enforcement remain inconsistent (DHSC Duty of Candour Call for Evidence, November 2024).
Candour about harm
- Regulation 20(3) requires the provider to provide the patient or their representative with a truthful account of all facts known about the incident at the time of the notification, provide reasonable support, and offer an apology. Regulation 20(5) requires the provider to provide a written notification including the results of any further enquiries into the incident (SI 2014/2936, Regulation 20).
- The Patient Safety Incident Response Framework (PSIRF), mandatory for all NHS-funded providers from autumn 2023, includes requirements for open and transparent communication with patients and families following patient safety incidents. PSIRF emphasises engagement with those affected throughout the investigation process (PSIRF, NHS England).
- DHSC's call for evidence on the duty of candour (November 2024) found that while the statutory obligation exists, compliance varies. Some respondents reported that organisations notify patients of incidents but do not always provide the ongoing explanation and support that Regulation 20 requires (DHSC Duty of Candour Call for Evidence, November 2024).
Candour about harm
Full and truthful answers must be given to any question reasonably asked about his or her past or intended treatment by a patient (or, if deceased, to any lawfully entitled personal representative).
- The GMC's "Good Medical Practice" (updated 2024) requires doctors to give patients the information they want or need about their condition, its treatment, and prognosis, including full and honest answers to their questions. The duty to be honest with patients applies to all interactions, not only when things have gone wrong (GMC Good Medical Practice).
- The NMC Code (2015), Standard 14, requires nurses and midwives to "be open and candid with all service users about all aspects of care and treatment, including when any mistakes or harm have taken place." Standard 10 requires keeping clear and accurate records of all interactions and decisions (NMC Code, 2015).
- The NHS Constitution (revised 2023) includes a patient right to be informed about their diagnosis, treatment options, and any known risks. The Constitution states that patients have a right to "be given information about the test and treatment options available to you, what they involve and their risks and benefits" (NHS Constitution, DHSC).
Openness with regulators
Any statement made to a regulator or a commissioner in the course of its statutory duties must be completely truthful and not misleading by omission.
- The Fit and Proper Person Requirement (Regulation 5 of the 2014 Regulations) requires that directors of registered providers must not have been responsible for, or privy to, any serious mismanagement or misconduct in the carrying on of a regulated activity. Providing misleading information to a regulator or commissioner could constitute evidence of unfitness under this requirement (SI 2014/2936, Regulation 5).
- The NHS Standard Contract 2024/25 includes provisions requiring providers to provide truthful and accurate information to commissioners. Breach of these provisions may give rise to contractual remedies including contract performance notices, withholding of payments, and termination (NHS Standard Contract, NHS England).
- The government's response in "Hard Truths" (Cm 8777, November 2013) stated that existing criminal sanctions under the Health and Social Care Act 2008 for providing false or misleading information to CQC would be maintained and that the new duty of candour framework would reinforce requirements for truthful statements to regulators and commissioners (Hard Truths, DHSC, November 2013).
Openness in public statements
Any public statement made by a healthcare organisation about its performance must be truthful and not misleading by omission.
- The NHS provider licence (condition FT4) requires foundation trusts to maintain effective systems of governance. This includes requirements for accurate and truthful reporting in annual reports, quality accounts, and other public documents. NHS England can take regulatory action where providers publish misleading information (NHS provider licence).
- Quality accounts regulations (the National Health Service (Quality Accounts) Regulations 2010, SI 2010/279, as amended) require NHS providers to publish annual quality accounts containing prescribed information about the quality of their services. External auditors review quality accounts for consistency with other information sources, providing a check on the accuracy of public performance claims (SI 2010/279).
- The government's response in "Hard Truths" (Cm 8777, November 2013) stated that the duty of candour framework would reinforce requirements for truthful public statements by healthcare organisations about their performance (Hard Truths, DHSC, November 2013).
Restrictive contractual clauses
- The Enterprise and Regulatory Reform Act 2013 (sections 17-19) amended the Employment Rights Act 1996 to strengthen whistleblowing protections. Section 17 removed the requirement that disclosures be made "in good faith" for the purpose of detriment protection. Section 18 extended protection to workers subjected to detriment by co-workers and agents of their employer. Section 19 introduced vicarious liability for employers where their workers subject a whistleblower to detriment (Enterprise and Regulatory Reform Act 2013, ss.17-19).
- NHS England issued guidance in 2014 stating that settlement agreements for NHS staff must not include clauses that prevent or discourage former employees from making disclosures about patient safety. The NHS Standard Contract includes provisions requiring NHS providers to ensure that their employment contracts and settlement agreements do not include gagging clauses that limit bona fide disclosure about patient safety concerns (NHS England settlement agreement guidance).
- The government's response in "Hard Truths" (Cm 8777, November 2013) stated that gagging clauses that seek to limit bona fide disclosure about patient safety would be prohibited in NHS contracts and settlement agreements (Hard Truths, DHSC, November 2013).
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).
Statutory duty of openness and transparency
- The Health and Social Care Act 2008 (section 91) makes it a criminal offence to provide false or misleading information to CQC. A person who knowingly or recklessly provides information to CQC that is false or misleading in a material respect is guilty of an offence. This applies to directors and other individuals who provide information on behalf of healthcare organisations (Health and Social Care Act 2008, s.91).
- The duty of candour under Regulation 20 imposes obligations on the registered provider as an organisation. The government's response in "Hard Truths" stated that the combination of the organisational duty of candour (Regulation 20), the criminal offence of providing false information to CQC (section 91), and the Fit and Proper Person Requirement (Regulation 5) provides a framework of accountability for directors in relation to truthful information provision (Hard Truths, DHSC, November 2013).
- The Kark Review (February 2019) found that the Fit and Proper Person Test "does not ensure directors are fit for the post they hold." The review recommended a central register of directors and strengthened enforcement. NHS England published an updated FPPT Framework in August 2023, though concerns remain about the effectiveness of enforcement (Kark Review, February 2019; NHS England FPPT Framework, August 2023).
Enforcement by the Care Quality Commission
- 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).
Focus on culture of caring
- Health Education England published its National Values Based Recruitment Framework in October 2014, setting expectations for higher education institutions to embed values-based recruitment into nursing selection processes by March 2015. The framework comprised tools for structured interviews and personality assessments to evaluate candidates' attitudes towards caring and compassion (Values Based Recruitment Framework, HEE, October 2014).
- The NMC published a revised Code of Professional Standards in March 2015, structured around four themes including "Prioritise people" and "Practise effectively." The NMC stated the Code reflected "patients' needs, modern healthcare practice and the recommendations of reviews such as the Francis Inquiry" (The Code: Professional Standards of Practice and Behaviour for Nurses, Midwives and Nursing Associates, NMC, March 2015).
- Lord Willis of Knaresborough published "Raising the Bar: Shape of Caring" in March 2015, making 34 recommendations for nursing and care assistant education, including strengthening pathways from healthcare assistant to nursing and ensuring consistent high-quality education (Raising the Bar: Shape of Caring, HEE, March 2015).
- The Care Certificate was launched on 1 April 2015 as a standardised induction for all new healthcare assistants and social care support workers, covering 15 standards including privacy and dignity, safeguarding, and communication (Care Certificate, HEE/Skills for Care/Skills for Health, April 2015).
- NMC Revalidation launched on 1 April 2016, requiring all registered nurses and midwives to revalidate every three years, demonstrating continued fitness to practise through 450 practice hours, 35 hours of CPD, five reflective accounts, and third-party confirmation (NMC Revalidation, NMC, April 2016).
- The NHS Long Term Workforce Plan (June 2023) committed to increasing adult nursing training places by 92% to nearly 38,000 by 2031/32, backed by over £2.4 billion over five years for additional education and training (NHS Long Term Workforce Plan, NHS England, June 2023).
Practical hands-on training and experience
Nursing training should be reviewed so that sufficient practical elements are incorporated to ensure that a consistent standard is achieved by all trainees throughout the country. This requires national standards.
- Lord Willis's "Raising the Bar: Shape of Caring" review (March 2015) recommended strengthening the care assistant role, creating pathways from healthcare assistant to nursing, and developing a flexible model of education with consistent practical standards (Raising the Bar: Shape of Caring, HEE, March 2015).
- The NMC published new Standards of Proficiency for Registered Nurses in 2018, implemented from September 2020 for all new pre-registration nursing programmes. The standards require a minimum of 2,300 practice hours across the three-year programme, with placements in a range of settings to ensure consistent practical competence (Future Nurse: Standards of Proficiency for Registered Nurses, NMC, 2018).
- The nursing associate role was developed in response to the Shape of Caring review to bridge the gap between healthcare assistants and registered nurses. Pilot programmes began in January 2017, with NMC registration opening in January 2019 (Nursing Associates Programme, HEE/NMC, 2017–2019).
- The NHS Long Term Workforce Plan (June 2023) committed to increasing nursing associate training places to 10,500 by 2031/32, projecting over 64,000 nursing associates in the NHS by 2036/37 (NHS Long Term Workforce Plan, NHS England, June 2023).
Practical hands-on training and experience
- The Care Certificate was launched on 1 April 2015 as a standardised induction for all new healthcare assistants and social care support workers, covering 15 standards to be completed within 12 weeks of employment. It was developed jointly by HEE, Skills for Care, and Skills for Health following the Cavendish Review (2013), itself a response to Mid Staffordshire (Care Certificate, HEE/Skills for Care/Skills for Health, April 2015).
- Lord Willis's "Raising the Bar: Shape of Caring" review (March 2015) recommended creating pathways from healthcare assistant to nursing, enabling care experience to count towards nurse training (Raising the Bar: Shape of Caring, HEE, March 2015).
- The NMC's 2018 Standards of Proficiency for Registered Nurses require a minimum of 2,300 practice hours across the programme, with placements in a range of settings including direct patient care. Practice experience must include care of older people in a variety of settings (Future Nurse: Standards of Proficiency for Registered Nurses, NMC, 2018).
- The nursing associate role, with NMC registration from January 2019, provides a structured route from healthcare assistant to registered professional, with a two-year foundation degree programme that includes substantial supervised clinical practice (Nursing Associates Programme, HEE/NMC, 2017–2019).
Recruitment for values and commitment
- Health Education England published its National Values Based Recruitment Framework in October 2014, applying to both higher education institutions recruiting student nurses and NHS employers recruiting qualified and unqualified nursing staff. The framework required employers to assess candidates' values, attitudes, and behaviours alongside clinical competence (Values Based Recruitment Framework, HEE, October 2014).
- The Care Certificate, launched 1 April 2015, requires all new healthcare assistants and social care support workers to complete a standardised induction covering 15 standards, providing a baseline assessment of unqualified staff's values and skills (Care Certificate, HEE/Skills for Care/Skills for Health, April 2015).
- CQC's inspection framework, introduced from October 2014, includes assessment of how providers recruit staff with the right values under the "well-led" key question. CQC inspectors examine recruitment processes as part of their assessment of whether services are safe and well-led (CQC Inspection Framework, CQC, 2014 onwards).
