Mid Staffordshire NHS Foundation Trust Public Inquiry

Completed

Mid Staffs Inquiry

Chair Robert Francis QC Legal professional (non-judge)
Established 09 Jun 2010
Final Report 06 Feb 2013
Commissioned by Department of Health and Social Care

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.

Evidence & Impact
The Mid Staffordshire NHS Foundation Trust Public Inquiry, chaired by Sir Robert Francis QC, examined failures in care at Stafford Hospital between 2005 and 2009. The inquiry's report, published in February 2013, made 290 recommendations aimed at preventing similar failures across the NHS.

The government responded through two documents: 'Patients First and Foremost' in March 2013 and 'Hard Truths: the Journey to Putting Patients First' in November 2013. According to these responses, the government accepted 201 recommendations (69%), accepted in principle 60 recommendations (21%), partially accepted 20 recommendations (7%), and did not accept 9 recommendations (3%).

The government response identified several key reforms, including establishing a new Chief Inspector of Hospitals, strengthening the Care Quality Commission's inspection regime, introducing a statutory duty of candour, and implementing a fit and proper person test for NHS directors. The response also referenced the creation of Health Education England and Healthwatch England as part of wider NHS reforms.

However, the available evidence indicates limited published documentation of progress beyond these initial responses. Of the 290 recommendations, 281 (97%) are recorded as 'Awaiting Action' with no formal progress updates or implementation reviews identified in the public record. This suggests that while the government accepted the majority of Francis's recommendations and announced several high-profile reforms, comprehensive evidence of wider implementation across all recommendations has not been published.

The absence of systematic progress reporting makes it difficult to assess which of the accepted recommendations have been acted upon beyond the headline reforms announced in 2013. No formal implementation review has been identified that would provide comprehensive evidence of progress across all 290 recommendations.
Reforms Attributed to This Inquiry
- Care Quality Commission inspection regime strengthened with new Chief Inspector of Hospitals position created
- Statutory duty of candour introduced requiring NHS organisations to inform patients when care goes wrong
- Fit and proper person test established for NHS directors
- Fundamental standards of care introduced as regulatory requirements
- NHS Constitution strengthened with explicit patient rights
- Health Education England established to oversee workforce planning and training
- Healthwatch England created as national consumer champion for health and social care
Unfinished Business
- No published evidence identified for progress on 281 of 290 recommendations (97%)
- Recommendations on nurse staffing levels and mandatory minimum ratios
- Proposals for enhanced whistleblowing protections and support systems
- Recommendations on professional regulation reform
- Proposals for patient complaint handling improvements
- Recommendations on healthcare professional training and development
- Proposals for NHS board governance and accountability mechanisms
AI-generated narrative. Generated 26 Mar 2026 using claude-opus-4. Assessment is indicative, not authoritative.
2 years, 8 months Duration
£13m Total Cost
250 Witnesses
139 Hearing Days
1,000,000 Documents
1,781 Report Pages
Government Response

Total Recommendations 290
Data last updated: 19 Nov 2013 · Source
Data verified: 26 May 2026 (import)
Blanket response: Government responded via "Hard Truths: The Journey to Putting Patients First" (2014), a single document covering all 290 recommendations with a blanket acceptance. Individual recommendation responses were not broken out.
How to read this

Government Response tracks what the government said it would do (accepted, rejected, etc.).

Full methodology

09 Jun 2010
Inquiry Announced
01 Nov 2010
Inquiry Established
06 Feb 2013
Final Report Published

Recommendations (290)

F1
Accepted
Implementing the recommendations
Recommendation
It is recommended that: All commissioning, service provision regulatory and ancillary organisations in healthcare should consider the findings and recommendations of this report and decide how to apply them to their own work; Each such organisation should announce at the … Read more
Published evidence summary
- The government published "Hard Truths: the Journey to Putting Patients First" (Cm 8777) in November 2013, responding to all 290 Francis recommendations. Volume 2 (Cm 8754) provided per-recommendation responses (Hard Truths Vols 1 and 2, Department of Health, November 2013).
- 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.
Department of Health and Social Care (Primary)
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F2
Accepted
Putting the patient first
Recommendation
The NHS and all who work for it must adopt and demonstrate a shared culture in which the patient is the priority in everything done. This requires: A common set of core values and standards shared throughout the system; Leadership … Read more
Published evidence summary
- The NHS Constitution for England was revised in 2013 and again on 27 July 2015, incorporating updated values including "patients come first in everything we do" as the lead value (NHS Constitution for England, Department of Health and Social Care, updated 17 August 2023).
- 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.
NHS (Primary)
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F3
Accepted
Clarity of values and principles
Recommendation

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.

Published evidence summary
- The NHS Constitution for England, first published in 2009 under the Health Act 2009, sets out patients' rights, staff rights, and the values of the NHS. Section 2 of the Health Act 2009 places a duty on NHS bodies and staff to have regard to the Constitution (Health Act 2009, s.2).
- 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).
Department of Health and Social Care (Primary)
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F4
Accepted
Clarity of values and principles
Recommendation

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.

Published evidence summary
- The NHS Constitution for England states "patients come first in everything we do" as the opening principle under the value "Working together for patients" (NHS Constitution for England, DHSC, 17 August 2023).
- 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).
Department of Health and Social Care (Primary)
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F5
Accepted
Clarity of values and principles
Recommendation
In reaching out to patients, consideration should be given to including expectations in the NHS Constitution that: Staff put patients before themselves; They will do everything in their power to protect patients from avoidable harm; They will be honest and … Read more
Published evidence summary
- The NHS Constitution for England includes a section titled "Staff: your responsibilities" which states that staff should aim to "provide all patients with safe care, and to do all you can to protect patients from avoidable harm" and "maintain the highest standards of care and service, treating every individual with compassion, dignity and respect" (NHS Constitution for England, DHSC, 17 August 2023).
- 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).
Department of Health and Social Care (Primary)
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F6
Accepted
Clarity of values and principles
Recommendation

The handbook to the NHS Constitution should be revised to include a much more prominent reference to the NHS values and their significance.

Published evidence summary
- The Handbook to the NHS Constitution for England was revised on 27 July 2015, providing "greater detail on the rights and pledges contained in the Constitution" including detailed explanation of the NHS values (Handbook to the NHS Constitution, DHSC, 27 July 2015).
- 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).
Department of Health and Social Care (Primary)
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F7
Accepted in Part
Clarity of values and principles
Recommendation

All NHS staff should be required to enter into an express commitment to abide by the NHS values and the Constitution, both of which should be incorporated into the contracts of employment.

Published evidence summary
- The NHS Constitution for England states that staff should "follow all guidance, standards and codes relevant to your role" and that staff have "a duty to accept professional accountability" (NHS Constitution for England, DHSC, 17 August 2023).
- The government stated in Hard Truths (November 2013) that it would work with NHS employers and trade unions to ensure the NHS Constitution and its values were reflected in employment contracts (Hard Truths Vol 1, Cm 8777, Department of Health, November 2013).
- The NHS Terms and Conditions of Service Handbook (Agenda for Change) references the NHS Constitution, though the extent to which individual employment contracts expressly incorporate the Constitution's values varies by employer (NHS Terms and Conditions of Service Handbook, NHS Employers, updated regularly).
- No published evidence of a single national mandate requiring all NHS employment contracts to expressly incorporate the NHS Constitution and values has been identified.
NHS (Primary)
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F8
Accepted
Clarity of values and principles
Recommendation
Contractors providing outsourced services should also be required to abide by these requirements and to ensure that staff employed by them for these purposes do so as well. These requirements could be included in the terms on which providers are … Read more
Published evidence summary
- The NHS Constitution for England states it applies to "private and voluntary sector providers supplying NHS services" and covers staff "whether in public, private or voluntary sector organisations" (NHS Constitution for England, DHSC, 17 August 2023).
- 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.
Commissioners (Primary)
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F9
Accepted in Part
Fundamental standards of behaviour
Recommendation

The NHS Constitution should include reference to all the relevant professional and managerial codes by which NHS staff are bound, including the Code of Conduct for NHS Managers.

Published evidence summary
- The NHS Constitution for England states that staff 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).
- The Constitution does not contain an explicit, itemised list of all professional and managerial codes of conduct by which NHS staff are bound, nor does it specifically reference the Code of Conduct for NHS Managers by name (NHS Constitution for England, DHSC, 17 August 2023).
- The Code of Conduct for NHS Managers was published by the Department of Health in October 2002. It has not been formally updated or re-issued since, though it remains referenced in some NHS employer policies (Code of Conduct for NHS Managers, Department of Health, October 2002).
- The Handbook to the NHS Constitution provides further context on staff rights and responsibilities but does not contain an itemised cross-reference to all relevant professional codes (Handbook to the NHS Constitution, DHSC, 24 January 2025).
Department of Health and Social Care (Primary)
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F10
Accepted in Part
Fundamental standards of behaviour
Recommendation
The NHS Constitution should incorporate an expectation that staff will follow guidance and comply with standards relevant to their work, such as those produced by the National Institute for Health and Clinical Excellence and, where relevant, the Care Quality Commission, … Read more
Published evidence summary
- The NHS Constitution for England states that 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).
- This expectation was incorporated into the revised Constitution published on 26 March 2013 and retained in the 2015 and 2023 editions (NHS Constitution for England, DHSC, 26 March 2013; 27 July 2015; 17 August 2023).
- The CQC fundamental standards under Regulation 12 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 require providers to ensure "safe care and treatment," which includes compliance with relevant clinical guidance (SI 2014/2936, Regulation 12).
- NICE guidelines are referenced in the NHS Standard Contract as part of quality requirements, and CQC inspections assess compliance with NICE guidance where relevant (NHS Standard Contract, NHS England; CQC inspection framework).
Department of Health and Social Care (Primary)
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F11
Accepted
Fundamental standards of behaviour
Recommendation
Healthcare professionals should be prepared to contribute to the development of, and comply with, standard procedures in the areas in which they work. Their managers need to ensure that their employees comply with these requirements. Staff members affected by professional … Read more
Published evidence summary
- The government stated in Hard Truths (November 2013) that it supported the development of evidence-based standard procedures and that professional bodies including royal colleges were engaged in this work (Hard Truths Vol 1, Cm 8777, Department of Health, November 2013).
- 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.
Healthcare providers (Primary)
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F12
Accepted
Fundamental standards of behaviour
Recommendation
Reporting of incidents of concern relevant to patient safety, compliance with fundamental standards or some higher requirement of the employer needs to be not only encouraged but insisted upon. Staff are entitled to receive feedback in relation to any report … Read more
Published evidence summary
- The statutory duty of candour was introduced through Regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, requiring registered providers to be open and transparent with patients when things go wrong (SI 2014/2936, Regulation 20, in force from 27 November 2014).
- 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).
Healthcare providers (Primary)
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F13
Accepted
The nature of standards
Recommendation
Standards should be divided into: Fundamental standards of minimum safety and quality – in respect of which non-compliance should not be tolerated. Failures leading to death or serious harm should remain offences for which prosecutions can be brought against organisations. … Read more
Published evidence summary
- The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 introduced fundamental standards divided into regulatory requirements enforceable by CQC, including person-centred care (Reg 9), dignity (Reg 10), safe care (Reg 12), good governance (Reg 17), and duty of candour (Reg 20) (SI 2014/2936, in force from 1 April 2015).
- 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).
Department of Health and Social Care (Primary)
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F14
Accepted in Part
The nature of standards
Recommendation
In addition to the fundamental standards of service, the regulations should include generic requirements for a governance system designed to ensure compliance with fundamental standards, and the provision and publication of accurate information about compliance with the fundamental and enhanced … Read more
Published evidence summary
- Regulation 17 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 establishes a fundamental standard for "Good governance," requiring providers to operate systems and processes to ensure compliance with the fundamental standards and to assess, monitor and improve the quality and safety of services (SI 2014/2936, Regulation 17).
- The 2014 Regulations require providers to publish information about compliance with fundamental standards as part of their regulatory obligations to CQC (SI 2014/2936).
- CQC inspections assess governance arrangements under the "Well-led" key question, examining whether organisations have effective governance systems for monitoring quality and compliance (CQC inspection framework).
- The Quality Accounts regulations (SI 2010/279, as amended) require NHS providers to publish annual reports on service quality, including information on safety, clinical effectiveness and patient experience (Health Act 2009, s.8; Quality Accounts regulations).
CQC (Primary)
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F15
Accepted in Part
The nature of standards
Recommendation

All the required elements of governance should be brought together into one comprehensive standard. This should require not only evidence of a working system but also a demonstration that it is being used to good effect.

Published evidence summary
- Regulation 17 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 requires providers to have systems and processes that enable them to assess, monitor and improve the quality and safety of services, evaluate and improve practice, and maintain accurate, complete and contemporaneous records (SI 2014/2936, Regulation 17).
- CQC inspections assess governance under the "Well-led" key question, which examines whether an organisation has effective governance structures, processes and systems of accountability that ensure the delivery of high-quality services (CQC inspection framework).
- The NHS Foundation Trust Code of Governance, published by NHS Improvement (now NHS England), sets out principles of good governance for NHS foundation trusts including board effectiveness and accountability (NHS Foundation Trust Code of Governance, Monitor/NHS Improvement, updated July 2014).
CQC (Primary)
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F16
Accepted
Responsibility for setting standards
Recommendation
The Government, through regulation, but after so far as possible achieving consensus between the public and professional representatives, should provide for the fundamental standards which should define outcomes for patients that must be avoided. These should be limited to those … Read more
Published evidence summary
- The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 established fundamental standards defining outcomes for patients that must be avoided. Regulations 9-20 set minimum standards covering person-centred care, dignity, consent, safe care, safeguarding, nutrition, premises, complaints, governance, staffing, fit and proper persons, and duty of candour (SI 2014/2936, in force from 1 April 2015).
- 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).
Department of Health and Social Care (Primary)
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F17
Accepted in Part
Responsibility for setting standards
Recommendation
The NHS Commissioning Board together with Clinical Commissioning Groups should devise enhanced quality standards designed to drive improvement in the health service. Failure to comply with such standards should be a matter for performance management by commissioners rather than the … Read more
Published evidence summary
- NHS England (formerly the NHS Commissioning Board) publishes quality standards and commissioning guidance. The NHS Outcomes Framework set out national outcome goals for the NHS, structured around five domains (NHS Outcomes Framework, Department of Health/DHSC, published annually 2012-2022).
- NICE quality standards provide evidence-based markers of high-quality care for commissioners to use when specifying services. Over 180 quality standards had been published by March 2026 (NICE quality standards, www.nice.org.uk).
- The NHS Standard Contract includes quality requirements and mechanisms for commissioners to performance-manage providers against quality standards (NHS Standard Contract, NHS England, annual publication).
- The NHS Outcomes Framework was integrated into the broader NHS planning guidance from 2023/24 onwards, and the independent role of commissioners in setting enhanced quality standards was reduced following the transition from Clinical Commissioning Groups to Integrated Care Boards under the Health and Care Act 2022 (Health and Care Act 2022, c.31).
- No published evidence that CQC has been specifically charged with enforcing the accuracy of provider information about compliance with enhanced quality standards, as distinct from its existing inspection role, has been identified.
NHS England (Primary)
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F18
Accepted
Responsibility for setting standards
Recommendation

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.

Published evidence summary
- NICE involves professional bodies, clinical experts and patient representatives in the development of guidelines and quality standards through its established guideline development process, including guideline committees with professional membership (NICE guidelines process and methods, NICE, www.nice.org.uk).
- 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).
Department of Health and Social Care (Primary)
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F19
Not Accepted
Gaps between the understood functions of separate regulators
Recommendation

There should be a single regulator dealing both with corporate governance, financial competence, viability and compliance with patient safety and quality standards for all trusts.

Published evidence summary
- The government did not accept the recommendation for a single regulator combining financial and quality oversight. Hard Truths (November 2013) stated that CQC and Monitor would retain separate but complementary roles (Hard Truths Vol 1, Cm 8777, Department of Health, November 2013).
- Monitor and the NHS Trust Development Authority were merged to form NHS Improvement in April 2016, bringing together financial oversight and performance management (NHS Improvement, established April 2016).
- NHS Improvement and NHS England formally merged on 1 July 2022 under the Health and Care Act 2022. Section 33 abolished Monitor and transferred its functions to NHS England; section 36 abolished the NHS Trust Development Authority (Health and Care Act 2022, c.31, ss.33, 36).
- CQC remains a separate regulator responsible for quality and safety standards. The recommendation for a single regulator covering both financial and quality regulation has not been implemented as described (CQC, continuing separate statutory role).
Department of Health and Social Care (Primary)
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F20
Accepted in Part
Responsibility for regulating and monitoring compliance
Recommendation
The Care Quality Commission should be responsible for policing the fundamental standards, through the development of its core outcomes, by specifying the indicators by which it intends to monitor compliance with those standards. It should be responsible not for directly … Read more
Published evidence summary
- CQC is responsible for monitoring and enforcing compliance with the fundamental standards set out in the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, Regulations 9-20 (SI 2014/2936).
- CQC's inspection model uses five key questions — Safe, Effective, Caring, Responsive, and Well-led — as the framework for assessing provider compliance. This model was introduced from October 2014 under the Chief Inspector of Hospitals (CQC inspection framework).
- CQC publishes ratings for each of the five key questions and an overall rating for each provider, making compliance assessment publicly visible (CQC ratings, published on CQC website).
- CQC's role in relation to enhanced standards is limited to monitoring the accuracy of published information rather than directly enforcing enhanced standards, consistent with the recommendation (CQC statutory framework).
CQC (Primary)
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F21
Accepted in Part
Responsibility for regulating and monitoring compliance
Recommendation
The regulator should have a duty to monitor the accuracy of information disseminated by providers and commissioners on compliance with standards and their compliance with the requirement of honest disclosure. The regulator must be willing to consider individual cases of … Read more
Published evidence summary
- CQC has a statutory duty under the Health and Social Care Act 2008 to assess whether providers are meeting the fundamental standards, and its inspection model examines governance and information accuracy under the "Well-led" key question (CQC inspection framework; Health and Social Care Act 2008).
- The statutory duty of candour (Regulation 20, SI 2014/2936) requires providers to be open and transparent with patients when things go wrong, and CQC can take enforcement action for breaches (SI 2014/2936, Regulation 20).
- CQC can and does investigate individual providers where concerns arise, including through focused inspections triggered by intelligence about potential failures (CQC enforcement policy).
- No published evidence has been identified of a specific, separate CQC duty to systematically monitor the accuracy of all information disseminated by providers and commissioners about their compliance with standards, as distinct from what CQC discovers through its inspection process.
CQC (Primary)
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F22
Accepted in Part
Responsibility for regulating and monitoring compliance
Recommendation
The National Institute for Health and Clinical Excellence should be commissioned to formulate standard procedures and practice designed to provide the practical means of compliance, and indicators by which compliance with both fundamental and enhanced standards can be measured. These … Read more
Published evidence summary
- NICE publishes clinical guidelines, quality standards, and technology appraisals that provide evidence-based guidance on compliance with standards. NICE quality standards include specific, measurable statements designed to drive quality improvement (NICE quality standards, www.nice.org.uk).
- NICE quality standards include both outcome and process measures, and are designed to be used by commissioners, providers and regulators to assess compliance (NICE quality standards methodology).
- NICE has published over 200 clinical guidelines and over 180 quality standards covering a wide range of clinical areas and patient pathways (NICE, www.nice.org.uk).
- NICE guidance is referenced in the NHS Standard Contract and CQC uses NICE guidelines in its assessment of whether providers are meeting the "Effective" key question (NHS Standard Contract, NHS England; CQC inspection framework).
F23
Accepted
Responsibility for regulating and monitoring compliance
Recommendation
The measures formulated by the National Institute for Health and Clinical Excellence should include measures not only of clinical outcomes, but of the suitability and competence of staff, and the culture of organisations. The standard procedures and practice should include … Read more
Published evidence summary
- NICE has published quality standards and clinical guidelines covering clinical outcomes across a range of specialties (NICE, www.nice.org.uk).
- 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.
F24
Accepted
Responsibility for regulating and monitoring compliance
Recommendation

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.