- The NHS Standard Contract includes provisions requiring providers to ensure that staff recruitment and selection processes are consistent with the values of the NHS Constitution (NHS Standard Contract, NHS England).
Nurse leadership
- The NHS Knowledge and Skills Framework remains in place as part of NHS Agenda for Change terms and conditions. It provides a framework for personal development planning and annual review for all staff on AfC contracts (NHS Knowledge and Skills Framework, NHS Employers).
- The NMC's revised Code (March 2015) explicitly prioritises compassion, dignity, and respect as core professional values, and the NMC's 2018 Standards of Proficiency include "Being an accountable professional" as the first platform. These standards inform continuing professional development expectations (NMC Code 2015; Future Nurse Standards of Proficiency, NMC, 2018).
- No published evidence has been identified of a specific formal review of the KSF to incorporate the explicit recognition of compassion, dignity, and leadership that Francis recommended. NHS Employers continues to publish guidance on the KSF's use, but updates have focused on pay progression and gateway points rather than the values-based elements Francis envisaged (NHS KSF Guidance, NHS Employers).
Measuring cultural health
- The NHS Staff Survey, conducted annually, includes questions on staff engagement, morale, safety culture, and willingness to recommend the organisation as a place to work or receive treatment. Results are published at organisation level and provide a partial measure of cultural health, though not at the ward-level granularity Francis recommended (NHS Staff Survey, NHS England, annual).
- CQC's inspection framework includes the "well-led" key question, which assesses organisational culture, leadership, and governance. Inspectors consider staff survey results and staff feedback as part of this assessment (CQC Inspection Framework, CQC).
- A specific national "cultural barometer" tool for front-line nursing workplaces, as Francis recommended, has not been mandated or deployed across the NHS. Some trusts have developed local cultural assessment tools, but there is no standardised national instrument measuring cultural health at ward or team level (NHS Staff Survey; CQC Well-Led Framework).
- No further published evidence has been identified of a national programme to develop the specific ward-level cultural measurement tool that Francis envisaged.
Key nurses
- Monitor published guidance in October 2014 on "Implementing the 'responsible consultant/clinician' and 'named nurse' in your NHS foundation trust," requesting all NHS foundation trusts to ensure that every patient has a named nurse displayed above their bed and to report on implementation progress by 31 October 2014 (Implementing the Responsible Consultant/Clinician and Named Nurse, Monitor, October 2014).
- The NHS Standard Contract includes provisions requiring providers to ensure that each patient has a named nurse or equivalent responsible for coordinating their care during each episode (NHS Standard Contract, NHS England).
- The NMC Code (March 2015) requires nurses to "make sure that everyone you delegate tasks to is adequately supervised and supported so they can provide safe and compassionate care" and to be accountable for the care they coordinate, supporting the named nurse model (The Code, NMC, March 2015).
Strengthening the nursing professional voice
The Royal College of Nursing should consider whether it should formally divide its "Royal College" functions and its employee representative/trade union functions between two bodies rather than behind internal "Chinese walls".
- The RCN commissioned a governance review led by Elizabeth Butler, resulting in the "Case for Change" report, with recommendations agreed at the RCN Annual General Meeting in June 2016 (RCN Governance Review, RCN, 2016).
- The RCN did not split into two separate organisations as Francis suggested. Instead, it reformed its governance structure to separate oversight of its professional and trade union functions. Two new Council committees — the Professional Nursing Committee and the Trade Union Committee — began work on 1 January 2018, each with directly elected members and separate budgets (RCN Governance Reform, RCN, January 2018).
- At RCN Congress 2023, members voted to reaffirm the RCN's dual role as both trade union and professional body, indicating that the organisation has chosen to maintain a combined structure with internal governance separation rather than the formal division Francis recommended (RCN Congress 2023, RCN).
Strengthening the nursing professional voice
- The NHS Terms and Conditions of Service Handbook (Agenda for Change) includes provisions for trade union facility time, requiring employers to allow accredited representatives reasonable paid time off to carry out their duties. The Social Partnership Forum, which brings together NHS employers, trade unions, and government, provides guidance on partnership working arrangements (NHS Terms and Conditions Handbook, NHS Employers).
- The Trade Union (Facility Time Publication Requirements) Regulations 2017, made under the Trade Union Act 2016, require public sector employers including NHS trusts to publish annual data on the use and cost of trade union facility time. These regulations introduced transparency requirements but also reflected a policy direction of scrutinising facility time levels in the public sector (Trade Union Act 2016; SI 2017/328).
- No published evidence has been identified of a specific national review of whether the time allowed for nursing representation at provider level is adequate, as Francis recommended. The arrangement remains a matter for local negotiation between employers and trade unions.
Strengthening the nursing professional voice
A forum for all directors of nursing from both NHS and independent sector organisations should be formed to provide a means of coordinating the leadership of the nursing profession.
- The Chief Nursing Officer Summit has been held as an annual national event bringing together directors of nursing from across the NHS and independent sector. In November 2014, hundreds of directors of nursing attended the CNO Summit in Manchester, themed "Experience Matters," organised by NHS England and Nursing Times (CNO Summit 2014, NHS England, November 2014).
- The CNO Policy Network was established in 2019, providing registered nurses, midwives, nursing associates, and students the opportunity to engage with and influence healthcare policy. The network is supported by the Office of the Chief Nursing Officer for England (CNO Policy Network, NHS England, 2019).
- Seven Regional Chief Nurses, appointed within NHS England's regional structure, convene regional nursing networks providing further forums for directors of nursing to coordinate and share practice (NHS England Regional Chief Nurses, NHS England).
Strengthening the nursing professional voice
- The Chief Nursing Officer for England role has been maintained as a senior leadership position within NHS England and the Department of Health and Social Care. Dame Ruth May held the role from 2019 to 2024 and was succeeded by Duncan Burton, appointed on 25 July 2024 (CNO Appointment, NHS England, July 2024).
- The CNO is supported by a Chief Midwifery Officer, four Deputy Chief Nursing Officers, and seven Regional Chief Nurses, providing a structure for national professional nursing leadership. The CNO office leads on workforce policies, patient safety, and professional standards for approximately 373,000 NHS nurses and midwives (Chief Nursing Officer for England, NHS England).
- The CNO Policy Network, established in 2019, enables registered nurses, midwives, and nursing associates to engage with and influence healthcare policy. The CNO also chairs the CNO Summit, an annual national event for directors of nursing, and participates in the Social Partnership Forum (CNO Policy Network, NHS England, 2019).
- The NHS Long Term Workforce Plan (June 2023) references the CNO's role in leading the nursing workforce strategy, including targets to expand nursing training places by 92% by 2031/32 (NHS Long Term Workforce Plan, NHS England, June 2023).
Code of conduct for healthcare support workers
There should be a national code of conduct for healthcare support workers.
- The Code of Conduct for Healthcare Support Workers and Adult Social Care Workers in England was published on 26 March 2013 by Skills for Care and Skills for Health, as part of the government's initial response "Patients First and Foremost" (Code of Conduct and National Minimum Training Standards Published, DHSC, 26 March 2013).
- The Code sets behavioural standards for healthcare support workers with patient-facing roles, covering areas including accountability, promoting and upholding privacy and dignity, working cooperatively, communicating effectively, respecting people's right to confidentiality, and maintaining clear professional boundaries.
- The Code remains in effect and is used alongside the Care Certificate (launched April 2015) as the framework for HCA professional conduct. CQC may reference the Code when inspecting providers, though compliance at the individual worker level is voluntary in the absence of statutory registration.
- The Cavendish Review (July 2013) endorsed the Code of Conduct approach and recommended that it be embedded into training through the proposed Certificate of Fundamental Care, which became the Care Certificate (Review of Healthcare Assistants and Support Workers in NHS and Social Care, Camilla Cavendish, July 2013).
Training standards for healthcare support workers
There should be a common set of national standards for the education and training of healthcare support workers.
- National Minimum Training Standards for Healthcare Support Workers and Adult Social Care Workers were published on 26 March 2013 by Skills for Care and Skills for Health alongside the Code of Conduct (Code of Conduct and National Minimum Training Standards Published, DHSC, 26 March 2013).
- The Care Certificate was launched on 1 April 2015, developed jointly by Health Education England, Skills for Care, and Skills for Health, implementing the Cavendish Review's recommendation for a Certificate of Fundamental Care. It defines 15 standards (expanded to 16 in March 2025) covering the minimum knowledge and skills expected of new healthcare assistants and social care support workers (Care Certificate Launching on 1 April 2015, DHSC, 25 March 2015).
- The 15 original standards include: understanding your role, personal development, duty of care, equality and diversity, person-centred care, communication, privacy and dignity, fluids and nutrition, mental health awareness, safeguarding adults, safeguarding children, basic life support, health and safety, handling information, and infection prevention and control. A 16th standard on learning disability and autism awareness was added in March 2025.
- CQC treats the Care Certificate as a benchmark for how providers meet staffing regulations, though it is not legally mandatory. Employers are expected to ensure new HCAs complete it within 12 weeks of employment.
Shared training
- The NHS Leadership Academy, established in 2012 as part of NHS England, delivers nationally recognised leadership development programmes including the Edward Jenner Programme (foundation-level), Mary Seacole Programme (first leadership role, leading to PGCert in Healthcare Leadership), and Nye Bevan Programme (senior leaders preparing for board roles, with over 1,000 senior leaders developed) (NHS Leadership Academy, NHS England).
- The Academy functions as the leadership training system Francis envisaged, though it is not a standalone staff college in the military model he referenced. It provides common professional training, promotes healthcare leadership, and administers structured development pathways.
- NHS England published a Management and Leadership Development long-read in 2024 confirming a three-year roadmap (2024/25–2026/27) for management and leadership development, with a new Management and Leadership Framework committed to as part of the 10-Year Health Plan (NHS England, Management and Leadership Development, 2024).
- The NHS Leadership Competency Framework for board members was published on 28 February 2024, effective from 1 April 2024, defining six competency domains that must be incorporated into all NHS board member role descriptions and recruitment processes (NHS England, NHS Leadership Competency Framework, February 2024).
Shared code of ethics
A common code of ethics, standards and conduct for senior board-level healthcare leaders and managers should be produced and steps taken to oblige all such staff to comply with the code and their employers to enforce it.
- The Code of Conduct for NHS Managers was issued in October 2002 under the Code of Conduct for NHS Managers Directions 2002, originally developed in response to the Bristol Royal Infirmary Inquiry. It sets out core standards of conduct including the Nolan Principles on Conduct in Public Life, but has not been substantially updated since 2002.
- The NHS Constitution (first published 2009, most recently updated 2024) includes pledges to staff and sets out expectations of managers, but does not constitute a dedicated professional code for senior board-level healthcare leaders with enforcement mechanisms.
- On 26 November 2024, the government launched a consultation "Leading the NHS: Proposals to Regulate NHS Managers." The consultation response (July 2025) confirmed the government will bring forward secondary legislation for a statutory barring system for senior NHS leaders, operated by the Health and Care Professions Council (HCPC). 92% of 4,924 respondents agreed NHS managers should be regulated (Leading the NHS: Consultation Response, DHSC, July 2025).
- Draft legislation is subject to a further 3-month statutory consultation, with parliamentary laying anticipated in H2 2026. The statutory barring mechanism will apply to board-level leaders and their direct reports, partially fulfilling this recommendation 13 years after the Francis Report.
Leadership framework
- The NHS Leadership Competency Framework (LCF) for board members, published 28 February 2024 and effective from 1 April 2024, is organised around six domains. Domain 1, "Driving high-quality and sustainable outcomes," directly addresses patient safety and quality of care as core leadership competencies, fulfilling Francis's call for increased emphasis on patient safety in the leadership framework (NHS England, NHS Leadership Competency Framework, February 2024).
- CQC's Well-Led Framework, first introduced in 2014 and revised in 2017, assesses whether "the leadership, management and governance of the organisation assures the delivery of high-quality care for patients." Safety is assessed as one of CQC's five key inspection questions alongside the well-led question, creating a direct link between leadership quality and patient safety outcomes (CQC, Well-Led Framework).
- The Healthcare Leadership Model (2013), developed by the NHS Leadership Academy, included nine behavioural dimensions applicable across all healthcare roles. Patient safety was embedded within the "delivering the strategy" and "evaluating information" dimensions.
- The NHS Patient Safety Strategy (published July 2019, updated 2021) established patient safety as a core leadership responsibility, introducing Patient Safety Specialists in every NHS organisation and a National Patient Safety Syllabus for all NHS staff (NHS England, NHS Patient Safety Strategy).
Enforcement of standards and accountability
- Regulation 5 requires that directors of CQC-registered providers are of good character, have the necessary qualifications and experience, and are not unfit by reason of misconduct or incompetence. However, the Kark Review (February 2019) found that "the promises made by the government in its 'Hard Truths' response to Sir Robert Francis QC's report on Mid Staffs that a new FPPT would enable the CQC to bar directors who are unfit from individual posts has not actually happened" — the CQC has no power over individual directors and is not structured to regulate individuals (Kark Review of the Fit and Proper Persons Test, Tom Kark KC, February 2019).
- The Kark Review recommended a disbarring power for directors guilty of serious misconduct, but this recommendation was initially rejected by the government.
- In July 2025, following a consultation launched 26 November 2024, the government announced it will bring forward legislation to provide the Health and Care Professions Council with powers to run a statutory barring system for NHS board-level leaders and their direct reports. Draft legislation is subject to further statutory consultation, with parliamentary laying anticipated H2 2026 (Leading the NHS: Consultation Response, DHSC, July 2025).
- The disqualification mechanism Francis envisaged in this recommendation has not yet been legislated, though it is now actively being developed 13 years after the Francis Report.
Ensuring common standards of competence and compliance
- From 1 April 2016, NHS Improvement (NHSI) was created as the operational name for an organisation bringing together Monitor (which oversaw foundation trusts) and the NHS Trust Development Authority (which oversaw non-foundation trusts), along with Patient Safety, the National Reporting and Learning System, and other functions. This unified oversight meant one body was responsible for overseeing all NHS providers (NHS Improvement, April 2016).
- NHS Improvement was subsequently merged into NHS England on 1 July 2022 under the Health and Care Act 2022, at which point Monitor and the NHS TDA were formally abolished as legal entities. NHS England now exercises a single oversight framework across all NHS providers regardless of foundation trust status (Health and Care Act 2022).
- CQC's Well-Led Framework, first introduced in 2014 and revised in 2017, applies equally to foundation trusts and non-foundation trusts, providing a consistent assessment of board competence and governance across all NHS providers (CQC, Well-Led Framework).
- The disparity in regulatory oversight between foundation trusts and other NHS bodies that Francis identified has been addressed through these structural changes.
General Medical Council Systemic investigation where needed
The General Medical Council should have a clear policy about the circumstances in which a generic complaint or report ought to be made to it, enabling a more proactive approach to monitoring fitness to practise.
- The GMC can investigate fitness to practise concerns based on information received from any source under Section 35C of the Medical Act 1983, not solely from formal complaints about named individual practitioners. The Medical Profession (Responsible Officers) Regulations 2010 created a framework where responsible officers in designated bodies have a statutory role in investigating fitness to practise concerns locally.
- A formal GMC-CQC Joint Operational Protocol governs information sharing: the GMC provides CQC with National Training Survey data, monthly enhanced monitoring summaries, and a monthly decision circular. CQC shares weekly inspection judgements and concerns about individual doctors (CQC-GMC Joint Operational Protocol).
- However, the GMC's statutory framework remains focused on individual registered practitioners rather than systemic or organisational concerns. The GMC does not have explicit powers to investigate organisations or generic patterns of concern without identifying individual practitioners.
- The draft General Medical Council Order 2026 (consultation launched 24 March 2026, closing 23 June 2026), the most significant overhaul of medical professional regulation since 1983, does not explicitly grant the GMC powers to investigate systemic concerns about organisations, though it will make fitness to practise processes swifter and strengthen information sharing with the PSA (Reforming the General Medical Council Legislative Framework, DHSC, March 2026).
Information sharing
Steps must be taken to systematise the exchange of information between the Royal Colleges and the General Medical Council, and to issue guidance for use by employers of doctors to the same effect.
- The Medical Profession (Responsible Officers) Regulations 2010 require every designated body, including Royal Colleges, to appoint a responsible officer with a statutory duty to report fitness to practise concerns to the GMC, creating a formal information exchange channel (Medical Profession (Responsible Officers) Regulations 2010, SI 2010/2841).
- The GMC-CQC Joint Operational Protocol includes provisions for sharing intelligence from inspections and training data, but the Royal Colleges' information sharing with the GMC is not governed by a single formal protocol. Individual Royal Colleges maintain their own arrangements with the GMC.
- The GMC's enhanced monitoring programme, which draws on National Training Survey data and deanery reports, provides a mechanism for systemic intelligence from training environments where Royal College curricula are delivered, indirectly facilitating information exchange.
- While statutory mechanisms exist for responsible officers to report concerns, the systematised exchange of information between all Royal Colleges and the GMC that Francis envisaged — including formal guidance for employers — has been partially but not comprehensively implemented. No single published guidance document addresses information sharing between all Royal Colleges and the GMC in the systematic manner Francis recommended.
Peer reviews
- Section 35 of the Medical Act 1983 empowers the GMC to commission performance assessments and peer reviews where concerns about a practitioner's fitness to practise are raised. Section 35C(4) allows the GMC to investigate based on information received from any source, providing a basis for proactive investigation arising from generic concerns.
- The GMC-CQC Joint Operational Protocol and emerging concerns protocol provide channels through which systemic concerns identified by CQC inspections can be shared with the GMC, potentially triggering peer review or investigation. Joint commissioning of reviews in appropriate cases is provided for within the protocol framework.
- In practice, the GMC's peer review powers under Section 35 have been used primarily in the context of individual practitioner concerns identified through the responsible officer network and enhanced monitoring, rather than as a routine response to generic organisational concerns. The extent to which the GMC commissions proactive peer reviews in response to systemic intelligence, as distinct from individual referrals, remains limited.
- The draft GMC Order 2026 (consultation launched March 2026) will modernise the fitness to practise framework but does not specifically expand the peer review commissioning powers Francis envisaged for systemic investigations (Reforming the General Medical Council Legislative Framework, DHSC, March 2026).
Administrative reform
- The NMC has undertaken multiple reform programmes since the Francis Report. The Professional Standards Authority's annual performance reviews have consistently identified areas requiring improvement in NMC administration, particularly in fitness to practise timeliness.
- The NMC Council approved a £30 million, 18-month improvement plan to address fitness to practise backlogs, targeting a two-month screening average in 2025/26 and a seven-month investigation average in 2026/27. This reflects continuing concern about administrative performance more than a decade after Francis flagged it as imperative (NMC, Fitness to Practise Improvement Plan).
- The NMC has modernised its data systems and processes, introduced online renewals and revalidation (from April 2016), and improved its public-facing digital services. However, PSA performance reviews have continued to identify standards not met in areas including timeliness of fitness to practise processes.
- The NMC has stated that its 2001 legislation is outdated and constrains its ability to operate efficiently, and has called for legislative modernisation to enable faster and more proportionate fitness to practise processes. The government has indicated it will bring forward NMC legislative reform during this parliamentary term (NMC, Why We Need Regulatory Reform).
Revalidation
- NMC revalidation was introduced on 1 April 2016, replacing the previous Post-Registration Education and Practice (PREP) system. The NMC confirmed this fulfilled "a key recommendation from the Francis report" (NMC, Revalidation Launch, April 2016).
- Revalidation requires all registered nurses and midwives to demonstrate continued fitness to practise every three years through: 450 practice hours (or 900 for dual registration), 35 hours of continuing professional development (20 participatory), five pieces of practice-related feedback, five written reflective accounts, a reflective discussion with a confirmer, a health and character declaration, a professional indemnity arrangement, and confirmation from a third party.
- Approximately 16,000 nurses and midwives went through the process in the initial round. The NMC's first review reported that revalidation was successfully introduced and was reinforcing professional standards and engagement with the Code.
- NMC revalidation is now an established feature of the nursing regulatory landscape, providing the additional protection to the public and reinforcement of professional competence that Francis recommended.
Profile
- The NMC has improved its public-facing communications and digital presence since the Francis Report, including a redesigned website, public-facing guidance on how to raise concerns, and an online register search facility allowing patients to check a nurse's or midwife's registration status.
- The NMC's revalidation process (introduced April 2016) raised the profile of the regulator among registrants, as all nurses and midwives must engage directly with the NMC every three years for revalidation.
- However, there is limited evidence of a systematic requirement that patients are informed at the point of service provision about the NMC's existence, role, and contact details, as Francis specifically recommended. While NHS complaints processes reference professional regulators, proactive notification to patients about the NMC at the point of care is not a national standard embedded in provider requirements.
- CQC inspection frameworks assess whether providers have visible information about how to raise concerns, which may include reference to professional regulators, but this is not specific to the NMC and varies by provider. The gap Francis identified — that patients receiving nursing care should be routinely informed about the NMC — has been partially but not systematically addressed.
Coordination with internal procedures
- The NMC has published guidance on the interaction between employer investigations and NMC fitness to practise proceedings, acknowledging that both processes can and should run in parallel where possible. The NMC's approach emphasises that employers should not delay local disciplinary action pending NMC proceedings.
- The NMC's Employer Link Service provides specialist regulation advisers who offer tailored advice to employers on managing fitness to practise concerns alongside employment processes, receiving 1,152 requests for advice in 2024/25 (NMC, Employer Link Service).