Published evidence summary
- CQC's five key questions — Safe, Effective, Caring, Responsive, and Well-led — are designed to be understood by the public and professionals. CQC publishes ratings using a four-point scale (Outstanding, Good, Requires Improvement, Inadequate) for each key question and overall (CQC inspection framework, from October 2014).
- 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).
CQC (Primary)
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F25
Accepted
Responsibility for regulating and monitoring compliance
Recommendation
It should be considered the duty of all specialty professional bodies, ideally together with the National Institute for Health and Clinical Excellence, to develop measures of outcome in relation to their work and to assist in the development of measures … Read more
Published evidence summary
- NICE works with specialist professional bodies and royal colleges in developing clinical guidelines and quality standards (NICE guidelines process, www.nice.org.uk).
- 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.
F26
Accepted
Responsibility for regulating and monitoring compliance
Recommendation
In policing compliance with standards, direct observation of practice, direct interaction with patients, carers and staff, and audit of records should take priority over monitoring and audit of policies and protocols. The regulatory system should retain the capacity to undertake … Read more
Published evidence summary
- CQC's inspection model, introduced from October 2014 under the Chief Inspector of Hospitals, prioritises direct observation of care, interviews with patients and staff, and review of records over audit of policies alone (CQC inspection framework, from October 2014).
- 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).
CQC (Primary)
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F27
Accepted
Responsibility for regulating and monitoring compliance
Recommendation
The healthcare systems regulator should promote effective enforcement by: use of a low threshold of suspicion; no tolerance of non-compliance with fundamental standards; and allowing no place for favourable assumptions, unless there is evidence showing that suspicions are ill-founded or … Read more
Published evidence summary
- CQC's enforcement policy states that it will take action proportionate to the seriousness of any breach and that it has "zero tolerance" of breaches of fundamental standards that put patients at risk (CQC enforcement policy).
- 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).
CQC (Primary)
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F28
Accepted
Sanctions and interventions for non-compliance
Recommendation
Zero tolerance: A service incapable of meeting fundamental standards should not be permitted to continue. Breach should result in regulatory consequences attributable to an organisation in the case of a system failure and to individual accountability where individual professionals are … Read more
Published evidence summary
- The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, Regulation 22, created a criminal offence where a registered person fails to comply with a fundamental standard and the failure results in avoidable harm to a service user, or exposes a service user to significant risk of such harm (SI 2014/2936, Regulation 22).
- 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).
CQC (Primary)
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F29
Accepted
Sanctions and interventions for non-compliance
Recommendation
It should be an offence for death or serious injury to be caused to a patient by a breach of these regulatory requirements, or, in any other case of breach, where a warning notice in respect of the breach has … Read more
Published evidence summary
- Regulation 22 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 created an offence where failure to comply with a fundamental standard results in avoidable harm or exposes a service user to significant risk of such harm. Regulation 22(3) provides a defence where the registered person can show that all reasonably practicable steps were taken to prevent the breach (SI 2014/2936, Regulation 22).
- 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).
Department of Health and Social Care (Primary)
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F30
Accepted
Interim measures
Recommendation
The healthcare regulator must be free to require or recommend immediate protective steps where there is reasonable cause to suspect a breach of fundamental standards, even if it has yet to reach a concluded view or acquire all the evidence. … Read more
Published evidence summary
- CQC has powers to impose urgent conditions on a provider's registration or to urgently suspend or cancel registration where there is a serious risk to a person's life, health or wellbeing. These powers can be exercised on an interim basis without prior consultation (Health and Social Care Act 2008, ss.31-32).
- 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).
CQC (Primary)
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F31
Accepted
Interim measures
Recommendation
Where aware of concerns that patient safety is at risk, Monitor and all other regulators of healthcare providers must have in place policies which ensure that they constantly review whether the need to protect patients requires use of their own … Read more
Published evidence summary
- NHS England (absorbing Monitor's and NHS Improvement's functions from July 2022) has oversight of NHS provider performance and can intervene where concerns about patient safety arise, including through the NHS Oversight Framework (NHS Oversight Framework, NHS England).
- 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).
Monitor (Primary)
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F32
Accepted
Interim measures
Recommendation
Where patient safety is believed on reasonable grounds to be at risk, Monitor and any other regulator should be obliged to take whatever action within their powers is necessary to protect patient safety. Such action should include, where necessary, temporary … Read more
Published evidence summary
- CQC has statutory powers to take urgent action to protect patients, including imposing urgent conditions on registration, urgent suspension, or urgent cancellation under sections 31-32 of the Health and Social Care Act 2008 (Health and Social Care Act 2008, ss.31-32).
- 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).
Monitor (Primary)
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F33
Accepted in Part
Interim measures
Recommendation

Insofar as healthcare regulators consider they do not possess any necessary interim powers, the Department of Health should consider introduction of the necessary amendments to legislation to provide such powers.

Published evidence summary
- CQC's interim powers were strengthened through amendments to the Health and Social Care Act 2008. Sections 31-32 provide powers for urgent conditions, suspension and cancellation of registration without prior notice where there is a serious risk (Health and Social Care Act 2008, ss.31-32).
- The Care Act 2014 and the Health and Care Act 2022 made further amendments to CQC's enforcement powers, including the power to conduct reviews of integrated care systems and expanded enforcement provisions (Care Act 2014; Health and Care Act 2022, c.31).
- The Criminal Justice and Courts Act 2015 added criminal offences for ill-treatment and wilful neglect (ss.20-21), providing an additional enforcement route beyond CQC's regulatory powers (Criminal Justice and Courts Act 2015, c.2, ss.20-21).
- No published evidence has been identified of any regulator reporting that it lacks necessary interim powers to protect patients since these legislative changes.
Department of Health and Social Care (Primary)
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F34
Accepted in Part
Interim measures
Recommendation

Where a provider is under regulatory investigation, there should be some form of external performance management involvement to oversee any necessary interim arrangements for protecting the public.

Published evidence summary
- Where CQC places a provider in special measures following an "Inadequate" rating, NHS England (and previously NHS Improvement) provides oversight and performance management support during the improvement period (CQC special measures framework; NHS England oversight arrangements).
- The NHS Oversight Framework, published by NHS England, sets out arrangements for identifying and supporting providers in difficulty, including the use of mandated support, recovery plans and, where necessary, intervention (NHS Oversight Framework, NHS England).
- For NHS foundation trusts, NHS England can appoint improvement directors or use its licensing powers to require governance improvements (NHS provider licence conditions).
- No published evidence of a formalised, independent external performance management body specifically mandated to oversee interim arrangements during regulatory investigations, as distinct from NHS England's existing oversight role, has been identified.
CQC (Primary)
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F35
Accepted
Need to share information between regulators
Recommendation
Sharing of intelligence between regulators needs to go further than sharing of existing concerns identified as risks. It should extend to all intelligence which when pieced together with that possessed by partner organisations may raise the level of concern. Work … Read more
Published evidence summary
- CQC, NHS England, the General Medical Council, the Nursing and Midwifery Council and other regulators have established memoranda of understanding and information-sharing agreements to facilitate the sharing of intelligence about provider concerns (inter-regulator memoranda of understanding).
- 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).
CQC (Primary)
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F36
Accepted
Use of information for effective regulation
Recommendation
A coordinated collection of accurate information about the performance of organisations must be available to providers, commissioners, regulators and the public, in as near real time as possible, and should be capable of use by regulators in assessing the risk … Read more
Published evidence summary
- CQC's Insight model brings together data from multiple sources including patient safety incidents, mortality statistics (including SHMI), staff survey data, complaints, whistleblowing intelligence, and information from other regulators to produce a risk-based assessment of provider performance (CQC Insight model).
- 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).
CQC (Primary)
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F37
Accepted
Use of information about compliance by regulator from: Quality accounts
Recommendation
Trust Boards should provide, through quality accounts, and in a nationally consistent format, full and accurate information about their compliance with each standard which applies to them. To the extent that it is not practical in a written report to … Read more
Published evidence summary
- The National Health Service (Quality Accounts) Regulations 2010 (SI 2010/279) require NHS providers to publish annual quality accounts containing prescribed information about service quality, including patient safety, clinical effectiveness and patient experience (SI 2010/279, Regulation 4 and Schedule).
- 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.
NHS Trusts (Primary)
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F38
Accepted
Use of information about compliance by regulator from: Complaints
Recommendation
The Care Quality Commission should ensure as a matter of urgency that it has reliable access to all useful complaints information relevant to assessment of compliance with fundamental standards, and should actively seek this information out, probably via its local … Read more
Published evidence summary
- Regulation 16 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 requires providers to establish and operate an accessible complaints system, investigate complaints, and take proportionate action. Regulation 16(3) requires providers to supply CQC with complaint summaries within 28 days on request (SI 2014/2936, Regulation 16).
- 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).
CQC (Primary)
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F39
Accepted in Part
Use of information about compliance by regulator from: Complaints
Recommendation

The Care Quality Commission should introduce a mandated return from providers about patterns of complaints, how they were dealt with and outcomes.

Published evidence summary
- Regulation 16(3) of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 requires providers to supply CQC with complaint summaries within 28 days when requested (SI 2014/2936, Regulation 16(3)).
- CQC inspections examine complaints data and processes under the "Responsive" key question. Inspectors can request complaints records during inspections (CQC inspection framework).
- No published evidence has been identified of a specific mandated return that all providers must submit to CQC on a regular basis covering patterns of complaints, how they were dealt with, and outcomes, distinct from the existing on-request power under Regulation 16(3) and information gathered during inspections.
- The Parliamentary and Health Service Ombudsman published NHS Complaint Standards providing a standardised approach to complaint handling across the NHS, though these are not a CQC-mandated return (PHSO, NHS Complaint Standards).
CQC (Primary)
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F40
Accepted
Use of information about compliance by regulator from: Complaints
Recommendation

It is important that greater attention is paid to the narrative contained in, for instance, complaints data, as well as to the numbers.

Published evidence summary
- CQC's inspection model examines complaints handling qualitatively under the "Responsive" key question, including how providers learn from the content and themes of complaints, not only complaint volumes (CQC inspection framework, from October 2014).
- 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).
CQC (Primary)
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F41
Accepted in Part
Use of information about compliance by regulator from: Patient safety alerts
Recommendation
The Care Quality Commission should have a clear responsibility to review decisions not to comply with patient safety alerts and to oversee the effectiveness of any action required to implement them. Information-sharing with the Care Quality Commission regarding patient safety … Read more
Published evidence summary
- The National Patient Safety Agency (NPSA) was abolished in June 2012. Its patient safety functions were transferred to NHS England (then the NHS Commissioning Board) (NPSA abolition, June 2012).
- NHS England operates the National Patient Safety Alerting System, which issues National Patient Safety Alerts with a standardised format requiring specific actions within defined timescales. The National Patient Safety Alerting Committee (NaPSAC) governed this system until November 2020, when its functions transferred to the National Patient Safety Committee (NaPSAC, NHS England).
- CQC inspections assess implementation of National Patient Safety Alerts, with the potential for regulatory action for non-compliance. CQC stated that inspection will focus on implementation of alerts (CQC inspection of patient safety alerts; NaPSAC framework).
- No published evidence has been identified of a specific, formalised CQC responsibility to review individual decisions not to comply with patient safety alerts, as distinct from examining alert implementation during inspections.
CQC (Primary)
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F42
Accepted
Use of information about compliance by regulator from: Serious untoward incidents
Recommendation

Strategic Health Authorities/their successors should

Published evidence summary
- Strategic Health Authorities were abolished on 1 April 2013 under the Health and Social Care Act 2012. Their functions relating to oversight of NHS providers transferred to NHS England and NHS Trust Development Authority (subsequently NHS Improvement, then merged into NHS England in July 2022) (Health and Social Care Act 2012; Health and Care Act 2022).
- 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).
F43
Accepted
Use of information about compliance by regulator from: Media
Recommendation

Those charged with oversight and regulatory roles in healthcare should monitor media reports about the organisations for which they have responsibility.

Published evidence summary
- The government stated in Hard Truths (November 2013) that regulators should be alert to information from all sources, including media reports, about the organisations they oversee (Hard Truths Vol 1, Cm 8777, Department of Health, November 2013).
- 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.
CQC (Primary)
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F44
Accepted in Part
Use of information about compliance by regulator from: Media
Recommendation
Any example of a serious incident or avoidable harm should trigger an examination by the Care Quality Commission of how that was addressed by the provider and a requirement for the trust concerned to demonstrate that the learning to be … Read more
Published evidence summary
- The Care Quality Commission (Registration) Regulations 2009, Regulations 16 and 18, require providers to notify CQC of deaths and other serious incidents (SI 2009/3112, Regulations 16, 18).
- CQC's inspection framework examines how providers investigate and learn from serious incidents and avoidable harm under the "Safe" and "Well-led" key questions. Inspectors review whether learning from incidents has been implemented (CQC inspection framework).
- The Patient Safety Incident Response Framework (PSIRF), mandatory from autumn 2023, requires providers to conduct proportionate investigations into patient safety events and to demonstrate that learning has been implemented (PSIRF, NHS England, August 2022).
- CQC can take enforcement action where it finds that a provider has failed to investigate incidents properly or implement learning, including through warning notices and conditions on registration (Health and Social Care Act 2008; CQC enforcement policy).
CQC (Primary)
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F45
Accepted in Part
Use of information about compliance by regulator from: Inquests
Recommendation

The Care Quality Commission should be notified directly of upcoming healthcare-related inquests, either by trusts or perhaps more usefully by coroners.

Published evidence summary
- The Care Quality Commission (Registration) Regulations 2009, Regulation 16, requires providers to notify CQC of the death of a service user (SI 2009/3112, Regulation 16).
- Coroners are required to send Prevention of Future Deaths (PFD) reports (formerly Rule 43 reports) to persons or organisations with the power to take action. CQC is listed as a "prescribed person" to whom relevant PFD reports should be copied (Coroners and Justice Act 2009; Chief Coroner's guidance).
- The government stated in Hard Truths (November 2013) that it supported the sharing of inquest-related information with CQC (Hard Truths Vol 2, Cm 8754, Department of Health, November 2013).
- No published evidence has been identified of a specific statutory requirement for coroners or trusts to notify CQC directly of all upcoming healthcare-related inquests in advance, as distinct from the existing PFD report-sharing arrangements after findings have been made.
CQC (Primary)
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F46
Accepted
Use of information about compliance by regulator from: Quality and risk profiles
Recommendation

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.

Published evidence summary
- CQC replaced the Quality and Risk Profile with its Insight model, which uses a wider range of intelligence sources and indicators to monitor provider risk (CQC Insight model, introduced progressively from 2014).
- 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).
CQC (Primary)
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F47
Accepted
Use of information about compliance by regulator from: Foundation trust governors and scrutiny committees
Recommendation

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'.

Published evidence summary
- CQC engages with local Healthwatch organisations (the successors to Local Involvement Networks established under the Health and Social Care Act 2012) as part of its intelligence gathering and inspection process (Health and Social Care Act 2012; CQC engagement with Healthwatch).
- 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.
CQC (Primary)
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F48
Accepted in Part
Use of information about compliance by regulator from: Foundation trust governors and scrutiny committees
Recommendation

The Care Quality Commission should send a personal letter, via each registered body, to each foundation trust governor on appointment, inviting them to submit relevant information about any concerns to the Care Quality Commission.

Published evidence summary
- NHS foundation trust governors have a statutory duty under the Health and Social Care Act 2006 (as amended by the Health and Social Care Act 2012) to hold the non-executive directors to account for the performance of the board, and may raise concerns about quality and safety (National Health Service Act 2006, s.151).
- CQC's inspection framework includes engagement with governors as part of the "Well-led" assessment, and governors can submit information to CQC about concerns (CQC inspection methodology).
- The government stated in Hard Truths (November 2013) that it supported governors having greater access to CQC and encouraged governors to report concerns (Hard Truths Vol 1, Cm 8777, Department of Health, November 2013).
- No published evidence has been identified that CQC sends a personal letter to each foundation trust governor on appointment inviting them to submit information about concerns, as described in this recommendation.
CQC (Primary)
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F49
Accepted
Enhancement of monitoring and the importance of inspection
Recommendation
Routine and risk-related monitoring, as opposed to acceptance of self-declarations of compliance, is essential. The Care Quality Commission should consider its monitoring in relation to the value to be obtained from: The Quality and Risk Profile; Quality Accounts; Reports from … Read more
Published evidence summary
- The government stated in Hard Truths (November 2013) that CQC would move to a system of routine monitoring and risk-based inspection, replacing reliance on provider self-declarations of compliance (Hard Truths Vol 1, Cm 8777, Department of Health, November 2013).
- 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).
CQC (Primary)
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F50
Accepted
Enhancement of monitoring and the importance of inspection
Recommendation

The Care Quality Commission should retain an emphasis on inspection as a central method of monitoring non-compliance.

Published evidence summary
- The government stated in Hard Truths (November 2013) that CQC would place far greater emphasis on inspection, with the appointment of Chief Inspectors of Hospitals, Adult Social Care, and General Practice (Hard Truths Vol 1, Cm 8777, Department of Health, November 2013).
- 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).
CQC (Primary)
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F51
Accepted
Enhancement of monitoring and the importance of inspection
Recommendation
The Care Quality Commission should develop a specialist cadre of inspectors by thorough training in the principles of hospital care. Inspections of NHS hospital care providers should be led by such inspectors who should have the support of a team, … Read more
Published evidence summary
- The government stated in Hard Truths (November 2013) that CQC would develop specialist inspection teams led by trained inspectors, including clinicians, other experts, and people with experience of using services (Hard Truths Vol 1, Cm 8777, Department of Health, November 2013).
- 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).
CQC (Primary)
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F52
Accepted
Enhancement of monitoring and the importance of inspection
Recommendation

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.

Published evidence summary
- CQC conducts Joint Targeted Area Inspections (JTAIs) alongside Ofsted, HMICFRS, and HM Inspectorate of Probation. These unannounced joint inspections evaluate the multi-agency response to child protection concerns. From April 2022, JTAIs take two forms: one evaluating the multi-agency "front door" of child protection, and another examining a specific theme such as domestic abuse, child sexual abuse in the family environment, or serious youth violence (Joint targeted area inspections framework, Ofsted/CQC/HMICFRS/HMIP, January 2018; New JTAI frameworks, Ofsted, April 2022).
- 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).
CQC (Primary)
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F53
Accepted
Care Quality Commission independence strategy and culture
Recommendation

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.

Published evidence summary
- The government stated in Hard Truths (November 2013) that it would retain CQC and reform it rather than replace it, consistent with this recommendation (Hard Truths Vol 1, Cm 8777, Department of Health, November 2013).
- 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).
Department of Health and Social Care (Primary)
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F54
Accepted
Care Quality Commission independence strategy and culture
Recommendation

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.

Published evidence summary
- The government stated in Hard Truths (November 2013) that CQC's independence would be strengthened and that relationships between CQC and other bodies would be clearly defined (Hard Truths Vol 1, Cm 8777, Department of Health, November 2013).
- 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.
CQC (Primary)
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F55
Accepted
Care Quality Commission independence strategy and culture
Recommendation

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.

Published evidence summary
- CQC undertook a comprehensive review of its processes following the Francis Report. The new inspection regime launched from October 2014 replaced the previous compliance-based model with specialist expert-led inspections against five key questions, a four-tier ratings system, and Fundamental Standards (CQC new inspection approach, CQC, September 2014).
- 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).
CQC (Primary)
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F56
Accepted
Care Quality Commission independence strategy and culture
Recommendation

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.