- The NMC has stated that 15% of concerns closed after initial assessment did not progress beyond screening and were raised by employers, indicating that the NMC seeks to support employers to manage concerns locally where appropriate rather than duplicating disciplinary processes.
- However, the NMC's fitness to practise process has faced significant timeliness challenges, which can create delays that obstruct parallel proceedings. The £30 million improvement plan targets a two-month screening average and seven-month investigation average, which if achieved would reduce the extent to which NMC proceedings delay employer processes. The underlying legislative framework, dating from 2001, also constrains the NMC's ability to streamline procedures.
Employment liaison officers
- The NMC has established an Employer Link Service (ELS), which provides specialist regulation advisers offering tailored advice and support to employers — particularly directors of nursing — on managing fitness to practise concerns and regulatory processes. This directly implements Francis's suggestion of employment liaison officers (NMC, Employer Link Service).
- The service received 1,152 requests for advice about potential fitness to practise concerns in 2024/25. The NMC has actively promoted the service, with its communications encouraging more employers to use the advice line (contact: 020 7462 8850 or employerlinkservice@nmc-uk.org).
- The Employer Link Service operates alongside the NMC's broader employer engagement programme, which includes webinars, guidance materials, and regional engagement events for directors of nursing and other senior nursing leaders.
- Francis's alternative suggestion — a support network of senior nurse leaders — has also been developed through NHS England's professional nursing leadership structure, including the Chief Nursing Officer, four Deputy Chief Nursing Officers, and seven Regional Chief Nurses, providing a support network complementing the NMC's liaison function.
For joint action Profile
- Both the GMC and NMC maintain informative websites with searchable registers, guidance for patients on how to raise concerns, and information about their roles and functions. The GMC website (gmc-uk.org) and NMC website (nmc.org.uk) both provide public-facing complaint and concern-raising portals.
- The NHS complaints process (established under the Local Authority Social Services and National Health Service Complaints (England) Regulations 2009) requires providers to signpost patients to relevant regulators, which includes the GMC and NMC where appropriate.
- However, Francis's specific recommendation was that patients should be made aware of the GMC and NMC "at the point of service provision" — meaning in the clinical environment, not just through complaints procedures. There is limited evidence of a systematic national requirement that patients are proactively informed about the existence and contact details of the GMC or NMC during their care.
- CQC's inspection framework assesses whether providers display information about how to raise concerns, which may include references to professional regulators, but this is general complaints information rather than the specific, routine notification about the GMC and NMC that Francis recommended at the point of service.
Cooperation with the Care Quality Commission
- A formal GMC-CQC Joint Operational Protocol governs information sharing between the two bodies. Under this protocol, the GMC provides CQC with National Training Survey data, monthly enhanced monitoring summaries, and a monthly decision circular. CQC shares weekly inspection judgements and concerns about individual doctors. An emerging and urgent concerns protocol allows ad hoc bilateral sharing outside routine channels (CQC-GMC Joint Operational Protocol).
- The NMC has established information sharing agreements with CQC, including arrangements for the NMC's Employer Link Service to coordinate with CQC where fitness to practise concerns arise in provider organisations. The NMC and CQC share intelligence on organisations of concern.
- Joint working mechanisms include cross-referral of concerns, coordinated responses to serious provider failings, and shared intelligence on workforce issues that may affect patient safety. When CQC identifies concerns about individual practitioners during inspections, these are referred to the relevant regulator.
- The draft GMC Order 2026 will further strengthen information-sharing requirements, including new obligations to share information with the PSA when requested, building on the existing bilateral protocols between GMC, NMC, and CQC (Reforming the General Medical Council Legislative Framework, DHSC, March 2026).
Identification of who is responsible for the patient
Hospitals should review whether to reinstate the practice of identifying a senior clinician who is in charge of a patient's case, so that patients and their supporters are clear who is in overall charge of a patient's care.
- The Academy of Medical Royal Colleges published "Taking Responsibility: Accountable Clinicians" in June 2014, commissioned by the Secretary of State for Health in direct response to the Francis Report. The guidance established the "responsible consultant/clinician" model, making a named doctor responsible for the whole of a patient's care during their hospital stay, with their name displayed above the patient's bed (Academy of Medical Royal Colleges, Taking Responsibility, June 2014).
- A "Named Nurse" requirement was introduced alongside the named consultant, providing patients with a primary point of contact for information about their care. Monitor wrote to all NHS foundation trusts in October 2014 requesting implementation updates.
- The NHS Standard Contract includes requirements for named clinician accountability, embedding the named consultant and named nurse policies in commissioning arrangements for NHS-funded services.
- Martha's Rule, announced in February 2024 and rolled out to 143 pilot sites from May 2024, provides patients, families and carers with an escalation route when concerns about deterioration are not addressed. Phase 2 commenced April 2025, expanding to all remaining acute inpatient services. Between September 2024 and January 2026, 11,238 Martha's Rule calls were made, with 2,110 requiring treatment changes including 486 transfers to higher care levels (NHS England, Martha's Rule, 2024).
Teamwork
- The NHS Patient Safety Strategy (July 2019) identifies safety culture as a key foundation, calling for a "just culture" approach and a systems and human factors approach. It promotes multidisciplinary teamwork and open communication as essential to patient safety (NHS England, NHS Patient Safety Strategy, July 2019).
- Safety huddles — daily, focused frontline team discussions of specific patient safety concerns lasting 5-15 minutes — have been spread across the NHS. The Health Foundation-funded HUSH (Huddle Up for Safer Healthcare) project scaled safety huddles across 136 wards in three NHS trusts, with over 70% of wards successfully embedding the practice and pooled results showing significant reduction in falls (Health Foundation, HUSH).
- SBAR (Situation-Background-Assessment-Recommendation), a structured clinical communication tool originating from TeamSTEPPS, is widely used across NHS nursing and medical practice for handovers and escalation of concerns, promoting effective communication between disciplines (NHS AQUA, SBAR Communication Tool).
- The RCP "Modern Ward Rounds" guidance (June 2021), published jointly with the RCN, Royal Pharmaceutical Society, Chartered Society of Physiotherapy, and NHS England, emphasises multidisciplinary inpatient review and provides self-assessment tools for effective ward round teamwork (Royal College of Physicians, Modern Ward Rounds, June 2021).
- While these initiatives promote effective teamwork, there is no single national standard mandating multidisciplinary teamwork at ward level; implementation and culture vary by trust.
Communication with and about patients
- The Seven Day Services Clinical Standards (first published 2015, updated February 2022) set national expectations for ward rounds: Standard 2 requires all emergency admissions to be seen by a suitable consultant within 14 hours of arrival; Standard 8 requires twice-daily consultant review in acute medical units, surgical assessment units, and ICUs, and at least once every 24 hours on general wards, seven days a week (NHS England, Seven Day Services Clinical Standards, February 2022).
- The Royal College of Physicians published "Modern Ward Rounds: Good Practice for Multidisciplinary Inpatient Review" in June 2021, jointly with the RCN, Royal Pharmaceutical Society, Chartered Society of Physiotherapy, and NHS England. The guidance addresses multidisciplinary review, communication with patients and families, and provides self-assessment tools for ward round quality (RCP, Modern Ward Rounds, June 2021).
- Francis's recommendation also addressed communication with patients and families, including email communication and discharge information. The NHS Standard Contract and CQC inspection framework both require providers to share care plans and discharge information with patients. The NHS App (launched December 2018) provides patients with electronic access to their medical records, appointment information, and GP correspondence.
- The recommendation that discharge letters should be timely and substantive is addressed by the Professional Record Standards Body (PRSB) discharge summary standard, adopted across NHS trusts, requiring structured discharge summaries sent to GPs within 24 hours.
Continuing responsibility for care
- NICE published NG27 "Transition between inpatient hospital settings and community or care home settings for adults with social care needs" in December 2015, recommending that from admission, hospital and community-based multidisciplinary teams should work together to identify factors that could prevent safe, timely transfer of care (NICE NG27, December 2015).
- The Hospital Discharge and Community Support Guidance (updated 2022) established four discharge pathways: Pathway 0 (home, no additional support), Pathway 1 (home with additional health/social care), Pathway 2 (24-hour bedded care for further recovery), and Pathway 3 (permanent new admission to 24-hour care). Assessment should occur within two hours of arriving home, with rapid access to care and support (Hospital Discharge and Community Support Guidance, DHSC, 2022).
- The Health and Care Act 2022 revoked Schedule 3 to the Care Act 2014, which had required long-term health and care needs assessments before discharge. From 1 April 2022, NHS bodies and local authorities should adopt "Discharge to Assess, Home First" models, ensuring patients are not held in hospital unnecessarily while awaiting assessments.
- NHS England's "Home First" approach encourages supported discharge with community-based assessment, addressing Francis's concern that care should not end when a patient surrenders a bed. CQC inspects discharge planning as part of its responsive key question.
Hygiene
All staff and visitors need to be reminded to comply with hygiene requirements. Any member of staff, however junior, should be encouraged to remind anyone, however senior, of these.
- The Health and Social Care Act 2008 Code of Practice on the Prevention and Control of Infections (updated 2015) sets out 10 criteria against which CQC judges providers on compliance with infection prevention and control requirements. Providers must demonstrate compliance with Regulation 12(2)(h) of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (Health and Social Care Act 2008 Code of Practice on IPC, DHSC).
- The National Infection Prevention and Control Manual (NIPCM) for England, first published April 2022 and regularly updated (latest version v2.12, July 2025), is the national standard for IPC. It covers standard and transmission-based precautions, including hand hygiene following the WHO "5 Moments" framework (NHS England, NIPCM).
- The manual and associated national hand hygiene policy explicitly support Francis's recommendation that all staff and visitors should comply with hygiene requirements and that any member of staff should be empowered to challenge non-compliance regardless of seniority — a principle embedded in the broader "freedom to speak up" culture promoted by NHS England.
- CQC assesses IPC compliance under its "safe" key question within the Single Assessment Framework, with specific quality statements on infection prevention and control. Individual trusts conduct hand hygiene audits, though there is no centrally published national aggregate compliance rate.
Provision of food and drink
The arrangements and best practice for providing food and drink to elderly patients require constant review, monitoring and implementation.
- NHS England published the National Standards for Healthcare Food and Drink in November 2022, setting eight mandatory standards for all NHS organisations. These include board-level accountability for food and nutrition, a food strategy requirement, dietetic input, 24/7 food provision appropriate to patient demographics, and workforce investment in food services. The standards note that "malnutrition affects a quarter of all patients in hospital" (NHS England, National Standards for Healthcare Food and Drink, November 2022).
- The "10 Key Characteristics of Good Nutrition and Hydration Care" is a requirement embedded in the NHS Standard Contract, mandating that providers demonstrate good practice in nutrition screening, care planning, and mealtime management (NHS England, 10 Key Characteristics).
- Protected mealtimes operate on wards across the NHS, with all non-urgent clinical activity ceasing during mealtimes to support patients in eating. The red tray system highlights patients at nutritional risk who may need additional assistance with eating and drinking.