Published evidence summary
- CQC published a series of "A fresh start" strategy documents in October 2013 setting out its new approach to regulation and inspection by sector, including for hospitals, adult social care, mental health, and GP practices (A fresh start, CQC, October 2013).
- 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).
CQC (Primary)
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F57
Accepted
Care Quality Commission independence strategy and culture
Recommendation
The Care Quality Commission should undertake a formal evaluation of how it would detect and take action on the warning signs and other events giving cause for concern at the Trust described in this report, and in the report of … Read more
Published evidence summary
- CQC developed "Intelligent Monitoring" reports from March 2014, which brought together over 150 indicators for acute NHS trusts to help identify where risks to quality of care might be greatest. These were designed to serve as an early warning system for potential quality failures (CQC Intelligent Monitoring, CQC, March 2014).
- 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.
CQC (Primary)
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F58
Accepted
Care Quality Commission independence strategy and culture
Recommendation
Patients, through their user group representatives, should be integrated into the structure of the Care Quality Commission. It should consider whether there is a place for a patients' consultative council with which issues could be discussed to obtain a patient … Read more
Published evidence summary
- CQC's Experts by Experience programme integrates people with personal experience of using health and social care services into inspection teams. Experts by Experience conduct conversations with service users during inspections, make observations, and contribute to inspection findings (Experts by Experience programme, CQC).
- 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.
CQC (Primary)
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F59
Accepted in Part
Care Quality Commission independence strategy and culture
Recommendation
Consideration should be given to the introduction of a category of nominated board members from representatives of the professions, for example, the Academy of Medical Royal Colleges, a representative of nursing and allied healthcare professionals, and patient representative groups. Read more
Published evidence summary
- CQC's board composition is governed by Schedule 1 to the Health and Social Care Act 2008, which provides for a Chair and non-executive members appointed by the Secretary of State, together with executive members. No statutory requirement for nominated board members from professional or patient representative bodies has been introduced (Health and Social Care Act 2008, Schedule 1).
- CQC's board as at 31 March 2024 comprised the Chair and up to 14 board members, the majority of whom must be non-executive. Non-executive directors are appointed through the standard public appointments process managed by the Cabinet Office (CQC corporate governance report 2023-24, CQC).
- CQC uses specialist professional advisers — including clinicians nominated by Royal Colleges and other professional bodies — on inspection teams, but these are operational roles, not board-level governance positions (CQC inspection team: NHS trusts, CQC).
- No published evidence has been identified that a category of nominated board members from the Academy of Medical Royal Colleges, nursing and allied healthcare professional representatives, or patient representative groups has been introduced at CQC.
CQC (Primary)
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F60
Accepted in Part
Consolidation of regulatory functions
Recommendation

The Secretary of State should consider transferring the functions of regulating governance of healthcare providers and the fitness of persons to be directors, governors or equivalent persons from Monitor to the Care Quality Commission.

Published evidence summary
- 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, giving CQC responsibility for ensuring that directors of registered providers meet fitness requirements including good character, qualifications, and competence. CQC can require the removal of directors who do not meet the standard (SI 2014/2936, Regulation 5).
- Monitor merged with the NHS Trust Development Authority to form NHS Improvement on 1 April 2016. NHS Improvement subsequently merged into NHS England from 1 July 2022 under sections 33 and 36 of the Health and Care Act 2022 (Health and Care Act 2022, ss.33, 36).
- The Kark review of the Fit and Proper Person Test (2019) found that it "does not ensure directors are fit for the post they hold, and does not stop the unfit from moving around the system." NHS England published an updated FPPT Framework effective 30 September 2023 requiring standardised board-level assessments (Kark review, February 2019; NHS England FPPT Framework, September 2023).
- CQC gained responsibility for the fitness of directors through Regulation 5, but broader governance regulation of foundation trusts (including the licensing regime) remained with Monitor/NHS Improvement/NHS England rather than being transferred to CQC. The regulatory landscape was reorganised but not in the manner Francis specifically recommended.
Department of Health and Social Care (Primary)
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F61
Not Accepted
Consolidation of regulatory functions
Recommendation
A merger of system regulatory functions between Monitor and the Care Quality Commission should be undertaken incrementally and after thorough planning. Such a move should not be used as a justification for reduction of the resources allocated to this area … Read more
Published evidence summary
- The government did not merge the system regulatory functions of Monitor and CQC as Francis recommended. Instead, it maintained CQC as an independent quality regulator while restructuring provider regulation separately (Hard Truths Vol 1, Cm 8777, Department of Health, November 2013).
- Monitor merged with the NHS Trust Development Authority to form NHS Improvement on 1 April 2016, bringing together financial regulation, performance management, and patient safety functions within a single organisation (Monitor is now part of NHS Improvement, DHSC, April 2016).
- NHS Improvement merged into NHS England from 1 July 2022 under sections 33 and 36 of the Health and Care Act 2022, formally abolishing Monitor and the NHS Trust Development Authority and transferring their functions to NHS England (Health and Care Act 2022, ss.33, 36).
- CQC remains a separate statutory body from NHS England. The regulatory architecture has been consolidated through successive mergers (Monitor→NHS Improvement→NHS England) but CQC has not been merged with any of these bodies. The specific merger of system regulatory functions between Monitor and CQC that Francis recommended has not been undertaken.
Department of Health and Social Care (Primary)
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F62
Accepted
Improved patient focus
Recommendation

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.

Published evidence summary
- Monitor merged with the NHS Trust Development Authority to form NHS Improvement on 1 April 2016. NHS Improvement subsequently merged into NHS England from 1 July 2022 under sections 33 and 36 of the Health and Care Act 2022. Monitor no longer exists as a separate body (Health and Care Act 2022, ss.33, 36).
- 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.
Monitor (Primary)
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F63
Accepted
Improved transparency
Recommendation

Monitor should publish all side letters and any rating issued to trusts as part of their authorisation or licence.

Published evidence summary
- Monitor's Risk Assessment Framework (revised August 2015) described how it assessed foundation trust compliance with licence conditions. Monitor assigned quarterly risk ratings for finance and governance, which were published (Monitor Risk Assessment Framework, Monitor, August 2015).
- 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.
Monitor (Primary)
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F64
Not Accepted
Authorisation of foundation trusts
Recommendation
The authorisation process should be conducted by one regulator, which should be equipped with the relevant powers and expertise to undertake this effectively. With due regard to protecting the public from the adverse consequences inherent to any reorganisation, the regulation … Read more
Published evidence summary
- The government did not transfer the foundation trust authorisation process to CQC as Francis recommended. Instead, it maintained separate roles: CQC assessed quality and published ratings, while Monitor (subsequently NHS Improvement, then NHS England) retained responsibility for the provider licensing regime (Hard Truths Vol 1, Cm 8777, Department of Health, November 2013).
- The NHS provider licence, published by Monitor on 14 February 2013, replaced foundation trusts' Terms of Authorisation from 1 April 2013. From 1 April 2023, all NHS trusts were also required to hold a provider licence, bringing both trust types under the same regulatory conditions (NHS provider licence consultation response, NHS England).
- The foundation trust application pipeline was effectively closed. Most applications were paused or deferred by January 2014, and no formal policy announcement ended the programme. The Health and Care Act 2022 significantly narrowed the practical distinction between NHS trusts and foundation trusts by bringing both under the same licensing regime and giving NHS England capital expenditure controls over foundation trusts (Health and Care Act 2022, ss.61-62).
- On 12 November 2025, the Secretary of State announced the Advanced Foundation Trust Programme, under which both NHS trusts and foundation trusts may apply for enhanced autonomy. First wave assessment is scheduled from April 2026. This represents a reinvention of the model rather than the single-regulator approach Francis envisaged (Advanced Foundation Trust Programme guide, NHS England, November 2025).
Department of Health and Social Care (Primary)
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F65
Accepted
Quality of care as a pre-condition for foundation trust applications
Recommendation

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.

Published evidence summary
- The NHS Trust Development Authority, established in 2012, oversaw NHS trusts that had not achieved foundation trust status. The TDA merged into NHS Improvement on 1 April 2016 (NHS Trust Development Authority, GOV.UK).
- 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.
F66
Accepted
Improving contribution of stakeholder opinions
Recommendation
The Department of Health, the NHS Trust Development Authority and Monitor should jointly review the stakeholder consultation process with a view to ensuring that: Local stakeholder and public opinion is sought on the fitness of a potential applicant NHS trust … Read more
Published evidence summary
- The government stated in Hard Truths (November 2013) that it would strengthen the foundation trust application process, including stakeholder consultation (Hard Truths Vol 1, Cm 8777, Department of Health, November 2013).
- 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).
Department of Health and Social Care (Primary)
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F67
Accepted
Focus on compliance with fundamental standards
Recommendation
The NHS Trust Development Authority should develop a rigorous process for the assessment as well as the support of potential applicants for foundation trust status. The assessment must include as a priority focus a review of the standard of service … Read more
Published evidence summary
- The NHS Trust Development Authority oversaw NHS trusts and was responsible for supporting and assessing potential foundation trust applicants. The TDA merged into NHS Improvement on 1 April 2016 (NHS Trust Development Authority, GOV.UK).
- 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).
F68
Accepted
Focus on compliance with fundamental standards
Recommendation
No NHS trust should be given support to make an application to Monitor unless, in addition to other criteria, the performance manager (the Strategic Health Authority cluster, the Department of Health team, or the NHS Trust Development Authority) is satisfied … Read more
Published evidence summary
- Strategic Health Authorities were abolished on 1 April 2013 under the Health and Social Care Act 2012. Their performance management functions transferred to the NHS Trust Development Authority (for NHS trusts) and NHS England (for commissioning) (Health and Social Care Act 2012).
- 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).
F69
Accepted
Focus on compliance with fundamental standards
Recommendation
The assessment criteria for authorisation should include a requirement that applicants demonstrate their ability to consistently meet fundamental patient safety and quality standards at the same time as complying with the financial and corporate governance requirements of a foundation trust. Read more
Published evidence summary
- The NHS provider licence, which replaced foundation trusts' Terms of Authorisation from 1 April 2013, includes Condition FT4 (Governance) requiring providers to demonstrate clear accountability for quality of care, including systems and processes for escalating and resolving quality issues to board level. All NHS provider trusts must self-certify annually against this condition (NHS provider licence conditions, NHS England).
- 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).
Monitor (Primary)
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F70
Accepted
Duty of utmost good faith
Recommendation
A duty of utmost good faith should be imposed on applicants for foundation trust status to disclose to the regulator any significant information material to the application and to ensure that any information is complete and accurate. This duty should … Read more
Published evidence summary
- Regulation 17(3) of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 requires providers to submit written reports to CQC within 28 days of request, and information provided must be "up to date, accurate and properly analysed and reviewed" (SI 2014/2936, Regulation 17).
- 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).
Monitor (Primary)
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F71
Accepted
Role of Secretary of State
Recommendation
The Secretary of State's support for an application should not be given unless he is satisfied that the proposed applicant provides a service to patients which is, at the time of his consideration, safe, effective and compliant with all relevant … Read more
Published evidence summary
- The foundation trust application pipeline was effectively closed by 2014, with most applications paused or deferred. No further trusts were authorised as foundation trusts through the standard application process after this period.
- 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).
Department of Health and Social Care (Primary)
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F72
Accepted
Assessment process for authorisation
Recommendation
The assessment for an authorisation of applicant for foundation trust status should include a full physical inspection of its primary clinical areas as well as all wards to determine whether it is compliant with fundamental safety and quality standards. Read more
Published evidence summary
- The foundation trust application pipeline was effectively closed by 2014. No published evidence has been identified that a specific requirement for full physical inspection of all primary clinical areas and wards was incorporated into the authorisation process before it ceased.
- 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).
Monitor (Primary)
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F73
Accepted
Need for constructive working with other parts of the system
Recommendation
The Department of Health's regular performance reviews of Monitor (and the Care Quality Commission) should include an examination of its relationship with the Department of Health and whether the appropriate degree of clarity of understanding of the scope of their … Read more
Published evidence summary
- The government stated in Hard Truths (November 2013) that it would strengthen the accountability and performance management of arm's-length bodies including Monitor and CQC (Hard Truths Vol 1, Cm 8777, Department of Health, November 2013).
- 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.
Department of Health and Social Care (Primary)
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F74
Accepted
Enhancement of role of governors
Recommendation
Monitor and the Care Quality Commission should publish guidance for governors suggesting principles they expect them to follow in recognising their obligation to account to the public, and in particular in arranging for communication with the public served by the … Read more
Published evidence summary
- Monitor published "Your Statutory Duties: A Reference Guide for NHS Foundation Trust Governors" in August 2013, updated November 2013. This guide sets out governors' statutory duties as amended by the Health and Social Care Act 2012, including their obligation to represent the interests of members and the public (Your Statutory Duties, Monitor, August 2013).
- 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).
Monitor (Primary)
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F75
Accepted in Part
Enhancement of role of governors
Recommendation
The Council of Governors and the board of each foundation trust should together consider how best to enhance the ability of the council to assist in maintaining compliance with its obligations and to represent the public interest. They should produce … Read more
Published evidence summary
- Section 151 of the Health and Social Care Act 2012 strengthened the role of councils of governors. New paragraph 10C inserted into Schedule 7 of the National Health Service Act 2006 provides that "the council of governors may require one or more of the directors to attend a meeting" for the purpose of obtaining information about the trust's performance or the directors' performance. Any such meetings must be reported in the trust's annual report (Health and Social Care Act 2012, s.151).
- Monitor published "Your Statutory Duties: A Reference Guide for NHS Foundation Trust Governors" (August 2013, updated November 2013) setting out governors' statutory duties and the expected relationship between the council of governors and the board of directors (Your Statutory Duties, Monitor, August 2013).
- NHS England published an addendum on 27 October 2022 explaining how governor duties support system working and collaboration, with examples of good practice in describing the governor role and how it is performed (Addendum to Your Statutory Duties, NHS England, October 2022).
- Foundation trusts are required to publish their constitutions, which describe the composition and role of the council of governors. The NHS provider licence Condition FT4 (Governance) requires providers to have effective governance arrangements (NHS provider licence conditions, NHS England).
NHS Trusts (Primary)
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F76
Accepted
Enhancement of role of governors
Recommendation

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.

Published evidence summary
- Section 151 of the Health and Social Care Act 2012 strengthened governor accountability by requiring councils of governors to hold non-executive directors to account for the performance of the board and enabling governors to require directors to attend meetings (Health and Social Care Act 2012, s.151).
- 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.
NHS Trusts (Primary)
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F77
Accepted
Enhancement of role of governors
Recommendation
Monitor and the NHS Commissioning Board should review the resources and facilities made available for the training and development of governors to enhance their independence and ability to expose and challenge deficiencies in the quality of the foundation trust's services. Read more
Published evidence summary
- NHS Providers (formerly the Foundation Trust Network) operates the GovernWell programme, established in 2013, providing national training and support for NHS foundation trust governors. The programme includes modules for new governors (introduction to the role, governance and accountability, effective questioning and challenge, member and public engagement) and experienced governors (NHS finance and business skills, recruitment and non-executive appointments, effective chairing). NHS Providers reports that 99% of delegates recommend the training (GovernWell, NHS Providers).
- 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).
NHS England (Primary)
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F78
Accepted
Enhancement of role of governors
Recommendation
The Care Quality Commission and Monitor should consider how best to enable governors to have access to a similar advisory facility in relation to compliance with healthcare standards as will be available for compliance issues in relation to breach of … Read more
Published evidence summary
- Section 39A of the National Health Service Act 2006 (inserted by the Health and Social Care Act 2012) provides for a panel to consider disputes between governors and boards of foundation trusts. This enables governors to refer questions about whether the trust has failed or is failing to comply with its constitution, or whether the directors have failed or are failing to comply with a duty under Chapter 5 of the 2006 Act (National Health Service Act 2006, s.39A).
- 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).
CQC (Primary)
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F79
Accepted in Part
Accountability of providers' directors
Recommendation
There should be a requirement that all directors of all bodies registered by the Care Quality Commission as well as Monitor for foundation trusts are, and remain, fit and proper persons for the role. Such a test should include a … Read more
Published evidence summary
- Regulation 5 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 introduced the Fit and Proper Person Requirement, in force from November 2014. It applies to all directors of bodies registered with CQC and requires them to be of good character, to have the necessary qualifications, competence, skills and experience, and to be physically and mentally fit. CQC can require the removal of directors who do not meet the standard (SI 2014/2936, Regulation 5).
- The Kark review (February 2019), commissioned by the Secretary of State, found that the FPPT "does not ensure directors are fit for the post they hold, and does not stop the unfit from moving around the system." The review made seven recommendations, including a central database of directors and a power to disbar for serious misconduct. The Secretary of State accepted five of the seven recommendations but did not accept the disbarment power at that time (Kark review of the fit and proper persons test, DHSC, February 2019).
- NHS England published an updated FPPT Framework effective 30 September 2023, implementing five of the Kark recommendations. The framework requires standardised documented FPPT assessments for all board member appointments and annually thereafter. A Leadership Competency Framework with six domains was published on 28 February 2024, to be incorporated into board member role descriptions and recruitment from 1 April 2024 (FPPT Framework for board members, NHS England, August 2023; Leadership Competency Framework, NHS England, February 2024).
- No published evidence has been identified of a single prescribed code of conduct specifically for NHS directors, as distinct from the general requirements of the FPPT, the Leadership Competency Framework, and the Nolan Principles of Public Life which apply to all holders of public office.
CQC (Primary)
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F80
Accepted in Part
Accountability of providers' directors
Recommendation

A finding that a person is not a fit and proper person on the grounds of serious misconduct or incompetence should be a circumstance added to the list of disqualifications in the standard terms of a foundation trust's constitution.

Published evidence summary
- The model core constitution for NHS foundation trusts, published by Monitor in May 2013 and updated in September 2014, includes disqualification criteria for directors. Following the introduction of Regulation 5 (November 2014), the model constitution was updated to provide that directors who are not "fit and proper" within the meaning of the Regulations are disqualified from holding office (NHS foundation trusts: model core constitution, Monitor/GOV.UK, May 2013, updated September 2014).
- The Kark review (February 2019) recommended a power to disbar individuals from board positions for serious misconduct (Recommendation 5). The Secretary of State did not accept this recommendation at the time (Kark review, DHSC, February 2019).
- The government subsequently reversed its position. A consultation on regulating NHS managers ran from 26 November 2024 to 18 February 2025. The consultation response, published 21 July 2025, confirmed that the government will bring forward secondary legislation to implement a statutory barring system for senior NHS leaders, to be operated by the Health and Care Professions Council. Those found to have committed serious misconduct will be added to a barred list preventing them from holding senior NHS management roles. Draft legislation is to be subject to further public consultation, with parliamentary debate anticipated in the second half of 2026 (Leading the NHS: proposals to regulate NHS managers, DHSC, consultation response, July 2025).
- The NHS England FPPT Framework (effective September 2023) introduced mandatory Board Member References when directors leave, which must include information about investigations relevant to serious misconduct within six years preceding departure. This aims to prevent unfit directors moving between organisations, though it operates through a reference system rather than a formal disqualification register (FPPT Framework, NHS England, August 2023).
CQC (Primary)
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F81
Accepted
Accountability of providers' directors
Recommendation

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.