- Patient-Led Assessments of the Care Environment (PLACE) include food quality assessment: the 2023 national scores were 90.98% for ward food and 91.17% for organisational food, based on 1,069 assessments (PLACE 2023, DHSC).
- CQC assesses nutrition and hydration under its inspection framework, with specific attention to whether patients receive adequate food and drink.
Medicines administration
- The Secretary of State for Health and Social Care issued Electronic Prescribing and Medicines Administration (ePMA) Directions in May 2024, placing a legal obligation on NHS England to collect and analyse secondary care ePMA data from all trusts using electronic prescribing systems. From 13 January 2025, NHS England collects weekly medicines data from each secondary care provider using ePMA (NHS England, ePMA Directions 2024).
- ePMA adoption rose from 19% of trusts in 2018 to an estimated 80%+ by March 2021. However, as of 2023, only 25% of trusts were fully electronic, with 71% using mixed paper and electronic systems, meaning not all medication administration is digitally tracked across all trusts.
- The NMC Code (2018) requires nurses to administer medicines in line with all relevant legal and ethical frameworks and adhere to national standards. The nurse in charge of a ward retains responsibility for overseeing patient care including medication administration, though specific standards on medication round oversight by the nurse in charge are embedded in local trust policies rather than a single national standard.
- Francis's specific concern about medication oversight when patients are moved between wards is addressed by electronic prescribing systems that maintain a continuous medication record, and by the PRSB transfer-of-care standards requiring medicines reconciliation at each transition point.
Recording of routine observations
- The National Early Warning Score 2 (NEWS2) was published by the Royal College of Physicians in December 2017, updating the original NEWS (2012). A joint Patient Safety Alert from NHS Improvement, the RCP, and NHS England (April 2018) set a deadline for full adoption of NEWS2 across all acute and ambulance trusts by 31 March 2019. NEWS2 provides the standardised clinical scoring system for routine observations that automated systems are built to calculate (RCP, NEWS2, December 2017; NHS England Patient Safety Alert, April 2018).
- The government's 2022 Plan for Digital Health and Social Care set a target for 90% of NHS trusts to have electronic patient records (EPRs) by December 2023, and all trusts by March 2025. NHS England announced in November 2023 that 90% of trusts were using EPRs. However, only 25% were fully electronic; 71% used mixed paper and electronic systems. Nearly £2 billion in funding has been allocated to support EPR implementation (A Plan for Digital Health and Social Care, DHSC, June 2022).
- Electronic observations systems that automatically record vital signs at the bedside and calculate NEWS2 scores are increasingly adopted but not yet universal. Specific data on the proportion of trusts using electronic bedside observations as distinct from broader EPR is not centrally published.
- Francis's fallback recommendation — that ward leaders and named nurses should be responsible for ensuring observations are carried out and recorded — is addressed through the named nurse policies and CQC's assessment of observation recording practices under its safe key question.
Common information practices shared data and electronic records
- The NHS App, launched in December 2018, provides patients with electronic access to their medical records, appointment information, GP correspondence, and test results, fulfilling the principle that patients should have user-friendly, real-time access to read their records (NHS App, NHS England).
- The government's "Data Saves Lives" strategy (June 2022) set out ambitions for common data practices across the NHS, including interoperable electronic patient records, patient access to records, and the use of data for quality improvement and research (Data Saves Lives: Reshaping Health and Social Care with Data, DHSC, June 2022).
- The Data Security and Protection Toolkit (DSPT), which replaced the Information Governance Toolkit from April 2018, establishes common information security practices based on the National Data Guardian's 10 data security standards. All organisations with access to NHS patient data must complete the DSPT annually (NHS England Digital, DSPT).
- Electronic patient record (EPR) adoption reached 90% of hospital trusts by November 2023, with nearly £2 billion in funding allocated, though only 25% of trusts were fully electronic with the remainder using mixed paper and electronic systems. Francis's vision of automated performance management and audit information collection directly from entries is partially realised through EPR systems but not yet universal.
- The specific design principles Francis articulated — prompts and defaults for safe care, alerts for missed actions, and systems designed by healthcare professionals with patient groups — are increasingly embedded in EPR functionality but implementation varies significantly across trusts.
Comparable quality accounts
- Quality Accounts were mandated by section 8 of the Health Act 2009, with detailed requirements set out in the National Health Service (Quality Accounts) Regulations 2010 (SI 2010/279), in force from 1 April 2010. All NHS providers meeting prescribed thresholds must publish annual Quality Accounts by 30 June each year (Health Act 2009; NHS (Quality Accounts) Regulations 2010).
- Quality Accounts must contain prescribed information in a common form: Part 1 (a summary statement on service quality signed by the responsible person); Part 2 (prescribed quality metrics enabling comparison between organisations); and Part 3 (additional quality information). The NHS (Quality Accounts) (Amendment) Regulations 2017 added a requirement for trusts to report on patient deaths during the reporting period.
- Quality Accounts are required to include commentary from commissioners (now ICBs), local Healthwatch organisations, and overview and scrutiny committees, as Francis specifically recommended (NHS England, Quality Accounts Requirements).
- The common format prescribed by the regulations enables comparison between organisations, directly fulfilling Francis's call for information "in a common form to enable comparisons to be made."
Accountability for quality accounts
Healthcare providers should be required to lodge their quality accounts with all organisations commissioning services from them, Local Healthwatch, and all systems regulators.
- The NHS (Quality Accounts) Regulations 2010 require providers to publish Quality Accounts and make them available to prescribed bodies. Providers must send a copy or link to the Secretary of State, and Quality Accounts must be published on the provider's website (NHS (Quality Accounts) Regulations 2010, SI 2010/279).
- Quality Accounts must include commentary from commissioning bodies (now Integrated Care Boards), local Healthwatch organisations, and overview and scrutiny committees, which requires the accounts to be shared with these bodies in advance of publication for their review and comment.
- CQC, as the systems regulator, receives and uses Quality Accounts data as part of its CQC Insight monitoring tool to inform inspection decisions. NHS England, having absorbed the functions of Monitor (the former foundation trust regulator), also has access to Quality Accounts through its oversight framework.
- The requirement to lodge accounts with all organisations Francis specified — commissioners, local Healthwatch, and systems regulators — is embedded in the Quality Accounts regulatory framework.
Accountability for quality accounts
Healthcare providers should be required to have their quality accounts independently audited. Auditors should be given a wider remit enabling them to use their professional judgement in examining the reliability of all statements in the accounts.
- NHS foundation trusts were previously required by Monitor to commission external assurance on aspects of their Quality Report in a prescribed format, providing a degree of independent audit. However, this requirement has been withdrawn; NHS foundation trusts no longer produce a separate Quality Report and there is no national requirement for external auditor assurance on Quality Accounts (NHS England, Quality Accounts Requirements).
- Quality Accounts remain a legal requirement under the NHS (Quality Accounts) Regulations 2010, but trusts may choose to locally commission assurance — this is voluntary, not mandatory.
- Integrated Care Boards have assumed responsibilities for review and scrutiny of Quality Accounts, providing a layer of external oversight, but this is not equivalent to the independent professional audit with a wider remit that Francis recommended.
- The Care Act 2014 (Sections 92-94) created a criminal offence for supplying false or misleading information (see F250), which provides a legal deterrent against inaccurate quality reporting. However, the wider auditor remit Francis envisaged — enabling professional judgement in examining the reliability of all statements in the accounts — has not been implemented as a mandatory requirement.
Access to data
It is important that the appropriate steps are taken to enable properly anonymised data to be used for managerial and regulatory purposes.
- The Health and Social Care Act 2012 established a comprehensive legal framework for the use of anonymised data for health service management, regulation, and research purposes. The Health and Social Care Information Centre (now part of NHS England) was given statutory powers to collect, analyse, and disseminate data including properly anonymised datasets.
- The "Data Saves Lives" strategy (June 2022) reaffirmed the government's commitment to enabling the use of properly anonymised data for quality improvement, research, and system management while maintaining public trust. It sets out principles for secure data environments (Trusted Research Environments) where anonymised data can be accessed for approved purposes (Data Saves Lives, DHSC, June 2022).
- The National Data Guardian's framework (established 2014, strengthened by the Health and Social Care (National Data Guardian) Act 2018) provides independent oversight of how patient data is used, including anonymised data. The NDG's 10 data security standards are embedded in the DSPT.
- NHS England operates national datasets (Hospital Episode Statistics, Mental Health Services Data Set, Community Services Data Set, and others) that provide anonymised data for managerial and regulatory purposes, enabling benchmarking, quality monitoring, and performance management across the NHS.
Access to quality and risk profile
- CQC's Quality and Risk Profiles (QRPs) were the original data-driven monitoring tool at the time of the Francis Report. These were replaced by Intelligent Monitoring (IM), which generated trust-level risk scores based on approximately 150 indicators, and then by CQC Insight, which brings together multiple data sources for monitoring at provider, location, and core service level.
- CQC Insight data, methodology, and ratings are publicly available through CQC's website. CQC publishes inspection reports, ratings, and the data indicators used to inform its monitoring and inspection decisions. Provider-specific Insight data is shared with individual providers, and summary-level indicator data is publicly accessible.
- CQC inspection ratings and reports are published on the CQC website for every registered provider, making the output of CQC's quality monitoring fully transparent to the public. The methodology used for inspections is published in CQC's provider handbooks and the Single Assessment Framework documentation.
- The progression from QRPs through Intelligent Monitoring to CQC Insight represents continuous development in placing quality monitoring information in the public domain with appropriate explanations, as Francis recommended.
Access for public and patient comments
- The Friends and Family Test (FFT), launched in April 2013 for inpatient and A&E services and subsequently expanded to maternity, GP, mental health, community, and outpatient services, provides one consistent gateway for patient feedback across the country. Approximately 2 million pieces of feedback are submitted monthly. Results are published by NHS England Digital on a monthly basis, enabling comparison between organisations (NHS England, Friends and Family Test).
- The CQC National Patient Survey Programme, established in 2002 and now covering inpatient, maternity, community mental health, urgent and emergency care, and children and young people's services, provides standardised annual patient experience data with results published per trust (CQC, NHS Patient Survey Programme).
- However, Francis's recommendation was about consistency across the many different comment and feedback gateways. In practice, multiple channels exist — FFT, CQC surveys, NHS website reviews, Healthwatch feedback, Patient Advice and Liaison Services (PALS), formal complaints processes, and third-party platforms — without a single unified output enabling fair comparison across all channels.
- The NHS website (nhs.uk) publishes patient ratings and reviews for individual services, providing some consolidation, but the landscape of patient feedback remains fragmented across multiple gateways with different methodologies.
Using patient feedback
Results and analysis of patient feedback including qualitative information need to be made available to all stakeholders in as near "real time" as possible, even if later adjustments have to be made.
- The Friends and Family Test (FFT), launched in April 2013, provides near-real-time patient feedback with results published monthly by NHS England Digital. Approximately 2 million pieces of feedback are submitted monthly, making it the largest source of patient opinion in the NHS. The FFT question was revised in April 2020 from asking about willingness to recommend to asking about overall experience of using the service (NHS England, Friends and Family Test).
- FFT results are available at service level (ward, department, practice) and published with minimal delay, addressing Francis's call for feedback in "as near real time as possible." Trusts can access their FFT data continuously for internal monitoring.
- The CQC National Patient Survey Programme provides standardised annual patient experience data across five survey types (inpatient, maternity, community mental health, urgent and emergency care, children and young people). Results are published per trust with full data tables enabling comparison (CQC, NHS Patient Survey Programme).
- While the annual CQC surveys do not provide real-time feedback, their findings are made available to all stakeholders on publication. The combination of real-time FFT data and periodic CQC survey data addresses both elements of this recommendation.
Follow up of patients
A proactive system for following up patients shortly after discharge would not only be good "customer service", it would probably provide a wider range of responses and feedback on their care.
- There is no national mandatory requirement for hospitals to contact patients after discharge to check on outcomes or experience. Government hospital discharge guidance focuses on the discharge process itself, including needs assessment and transfer of care, but does not mandate post-discharge follow-up contact by the discharging hospital (Hospital Discharge and Community Support Guidance, DHSC, 2022).
- Some trusts operate post-discharge phone call schemes as local good practice — for example, 24-hour post-discharge phone calls — but these are voluntary initiatives, not national requirements. NHS England has published case studies of such schemes to encourage adoption (NHS England, Post-Discharge Phone Calls Case Study).
- Healthwatch, in its November 2023 position on safe hospital discharge, called for "new minimum standards on post-discharge contact times to be included in updated guidance," indicating that such standards do not currently exist (Healthwatch, Our Position on Safe Hospital Discharge, November 2023).
- The Friends and Family Test captures some post-discharge feedback, but this is a general experience survey rather than the proactive clinical follow-up system Francis recommended to check patient wellbeing and identify problems after discharge.
Role of the Health and Social Care Information Centre
The Information Centre should continue to develop and maintain learning, standards and consensus with regard to information methodologies, with particular reference to comparative performance statistics.
- NHS Digital (now part of NHS England) developed and maintained standards for healthcare information methodology, including the Summary Hospital-level Mortality Indicator (SHMI), Hospital Episode Statistics (HES) data quality standards, and reference data standards for NHS organisations. These methodologies are published with technical specifications enabling scrutiny and comparison.
- NHS England continues to maintain and develop information methodology standards following the merger with NHS Digital. Published methodologies include SHMI (with regular methodological reviews), clinical coding standards (maintained by the NHS Classifications Service), and data quality dashboards enabling trusts to assess their own data quality.
- The NHS Data Model and Dictionary provides a standardised reference for NHS information, maintained by NHS England, establishing common definitions and standards for data collection across the service.
- The Office for Statistics Regulation (part of the UK Statistics Authority) designates NHS statistics as National Statistics or Official Statistics where they meet the required standards, providing independent oversight of the quality of healthcare statistical methodology.
Role of the Health and Social Care Information Centre
The Information Centre, in consultation with the Department of Health, the NHS Commissioning Board and the Parliamentary and Health Service Ombudsman, should develop a means of publishing more detailed breakdowns of clinically related complaints.
- NHS England (formerly NHS Digital) publishes statistics on written complaints made about NHS hospital, community, and primary care services using the KO41a and KO41b data collections. Publication frequency changed from quarterly (2015-16 to 2021-22) to annual (2022-23 onwards). The data covers complaints received by NHS organisations themselves, broken down by subject, service area, and outcome (NHS England Digital, Data on Written Complaints in the NHS).
- The Parliamentary and Health Service Ombudsman (PHSO) publishes its own quarterly reports on complaints about NHS organisations and annual data on complaints received and decisions made, providing statistics on cases escalated beyond the NHS internal complaints process (PHSO, Quarterly Reports on Complaints).
- However, NHS complaints data and PHSO complaints data are published separately by different bodies. Francis recommended that the Information Centre should develop, in consultation with PHSO, a means of publishing more detailed breakdowns of clinically related complaints — this integrated publication bringing together NHS-level and Ombudsman-level complaints data in a single analytical framework has not been established.
- The separation means stakeholders must cross-reference two different publications to understand the full complaints picture for a given organisation, from initial complaint through to Ombudsman investigation.
Information standards
The Information Centre should be enabled to undertake more detailed statistical analysis of its own than currently appears to be the case.
- The Health and Social Care Information Centre (established April 2013, rebranded as NHS Digital July 2016) was given expanded statutory functions for data collection, analysis, and publication under the Health and Social Care Act 2012. NHS Digital developed significant analytical capability, including the Summary Hospital-level Mortality Indicator (SHMI), Hospital Episode Statistics analysis, and various quality dashboards.
- NHS Digital was merged into NHS England on 1 February 2023, with all data and analytical functions absorbed into the combined organisation. NHS England now operates the national healthcare data infrastructure, including analysis of Hospital Episode Statistics, patient safety events (LFPSE), clinical outcomes, and workforce data (NHS England, NHS Digital Merger, February 2023).
- Francis's concern was that the Information Centre should be enabled to undertake more detailed statistical analysis than it was able to at the time of his report. The analytical capacity of what is now NHS England's data services directorate has expanded considerably since 2013, with new tools, datasets, and analytical capabilities.
- However, as noted in F257, the merger into NHS England means the analytical function is no longer held by an independently governed body. This raises questions about whether detailed statistical analysis that might be critical of NHS performance retains the independence Francis valued, given the analytical team now sits within the organisation responsible for delivering the services being analysed.
Enhancing the use analysis and dissemination of healthcare information
- The NHS Outcomes Framework, first published on 20 December 2010, established five outcome domains covering mortality, quality of life, recovery, patient experience, and patient safety, providing a national framework for measuring healthcare provider performance against quality standards (NHS Outcomes Framework, DHSC, December 2010).
- The National Clinical Audit and Patient Outcomes Programme (NCAPOP), managed by the Healthcare Quality Improvement Partnership (HQIP) on behalf of NHS England, comprises more than 30 national clinical audits and four Clinical Outcome Review Programmes. Participation is a condition of the NHS Standard Contract. Each audit provides trusts with benchmarked reports on care standards and outcomes for specific conditions (NHS England, Clinical Audit; HQIP, National Programmes).
- Getting It Right First Time (GIRFT), piloted in 2012 and established as a national programme in November 2016, provides clinically-led, data-driven reviews across more than 50 areas of clinical practice, examining specialty-level outcomes including mortality, morbidity, and patient satisfaction. GIRFT was formally adopted and funded by NHS England in 2022 (GIRFT).
- The Model Health System (incorporating Model Hospital), developed following Lord Carter's 2016 productivity review, enables trusts to benchmark quality and productivity against peers with data updated monthly across 16+ specialties, providing the real-time performance information Francis envisaged (NHS England, Model Health System).
Enhancing the use analysis and dissemination of healthcare information
It must be recognised to be the professional duty of all healthcare professionals to collaborate in the provision of information required for such statistics on the efficacy of treatment in specialties.
- Participation in the National Clinical Audit and Patient Outcomes Programme (NCAPOP) is a condition of the NHS Standard Contract, establishing a professional obligation for healthcare organisations and their clinicians to contribute data to national audits. NCAPOP comprises more than 30 audits covering the most common conditions (NHS England, Clinical Audit).
- The General Medical Council's Good Medical Practice (updated 2024) and the NMC Code (2018) both require practitioners to participate in systems to monitor the quality of their practice, including contributing to clinical audits and providing data for quality improvement.
- GMC revalidation (introduced December 2012) requires doctors to demonstrate participation in quality improvement activities, including clinical audit, as a condition of maintaining their registration. NMC revalidation (introduced April 2016) requires similar engagement with quality improvement.
- GIRFT's methodology specifically relies on clinician collaboration in providing specialty-level treatment outcome data, with clinical leads appointed from within each specialty to drive engagement and data quality (GIRFT).
Enhancing the use analysis and dissemination of healthcare information
In the case of each specialty, a programme of development for statistics on the efficacy of treatment should be prepared, published, and subjected to regular review.
- Getting It Right First Time (GIRFT) has developed specialty-specific programmes across more than 50 areas of clinical practice since its establishment as a national programme in November 2016. Each specialty programme involves clinically-led reviews combining data analysis with senior clinical input to examine treatment outcomes, variation, and best practice. Programmes are reviewed and updated regularly (GIRFT).
- The National Clinical Audit and Patient Outcomes Programme (NCAPOP) publishes annual reports for each of its 30+ national audits, including analysis of treatment efficacy, compliance with clinical standards, and outcome variation between providers. Each audit publishes a methodology, data quality assessment, and recommendations for improvement (HQIP, National Programmes).
- The Model Health System provides specialty-level benchmarking data updated monthly across 16+ surgical and medical specialties, including metrics such as length of stay, day case rates, readmissions, and mortality. This provides the ongoing, publicly available specialty statistics programme Francis envisaged (NHS England, Model Health System).
- Medical Royal Colleges and specialist societies maintain their own outcome registries and quality improvement programmes, complementing the national infrastructure.
Enhancing the use analysis and dissemination of healthcare information
- GIRFT engages directly with representative specialty organisations: each GIRFT programme is led by a clinical lead from within the relevant specialty, working with the relevant Royal College and professional association. GIRFT has covered more than 50 specialty areas, developing comparative statistics on treatment efficacy in collaboration with specialty bodies (GIRFT).
- NCAPOP audits are developed in collaboration with the relevant specialty organisations, Royal Colleges, and professional bodies. Each national audit has a clinical advisory group involving specialty representatives who advise on methodology, data collection, and reporting (HQIP, National Programmes).
- NHS England (formerly NHS Digital) publishes specialty-level Hospital Episode Statistics (HES) data and works with specialty organisations and CQC to develop clinical indicators. The NHS Outcomes Framework indicators were developed in consultation with clinical specialty groups.
- CQC's inspection methodology includes engagement with specialist advisers from relevant clinical specialties who participate in inspections and contribute to the assessment of service quality.
Enhancing the use analysis and dissemination of healthcare information
- The NHS Outcomes Framework indicators were developed following public consultation, including engagement with patient groups and the public on what outcome measures matter to patients. The framework has been subject to periodic consultations on changes, most recently from December 2023 to March 2024 (NHS Outcomes Framework, DHSC).
- Healthwatch England, established under the Health and Social Care Act 2012, provides a statutory mechanism for patient and public voice in health and social care policy, including input on the design and presentation of quality information.
- Individual NCAPOP audits involve patient and public representatives in their advisory structures, and some audits collect patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) as part of their data collection.
- However, there is limited evidence of systematic, routine engagement with patient groups in the design and presentation of all clinical statistics across all specialties. Engagement varies by programme and audit, and there is no single national mechanism ensuring patient and public views are sought in designing the methodology and presentation of every set of comparative healthcare statistics.