Published evidence summary
- Regulation 5 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 requires that directors possess "the qualifications, competence, skills and experience which are necessary for the relevant office or position or the work for which they are employed." However, the regulation does not prescribe specific minimum levels of experience or particular qualifications (SI 2014/2936, Regulation 5).
- 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).
CQC (Primary)
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F82
Accepted
Accountability of providers' directors
Recommendation
Provision should be made for regulatory intervention to require the removal or suspension from office after due process of a person whom the regulator is satisfied is not or is no longer a fit and proper person, regardless of whether … Read more
Published evidence summary
- Regulation 5 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 provides that CQC can require the removal of directors who do not meet the fit and proper person standard. However, CQC cannot prosecute for a breach of Regulation 5. The responsibility for appointing, managing and dismissing directors rests with providers, not CQC (SI 2014/2936, Regulation 5; CQC guidance on Regulation 5).
- 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).
CQC (Primary)
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F83
Accepted
Accountability of providers' directors
Recommendation
If a "fit and proper person test" is introduced as recommended, Monitor should issue guidance on the principles on which it would exercise its power to require the removal or suspension or disqualification of directors who did not fulfil it, … Read more
Published evidence summary
- CQC published guidance on Regulation 5 (Fit and Proper Persons: Directors) setting out the requirements that providers must meet and the approach CQC takes to assessing compliance. The guidance states that CQC can "insist on the removal of directors that fail this test" but that the responsibility for appointing, managing and dismissing directors sits with providers (CQC guidance on Regulation 5, CQC).
- 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).
Monitor (Primary)
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F84
Accepted in Part
Accountability of providers' directors
Recommendation
Where the contract of employment or appointment of an executive or non-executive director is terminated in circumstances in which there are reasonable grounds for believing that he or she is not a fit and proper person to hold such a … Read more
Published evidence summary
- The NHS England FPPT Framework (effective September 2023) mandates that organisations complete a Board Member Reference (BMR) when any board member leaves their position, regardless of the reason for departure and regardless of whether a future employer has requested a reference. References must include information about investigations (upheld, ongoing, or discontinued) relevant to serious misconduct or mismanagement within six years preceding departure. References are retained on a career-long basis (Guidance for chairs on FPPT implementation, NHS England, September 2023).
- The FPPT Framework requires annual submissions to NHS England regional directors summarising FPPT outcomes for each board member. Any adverse findings must include written records of mitigations. For NHS England-appointed chairs, exit BMRs should be retained by both the local organisation and NHS England's Appointments team (FPPT Framework, NHS England, August 2023).
- The framework operates through a mandatory reference system rather than through a real-time notification obligation to CQC at the point of departure. No published evidence has been identified of a specific licence condition requiring trusts to report to CQC when a director's contract is terminated amid fitness concerns, as distinct from the BMR system and annual FPPT reporting to NHS England.
- The government consultation response on regulating NHS managers (July 2025) confirmed plans for a statutory barring system operated by the Health and Care Professions Council. Once implemented, this would create a formal regulatory mechanism for recording and sharing information about directors found guilty of serious misconduct (Leading the NHS consultation response, DHSC, July 2025).
Healthcare providers (Primary)
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F85
Accepted
Accountability of providers' directors
Recommendation
Monitor and the Care Quality Commission should produce guidance to NHS and foundation trusts on procedures to be followed in the event of an executive or non-executive director being found to have been guilty of serious failure in the performance … Read more
Published evidence summary
- CQC published guidance on Regulation 5 (Fit and Proper Persons: Directors) setting out the circumstances in which directors may be found not to meet the fitness standard (CQC guidance on Regulation 5, CQC).
- 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).
CQC (Primary)
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F86
Accepted
Requirement of training of directors
Recommendation

A requirement should be imposed on foundation trusts to have in place an adequate programme for the training and continued development of directors.

Published evidence summary
- The NHS Leadership Academy provides multiple board-level development programmes including the Nye Bevan Programme (12-month programme for aspiring board members), the Aspiring Chief Executive Programme (joint with NHS Providers), First Time Chief Executives support modules, the Aspirant Chair Talent Programme, and the NExT Director Programme for aspiring non-executive directors (NHS Leadership Academy programmes).
- 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.
NHS Trusts (Primary)
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F87
Accepted in Part
Ensuring the utility of a health and safety function in a clinical setting
Recommendation
The Health and Safety Executive is clearly not the right organisation to be focusing on healthcare. Either the Care Quality Commission should be given power to prosecute 1974 Act offences or a new offence containing comparable provisions should be created … Read more
Published evidence summary
- CQC was given powers to prosecute for offences of ill-treatment or wilful neglect of individuals by care providers or care workers under sections 20 and 21 of the Criminal Justice and Courts Act 2015, which came into force on 13 April 2015. The offence of ill-treatment or wilful neglect by a care provider (section 21) carries an unlimited fine on conviction on indictment (Criminal Justice and Courts Act 2015, ss.20-21).
- CQC was given the power to prosecute providers registered under the Health and Social Care Act 2008 for a wider range of regulatory offences under the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. These include offences for failure to provide safe care and treatment (Regulation 12), failure to meet nutritional and hydration needs (Regulation 14), and other fundamental standards where a breach results in avoidable harm or a significant risk of harm (SI 2014/2936).
- HSE and CQC published a memorandum of understanding (most recently revised 2014) setting out their respective roles in relation to health and safety in healthcare settings. The MoU provides that CQC leads on patient safety matters, while HSE leads on workplace safety, with arrangements for information sharing and referral between the two bodies (HSE/CQC Memorandum of Understanding, 2014).
- The Health and Safety Executive retains responsibility for enforcing the Health and Safety at Work etc. Act 1974 in healthcare settings where the risk relates to workers or members of the public other than patients. CQC has not been given statutory power to prosecute under the 1974 Act itself. The approach taken was to strengthen CQC's own prosecution powers for patient safety offences rather than to transfer 1974 Act prosecution powers to CQC (Health and Safety at Work etc. Act 1974; Health and Social Care Act 2008 (Regulated Activities) Regulations 2014).
Department of Health and Social Care (Primary)
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F88
Accepted in Part
Information sharing
Recommendation
The information contained in reports for the Reporting of Injuries, Diseases and Dangerous Occurrences Regulations should be made available to healthcare regulators through the serious untoward incident system in order to provide a check on the consistency of trusts' practice … Read more
Published evidence summary
- HSE and CQC published a memorandum of understanding setting out arrangements for information sharing between the two organisations. Under the MoU, HSE shares information with CQC about RIDDOR reports received from healthcare providers, including reports of deaths, specified injuries and dangerous occurrences. CQC uses RIDDOR data as part of its intelligence model for monitoring providers (HSE/CQC Memorandum of Understanding, 2014).
- The Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 2013 (RIDDOR) require employers, including NHS trusts, to report specified workplace incidents to HSE. This includes deaths arising out of or in connection with work, and specified injuries to workers or non-workers (including patients in some circumstances). NHS trusts report through the HSE online reporting system (SI 2013/1471).
- CQC's Insight intelligence model, introduced from 2017, draws on multiple data sources including RIDDOR reports shared by HSE, alongside other datasets such as the National Reporting and Learning System, mortality data, staff surveys, and complaints data, to identify providers requiring regulatory attention (CQC corporate strategy and Insight model documentation).
- The Patient Safety Incident Response Framework (PSIRF), which became mandatory for NHS trusts from autumn 2023, replaced the Serious Incident Framework. PSIRF requires trusts to record and respond to patient safety incidents through the Learn from Patient Safety Events (LFPSE) service. RIDDOR reporting obligations run in parallel to LFPSE reporting where incidents meet the criteria for both systems (PSIRF, NHS England, August 2022).
F89
Accepted in Part
Information sharing
Recommendation

Reports on serious untoward incidents involving death of or serious injury to patients or employees should be shared with the Health and Safety Executive.

Published evidence summary
- HSE and CQC published a memorandum of understanding (most recently revised 2014) providing for reciprocal information sharing. Under the MoU, CQC shares serious incident information with HSE where incidents may engage health and safety at work legislation, and HSE shares RIDDOR reports with CQC to support its regulatory intelligence (HSE/CQC Memorandum of Understanding, 2014).
- The Patient Safety Incident Response Framework (PSIRF), mandatory for NHS trusts from autumn 2023, requires trusts to record all patient safety incidents through the Learn from Patient Safety Events (LFPSE) service. LFPSE replaced the National Reporting and Learning System (NRLS), which was decommissioned in June 2024. Where a patient safety incident also meets RIDDOR reporting criteria (e.g. a death arising out of or in connection with work), the trust must report to both LFPSE and HSE (PSIRF, NHS England, August 2022; LFPSE service, NHS England).
- The Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 2013 require healthcare providers to report to HSE deaths and specified injuries to any person arising out of or in connection with work activities, which can include deaths of patients in certain circumstances (SI 2013/1471).
- The NHS England National Patient Safety Alerting System issues national patient safety alerts through the Central Alerting System (CAS). These alerts are shared across the health system and are accessible to all relevant regulatory bodies including HSE (NHS England patient safety alerting).
Healthcare providers (Primary)
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F90
Accepted
Assistance in deciding on prosecutions
Recommendation
In order to determine whether a case is so serious, either in terms of the breach of safety requirements or the consequences for any victims, that the public interest requires individuals or organisations to be brought to account for their … Read more
Published evidence summary
- HSE published guidance on the selection and management of expert witnesses in enforcement proceedings, including healthcare-related cases. HSE uses expert medical and clinical advisors when investigating potential health and safety offences in healthcare settings (HSE enforcement guidance).
- 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).
F91
Accepted in Part
NHS Litigation Authority Improvement of risk management
Recommendation
The Department of Health and NHS Commissioning Board should consider what steps are necessary to require all NHS providers, whether or not they remain members of the NHS Litigation Authority scheme, to have and to comply with risk management standards … Read more
Published evidence summary
- NHS Resolution (formerly the NHS Litigation Authority, renamed in April 2017) operates three risk management schemes: the Clinical Negligence Scheme for Trusts (CNST), the Risk Pooling Scheme for Trusts (RPST), and the Existing Liabilities Scheme (ELS). All NHS trusts in England are members of CNST; membership is effectively a condition of participation in the NHS (NHS Resolution annual report and accounts 2023-24).
- NHS Resolution's Clinical Negligence Scheme for Trusts has a maternity incentive scheme (MIS), introduced in 2018 and now in its sixth year, which requires trusts to meet ten safety actions to qualify for a contribution rebate. For the sixth year (2024-25), trusts must demonstrate compliance with safety standards including those relating to incident investigation, learning from incidents, and safety culture (CNST Maternity Incentive Scheme Year 6, NHS Resolution).
- The NHS Standard Contract, mandated for all NHS-funded secondary care services, requires providers to have in place risk management systems and to comply with CQC fundamental standards including Regulation 12 (safe care and treatment) and Regulation 17 (good governance). Non-compliance is enforceable through contract mechanisms by commissioners (NHS Standard Contract 2024/25, NHS England).
- CQC's fundamental standards (the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014) apply to all registered providers regardless of CNST membership status. Regulation 17 (good governance) requires providers to "assess, monitor and mitigate the risks relating to the health, safety and welfare of service users" (SI 2014/2936, Regulation 17).
Department of Health and Social Care (Primary)
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F92
Accepted
NHS Litigation Authority Improvement of risk management
Recommendation

The financial incentives at levels below level 3 should be adjusted to maximise the motivation to reach level 3.

Published evidence summary
- NHS Resolution (formerly the NHS Litigation Authority) operated a Clinical Risk Management Standards (CRMS) assessment scheme with three levels, where trusts assessed at level 3 received larger premium discounts than those at lower levels. This was the scheme to which the recommendation referred.
- 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.
F93
Accepted in Part
NHS Litigation Authority Improvement of risk management
Recommendation
The NHS Litigation Authority should introduce requirements with regard to observance of the guidance to be produced in relation to staffing levels, and require trusts to have regard to evidence-based guidance and benchmarks where these exist and to demonstrate that … Read more
Published evidence summary
- NICE published safe staffing guidance SG1 (Safe staffing for nursing in adult inpatient wards in acute hospitals) in July 2014, directly in response to the Francis Report. The guidance endorsed the use of evidence-based tools and professional judgement to set staffing levels, including the Safer Nursing Care Tool and the Shelford Group Safer Nursing Care Tool (SG1, NICE, July 2014).
- NHS Resolution's maternity incentive scheme (MIS) includes safety actions related to safe staffing. Year 6 (2024-25) requires trusts to demonstrate they have effective workforce planning processes and that they can evidence how staffing decisions take account of acuity and activity (CNST Maternity Incentive Scheme Year 6, NHS Resolution).
- NHS England published the Developing Workforce Safeguards framework (October 2018), which requires all NHS trusts to use evidence-based tools, professional judgement, and outcomes data to inform staffing decisions. CQC uses the Developing Workforce Safeguards as a reference point when assessing staffing under the well-led framework (Developing Workforce Safeguards, NHS England, October 2018).
- The NHS Standard Contract requires providers to maintain adequate staffing levels to deliver safe care and comply with CQC fundamental standards. Regulation 18 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 requires sufficient numbers of suitably qualified, competent, skilled and experienced staff to meet care needs (SI 2014/2936, Regulation 18).
F94
Accepted
Evidence-based assessment
Recommendation
As some form of running record of the evidence reviewed must be retained on each claim in order for these reports to be produced, the NHS Litigation Authority should consider development of a relatively simple database containing the same information. Read more
Published evidence summary
- NHS Resolution (formerly the NHS Litigation Authority, renamed April 2017) maintains a claims management database covering all CNST claims. The NHS Resolution annual report (2023-24) reports that the organisation handled 15,078 clinical negligence claims in 2023-24 and publishes detailed statistical analysis of claims data by specialty, cause, and trust (NHS Resolution annual report and accounts 2023-24).
- 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).
F95
Accepted
Information sharing
Recommendation
As the interests of patient safety should prevail over the narrow litigation interest under which confidentiality or even privilege might be claimed over risk reports, consideration should also be given to allowing the Care Quality Commission access to these reports. Read more
Published evidence summary
- NHS Resolution shares claims data and risk information with CQC. The NHS Resolution annual report (2023-24) states that the organisation works with CQC and other system partners "to share data and intelligence that supports patient safety" (NHS Resolution annual report and accounts 2023-24).
- 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).
F96
Accepted
Information sharing
Recommendation

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.

Published evidence summary
- NHS Resolution (formerly the NHS Litigation Authority) discontinued the three-level Clinical Risk Management Standards (CRMS) assessment programme. The CRMS assessments were the "standards assessments" to which this recommendation referred.
- 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).
F97
Accepted in Part
National Patient Safety Agency functions
Recommendation

The National Patient Safety Agency's resources need to be well protected and defined. Consideration should be given to the transfer of this valuable function to a systems regulator.

Published evidence summary
- The National Patient Safety Agency (NPSA) was abolished on 1 June 2012. Its patient safety functions, including the National Reporting and Learning System, were transferred to the NHS Commissioning Board Special Health Authority (which became NHS England from April 2013). This transferred the function to a systems-level body as the recommendation envisaged (Health and Social Care Act 2012; NPSA closure announcement, DH, 2012).
- The Health and Care Act 2022 (Part 4) established the Health Services Safety Investigations Body (HSSIB) as an independent statutory body, which commenced operations on 1 October 2023. HSSIB replaced the Healthcare Safety Investigation Branch (HSIB), which had operated since April 2017 as a non-statutory body within NHS England. HSSIB conducts independent investigations into patient safety incidents of national significance and has statutory powers to protect information disclosed during investigations (Health and Care Act 2022, ss.94-121).
- The Patient Safety Commissioner, Dr Henrietta Hughes, was appointed in September 2022 under the Medicines and Medical Devices Act 2021 (section 11). The Commissioner's role is to promote the safety of patients and the interests of patients in relation to the safety of medicines and medical devices (Medicines and Medical Devices Act 2021, s.11).
- NHS England's National Patient Safety Team leads system-wide patient safety improvement work, including managing the Learn from Patient Safety Events (LFPSE) service which replaced the NRLS (decommissioned June 2024), and the Patient Safety Incident Response Framework (PSIRF), mandatory from autumn 2023 (NHS England patient safety).
NHS England (Primary)
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F98
Accepted in Part
National Patient Safety Agency functions
Recommendation

Reporting to the National Reporting and Learning System of all significant adverse incidents not amounting to serious untoward incidents but involving harm to patients should be mandatory on the part of trusts.

Published evidence summary
- The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, Regulation 20 (duty of candour), requires registered providers to act in an open and transparent way with patients when things go wrong. CQC monitors compliance with this duty (SI 2014/2936, Regulation 20).
- The Patient Safety Incident Response Framework (PSIRF), mandatory for NHS trusts from autumn 2023, replaced the Serious Incident Framework 2015. Under PSIRF, trusts must record all patient safety incidents — including those involving harm that do not meet the previous "serious incident" threshold — through the Learn from Patient Safety Events (LFPSE) service. LFPSE replaced the National Reporting and Learning System (NRLS), which was decommissioned in June 2024 (PSIRF, NHS England, August 2022; LFPSE, NHS England).
- Reporting patient safety incidents through LFPSE is mandatory for NHS trusts in England. The NHS Standard Contract 2024/25 requires providers to comply with PSIRF and report patient safety incidents in accordance with NHS England requirements (NHS Standard Contract 2024/25, NHS England).
- NHS England publishes patient safety incident data from the reporting system, including the number of incidents reported, severity levels, and incident types, enabling analysis of patterns across the NHS. The transition from NRLS to LFPSE expanded the categories of incidents that can be reported and improved the data structure for analysis (NHS England patient safety data publications).
NHS England (Primary)
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F99
Accepted in Part
National Patient Safety Agency functions
Recommendation
The reporting system should be developed to make more information available from this source. Such reports are likely to be more informative than the corporate version where an incident has been properly reported, and invaluable where it has not been. Read more
Published evidence summary
- The Learn from Patient Safety Events (LFPSE) service, which replaced the National Reporting and Learning System (NRLS, decommissioned June 2024), was specifically designed to capture more detailed and structured information about patient safety incidents. LFPSE uses a new taxonomy and data structure that enables richer categorisation of incident types, contributory factors, and outcomes than was possible under the NRLS (LFPSE service documentation, NHS England).
- LFPSE collects data on patient safety incidents, patient safety events (including near misses), and "did not occur" events (situations where a patient safety incident could have occurred but was prevented). This broadens the scope of reportable events beyond the NRLS, which focused primarily on incidents that reached the patient (NHS England LFPSE guidance).
- NHS England publishes analysis and reports based on patient safety incident data, including national patient safety alerts through the Central Alerting System (CAS) where patterns of risk are identified. The National Patient Safety Alerting System was strengthened following the 2018 Never Events policy review (NHS England patient safety alerting).
- The Patient Safety Incident Response Framework (PSIRF, mandatory from autumn 2023) requires trusts to use local incident data to develop Patient Safety Incident Response Plans (PSIRPs), which identify how the trust will respond to and learn from the specific types of incidents most relevant to their services (PSIRF, NHS England, August 2022).
NHS England (Primary)
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F100
Accepted in Part
National Patient Safety Agency functions
Recommendation

Individual reports of serious incidents which have not been otherwise reported should be shared with a regulator for investigation, as the receipt of such a report may be evidence that the mandatory system has not been complied with.

Published evidence summary
- The Learn from Patient Safety Events (LFPSE) service accepts reports from individual staff members as well as organisational reporters. Individual clinicians or other healthcare workers can report patient safety incidents directly through LFPSE, creating a route for incidents to be captured even where the organisation's own reporting systems have not recorded them (LFPSE service, NHS England).
- PSIRF (mandatory from autumn 2023) requires trusts to have systems for staff to report patient safety incidents and to ensure a supportive culture for reporting. The framework explicitly states that "all patient safety incidents and the concerns of patients, families and staff must be recorded" regardless of severity (PSIRF, NHS England, August 2022).
- CQC uses patient safety incident reporting data from LFPSE (and previously NRLS) as part of its Insight intelligence model for monitoring providers. Anomalies in reporting rates — including unusually low reporting — may be used as an indicator of potential concern about safety culture or compliance with reporting requirements (CQC Insight model).
- The Health Services Safety Investigations Body (HSSIB), established as an independent statutory body on 1 October 2023 under the Health and Care Act 2022, can receive referrals about patient safety concerns and can initiate investigations into incidents of national significance. HSSIB has statutory safe space protections for information disclosed during investigations (Health and Care Act 2022, Part 4).
CQC (Primary)
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F101
Accepted
National Patient Safety Agency functions
Recommendation
While it may be impracticable for the National Patient Safety Agency or its successor to have its own team of inspectors, it should be possible to organise for mutual peer review inspections or the inclusion in Patient Environment Action Team … Read more
Published evidence summary
- The National Patient Safety Agency (NPSA) was abolished on 1 June 2012, with its patient safety functions transferred to NHS England. The recommendation related to the NPSA's inspection and peer review arrangements.
- 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).
NHS England (Primary)
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F102
Accepted
Transparency use and sharing of information
Recommendation

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.