Enhancing the use analysis and dissemination of healthcare information
All such statistics should be made available online and accessible through provider websites, as well as other gateways such as the Care Quality Commission.
- NHS England Digital (formerly NHS Digital) publishes healthcare statistics online, including SHMI, Hospital Episode Statistics, patient survey data, waiting times, and clinical audit results. All publications are accessible through the NHS England Digital website (digital.nhs.uk) (NHS England Digital).
- CQC publishes inspection reports, ratings, and quality indicator data for all registered providers on its website (cqc.org.uk), providing a major public gateway for healthcare quality information. CQC Insight data is also made available.
- Individual NCAPOP audit results are published online, typically with trust-level data tables enabling public comparison. GIRFT national reports are published on the GIRFT website. The Model Health System provides benchmarking data accessible through NHS systems.
- Provider organisations are required under the NHS Standard Contract to publish Quality Accounts on their websites. The nhs.uk website aggregates service information including CQC ratings, patient reviews, and performance data for individual providers, functioning as a public-facing gateway as Francis envisaged.
Resources
Resources must be allocated to and by provider organisations to enable the relevant data to be collected and forwarded to the relevant central registry.
- The NHS Standard Contract requires provider organisations to participate in national clinical audits (NCAPOP) and submit data to national datasets including Hospital Episode Statistics, the Mental Health Services Data Set, and other mandatory collections. This establishes a contractual obligation to allocate resources for data collection.
- NHS England has invested in digital infrastructure to support data collection, including nearly £2 billion for EPR implementation across all trusts. The Data Security and Protection Toolkit (DSPT) includes requirements for organisations to allocate appropriate resources to information governance and data quality.
- However, data quality challenges persist. Clinical coding accuracy varies between trusts, and the resources allocated to clinical coding teams and data quality assurance vary significantly. GIRFT reports have consistently identified clinical coding quality as a concern affecting the reliability of comparative statistics.
- The move from the National Reporting and Learning System (NRLS) to the Learn from Patient Safety Events (LFPSE) service required significant investment in new data collection systems, completed with NRLS decommissioned on 30 June 2024. While national infrastructure investment has been substantial, local resource allocation for data collection remains variable.
Improving and assuring accuracy
The only practical way of ensuring reasonable accuracy is vigilant auditing at local level of the data put into the system. This is important work, which must be continued and where possible improved.
- Clinical coding is the primary mechanism for ensuring accuracy of data entering national healthcare datasets. NHS trusts employ clinical coding teams who translate clinical records into standardised codes. The NHS Classifications Service maintains coding standards and provides training.
- The Data Security and Protection Toolkit (DSPT) includes requirements for data quality assurance, and NHS England publishes data quality dashboards enabling trusts to assess their own data quality against national benchmarks.
- However, GIRFT reports have repeatedly identified clinical coding quality as a significant concern, with substantial variation between trusts in coding accuracy and depth. Coding accuracy affects the reliability of all derived statistics including mortality indicators, outcome measures, and benchmarking tools.
- The Care Act 2014 false information offence (Sections 92-94) provides a legal deterrent against materially inaccurate data submission, but the focus of local auditing remains primarily on financial coding accuracy (for payment by results) rather than systematic clinical accuracy auditing across all data fields. The gap between financial coding audit and comprehensive clinical data quality audit identified by Francis has been partially but not fully addressed.
Improving and assuring accuracy
- The Office for Statistics Regulation (OSR) assessed SHMI in Assessment Report 308 (published 30 July 2015) and confirmed it as National Statistics (now termed "Accredited Official Statistics"), the highest designation for official statistics in the UK. The assessment was conducted following a request from the Secretary of State for Health (OSR, Assessment Report 308, July 2015).
- SHMI has been published monthly since January 2019 (previously quarterly), providing more frequent and accessible mortality data for providers and the public. It is published by NHS England Digital with full methodology documentation (NHS England Digital, SHMI).
- The NHS Outcomes Framework publishes patient outcome statistics across five domains, with indicators reviewed through periodic consultations. The framework has been published annually since March 2022 (previously quarterly).
- NHS England Digital publishes indicator data on the Indicator Portal, providing access to a wide range of outcome, quality, and safety indicators in formats enabling public use and comparison. The review of patient outcome statistics that Francis recommended has been substantially implemented through these mechanisms.
Improving and assuring accuracy
- SHMI was confirmed as National Statistics (now termed "Accredited Official Statistics") by the UK Statistics Authority's Office for Statistics Regulation in Assessment Report 308, published 30 July 2015. The assessment was requested by the Secretary of State for Health (OSR, Assessment Report 308, July 2015).
- SHMI is published monthly by NHS England Digital with provider-level detail, methodology documentation, and contextual indicators to support interpretation. The accreditation confirms that SHMI meets the Code of Practice for Statistics principles of Trustworthiness, Quality, and Value.
- Francis recommended that SHMI and other patient outcome statistics should achieve official or national statistics status. The formal accreditation of SHMI directly fulfils this recommendation for the principal hospital mortality indicator.
Improving and assuring accuracy
- Section 280 of the Health and Social Care Act 2012 inserted powers for the Secretary of State to establish an accreditation scheme for healthcare information methodology, as Francis noted. However, these powers have not been exercised to create a formal accreditation scheme for statistical methodologies.
- The Office for Statistics Regulation (OSR) provides independent review and accreditation of official statistics, and has accredited SHMI as meeting the Code of Practice for Statistics. This provides quality assurance for individual statistical products but is not equivalent to the broader healthcare-specific methodological accreditation scheme Francis envisaged.
- Individual statistical methodologies are reviewed through academic peer review, expert advisory groups, and public consultation (for example, SHMI methodology is reviewed by an expert advisory group). But there is no systematic accreditation system covering all healthcare-relevant statistical methodologies.
- The power to create an accreditation scheme exists in legislation but has not been used. This recommendation remains partially fulfilled through OSR's existing official statistics accreditation framework, but the healthcare-specific methodological accreditation scheme Francis recommended has not been established.
Information to coroners
- The statutory duty of candour (CQC Regulation 20, in force from November 2014 for NHS trusts and April 2015 for all CQC-registered providers) provides an unequivocal legal requirement for openness with patients and families when notifiable safety incidents occur. Apologising is not an admission of liability, as confirmed by NHS Resolution (CQC, Regulation 20: Duty of Candour).
- A review of the statutory duty of candour was announced on 6 December 2023, with a call for evidence published on 16 April 2024. The review found that only 40% of respondents thought the purpose is clear and well understood, and only 23% said the duty is correctly complied with when a notifiable safety incident occurs, suggesting implementation gaps remain (Duty of Candour Review, DHSC, April 2024).
- The Caldicott 2 review (April 2013) and the addition of the seventh and eighth Caldicott principles reinforced the duty to share information and be transparent with patients about how their data is used.
- NHS Resolution has published guidance for trusts and their legal advisers on being open and transparent, emphasising that legal professional privilege should not be used to obstruct the sharing of information with patients, families, or coroners. However, the duty of candour review findings suggest that in practice, the cultural shift towards openness that Francis called for remains incomplete.
Independent medical examiners
Sufficient numbers of independent medical examiners need to be appointed and resourced to ensure that they can give proper attention to the workload.
- The statutory medical examiner system, which commenced on 9 September 2024, requires sufficient medical examiners to be appointed across England and Wales to scrutinise all non-coronial deaths. NHS England funded the establishment of Medical Examiner Offices across all acute trusts during the non-statutory rollout from April 2019 (NHS England, Medical Examiner System).
- Central funding was established in March 2022 to support medical examiner resourcing, replacing the earlier cremation fee funding model. The Medical Examiners (England) Regulations 2024, laid before Parliament on 15 April 2024, set out the statutory requirements for the system including resourcing obligations.
- The National Medical Examiner oversees workforce planning and quality assurance for the medical examiner system nationally. The Royal College of Pathologists leads medical examiner education, providing 24 e-learning modules plus face-to-face training.
- The system now covers deaths in all settings, not just acute hospitals, following the September 2024 statutory commencement. This required expansion of the medical examiner workforce to manage the increased workload.
Death certification
National guidance should set out standard methodologies for approaching the certification of the cause of death to ensure, so far as possible, that similar approaches are universal.
- The National Medical Examiner has published guidance on standard methodologies for death certification, providing a consistent approach across England and Wales. The Medical Certificate of Cause of Death Regulations 2024, laid before Parliament on 15 April 2024, set out statutory requirements for death certification methodology.
- The statutory medical examiner system (from 9 September 2024) ensures that all non-coronial deaths are scrutinised by a medical examiner before the cause of death is certified, providing a consistent national approach to death certification that did not exist before.
- The Royal College of Pathologists provides standardised training for medical examiners through 24 e-learning modules and face-to-face training, ensuring a common methodological approach to certification.
- The National Medical Examiner issues regular updates and guidance notes to maintain consistency of practice across the network, addressing the variation in death certification approaches that Francis identified as a concern.
Death certification
- The statutory medical examiner role (from 9 September 2024) includes scrutiny of the medical records of the deceased, which encompasses reviewing any reported patient safety incidents, serious untoward incidents, or adverse events relating to the deceased's care. The National Medical Examiner's guidance establishes this as a core part of the death scrutiny process (NHS England, Medical Examiner System).
- Medical examiners are required to consider all available information about the circumstances of a death, not just the medical records and the certifying doctor's account. This includes accessing incident reports and other relevant documentation held by the provider.
- The Learn from Patient Safety Events (LFPSE) service and its predecessor the National Reporting and Learning System (NRLS) provide records of patient safety incidents that medical examiners can reference when scrutinising deaths. The integration of incident reporting data with death scrutiny was identified as a priority during the system's development.
- This recommendation is directly fulfilled by the statutory medical examiner role, which requires a holistic review of the circumstances surrounding each death.
Death certification
So far as is practicable, the responsibility for certifying the cause of death should be undertaken and fulfilled by the consultant, or another senior and fully qualified clinician in charge of a patient's case or treatment.
- The Medical Certificate of Cause of Death Regulations 2024 set out requirements for who may certify the cause of death. The attending practitioner (the doctor who attended the deceased during their last illness) is responsible for certification.
- The statutory medical examiner system (from 9 September 2024) provides an additional layer of scrutiny: while the attending practitioner certifies the cause of death, the medical examiner independently reviews the proposed cause and may refer the case to the coroner if there are concerns. This dual system ensures senior clinical oversight of all death certification.
- National Medical Examiner guidance emphasises that the certifying doctor should have sufficient knowledge of the patient's condition and treatment to certify accurately. Where a junior doctor has been involved in care, the consultant or senior clinician in charge of the case should certify or closely supervise the certification process.
- The combination of the attending practitioner requirement and independent medical examiner scrutiny addresses Francis's concern that death certification should involve senior clinicians with adequate knowledge of the patient's case.
Appropriate and sensitive contact with bereaved families
- The statutory medical examiner system (from 9 September 2024) requires medical examiners to speak with the bereaved family or nominated next of kin as part of the death scrutiny process. This conversation provides an opportunity for families to raise any concerns about the death or the circumstances surrounding it (NHS England, Medical Examiner System).
- Medical examiners also discuss the proposed cause of death with the certifying doctor, providing an opportunity for the doctor to raise any concerns about the death or the care provided.
- National Medical Examiner guidance requires medical examiners to create an environment where hospital staff feel able to raise concerns about deaths, complementing the broader Freedom to Speak Up framework. Medical examiner offices provide a channel for staff concerns to be identified and acted upon.
- This recommendation is directly implemented through the statutory medical examiner role, which builds family engagement and clinical concern-raising into the routine death scrutiny process for all non-coronial deaths.
Appropriate and sensitive contact with bereaved families
It is important that independent medical examiners and any others having to approach families for this purpose have careful training in how to undertake this sensitive task in a manner least likely to cause additional and unnecessary distress.
- The Royal College of Pathologists provides standardised training for medical examiners, including 24 e-learning modules and face-to-face training. Communication with bereaved families is a core component of the training curriculum, covering how to conduct sensitive conversations, explain the death scrutiny process, and invite families to raise concerns.
- National Medical Examiner guidance sets out the expectations for family engagement, including the approach to be taken in initial contact, the information to be provided, and the handling of concerns raised. Training on family engagement is mandatory for all appointed medical examiners.
- The statutory commencement of the system on 9 September 2024 means all medical examiners must have completed the required training, including communication skills modules, before exercising the statutory function.
- This recommendation is directly addressed through the structured training programme for medical examiners, with family engagement as a core competency requirement.
Information for and from inquests
Coroners should send copies of relevant Rule 43 reports to the Care Quality Commission.
- Prevention of Future Deaths (PFD) reports, formerly known as Rule 43 reports, are now governed by Regulation 28 of the Coroners (Investigations) Regulations 2013. Coroners have a duty to make a PFD report where they believe action should be taken to prevent future deaths. Recipients must respond within 56 days (Regulation 28, Coroners (Investigations) Regulations 2013).
- PFD reports can be sent to any person, organisation, local authority, or government department that the coroner believes has the power to take relevant action — this includes CQC where the concerns relate to the quality or safety of care provided by a CQC-registered organisation.
- NHS England published guidance on "Action to Prevent Future Deaths Reports (Regulation 28)" providing a framework for NHS organisations to respond to and learn from PFD reports (NHS England, Action to Prevent Future Deaths Reports).
- PFD reports and responses are published on the judiciary.uk website, maintained by the Chief Coroner's office, providing transparency and enabling learning across the system (Judiciary, Prevention of Future Death Reports).
Information for and from inquests
Guidance should be developed for coroners' offices about whom to approach in gathering information about whether to hold an inquest into the death of a patient. This should include contact with the patient's family.
- The Chief Coroner has issued a comprehensive series of numbered guidance notes covering various aspects of coroner practice, many of which have been consolidated into "Guidance for Coroners on the Bench" (a comprehensive bench book). This guidance covers whom to approach in gathering information about whether to hold an inquest, including contact with the deceased's family (Chief Coroner's Guidance, Judiciary).
- The Coroners and Justice Act 2009 establishes a general duty on the senior coroner to investigate deaths where the coroner has reason to suspect that the death was violent or unnatural, or the cause of death is unknown. The investigation process includes gathering information from medical professionals, employers, and the deceased's family.
- The Chief Coroner's Guide to the Coroners and Justice Act 2009 (published September 2013) provides detailed guidance on the Act's provisions including information-gathering procedures.
- The statutory medical examiner system (from September 2024) complements this by providing a formal channel through which concerns identified during medical examiner scrutiny — including family concerns — can be referred to the coroner.
Appointment of assistant deputy coroners
The Lord Chancellor should issue guidance as to the criteria to be adopted in the appointment of assistant deputy coroners.
- The Coroners and Justice Act 2009 reformed the appointment process for coroners. The Chief Coroner, first appointed on 17 September 2012 (His Honour Judge Peter Thornton QC), has oversight of the coroner system including appointment standards.
- Under the 2009 Act, assistant coroners (replacing the former assistant deputy coroner role) must meet prescribed eligibility criteria: they must have a minimum of five years' legal qualification (as a barrister, solicitor, or Fellow of the Chartered Institute of Legal Executives). The Lord Chancellor retains the power to issue guidance on appointment criteria.
- All coroners, including assistant coroners, must attend compulsory annual continuation training. New assistant coroners must complete mandatory induction training before undertaking any inquest work, including inquests in writing.
- The Chief Coroner's guidance notes and bench book provide detailed direction on the standards expected of all coroners including assistant coroners, establishing a framework for consistent practice across the coroner service.
Appointment of assistant deputy coroners
The Chief Coroner should issue guidance on how to avoid the appearance of bias when assistant deputy coroners are associated with a party in a case.
- The Chief Coroner has issued a comprehensive series of guidance notes covering standards of conduct for coroners, many consolidated into the bench book "Guidance for Coroners on the Bench." These include guidance on judicial conduct, independence, and the avoidance of conflicts of interest (Chief Coroner's Guidance, Judiciary).
- The Coroners and Justice Act 2009 established the Chief Coroner's role with powers to set standards across the coroner service. The Act requires coroners to act judicially, which encompasses the duty to avoid actual and perceived bias.
- The Judicial Conduct Investigations Office (JCIO) handles complaints about the conduct of coroners, providing an independent mechanism for addressing concerns about bias or conflicts of interest.
- Compulsory annual training for all coroners, including assistant coroners, covers judicial conduct, independence, and the management of potential conflicts of interest. The requirement for mandatory induction training before new assistant coroners can conduct any inquest work ensures awareness of these obligations from the outset.
Impact assessments before structural change
- The Health and Care Act 2022 was accompanied by seven published impact assessments, rated as fit for purpose by the Regulatory Policy Committee. These assessed the legislative provisions (ICS establishment, HSSIB creation, etc.) and were published on 4 November 2022. The Act followed a white paper ("Integration and Innovation") published in February 2021 (Health and Care Act 2022: Combined Impact Assessments, DHSC, November 2022).
- However, subsequent major structural changes to the NHS — including the abolition of approximately 18,000 administrative posts across NHS England and ICBs, announced in 2024-2025 — have not been accompanied by formal public impact assessments evaluating the effect on frontline clinical services. A parliamentary petition called for an impact assessment before proceeding with these redundancies.
- Francis's recommendation specified that impact assessments for structural changes should cover preservation of existing skills and knowledge, continuity during transition, and risks to safety and welfare. While the 2022 Act's impact assessments covered the legislative measures themselves, the operational restructuring decisions — which arguably have a greater direct impact on services — have not been subject to equivalent published analysis.
- The pattern of NHS structural reorganisation without comprehensive published impact assessment persists, suggesting this recommendation has been applied selectively rather than as a consistent principle for all major changes.
Impact assessments before structural change
- CQC's regulatory framework has developed considerably since the Francis Report. The Single Assessment Framework (introduced from 2023) provides a coherent structure for assessing quality across five key questions (safe, effective, caring, responsive, well-led), with quality statements derived from legislation and guidance.
- The fundamental standards in the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 established minimum quality and safety standards that all CQC-registered providers must meet, directly implementing Francis's call for fundamental standards.
- However, Francis envisaged a broader structure encompassing fundamental, enhanced, and developmental standards developed through consensus between the public and healthcare professionals. While CQC's registration requirements cover fundamental standards, the concept of a publicly-debated hierarchy of standards from minimum to aspirational has not been fully implemented as a coherent national framework.
- The NHS Constitution (most recently updated 2024) sets out rights and pledges for patients, but the relationship between the Constitution, CQC standards, professional standards, and clinical guidelines remains complex rather than the coherent, easily accessible structure Francis recommended.
Clinical input
The Department of Health should ensure that there is senior clinical involvement in all policy decisions which may impact on patient safety and well-being.
- DHSC has six chief professional officers who provide expert clinical and professional advice to ministers and policy teams: the Chief Medical Officer (CMO), Chief Nursing Officer (CNO), Chief Scientific Officer, Chief Dental Officer, Chief Pharmaceutical Officer, and Chief Social Worker. The CMO and CNO are directors on the department's board, ensuring senior clinical involvement at the highest level of policy-making (DHSC).
- The CMO provides independent advice on public health issues, recommends policy changes, and interfaces between government and medical researchers and clinical professionals. The CNO provides professional leadership for all nurses, midwives, and care staff and is the principal adviser to the Government on nursing and midwifery.
- NHS England employs National Clinical Directors for specific clinical areas (such as cancer, mental health, urgent care) who provide clinical leadership in policy development and implementation. The NHS Medical Director and NHS Chief Nursing Officer sit on the NHS England executive team.
- The integration of DHSC and NHS England leadership functions means clinical advisers are embedded across the policy-making structure, from departmental board level through to operational delivery.
Experience on the front line
- DHSC officials engage with the NHS through various mechanisms including secondments, visits, and working with arm's-length bodies. The integration of DHSC and NHS England governance structures has brought policy officials closer to operational delivery.
- Healthwatch England, established under the Health and Social Care Act 2012, provides a statutory mechanism for patient and public voice to inform DHSC and NHS England policy. Local Healthwatch organisations gather patient experience data that feeds into national policy discussions.
- However, Francis's specific recommendation was about personal contact between DHSC officials and those who have suffered poor experiences, and the creation of a patient/service user consultative forum within the Department. While DHSC engages with patient groups on specific policy consultations, there is limited evidence of a standing internal consultative forum of patient representatives of the kind Francis described.
- The Patient and Public Voice Assurance Group and patient participation initiatives exist within NHS England, but the direct personal connection between DHSC policy officials and patients who have experienced poor care — as distinct from formal consultation processes — is difficult to evidence systematically.
Experience on the front line
- DHSC has taken steps towards greater transparency and openness since the Francis Report. The NHS Constitution (most recently updated 2024) sets out values including accountability, openness, and honesty. The statutory duty of candour (CQC Regulation 20, from November 2014) embeds the principle of openness about deficiencies at provider level.
- The government's responses to subsequent inquiries — including Grenfell Tower, Infected Blood, and the Post Office Horizon IT Inquiry — have been subject to public scrutiny and parliamentary debate, demonstrating a degree of openness about systemic failings.
- However, the cultural change Francis recommended at departmental level — being open about deficiencies, ensuring those harmed have a remedy, and publishing detailed performance information — is inherently difficult to assess from outside. The duty of candour review (2024) found that only 23% of respondents thought the duty is correctly complied with when a notifiable safety incident occurs, suggesting the culture of openness remains a work in progress across the system.
- The publication of detailed performance data has improved significantly through NHS England Digital, CQC, and the Model Health System, addressing the information transparency element of this recommendation. Whether DHSC itself models a positive culture of openness about deficiencies in its own policy-making is a judgement that falls outside the scope of published evidence.