Published evidence summary
- The National Reporting and Learning System (NRLS), originally operated by the NPSA and subsequently by NHS England, published regular data summaries and analysis. The NRLS was decommissioned in June 2024 and replaced by the Learn from Patient Safety Events (LFPSE) service (NHS England LFPSE announcement).
- 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).
NHS England (Primary)
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F103
Accepted
Transparency use and sharing of information
Recommendation

The National Patient Safety Agency or its successor should regularly share information with Monitor.

Published evidence summary
- The National Patient Safety Agency (NPSA) was abolished on 1 June 2012, with its patient safety functions transferred to NHS England. Monitor merged into NHS Improvement in April 2016, and NHS Improvement subsequently merged into NHS England in July 2022. The patient safety function and the oversight function are now both within NHS England (Health and Social Care Act 2012; Health and Care Act 2022).
- 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).
NHS England (Primary)
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F104
Accepted
Transparency use and sharing of information
Recommendation
The Care Quality Commission should be enabled to exploit the potential of the safety information obtained by the National Patient Safety Agency or its successor to assist it in identifying areas for focusing its attention. There needs to be a … Read more
Published evidence summary
- CQC confirmed that it uses patient safety incident data from the National Reporting and Learning System (and its successor LFPSE) as part of its Insight intelligence model for monitoring providers. CQC's Insight model draws on over 300 indicators from multiple data sources to assess provider risk and identify outliers requiring regulatory attention (CQC Insight model documentation).
- 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).
CQC (Primary)
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F105
Accepted
Transparency use and sharing of information
Recommendation

Consideration should be given to whether information from incident reports involving deaths in hospital could enhance consideration of the hospital standardised mortality ratio.

Published evidence summary
- The Summary Hospital-level Mortality Indicator (SHMI) is published quarterly by NHS England (formerly by the Health and Social Care Information Centre, now NHS Digital, which merged into NHS England in February 2023). SHMI reports on mortality at trust level for patients who die in hospital or within 30 days of discharge, and was designated as an Official Statistic by the UK Statistics Authority (SHMI publication, NHS England).
- 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).
NHS England (Primary)
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F106
Accepted
Health Protection Agency Coordination and publication of providers' information on healthcare associated infections
Recommendation
The Health Protection Agency and its successor, should coordinate the collection, analysis and publication of information on each provider's performance in relation to healthcare associated infections, working with the Health and Social Care Information Centre. Read more
Published evidence summary
- The Health Protection Agency was abolished on 1 April 2013 and its functions were transferred to Public Health England (PHE), which in turn was replaced by the UK Health Security Agency (UKHSA) on 1 October 2021. UKHSA coordinates the national surveillance of healthcare associated infections (Health and Social Care Act 2012; UKHSA establishment announcement, DHSC, 2021).
- 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).
F107
Accepted
Sharing concerns
Recommendation
If the Health Protection Agency or its successor, or the relevant local director of public health or equivalent official, becomes concerned that a provider's management of healthcare associated infections is or may be inadequate to provide sufficient protection of patients … Read more
Published evidence summary
- The Health Protection Agency was abolished on 1 April 2013. Its health protection functions were transferred to Public Health England, which was subsequently replaced by the UK Health Security Agency (UKHSA) on 1 October 2021. Directors of Public Health in local authorities retain responsibility for local health protection oversight (Health and Social Care Act 2012; UKHSA establishment, DHSC, 2021).
- 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).
F108
Accepted
Support for other agencies
Recommendation

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.

Published evidence summary
- Public Health England (PHE) was established on 1 April 2013, assuming the health protection functions of the Health Protection Agency. PHE was subsequently replaced by the UK Health Security Agency (UKHSA) on 1 October 2021 (Health and Social Care Act 2012; UKHSA establishment, DHSC, 2021).
- 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).
F109
Accepted
Effective complaints handling
Recommendation
Methods of registering a comment or complaint must be readily accessible and easily understood. Multiple gateways need to be provided to patients, both during their treatment and after its conclusion, although all such methods should trigger a uniform process, generally … Read more
Published evidence summary
- The Local Authority Social Services and National Health Service Complaints (England) Regulations 2009 (SI 2009/309) established a single complaints procedure for health and social care, requiring NHS bodies to make arrangements for the handling and consideration of complaints. The regulations require complaints to be acknowledged within three working days and investigated within a timeframe agreed with the complainant (SI 2009/309).
- 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).
Healthcare providers (Primary)
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F110
Accepted
Lowering barriers
Recommendation
Actual or intended litigation should not be a barrier to the processing or investigation of a complaint at any level. It may be prudent for parties in actual or potential litigation to agree to a stay of proceedings pending the … Read more
Published evidence summary
- The Local Authority Social Services and National Health Service Complaints (England) Regulations 2009 do not contain any provision requiring or permitting complaints to be stayed or refused on the grounds that litigation is pending or contemplated. The complaints procedure operates independently of any legal proceedings (SI 2009/309).
- 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).
Healthcare providers (Primary)
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F111
Accepted
Lowering barriers
Recommendation
Provider organisations must constantly promote to the public their desire to receive and learn from comments and complaints; constant encouragement should be given to patients and other service users, individually and collectively, to share their comments and criticisms with the … Read more
Published evidence summary
- The NHS Constitution (revised 2023) includes a pledge that "the NHS will ensure you are treated with courtesy and you receive appropriate support throughout the handling of a complaint; and the fact that you have complained will not adversely affect your future treatment." The Constitution also pledges that organisations will "welcome feedback on your health and care experiences" (NHS Constitution, DHSC).
- 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).
Healthcare providers (Primary)
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F112
Accepted
Lowering barriers
Recommendation
Patient feedback which is not in the form of a complaint but which suggests cause for concern should be the subject of investigation and response of the same quality as a formal complaint, whether or not the informant has indicated … Read more
Published evidence summary
- The PHSO's NHS Complaint Standards (July 2022) state that organisations should treat all expressions of dissatisfaction that require a response as complaints, regardless of whether the person making the feedback uses the word "complaint." The standards require that "all concerns are taken seriously and responded to promptly" whether or not they are formally categorised as complaints (NHS Complaint Standards, PHSO, July 2022).
- 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).
Healthcare providers (Primary)
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F113
Accepted
Complaints handling
Recommendation

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.

Published evidence summary
- The Patients Association conducted a peer review of complaints handling at Mid Staffordshire NHS Foundation Trust, published in 2011. The review made recommendations about complaint handling standards including timeliness, quality of investigation, and communication with complainants (Patients Association peer review, 2011).
- 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.
NHS (Primary)
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F114
Accepted
Complaints handling
Recommendation

Comments or complaints which describe events amounting to an adverse or serious untoward incident should trigger an investigation.

Published evidence summary
- The Patient Safety Incident Response Framework (PSIRF), mandatory for NHS trusts from autumn 2023, requires trusts to consider all sources of information — including complaints — when identifying patient safety incidents for investigation. PSIRF states that trusts should have processes for identifying patient safety incidents from multiple sources including "complaints, claims, inquests, patient and staff feedback" (PSIRF, NHS England, August 2022).
- 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).
Healthcare providers (Primary)
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F115
Accepted in Part
Investigations
Recommendation
Arms-length independent investigation of a complaint should be initiated by the provider trust where any one of the following apply: A complaint amounts to an allegation of a serious untoward incident; Subject matter involving clinically related issues is not capable … Read more
Published evidence summary
- The Local Authority Social Services and National Health Service Complaints (England) Regulations 2009 require responsible bodies to investigate complaints but do not prescribe specific circumstances in which an independent investigation must be commissioned. The decision on how to investigate, including whether to commission an independent investigation, rests with the responsible body (SI 2009/309).
- The PHSO's NHS Complaint Standards (July 2022) state that organisations should consider the seriousness and complexity of a complaint when deciding how to investigate it, and that "where an investigation involves clinical issues, clinical input and/or advice should be sought." However, the standards do not mandate independent investigation for specific categories of complaint as Francis recommended (NHS Complaint Standards, PHSO, July 2022).
- The Clwyd-Hart Review (October 2013) recommended that trusts should commission independent investigations of complaints where the subject matter involves clinical issues beyond the expertise of the complaints team, or where the complaint raises serious concerns about patient safety or professional conduct. The government accepted this recommendation in principle (Clwyd-Hart Review, DHSC, October 2013).
- No published evidence has been identified of a regulatory requirement mandating independent investigation for the specific categories of complaint identified by Francis (serious untoward incidents, complex clinical issues, professional misconduct, commissioning issues). The decision remains at the discretion of the provider trust.
Healthcare providers (Primary)
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F116
Accepted
Support for complainants
Recommendation

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.

Published evidence summary
- The Health and Social Care Act 2012 (section 185) placed a duty on local authorities to commission independent advocacy services for people making or intending to make complaints about health or social care services. This replaced the previous Independent Complaints Advocacy Service (ICAS) which had been nationally commissioned (Health and Social Care Act 2012, s.185).
- 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).
Healthcare providers (Primary)
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F117
Accepted in Part
Support for complainants
Recommendation

A facility should be available to Independent Complaints Advocacy Services advocates and their clients for access to expert advice in complicated cases.

Published evidence summary
- The Health and Social Care Act 2012 (section 185) placed a duty on local authorities to commission independent advocacy services for people making NHS complaints. However, the commissioning and scope of advocacy services varies between local authorities, and there is no national standard requiring access to clinical or expert advice for advocates and their clients in complex cases (Health and Social Care Act 2012, s.185).
- The Clwyd-Hart Review (October 2013) recommended that advocacy services should have "the experience and expertise necessary to provide effective support" and that advocates should be able to access expert clinical advice when needed to support complainants in complex cases. The government accepted this recommendation (Clwyd-Hart Review, DHSC, October 2013).
- Healthwatch England published reports noting variation in the availability and quality of NHS complaints advocacy across England. A 2019 report found that advocacy services were "patchy" and that some areas lacked specialist health complaints advocacy entirely (Healthwatch England reports on advocacy).
- No published evidence has been identified of a nationally commissioned facility providing systematic access to expert clinical advice for complaints advocates and their clients, as distinct from the general right to advocacy support under the 2012 Act.
Department of Health and Social Care (Primary)
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F118
Accepted in Part
Learning and information from complaints
Recommendation
Subject to anonymisation, a summary of each upheld complaint relating to patient care, in terms agreed with the complainant, and the trust's response should be published on its website. In any case where the complainant or, if different, the patient, … Read more
Published evidence summary
- The Local Authority Social Services and National Health Service Complaints (England) Regulations 2009 require NHS bodies to prepare an annual report on complaints handling, including the number of complaints received and how they were dealt with. These reports must be made available to the public (SI 2009/309, Regulation 18).
- CQC requires registered providers to submit complaints data as part of the Notifications regulations. CQC's Regulation 16 (receiving and acting on complaints) requires providers to have an accessible complaints system, to investigate complaints, and to take action where necessary. CQC assesses complaint handling during inspections (SI 2014/2936, Regulation 16).
- The PHSO's NHS Complaint Standards (July 2022) state that organisations should use complaints data for learning and improvement and should be transparent about complaints outcomes. However, the standards do not specifically require the publication of individual upheld complaint summaries on trust websites as Francis recommended (NHS Complaint Standards, PHSO, July 2022).
- No published evidence has been identified of a national requirement for trusts to publish anonymised summaries of each individual upheld complaint on their websites. Most trusts publish aggregated complaints data in annual reports and quality accounts, but not individual complaint summaries.
Healthcare providers (Primary)
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F119
Accepted
Learning and information from complaints
Recommendation

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.

Published evidence summary
- Local Healthwatch organisations were established under the Health and Social Care Act 2012 (sections 221-227), replacing Local Involvement Networks (LINks) from April 2013. Local Healthwatch has a statutory right to enter and view NHS premises and to obtain information from NHS providers for the purpose of carrying out its functions, including gathering the views of patients about services (Health and Social Care Act 2012, ss.221-227).
- 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).
Healthcare providers (Primary)
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F120
Accepted in Part
Learning and information from complaints
Recommendation
Commissioners should require access to all complaints information as and when complaints are made, and should receive complaints and their outcomes on as near a real-time basis as possible. This means commissioners should be required by the NHS Commissioning Board … Read more
Published evidence summary
- Integrated Care Boards (ICBs), which replaced Clinical Commissioning Groups from July 2022 under the Health and Care Act 2022, have responsibility for commissioning most NHS services. ICBs are expected to use complaints data as part of their quality assurance and contract monitoring of providers (Health and Care Act 2022).
- The NHS Standard Contract 2024/25 requires providers to share complaints data with commissioners and to report on complaints trends as part of quality monitoring. The contract includes provisions for commissioners to access information about complaints and their outcomes (NHS Standard Contract 2024/25, NHS England).
- The PHSO's NHS Complaint Standards (July 2022) state that organisations should share learning from complaints with commissioners and other relevant bodies. However, the standards do not specify real-time sharing of individual complaints with commissioners as Francis recommended (NHS Complaint Standards, PHSO, July 2022).
- No published evidence has been identified of a specific national requirement for providers to share individual complaints with commissioners on a real-time basis as they are made. The standard practice is for commissioners to receive aggregated complaints data through contract monitoring arrangements, with individual complaints shared where they raise significant quality or safety concerns.
Commissioners (Primary)
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F121
Accepted
Learning and information from complaints
Recommendation

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.

Published evidence summary
- CQC's Insight intelligence model draws on complaints data from multiple sources to identify providers requiring regulatory attention. CQC receives information about complaints through its statutory notifications system, through data shared by PHSO, through local Healthwatch, and through direct contact from members of the public (CQC Insight model).
- 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).
CQC (Primary)
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F122
Accepted in Part
Handling large-scale complaints
Recommendation
Large-scale failures of clinical service are likely to have in common a need for: Provision of prompt advice, counselling and support to very distressed and anxious members of the public; Swift identification of persons of independence, authority and expertise to … Read more
Published evidence summary
- The National Quality Board (NQB), a multi-stakeholder body bringing together NHS England, CQC, NICE, HSSIB, NHSE regional teams and other system partners, has published guidance on quality governance frameworks and system oversight. NQB published "Shared Commitment to Quality" (March 2021) setting out the framework for system-wide quality governance including coordination of responses to quality failures (National Quality Board, NHS England).
- NHS England published the Patient Safety Incident Response Framework (PSIRF, mandatory from autumn 2023), which sets out a national framework for responding to patient safety incidents including serious incidents. PSIRF establishes clear responsibilities for providers, commissioners, and national bodies in investigating and responding to incidents (PSIRF, NHS England, August 2022).
- NHS England's Quality Board and regional quality teams coordinate the multi-agency response to large-scale quality failures through the System Oversight Framework (SOF). Providers in SOF segment 4 (mandated support) receive coordinated intervention from NHS England, CQC, and other bodies. The recovery support programme for trusts in special measures involves clinical experts, communications support, and public engagement (NHS System Oversight Framework, NHS England).
- The Health Services Safety Investigations Body (HSSIB), established as an independent statutory body on 1 October 2023 under the Health and Care Act 2022, provides independent expert-led investigation of patient safety incidents of national significance, with statutory powers to protect information and compel evidence (Health and Care Act 2022, Part 4).
F123
Accepted
Responsibility for monitoring delivery of standards and quality
Recommendation
GPs need to undertake a monitoring role on behalf of their patients who receive acute hospital and other specialist services. They should be an independent, professionally qualified check on the quality of service, in particular in relation to an assessment … Read more
Published evidence summary
- The Health and Care Act 2022 established Integrated Care Boards (ICBs) as the statutory commissioners of NHS services from July 2022, replacing Clinical Commissioning Groups (CCGs). ICBs are required to assess the needs of their population, commission services to meet those needs, and monitor the quality of commissioned services. GPs participate in ICB governance through place-based partnerships (Health and Care Act 2022).
- 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).
F124
Accepted in Part
Duty to require and monitor delivery of fundamental standards
Recommendation
The commissioner is entitled to and should, wherever it is possible to do so, apply a fundamental safety and quality standard in respect of each item of service it is commissioning. In relation to each such standard, it should agree … Read more
Published evidence summary
- The NHS Standard Contract 2024/25, mandated for all NHS-funded secondary care services, includes quality requirements, performance standards, and provisions for remedial action where standards are not met. The contract includes specific quality standards that commissioners can enforce, with mechanisms for financial withholding or recovery where providers fail to meet contractual quality requirements (NHS Standard Contract 2024/25, NHS England).
- CQC's fundamental standards (the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014) set minimum safety and quality standards that all registered providers must meet. These include Regulation 12 (safe care and treatment), Regulation 17 (good governance), and Regulation 20 (duty of candour). The NHS Standard Contract requires providers to comply with all CQC fundamental standards as a contractual obligation (SI 2014/2936).
- The Commissioning for Quality and Innovation (CQUIN) framework provides a mechanism for commissioners to incentivise quality improvement by linking a proportion of provider income to the achievement of quality goals agreed between commissioner and provider. For 2024/25, CQUIN indicators cover areas including antimicrobial stewardship, malnutrition screening, and staff flu vaccination (CQUIN, NHS England).
- NHS England published guidance on quality in commissioning, setting out expectations for how ICBs should set quality standards in contracts, monitor compliance, and take action where standards are not met (NHS England commissioning guidance).
Commissioners (Primary)
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F125
Accepted
Responsibility for requiring and monitoring delivery of enhanced standards
Recommendation
In addition to their duties with regard to the fundamental standards, commissioners should be enabled to promote improvement by requiring compliance with enhanced standards or development towards higher standards. They can incentivise such improvements either financially or by other means … Read more
Published evidence summary
- The Commissioning for Quality and Innovation (CQUIN) framework enables commissioners to incentivise quality improvement above the level of fundamental standards. CQUIN links a proportion of provider income (currently 1.25% of contract value) to achievement of quality improvement goals. CQUIN indicators for 2024/25 include areas such as appropriate antibiotic prescribing, nutrition screening, and timely communication of changes to medication to community pharmacists (CQUIN 2024/25, NHS England).
- 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).
Commissioners (Primary)
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F126
Accepted
Preserving corporate memory
Recommendation
The NHS Commissioning Board and local commissioners should develop and oversee a code of practice for managing organisational transitions, to ensure the information conveyed is both candid and comprehensive. This code should cover both transitions between commissioners, for example as … Read more
Published evidence summary
- The Health and Care Act 2022 established Integrated Care Boards (ICBs) from July 2022, replacing 106 CCGs with 42 ICBs (subsequently reduced to 36 following mergers). The transition from CCGs to ICBs was managed through an NHS England-led programme with guidance on the transfer of commissioning functions, contracts, staff, and information (Health and Care Act 2022; NHS England ICB establishment guidance).
- 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.
NHS England (Primary)
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F127
Accepted
Resources for scrutiny
Recommendation
The NHS Commissioning Board and local commissioners must be provided with the infrastructure and the support necessary to enable a proper scrutiny of its providers' services, based on sound commissioning contracts, while ensuring providers remain responsible and accountable for the … Read more
Published evidence summary
- The Health and Care Act 2022 established Integrated Care Boards (ICBs) as statutory bodies with their own budgets, staff, and governance arrangements. ICBs are required to have constitutions setting out their governance and decision-making arrangements, and must appoint a chief executive, chief finance officer, chief nursing officer, and chief medical officer (Health and Care Act 2022, ss.14Z25-14Z44).
- 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).
NHS England (Primary)
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F128
Accepted
Expert support
Recommendation
Commissioners must have access to the wide range of experience and resources necessary to undertake a highly complex and technical task, including specialist clinical advice and procurement expertise. When groups are too small to acquire such support, they should collaborate … Read more
Published evidence summary
- Integrated Care Boards (ICBs) are required under the Health and Care Act 2022 to have access to clinical expertise for commissioning decisions. ICBs must appoint a chief medical officer and chief nursing officer to their boards, ensuring clinical leadership in commissioning decisions (Health and Care Act 2022).
- 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).
Commissioners (Primary)
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F129
Accepted
Ensuring assessment and enforcement of fundamental standards through contracts
Recommendation
In selecting indicators and means of measuring compliance, the principal focus of commissioners should be on what is reasonably necessary to safeguard patients and to ensure that at least fundamental safety and quality standards are maintained. This requires close engagement … Read more
Published evidence summary
- The NHS Standard Contract 2024/25 includes a suite of quality indicators and performance measures that commissioners use to monitor provider compliance with safety and quality standards. The contract requires providers to report against specified quality metrics and to participate in national clinical audits and quality improvement programmes (NHS Standard Contract 2024/25, NHS England).
- 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).
Commissioners (Primary)
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F130
Accepted
Relative position of commissioner and provider
Recommendation
Commissioners – not providers – should decide what they want to be provided. They need to take into account what can be provided, and for that purpose will have to consult clinicians both from potential providers and elsewhere, and to … Read more
Published evidence summary
- The Health and Care Act 2022 establishes ICBs as the statutory commissioners responsible for planning and commissioning NHS services to meet the needs of their population. ICBs have a duty to commission services that are appropriate to meet the needs of the people in their area, having regard to the NHS Constitution and the mandate from the Secretary of State (Health and Care Act 2022).
- 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).
Commissioners (Primary)
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F131
Accepted
Development of alternative sources of provision
Recommendation
Commissioners need, wherever possible, to identify and make available alternative sources of provision. This may mean that commissioning has to be undertaken on behalf of consortia of commissioning groups to provide the negotiating weight necessary to achieve a negotiating balance … Read more
Published evidence summary
- The Provider Selection Regime (PSR), introduced in January 2024 under SI 2023/1348, provides commissioners with a structured framework for identifying and selecting alternative providers. The PSR includes the competitive process (open competition between providers), the most suitable provider process (comparative evaluation), and the direct award process, enabling commissioners to identify and commission from alternative providers where current provision is inadequate (Provider Selection Regime, NHS England).
- 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).
Commissioners (Primary)
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F132
Accepted
Monitoring tools
Recommendation
Commissioners must have the capacity to monitor the performance of every commissioning contract on a continuing basis during the contract period: Such monitoring may include requiring quality information generated by the provider. Commissioners must also have the capacity to undertake … Read more
Published evidence summary
- The NHS Standard Contract 2024/25 includes comprehensive provisions for commissioner monitoring of provider performance. The contract requires providers to submit regular quality and performance data to commissioners, to permit commissioner access to premises for audit and inspection, and to cooperate with commissioner investigations into quality concerns. The contract specifies remedial mechanisms including contract performance notices, withholding of payments, and termination rights (NHS Standard Contract 2024/25, NHS England).
- 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).
Commissioners (Primary)
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F133
Accepted in Part
Role of commissioners in complaints
Recommendation
Commissioners should be entitled to intervene in the management of an individual complaint on behalf of the patient where it appears to them it is not being dealt with satisfactorily, while respecting the principle that it is the provider who … Read more
Published evidence summary
- The NHS Standard Contract 2024/25 includes provisions requiring providers to have effective complaint handling arrangements and to report complaints data to commissioners. Commissioners can raise concerns about complaint handling with providers through contract performance management arrangements (NHS Standard Contract 2024/25, NHS England).
- The PHSO's NHS Complaint Standards (July 2022) state that commissioners should "use their commissioning levers to promote good complaint handling" among providers. However, the standards do not explicitly provide for commissioners to intervene in the handling of individual complaints on behalf of patients (NHS Complaint Standards, PHSO, July 2022).
- The Local Authority Social Services and National Health Service Complaints (England) Regulations 2009 designate the provider as the "responsible body" for handling complaints about its services. Where a complaint is made to a commissioner about a provider, the regulations require the commissioner to pass it to the provider unless the complainant objects (SI 2009/309, Regulation 7).
- No published evidence has been identified of a specific regulatory provision enabling commissioners to intervene in the management of an individual complaint being handled by a provider, as distinct from raising systemic concerns about complaint handling through contract management mechanisms.
Commissioners (Primary)
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F134
Accepted
Role of commissioners in provision of support for complainants
Recommendation

Consideration should be given to whether commissioners should be given responsibility for commissioning patients' advocates and support services for complaints against providers.

Published evidence summary
- The Health and Social Care Act 2012 (section 185) placed a duty on local authorities (not NHS commissioners) to commission independent advocacy services for people making NHS complaints. This transferred the function from the nationally commissioned Independent Complaints Advocacy Service (ICAS) to local authorities from April 2013 (Health and Social Care Act 2012, s.185).
- 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.
Commissioners (Primary)
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F135
Accepted in Part
Public accountability of commissioners and public engagement
Recommendation
Commissioners should be accountable to their public for the scope and quality of services they commission. Acting on behalf of the public requires their full involvement and engagement: There should be a membership system whereby eligible members of the public … Read more
Published evidence summary
- The Health and Care Act 2022 requires ICBs to involve patients and the public in decisions about the commissioning of services. ICBs must make arrangements for public involvement in planning, proposals for changes, and decisions affecting the operation of commissioning. ICB constitutions must include provisions for public participation (Health and Care Act 2022, s.14Z44).
- ICBs are required to have a minimum of two lay members (known as partner members) on their boards, including a chair who must be a non-executive member. The ICB constitution must set out arrangements for public meetings and transparency of decision-making (Health and Care Act 2022, s.14Z25).
- Integrated Care Partnerships (ICPs), established alongside each ICB under the Health and Care Act 2022, bring together NHS, local authority, voluntary sector, and community representatives to develop integrated care strategies. ICPs provide a forum for broader public and stakeholder engagement in health and care planning (Health and Care Act 2022, s.116ZA).
- The NHS Constitution (revised 2023) includes the right of patients and the public to be involved in planning and decisions about health services, and to have their views taken into account. ICBs must have regard to the NHS Constitution in exercising their functions (NHS Constitution, DHSC).
Commissioners (Primary)
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F136
Accepted
Public accountability of commissioners and public engagement
Recommendation
Commissioners need to be recognisable public bodies, visibly acting on behalf of the public they serve and with a sufficient infrastructure of technical support. Effective local commissioning can only work with effective local monitoring, and that cannot be done without … Read more
Published evidence summary
- Integrated Care Boards (ICBs) are established as statutory NHS bodies under the Health and Care Act 2022, with their own legal identity, branding, websites, and public-facing governance arrangements. Each ICB covers a defined geographic area and has a named chair, chief executive, and board. ICBs are accountable to NHS England and to the public they serve (Health and Care Act 2022).
- 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).
Commissioners (Primary)
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F137
Not Accepted
Intervention and sanctions for substandard or unsafe services
Recommendation
Commissioners should have powers of intervention where substandard or unsafe services are being provided, including requiring the substitution of staff or other measures necessary to protect patients from the risk of harm. In the provision of the commissioned services, such … Read more
Published evidence summary
- The NHS Standard Contract 2024/25 includes provisions enabling commissioners to take action where providers fail to meet contractual quality standards. These include issuing contract performance notices, requiring remedial action plans, withholding or recovering payments, and ultimately terminating contracts. Commissioners can also require the substitution of named individuals where there are concerns about their performance (NHS Standard Contract 2024/25, NHS England).
- NHS England has powers under the Health and Care Act 2022 to give directions to ICBs and to intervene in ICB commissioning decisions. NHS England's System Oversight Framework provides a graduated approach to intervention, with providers in SOF segments 3 and 4 receiving enhanced oversight and mandated support respectively. In the most serious cases, NHS England can direct that services be provided by alternative providers (NHS System Oversight Framework, NHS England).
- CQC has independent enforcement powers including the power to impose conditions on a provider's registration, issue warning notices, and in the most serious cases to cancel a provider's registration (preventing it from providing services). CQC's enforcement powers operate alongside commissioner contract powers, and both can act independently (CQC enforcement policy; Health and Social Care Act 2008).
- The Health and Care Act 2022 includes provisions for NHS England to direct providers to take specified actions where there are concerns about the quality or safety of services, providing a system-level intervention power that supplements commissioner and regulatory powers (Health and Care Act 2022).
Commissioners (Primary)
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F138
Accepted
Local scrutiny
Recommendation

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.

Published evidence summary
- NHS England's System Oversight Framework (SOF) includes requirements for ICBs and NHS England regional teams to have contingency plans for the continuity of services where providers are failing. The SOF graduated approach provides for early warning, enhanced oversight, and mandated support, with contingency planning for service continuity at each stage (NHS System Oversight Framework, NHS England).
- 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).
Commissioners (Primary)
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F139
Accepted
The need to put patients first at all times
Recommendation
The first priority for any organisation charged with responsibility for performance management of a healthcare provider should be ensuring that fundamental patient safety and quality standards are being met. Such an organisation must require convincing evidence to be available before … Read more
Published evidence summary
- NHS England's System Oversight Framework (SOF) establishes patient safety and quality as the primary considerations in oversight of NHS providers and ICBs. SOF assessment begins with quality and safety metrics, and providers triggering concerns on safety indicators are escalated to enhanced oversight regardless of performance in other domains (NHS System Oversight Framework, NHS England).
- 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).
NHS England (Primary)
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F140
Accepted
Performance managers working constructively with regulators
Recommendation
Where concerns are raised that such standards are not being complied with, a performance management organisation should share, wherever possible, all relevant information with the relevant regulator, including information about its judgement as to the safety of patients of the … Read more
Published evidence summary
- NHS England and CQC operate a memorandum of understanding governing the sharing of information about provider quality and safety. The agreement provides for the sharing of intelligence including inspection findings, performance data, whistleblowing concerns, and soft intelligence about provider quality. This includes sharing at regional and national level (NHS England and CQC memorandum of understanding).
- 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).
NHS England (Primary)
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F141
Accepted in Part
Taking responsibility for quality
Recommendation
Any differences of judgement as to immediate safety concerns between a performance manager and a regulator should be discussed between them and resolved where possible, but each should recognise its retained individual responsibility to take whatever action within its power … Read more
Published evidence summary
- The System Oversight Framework (SOF) provides a structured mechanism for resolving differences between NHS England (as performance manager) and CQC (as regulator) regarding provider safety. Multi-agency support groups for providers in SOF segments 3 and 4 include both NHS England and CQC, with agreed escalation routes and joint decision-making on intervention (NHS System Oversight Framework, NHS England).
- The National Quality Board (NQB) provides a senior leadership forum where NHS England and CQC can resolve strategic differences about quality and safety matters. NQB's membership includes the chief executives or senior representatives of both organisations (National Quality Board, NHS England).
- CQC retains independent statutory powers to take enforcement action regardless of the views of NHS England or commissioners. CQC can issue warning notices, impose conditions on registration, or cancel registration where it judges there is a risk to patient safety, without requiring agreement from other bodies (Health and Social Care Act 2008, Part 1; CQC enforcement policy).
- NHS England similarly retains powers under the Health and Care Act 2022 to give directions to providers and ICBs where it considers action is necessary. The independence of each body's statutory powers means that disagreements about the need for action do not prevent either body from acting unilaterally where it judges patient safety requires it (Health and Care Act 2022).
NHS England (Primary)
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F142
Accepted
Clear lines of responsibility supported by good information flows
Recommendation

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.

Published evidence summary
- The Health and Care Act 2022 established a statutory framework for information flows within the NHS. ICBs have duties to obtain information about the quality of services they commission, and providers have corresponding duties to provide information to commissioners and regulators. The Act places duties on system participants to cooperate and share information (Health and Care Act 2022).
- 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).
NHS England (Primary)
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F143
Accepted
Clear metrics on quality
Recommendation
Metrics need to be established which are relevant to the quality of care and patient safety across the service, to allow norms to be established so that outliers or progression to poor performance can be identified and accepted as needing … Read more
Published evidence summary
- The NHS Outcomes Framework (NHS OF) provides a national set of outcome indicators across five domains: preventing people from dying prematurely, enhancing quality of life for people with long-term conditions, helping people recover from episodes of ill health, ensuring people have a positive experience of care, and treating and caring for people in a safe environment. The framework enables benchmarking of outcomes nationally and identification of outlying performance (NHS Outcomes Framework, NHS England Digital).
- 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).
NHS England (Primary)
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F144
Accepted
Need for ownership of quality metrics at a strategic level
Recommendation

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.

Published evidence summary
- NHS England (originally the NHS Commissioning Board) developed and maintains the NHS Outcomes Framework, a suite of outcome indicators used to assess the overall performance of the NHS at national and local level. The framework was first published in 2012 and has been updated annually, with the most recent publication in February 2025. It provides national-level accountability across five domains covering mortality, quality of life, recovery, patient experience, and safety (NHS Outcomes Framework, NHS England Digital).
- 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).
NHS England (Primary)
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F145
Not Accepted
Structure of Local Healthwatch
Recommendation

There should be a consistent basic structure for Local Healthwatch throughout the country, in accordance with the principles set out in Chapter 6: Patient and public local involvement and scrutiny.

Published evidence summary
- The Health and Social Care Act 2012 (sections 221-227) established the statutory framework for Local Healthwatch organisations. Every upper-tier local authority in England is required to commission a Local Healthwatch for its area. 152 Local Healthwatch organisations were established from April 2013, covering every local authority area in England (Health and Social Care Act 2012, Part 5, Chapter 1).
- Local Healthwatch organisations have a consistent set of statutory functions set out in the Health and Social Care Act 2012: obtaining the views of people about their needs and experiences of local health and social care services; making reports and recommendations about how services could be improved; providing information and advice to the public; making the views and experiences of people known to Healthwatch England; and making recommendations to those who commission, provide, and regulate health and social care services (Health and Social Care Act 2012, s.221).
- Healthwatch England, initially established as a statutory committee of CQC under the Health and Social Care Act 2012, provides national coordination and support to the Local Healthwatch network. Healthwatch England publishes guidance, quality standards, and best practice resources for Local Healthwatch organisations, promoting consistency across the network (Healthwatch England).
- The Local Healthwatch Regulations 2013 (SI 2013/154) set out further requirements for the governance and operation of Local Healthwatch organisations, including requirements for annual reporting and the involvement of volunteers and lay people in Healthwatch activities (SI 2013/154).
Department of Health and Social Care (Primary)
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F146
Accepted in Part
Finance and oversight of Local Healthwatch
Recommendation
Local authorities should be required to pass over the centrally provided funds allocated to its Local Healthwatch, while requiring the latter to account to it for its stewardship of the money. Transparent respect for the independence of Local Healthwatch should … Read more
Published evidence summary
- The Health and Social Care Act 2012 placed a duty on local authorities to commission Local Healthwatch for their area, with funding provided through the local government finance settlement rather than a ring-fenced central grant. Local authorities determine the level of funding allocated to Local Healthwatch from within their overall budgets (Health and Social Care Act 2012, s.221).
- Healthwatch England has reported concerns about the adequacy and consistency of Local Healthwatch funding across different local authority areas. In its 2023-24 annual report, Healthwatch England noted that Local Healthwatch budgets vary significantly between local authority areas and that funding has declined in real terms since 2013, affecting the capacity of some Local Healthwatch organisations to fulfil their statutory functions (Healthwatch England Annual Report 2023-24).
- The government's response to the Francis Report in "Hard Truths" (Cm 8777, November 2013) stated that local authorities are responsible for ensuring their Local Healthwatch is adequately resourced but did not require ring-fencing of the central funding allocation. The government stated it would monitor the adequacy of Local Healthwatch funding through Healthwatch England (Hard Truths, DHSC, November 2013).
- Local authorities are subject to the "best value" duty under the Local Government Act 1999, which requires them to secure continuous improvement in the way they exercise their functions, having regard to economy, efficiency, and effectiveness. This provides a general accountability mechanism but does not specifically protect Local Healthwatch budgets from reductions in local authority spending (Local Government Act 1999).
F147
Accepted
Coordination of local public scrutiny bodies
Recommendation

Guidance should be given to promote the coordination and cooperation between Local Healthwatch, Health and Wellbeing Boards, and local government scrutiny committees.

Published evidence summary
- The Department of Health and Social Care published updated guidance on Health and Wellbeing Boards in November 2022, following the Health and Care Act 2022. The guidance sets out the role of Health and Wellbeing Boards (HWBs) within the new integrated care system architecture and clarifies how HWBs should work alongside ICBs, Integrated Care Partnerships, and local Healthwatch organisations (Health and Wellbeing Boards Guidance, DHSC, November 2022).
- 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).
Department of Health and Social Care (Primary)
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F148
Accepted
Training
Recommendation

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.

Published evidence summary
- Healthwatch England provides a programme of support and development resources for Local Healthwatch organisations, including guidance documents, webinars, and network events. Healthwatch England's Quality Framework sets out expectations for the operation of Local Healthwatch, including leadership development and capability building (Healthwatch England Quality Framework).
- 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.
F149
Accepted
Expert assistance
Recommendation

Scrutiny committees should be provided with appropriate support to enable them to carry out their scrutiny role, including easily accessible guidance and benchmarks.

Published evidence summary
- The Local Authority (Public Health, Health and Wellbeing Boards and Health Scrutiny) Regulations 2013 (SI 2013/218) set out the powers and duties of local authority health scrutiny committees, including powers to require NHS bodies to provide information, to require attendance of NHS officers, and to be consulted on substantial variations in services (SI 2013/218).
- 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).
F150
Accepted in Part
Inspection powers
Recommendation
Scrutiny committees should have powers to inspect providers, rather than relying on local patient involvement structures to carry out this role, or should actively work with those structures to trigger and follow up inspections where appropriate, rather than receiving reports … Read more
Published evidence summary
- The Local Authority (Public Health, Health and Wellbeing Boards and Health Scrutiny) Regulations 2013 (SI 2013/218) provide local authority health scrutiny committees with powers to require information from NHS bodies and to require NHS officers to attend committee meetings. However, the regulations do not grant scrutiny committees a statutory power of entry to inspect NHS provider premises (SI 2013/218).
- Local Healthwatch organisations have a statutory power of entry to inspect premises where NHS-funded care is provided, under the Health and Social Care Act 2012 (section 225). This power enables authorised Healthwatch representatives to enter and view premises, observe the nature and quality of services, and interview willing service users and staff. This power rests with Local Healthwatch rather than scrutiny committees (Health and Social Care Act 2012, s.225).
- The government's response to the Francis Report in "Hard Truths" (Cm 8777, November 2013) noted that Local Healthwatch "enter and view" powers provide a mechanism for local patient representatives to observe services at provider premises, and that scrutiny committees should work with Local Healthwatch to make use of these powers where appropriate, rather than scrutiny committees themselves being granted separate inspection powers (Hard Truths, DHSC, November 2013).
- The DHSC's statutory guidance on health scrutiny (June 2014) encourages scrutiny committees to work with Local Healthwatch and to use Local Healthwatch's enter and view powers to inform scrutiny work, but does not provide for scrutiny committees to conduct their own inspections of provider premises (DHSC health scrutiny guidance, June 2014).
F151
Accepted in Part
Complaints to MPs
Recommendation
MPs are advised to consider adopting some simple system for identifying trends in the complaints and information they received from constituents. They should also consider whether individual complaints imply concerns of wider significance than the impact on one individual patient. Read more
Published evidence summary
- The government's response to the Francis Report in "Hard Truths" (Cm 8777, November 2013) noted that MPs have a significant role in representing the interests of their constituents in relation to NHS services, but stated that it is for individual MPs to determine how they manage and respond to the correspondence and information they receive from constituents. The government did not impose a formal requirement on MPs to adopt complaint-tracking systems (Hard Truths, DHSC, November 2013).
- The Parliamentary and Health Service Ombudsman (PHSO) publishes data on complaints referred by MPs about NHS services. PHSO's annual reports provide analysis of complaint trends by service type and issue, which is available to MPs and the public. PHSO accepted 1,299 complaints about NHS bodies for investigation in 2023-24 (PHSO Annual Report 2023-24).
- The House of Commons Library has published briefing papers on NHS complaints handling, providing MPs with information about complaint trends and the complaints system. Individual MPs' offices typically log constituent casework, but there is no standardised system across Parliament for identifying trends in health-related complaints (House of Commons Library).
- No published evidence has been identified that Parliament has adopted a formal system for identifying trends in constituency health complaints as Francis recommended. The recommendation was directed at individual MPs as advice rather than as a structural reform requiring government or parliamentary action.
Parliament (Primary)
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F152
Accepted
Medical training
Recommendation
Any organisation which in the course of a review, inspection or other performance of its duties, identifies concerns potentially relevant to the acceptability of training provided by a healthcare provider, must be required to inform the relevant training regulator of … Read more
Published evidence summary
- The Health and Social Care Act 2012 (section 96) placed a statutory duty on specified bodies — including CQC, NHS England (then the NHS Commissioning Board), Monitor, and Health Education England — to cooperate with one another in the exercise of their functions. This duty applies where cooperation would be conducive to the exercise of each body's functions and specifically covers the sharing of information relevant to patient safety (Health and Social Care Act 2012, s.96).
- 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).
Healthcare providers (Primary)
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F153
Accepted in Part
Medical training
Recommendation
The Secretary of State should by statutory instrument specify all medical education and training regulators as relevant bodies for the purpose of their statutory duty to cooperate. Information sharing between the deanery, commissioners, the General Medical Council, the Care Quality … Read more
Published evidence summary
- The Health and Social Care Act 2012 (section 96) placed a statutory duty to cooperate on CQC, NHS England, Monitor, and HEE. The Secretary of State made the Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2012 specifying further bodies for the purpose of CQC's duty to cooperate. The GMC is specified as a relevant body for the purposes of inter-regulatory cooperation (Health and Social Care Act 2012, s.96).
- The Professional Standards Authority (PSA), established under the Health and Social Care Act 2012, oversees the health and care professional regulatory bodies including the GMC, NMC, and HCPC. PSA has a statutory function of promoting cooperation between regulators and sharing information relevant to patient safety (Health and Social Care Act 2012, s.225A).
- The government's response in "Hard Truths" (Cm 8777, November 2013) committed to reviewing information-sharing arrangements between the deanery (now NHS England Workforce, Training and Education), commissioners, GMC, CQC, and Monitor. The government stated that the statutory duty to cooperate and existing memoranda of understanding would be strengthened to ensure comprehensive information sharing on patient safety issues (Hard Truths, DHSC, November 2013).
- Health Education England 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. Deanery functions are now exercised by NHS England's Workforce, Training and Education directorate, simplifying the information-sharing arrangements between the training function and NHS England's commissioning and oversight functions (Health and Care Act 2022, s.96).
Department of Health and Social Care (Primary)
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F154
Accepted
Medical training
Recommendation
The Care Quality Commission and Monitor should develop practices and procedures with training regulators and bodies responsible for the commissioning and oversight of medical training to coordinate their oversight of healthcare organisations which provide regulated training. Read more
Published evidence summary
- CQC and the GMC operate a memorandum of understanding governing information sharing and coordination of oversight of healthcare organisations that provide medical education and training. The agreement provides for sharing of inspection findings, intelligence about provider quality, and coordination of regulatory action where both training quality and patient safety are at risk (CQC and GMC memorandum of understanding).
- 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).
CQC (Primary)
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F155
Accepted
Medical training
Recommendation
The General Medical Council should set out a standard requirement for routine visits to each local education provider, and programme in accordance with the following principles: The Postgraduate Dean should be responsible for managing the process at the level of … Read more
Published evidence summary
- The GMC published "Promoting Excellence: Standards for Medical Education and Training" in 2015, replacing "Tomorrow's Doctors" (2009) and "The Trainee Doctor" (2011). The standards set out requirements for the quality assurance of medical education and training, including requirements for regular visits to local education providers by postgraduate deans and the GMC (GMC, Promoting Excellence, 2015).
- 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).
GMC (Primary)
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F156
Accepted
Medical training
Recommendation

The system for approving and accrediting training placement providers and programmes should be configured to apply the principles set out above.

Published evidence summary
- The GMC's "Promoting Excellence: Standards for Medical Education and Training" (2015) sets out the standards for the approval and accreditation of medical education and training placements. The standards require that training environments meet minimum requirements for patient safety, supervision, and educational quality before they are approved as training placements (GMC, Promoting Excellence, 2015).
- 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).
GMC (Primary)
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F157
Accepted
Matters to be reported to the General Medical Council
Recommendation
The General Medical Council should set out a clear statement of what matters; deaneries are required to report to the General Medical Council either routinely or as they arise. Reports should include a description of all relevant activity and findings … Read more
Published evidence summary
- The GMC's "Promoting Excellence: Standards for Medical Education and Training" (2015) includes requirements for designated bodies (employers of doctors) and postgraduate deans to report concerns to the GMC. The standards require reporting not only of exceptional matters of non-compliance but also of routine quality data and findings from monitoring activity (GMC, Promoting Excellence, 2015).
- 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).
GMC (Primary)
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F158
Accepted
Training and training establishments as a source of safety information
Recommendation
The General Medical Council should amend its standards for undergraduate medical education to include a requirement that providers actively seek feedback from students and tutors on compliance by placement providers with minimum standards of patient safety and quality of care, … Read more
Published evidence summary
- The GMC published "Promoting Excellence: Standards for Medical Education and Training" in 2015, which includes specific requirements for medical schools to actively seek and act on feedback from students about the quality and safety of clinical placements. Theme 5 of the standards requires that "the learning environment is safe for patients and supportive for learners and educators" and that medical schools have systems in place to identify and act on concerns about patient safety raised by students (GMC, Promoting Excellence, 2015).
- 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).
GMC (Primary)
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F159
Accepted
Training and training establishments as a source of safety information
Recommendation
Surveys of medical students and trainees should be developed to optimise them as a source of feedback of perceptions of the standards of care provided to patients. The General Medical Council should consult the Care Quality Commission in developing the … Read more
Published evidence summary
- The GMC's National Training Survey (NTS) is conducted annually and collects data from all doctors in training in the UK. The NTS includes questions on patient safety, clinical supervision, workload, and the quality of the training environment. NTS results are published at placement, programme, and national level, enabling identification of training environments where patient safety standards may not be met (GMC National Training Survey).
- 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).
GMC (Primary)
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F160
Accepted
Training and training establishments as a source of safety information
Recommendation

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.

Published evidence summary
- The Freedom to Speak Up Review (Sir Robert Francis QC, February 2015) made 20 recommendations for creating a culture of openness in the NHS, including specific protections for trainees. The review found that trainees were particularly vulnerable to adverse consequences from raising concerns due to their dependence on supervisors for training progression and career references (Freedom to Speak Up Review, February 2015).
- 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).
GMC (Primary)
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F161
Accepted
Training and training establishments as a source of safety information
Recommendation
Training visits should make an important contribution to the protection of patients: Obtaining information directly from trainees should remain a valuable source of information – but it should not be the only method used. Visits to, and observation of, the … Read more
Published evidence summary
- The GMC's "Promoting Excellence: Standards for Medical Education and Training" (2015) sets out requirements for quality assurance visits to training environments, including direct observation of the training environment rather than relying solely on trainee feedback. Theme 5 requires that "the learning environment is safe for patients and supportive for learners" and that quality assurance includes inspection of the physical training environment (GMC, Promoting Excellence, 2015).
- 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).
GMC (Primary)
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F162
Accepted
Training and training establishments as a source of safety information
Recommendation
The General Medical Council should in the course of its review of its standards and regulatory process ensure that the system of medical training and education maintains as its first priority the safety of patients. It should also ensure that … Read more
Published evidence summary
- The GMC published "Promoting Excellence: Standards for Medical Education and Training" in 2015, following a comprehensive review of its education and training standards. The standards place patient safety as the overarching priority: Theme 1 states that "patient safety is the first priority" and requires that education and training providers ensure patient safety is not compromised by the delivery of medical education (GMC, Promoting Excellence, 2015).
- 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).
GMC (Primary)
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F163
Accepted
Safe staff numbers and skills
Recommendation
The General Medical Council's system of reviewing the acceptability of the provision of training by healthcare providers must include a review of the sufficiency of the numbers and skills of available staff for the provision of training and to ensure … Read more
Published evidence summary
- The GMC's "Promoting Excellence: Standards for Medical Education and Training" (2015) includes requirements that education and training providers must have sufficient numbers of appropriately qualified staff to deliver training and to ensure patient safety. Standard R1.19 requires that "the educational and clinical governance systems must ensure the educational environment is safe" and that "the organisation must ensure there are enough staff with the right skills, experience and qualifications to provide safe and effective training" (GMC, Promoting Excellence, 2015).
- 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).
GMC (Primary)
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F164
Accepted in Part
Approved Practice Settings
Recommendation
The Department of Health and the General Medical Council should review whether the resources available for regulating Approved Practice Setting are adequate and, if not, make arrangements for the provision of the same. Consideration should be given to empowering the … Read more
Published evidence summary
- The GMC's approved practice settings scheme enables doctors working outside NHS trusts (for example, in locum agencies, private practice, or non-NHS organisations) to satisfy the requirements of medical revalidation. The Medical Act 1983 (as amended by the Health and Social Care Act 2008) requires all licensed doctors to be connected to a designated body for the purposes of revalidation (Medical Act 1983, s.29A; SI 2014/1887).
- The government's response in "Hard Truths" (Cm 8777, November 2013) stated that the Department of Health and the GMC would review whether the resources available for regulating approved practice settings were adequate and would consider empowering the GMC to charge organisations a fee for approval (Hard Truths, DHSC, November 2013).
- The Medical Profession (Responsible Officers) Regulations 2010 (SI 2010/2841, as amended by SI 2013/391) require designated bodies to appoint a responsible officer to evaluate and make recommendations about the fitness to practise of doctors connected to that body. This extends the revalidation framework to non-NHS settings, but resource adequacy for monitoring approved practice settings has not been the subject of published review since Francis (SI 2010/2841).
- No published evidence has been identified of a completed review of the adequacy of resources for regulating approved practice settings or of legislation empowering the GMC to charge fees specifically for approved practice setting approval.
GMC (Primary)
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F165
Accepted in Part
Approved Practice Settings
Recommendation

The General Medical Council should immediately review its approved practice settings criteria with a view to recognition of the priority to be given to protecting patients and the public.

Published evidence summary
- The GMC reviewed and updated its approved practice settings criteria following the Francis Report. The Medical Act 1983 (section 29A, inserted by the Health and Social Care Act 2008) provides the statutory framework for revalidation, requiring all licensed doctors to demonstrate their fitness to practise through periodic revalidation connected to a designated body (Medical Act 1983, s.29A).
- The Medical Profession (Responsible Officers) Regulations 2010 (SI 2010/2841, as amended by SI 2013/391) set out the responsibilities of responsible officers in designated bodies, including approved practice settings. Responsible officers must evaluate and make recommendations about the fitness to practise of connected doctors, with patient safety as the primary consideration (SI 2010/2841).
- The GMC's "Good Medical Practice" (updated 2024) sets out the professional standards expected of all registered doctors, including those practising in approved practice settings. The standards emphasise that doctors must put patient safety first and must raise concerns where they believe patient safety is at risk (GMC, Good Medical Practice, 2024).
- The government's response in "Hard Truths" (Cm 8777, November 2013) stated that the GMC should review its approved practice settings criteria with a view to giving priority to protecting patients and the public (Hard Truths, DHSC, November 2013).
GMC (Primary)
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F166
Accepted in Part
Approved Practice Settings
Recommendation
The General Medical Council should in consultation with patient interest groups and the public immediately review its procedures for assuring compliance with its approved practice settings criteria with a view in particular to provision for active exchange of relevant information … Read more
Published evidence summary
- The GMC's quality assurance framework for approved practice settings includes active information sharing with CQC and other healthcare regulators. The statutory duty to cooperate under the Health and Social Care Act 2012 (section 96) requires the GMC, CQC, and NHS England to cooperate and share information relevant to the exercise of their respective functions, including information about the quality and safety of services in settings where doctors practise (Health and Social Care Act 2012, s.96).
- The GMC's revalidation process, launched in December 2012, requires all licensed doctors to be connected to a designated body and to demonstrate their fitness to practise every five years through a structured appraisal process. Responsible officers in designated bodies — including approved practice settings — must report concerns about doctor performance or patient safety to the GMC (Medical Act 1983, s.29A; SI 2010/2841).
- CQC registers and inspects independent healthcare providers, including those that may operate as approved practice settings. CQC inspection findings are shared with the GMC where relevant to the fitness to practise of doctors or the suitability of the setting as a place of practice (CQC and GMC memorandum of understanding).
- The government's response in "Hard Truths" (Cm 8777, November 2013) stated that the GMC should review its procedures for assuring compliance with approved practice settings criteria, including provision for active information exchange with CQC and coordination of monitoring processes (Hard Truths, DHSC, November 2013).
GMC (Primary)
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F167
Accepted in Part
Approved Practice Settings
Recommendation
The Department of Health and the General Medical Council should review the powers available to the General Medical Council in support of assessment and monitoring of approved practice settings establishments with a view to ensuring that the General Medical Council … Read more
Published evidence summary
- The GMC has powers under the Medical Act 1983 to set standards for medical education and training and to conduct quality assurance visits to training providers. However, the GMC's powers in relation to approved practice settings for revalidation purposes are more limited; the GMC can set criteria for approval but does not have a specific statutory power to inspect approved practice settings in the same way that CQC can inspect registered providers (Medical Act 1983).
- CQC has statutory powers to inspect all registered healthcare providers under the Health and Social Care Act 2008, including providers that operate as approved practice settings. CQC can enter premises, observe care, and take enforcement action where standards are not met. This provides an inspection power covering many, but not all, settings where doctors practise (Health and Social Care Act 2008, Part 1).
- The government's response in "Hard Truths" (Cm 8777, November 2013) stated that the Department of Health and GMC should review the powers available to the GMC for assessment and monitoring of approved practice settings, with a view to ensuring appropriate inspection powers exist. The response noted that CQC's existing inspection powers might be the most appropriate mechanism for some settings (Hard Truths, DHSC, November 2013).
- No published evidence has been identified of a completed review of GMC inspection powers for approved practice settings or of legislation granting the GMC specific powers to inspect such settings, as distinct from CQC's existing powers to inspect registered providers.
GMC (Primary)
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F168
Accepted in Part
Approved Practice Settings
Recommendation

The Department of Health and the General Medical Council should consider making the necessary statutory (and regulatory changes) to incorporate the approved practice settings scheme into the regulatory framework for post graduate training.

Published evidence summary
- The Medical Act 1983 provides the statutory framework for the regulation of medical education and training by the GMC, including the approval of training programmes and providers. The approved practice settings scheme operates under the revalidation provisions of the Medical Act (section 29A, inserted by the Health and Social Care Act 2008) and the Medical Profession (Responsible Officers) Regulations 2010 (Medical Act 1983; SI 2010/2841).
- The government's response in "Hard Truths" (Cm 8777, November 2013) stated that the Department of Health and GMC should consider making the necessary statutory and regulatory changes to incorporate the approved practice settings scheme into the regulatory framework for postgraduate training (Hard Truths, DHSC, November 2013).
- No published evidence has been identified of statutory or regulatory changes made specifically to incorporate the approved practice settings scheme into the framework for postgraduate medical training. The approved practice settings scheme continues to operate under the revalidation provisions of the Medical Act 1983 rather than under the postgraduate training provisions (Medical Act 1983, Part V).
- The Health and Care Act 2022 abolished Health Education England and transferred its functions to NHS England (section 96), consolidating the oversight of medical training within NHS England. However, this did not specifically address the integration of approved practice settings into the postgraduate training regulatory framework (Health and Care Act 2022, s.96).
Department of Health and Social Care (Primary)
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F169
Accepted in Part
Role of the Department of Health and the National Quality Board
Recommendation
The Department of Health, through the National Quality Board, should ensure that procedures are put in place for facilitating the identification of patient safety issues by training regulators and cooperation between them and healthcare systems regulators. Read more
Published evidence summary
- The National Quality Board (NQB), established as a multi-stakeholder body bringing together NHS England, CQC, NICE, GMC, HSSIB, and other system leaders, provides a forum for coordinating quality oversight including the interface between training regulators and healthcare systems regulators. NQB's "Shared Commitment to Quality" framework sets out expectations for how system organisations should cooperate on quality and patient safety, including facilitating the identification of patient safety issues by training regulators (NQB, Shared Commitment to Quality, NHS England).
- The Health and Social Care Act 2012 (section 96) placed a statutory duty on specified bodies to cooperate with one another. This duty covers cooperation between CQC, NHS England, and the GMC in relation to the identification and sharing of patient safety concerns arising from the training environment (Health and Social Care Act 2012, s.96).
- The GMC's quality assurance of medical education and training includes a process for identifying patient safety concerns during training visits and the National Training Survey. Where concerns are identified, the GMC shares these with CQC and NHS England through established information-sharing protocols. CQC in turn shares inspection findings relevant to training quality with the GMC (GMC quality assurance framework; CQC-GMC information-sharing agreements).
- The government's response in "Hard Truths" (Cm 8777, November 2013) stated that the NQB should ensure that procedures are in place for facilitating cooperation between training regulators and healthcare systems regulators on patient safety issues (Hard Truths, DHSC, November 2013).
Department of Health and Social Care (Primary)
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F170
Accepted
Health Education England
Recommendation

Health Education England should have a medically qualified director of medical education and a lay patient representative on its board.

Published evidence summary
- Health Education England (HEE) was established as a non-departmental public body in June 2012 (as a special health authority) and given statutory footing under the Care Act 2014. HEE had a board that included clinical and lay members. HEE's board included a chief medical officer/medical director role and non-executive directors with patient and public backgrounds (HEE governance arrangements).
- 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.
NHS England (Primary)
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F171
Accepted
Deans
Recommendation

All Local Education and Training Boards should have a post of medically qualified postgraduate dean responsible for all aspects of postgraduate medical education.

Published evidence summary
- Health Education England established Local Education and Training Boards (LETBs) across England, each with a medically qualified postgraduate dean responsible for all aspects of postgraduate medical education in their area. Postgraduate deans are senior medical professionals responsible for the quality of medical training, trainee welfare, and the interface between training and patient safety (HEE governance arrangements).
- 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).
NHS England (Primary)
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F172
Accepted
Proficiency in the English language
Recommendation
The Government should consider urgently the introduction of a common requirement of proficiency in communication in the English language with patients and other persons providing healthcare to the standard required for a registered medical practitioner to assume professional responsibility for … Read more
Published evidence summary
- The Medical Act 1983 was amended by the Health Care and Associated Professions (Knowledge of English) Order 2014 (SI 2014/1887) and by the Health and Social Care (Safety and Quality) Act 2015 to strengthen the GMC's powers to require evidence of English language proficiency from doctors seeking registration or a licence to practise. The amendments enable the GMC to refuse registration or a licence to practise where a doctor cannot demonstrate the necessary knowledge of English (SI 2014/1887; Medical Act 1983, s.35C).
- 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).
Department of Health and Social Care (Primary)
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F173
Accepted
Principles of openness transparency and candour
Recommendation
Every healthcare organisation and everyone working for them must be honest, open and truthful in all their dealings with patients and the public, and organisational and personal interests must never be allowed to outweigh the duty to be honest, open … Read more
Published evidence summary
- The statutory duty of candour was enacted as Regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. It came into force for NHS bodies on 27 November 2014 and was extended to all other registered providers from 1 April 2015. Regulation 20 requires registered persons to act in an open and transparent way with relevant persons in relation to care and treatment provided in carrying on a regulated activity (SI 2014/2936, Regulation 20).
- 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).
Healthcare providers (Primary)
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F174
Accepted
Candour about harm
Recommendation
Where death or serious harm has been or may have been caused to a patient by an act or omission of the organisation or its staff, the patient (or any lawfully entitled personal representative or other authorised person) should be … Read more
Published evidence summary
- Regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 imposes a specific obligation on registered providers to notify patients (or their representative) as soon as reasonably practicable after becoming aware that a "notifiable safety incident" has occurred. The regulation defines a notifiable safety incident as one that, in the reasonable opinion of a health care professional, has resulted in or could result in death or serious harm (SI 2014/2936, Regulation 20).
- 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).
Healthcare providers (Primary)
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F175
Accepted
Candour about harm
Recommendation

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).

Published evidence summary
- Regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 requires registered providers to be open and transparent with patients about their care and treatment. While the regulation's specific notification duty is triggered by "notifiable safety incidents," the broader requirement for openness applies to all aspects of care. The regulation requires that information about incidents is provided whether or not the patient has asked for it (SI 2014/2936, Regulation 20).
- 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).
Healthcare providers (Primary)
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F176
Accepted
Openness with regulators
Recommendation

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.

Published evidence summary
- Regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 applies the duty of candour to registered providers in their dealings with patients and their representatives. The Health and Social Care Act 2008 (section 91) makes it an 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 punishable by fine or imprisonment (Health and Social Care Act 2008, s.91).
- 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).
Healthcare providers (Primary)
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F177
Accepted
Openness in public statements
Recommendation

Any public statement made by a healthcare organisation about its performance must be truthful and not misleading by omission.

Published evidence summary
- Regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 requires registered providers to act in an open and transparent way, which extends to public statements about their services and performance. The duty of candour framework establishes a general principle that healthcare organisations should be honest in their communications with patients and the public (SI 2014/2936, Regulation 20).
- 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).
Healthcare providers (Primary)
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F178
Accepted in Part
Implementation of the duty Ensuring consistency of obligations under the duty of openness transparency and candour
Recommendation
The NHS Constitution should be revised to reflect the changes recommended with regard to a duty of openness, transparency and candour, and all organisations should review their contracts of employment, policies and guidance to ensure that, where relevant, they expressly … Read more
Published evidence summary
- The NHS Constitution was updated in July 2015 to incorporate the principles of openness, transparency, and candour recommended by Francis. The Constitution includes a patient right to be informed of patient safety incidents affecting their care and states the NHS commitment to being open and honest. The Constitution was further updated in 2023, maintaining these provisions (NHS Constitution, DHSC, revised 2023).
- The NHS Constitution Handbook (revised to accompany each Constitution update) includes detailed guidance on the application of the duty of candour, cross-referencing the statutory duty under Regulation 20 and the professional duties under the GMC and NMC codes (NHS Constitution Handbook, DHSC).
- The government's response in "Hard Truths" (Cm 8777, November 2013) committed to revising the NHS Constitution to reflect the duty of candour and stated that all NHS organisations should review their contracts of employment, policies, and guidance to ensure consistency with the duty of candour principles (Hard Truths, DHSC, November 2013).
- NHS England's standard employment contract terms for NHS staff include provisions consistent with the duty of candour and Freedom to Speak Up principles. The NHS Terms and Conditions of Service Handbook includes requirements for staff to act with honesty and integrity and to raise concerns about patient safety (NHS Terms and Conditions, NHS Employers).
Department of Health and Social Care (Primary)
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F179
Accepted
Restrictive contractual clauses
Recommendation
"Gagging clauses" or non disparagement clauses should be prohibited in the policies and contracts of all healthcare organisations, regulators and commissioners; insofar as they seek, or appear, to limit bona fide disclosure in relation to public interest issues of patient … Read more
Published evidence summary
- The Freedom to Speak Up Review (Sir Robert Francis QC, February 2015) specifically addressed the use of gagging clauses in NHS contracts and settlement agreements. The review recommended that confidentiality clauses should not be used in a way that prevents or inhibits staff from making protected disclosures about patient safety (Freedom to Speak Up Review, February 2015).
- 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).
Department of Health and Social Care (Primary)
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F180
Accepted
Candour about incidents
Recommendation

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.

Published evidence summary
- The National Patient Safety Agency's "Being Open" guidance (2009) was superseded by the statutory duty of candour under Regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. The statutory duty provides a legally enforceable framework that goes beyond the non-statutory "Being Open" guidance, requiring notification, disclosure, and apology following notifiable safety incidents (SI 2014/2936, Regulation 20).
- 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).
Healthcare providers (Primary)
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F181
Accepted in Part
Enforcement of the duty Statutory duties of candour in relation to harm to patients
Recommendation
A statutory obligation should be imposed to observe a duty of candour: On healthcare providers who believe or suspect that treatment or care provided by it to a patient has caused death or serious injury to a patient to inform … Read more
Published evidence summary
- The statutory duty of candour on healthcare providers was enacted as Regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. Regulation 20 requires registered providers to notify patients (or their representative) when a "notifiable safety incident" — one that has resulted in or could result in death or serious harm — has occurred. The duty came into force for NHS bodies on 27 November 2014 and was extended to all registered providers from April 2015 (SI 2014/2936, Regulation 20).
- Francis recommended a statutory duty of candour on individual registered professionals as well as on providers. The government's response in "Hard Truths" (Cm 8777, November 2013) accepted the duty on providers but stated that the individual professional duty of candour would be addressed through professional regulation rather than statute. The GMC and NMC subsequently strengthened their professional codes to include explicit candour requirements (Hard Truths, DHSC, November 2013).
- The NMC updated its Code in March 2015 to include 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." The GMC's "Good Medical Practice" requires doctors to be open with patients when things go wrong. Both regulators can take fitness to practise action against registrants who breach these professional candour duties (NMC Code 2015; GMC Good Medical Practice).
- DHSC's call for evidence on the duty of candour (November 2024) examined whether the current split between a statutory organisational duty and a professional individual duty is effective. Some respondents argued that a statutory duty on individuals as well as providers would strengthen compliance (DHSC Duty of Candour Call for Evidence, November 2024).
Department of Health and Social Care (Primary)
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F182
Accepted
Statutory duty of openness and transparency
Recommendation
There should be a statutory duty on all directors of healthcare organisations to be truthful in any information given to a healthcare regulator or commissioner, either personally or on behalf of the organisation, where given in compliance with a statutory … Read more
Published evidence summary
- The Fit and Proper Person Requirement (Regulation 5 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014) requires directors of registered providers to be of good character and to have the qualifications, competence, skills, and experience necessary for their role. A director who has been responsible for providing misleading information to a regulator or commissioner could be found to be unfit under this regulation (SI 2014/2936, Regulation 5).
- 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).
Department of Health and Social Care (Primary)
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F183
Not Accepted
Criminal liability
Recommendation
It should be made a criminal offence for any registered medical practitioner, or nurse, or allied health professional or director of an authorised or registered healthcare organisation: Knowingly to obstruct another in the performance of these statutory duties; To provide … Read more
Published evidence summary
- The Criminal Justice and Courts Act 2015 (sections 20-21), which received Royal Assent on 12 February 2015, created two new criminal offences directly relevant to Francis's recommendation. Section 20 creates the offence of ill-treatment or wilful neglect of an individual by a care worker, carrying a maximum sentence of five years' imprisonment. Section 21 creates the offence of a care provider supplying or publishing a statement that is false or misleading in a material respect, where the statement relates to the provision of health or social care (Criminal Justice and Courts Act 2015, ss.20-21).
- The Health and Social Care Act 2008 (section 91) already made it a criminal offence to knowingly or recklessly provide false or misleading information to CQC, punishable by fine or imprisonment of up to two years. This provision was in force before the Francis Report and remains in force alongside the 2015 Act provisions (Health and Social Care Act 2008, s.91).
- CQC has the power to prosecute providers and individuals for breaches of the Health and Social Care Act 2008, including the offence under section 91. CQC's enforcement policy sets out the circumstances in which it will consider prosecution, including cases of deliberate deception or obstruction (CQC enforcement policy).
- The government's response in "Hard Truths" (Cm 8777, November 2013) stated that legislation would be introduced to create new criminal offences of ill-treatment and wilful neglect. This was implemented through sections 20 and 21 of the Criminal Justice and Courts Act 2015 (Hard Truths, DHSC, November 2013).
Department of Health and Social Care (Primary)
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F184
Accepted
Enforcement by the Care Quality Commission
Recommendation
Observance of the duty should be policed by the Care Quality Commission, which should have powers in the last resort to prosecute in cases of serial non-compliance or serious and wilful deception. The Care Quality Commission should be supported by … Read more
Published evidence summary
- CQC has statutory responsibility for monitoring and enforcing compliance with the duty of candour under Regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. CQC assesses compliance with the duty of candour as part of its inspection programme, primarily under the "well-led" and "safe" key questions. Where providers fail to meet the duty of candour, CQC can issue requirement notices, impose conditions on registration, and in serious cases prosecute for breach of regulatory requirements (SI 2014/2936, Regulation 20; CQC enforcement policy).
- CQC has powers under the Health and Social Care Act 2008 to prosecute registered persons for breaches of regulations including the duty of candour. CQC can also prosecute under section 91 of the Act for the provision of false or misleading information. These powers provide the "last resort" prosecution capability that Francis recommended (Health and Social Care Act 2008; CQC enforcement policy).
- DHSC's call for evidence on the duty of candour (November 2024) found that 52% of respondents considered that CQC had not adequately monitored compliance with the duty of candour. The Penny Dash Review of CQC (October 2024) identified significant failings in CQC's regulatory performance, including reduced inspection activity and inconsistent enforcement, raising questions about the effectiveness of CQC's policing of the duty of candour in practice (DHSC Duty of Candour Call for Evidence, November 2024; Penny Dash Review, October 2024).
- Commissioners support CQC's monitoring through the NHS Standard Contract, which requires providers to comply with the duty of candour and to report notifiable safety incidents to commissioners. Commissioners can take contractual action where providers fail to comply with candour requirements (NHS Standard Contract, NHS England).
CQC (Primary)
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F185
Accepted
Focus on culture of caring
Recommendation
There should be an increased focus in nurse training, education and professional development on the practical requirements of delivering compassionate care in addition to the theory. A system which ensures the delivery of proper standards of nursing requires: Selection of … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation and committed to strengthening values-based recruitment and training across the NHS (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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).
NMC (Primary)
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F186
Accepted
Practical hands-on training and experience
Recommendation

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.

Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation and committed to reviewing nursing training to incorporate sufficient practical elements (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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).
NMC (Primary)
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F187
Accepted
Practical hands-on training and experience
Recommendation
There should be a national entry-level requirement that student nurses spend a minimum period of time, at least three months, working on the direct care of patients under the supervision of a registered nurse. Such experience should include direct care … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation in principle and committed to ensuring nursing students gain sufficient direct patient care experience (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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).
NMC (Primary)
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F188
Accepted in Part
Aptitude test for compassion and caring
Recommendation
The Nursing and Midwifery Council, working with universities, should consider the introduction of an aptitude test to be undertaken by aspirant registered nurses at entry into the profession, exploring, in particular, candidates' attitudes towards caring, compassion and other necessary professional … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation and stated that HEE would work with the NMC and universities to develop values-based selection for student nurses (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- Health Education England published its National Values Based Recruitment Framework in October 2014, requiring higher education institutions to embed values-based recruitment into nursing selection processes by March 2015. The framework included structured interviews and selection centre tools to assess candidates' attitudes towards caring and compassion (Values Based Recruitment Framework, HEE, October 2014).
- The NMC did not introduce a formal standardised aptitude test as Francis specifically recommended. Values-based recruitment was adopted as the approach to assessing candidates' attitudes and values at entry, rather than a single common aptitude test administered by or on behalf of the NMC (Values Based Recruitment Framework, HEE, October 2014).
- No further published evidence has been identified since 2016 of progress towards a specific NMC-administered aptitude test for nursing candidates.
NMC (Primary)
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F189
Accepted in Part
Consistent training
Recommendation

The Nursing and Midwifery Council and other professional and academic bodies should work towards a common qualification assessment/examination.

Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) noted this recommendation and stated that it would work with the NMC and other professional bodies to improve consistency in nurse education and assessment (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- The NMC published new Standards of Proficiency for Registered Nurses in 2018, providing a single set of proficiency standards that all approved education institutions must use. These standards apply to all NMC-approved pre-registration nursing programmes across England, Wales, Scotland, and Northern Ireland (Future Nurse: Standards of Proficiency for Registered Nurses, NMC, 2018).
- The NMC launched an updated Test of Competence on 2 August 2021 for internationally trained nurses, consisting of a computer-based test and a 10-station Objective Structured Clinical Examination. This provides a common assessment for overseas-trained nurses seeking UK registration (Test of Competence 2021, NMC, August 2021).
- A common qualification examination across all domestic nursing programmes has not been introduced. Assessment of student nurses remains the responsibility of individual approved education institutions, though all must demonstrate that graduates meet the NMC's standards of proficiency (NMC Education Standards, NMC).
NMC (Primary)
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F190
Accepted in Part
National standards
Recommendation

There should be national training standards for qualification as a registered nurse to ensure that newly qualified nurses are competent to deliver a consistent standard of the fundamental aspects of compassionate care.

Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation and committed to establishing national training standards for nurses (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- The NMC published a revised Code of Professional Standards in March 2015, setting out the professional standards that all registered nurses and midwives must uphold, with "Prioritise people" as the first theme (The Code: Professional Standards of Practice and Behaviour for Nurses, Midwives and Nursing Associates, NMC, March 2015).
- The NMC published new Standards of Proficiency for Registered Nurses in 2018, replacing the 2010 standards. The new standards are organised around seven platforms including "Being an accountable professional," "Promoting health and preventing ill health," and "Providing and evaluating care." All approved education institutions must ensure their programmes enable students to meet these proficiencies (Future Nurse: Standards of Proficiency for Registered Nurses, NMC, 2018).
- All new pre-registration nursing programmes in the UK were required to align with the 2018 standards from September 2020, providing a single national framework for the education and assessment of newly qualified nurses (NMC Standards for Pre-registration Nursing Programmes, NMC, 2018).
NMC (Primary)
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F191
Accepted
Recruitment for values and commitment
Recommendation
Healthcare employers recruiting nursing staff, whether qualified or unqualified, should assess candidates' values, attitudes and behaviours towards the well-being of patients and their basic care needs, and care providers should be required to do so by commissioning and regulatory requirements. Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation and committed to ensuring values-based recruitment was adopted across the NHS for both qualified and unqualified staff (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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).
Healthcare providers (Primary)
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F192
Accepted in Part
Strong nursing voice
Recommendation

The Department of Health and Nursing and Midwifery Council should introduce the concept of a Responsible Officer for nursing, appointed by and accountable to, the Nursing and Midwifery Council.

Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) did not accept the specific proposal for a "Responsible Officer" for nursing equivalent to the medical model. The government stated that the proposed NMC revalidation scheme would provide an alternative mechanism for assuring nurses' continued fitness to practise without requiring a statutory responsible officer role (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- NMC Revalidation, launched 1 April 2016, requires nurses and midwives to obtain "confirmation" from a third-party confirmer (typically a line manager) that they have met the revalidation requirements. The confirmer role is less formal than the medical Responsible Officer role established under the Medical Profession (Responsible Officers) Regulations 2010, which gives designated doctors statutory duties in relation to medical revalidation (NMC Revalidation, NMC, April 2016).
- The medical Responsible Officer model, under which a designated senior doctor in each healthcare organisation is accountable to the GMC for the revalidation of doctors in that organisation, has not been replicated for nursing. No equivalent statutory framework has been introduced for nursing (Medical Profession (Responsible Officers) Regulations 2010, as amended).
- No further published evidence has been identified of plans to introduce a Responsible Officer role for nursing.
NMC (Primary)
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F193
Accepted in Part
Standards for appraisal and support
Recommendation
Without introducing a revalidation scheme immediately, the Nursing and Midwifery Council should introduce common minimum standards for appraisal and support with which responsible officers would be obliged to comply. They could be required to report to the Nursing and Midwifery … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted the principle of this recommendation and stated that the NMC would develop a revalidation scheme incorporating minimum appraisal standards (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- The NMC published a revised Code in March 2015, which set out the professional standards against which nurses and midwives would be appraised and revalidated (The Code: Professional Standards of Practice and Behaviour for Nurses, Midwives and Nursing Associates, NMC, March 2015).
- NMC Revalidation launched on 1 April 2016, establishing minimum standards for ongoing professional assurance. All registered nurses and midwives must revalidate every three years by demonstrating 450 practice hours, 35 hours of CPD (including 20 hours participatory), five written reflective accounts linked to the Code, a reflective discussion with another NMC registrant, and confirmation from a third-party confirmer (NMC Revalidation, NMC, April 2016).
- The revalidation process requires a confirmer to verify that the nurse or midwife has met all the requirements, including engaging in professional development and reflecting on the Code. This provides a regular checkpoint mechanism as Francis recommended, though the confirmation role is less formal than the Responsible Officer model he envisaged (NMC Revalidation, NMC, April 2016).
NMC (Primary)
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F194
Accepted in Part
Standards for appraisal and support
Recommendation
As part of a mandatory annual performance appraisal, each Nurse, regardless of workplace setting, should be required to demonstrate in their annual learning portfolio an up-to-date knowledge of nursing practice and its implementation. Alongside developmental requirements, this should contain documented … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation and stated that the NMC revalidation model would incorporate annual appraisal elements and portfolio-based evidence of continuing competence (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- NMC Revalidation, launched 1 April 2016, requires all registered nurses and midwives to maintain a portfolio demonstrating 450 practice hours, 35 hours of CPD (including 20 hours participatory learning), and five written reflective accounts linked to the Code. The portfolio must be made available to the NMC if requested as part of a verification process (NMC Revalidation, NMC, April 2016).
- The revalidation process requires a reflective discussion with another NMC registrant and confirmation from a third-party confirmer that the nurse has met all requirements, providing a structured annual/triennial review mechanism (NMC Revalidation, NMC, April 2016).
- NMC revalidation requires nurses to obtain feedback from patients, service users, students, or colleagues and to reflect on that feedback in their reflective accounts. However, the specific mechanism is less prescriptive than Francis's recommendation of documented patient and family feedback on care provided (NMC Revalidation, NMC, April 2016).
- The NHS Knowledge and Skills Framework remains the nationally agreed framework underpinning annual development reviews for all staff on Agenda for Change contracts, supporting annual appraisal processes at employer level (NHS Knowledge and Skills Framework, NHS Employers).
NMC (Primary)
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F195
Accepted in Part
Nurse leadership
Recommendation
Ward nurse managers should operate in a supervisory capacity, and not be office-bound or expected to double up, except in emergencies as part of the nursing provision on the ward. They should know about the care plans relating to every … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation and stated that ward managers should be supervisory leaders, visible and accessible to patients and staff (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- Monitor published guidance in October 2014 on implementing the "named nurse" initiative, requesting NHS foundation trusts to ensure every patient has a named nurse responsible for coordinating their care. The guidance supported the principle of visible ward-level nursing leadership (Implementing the Responsible Consultant/Clinician and Named Nurse, Monitor, October 2014).
- The NHS Leadership Academy offers a tiered suite of leadership programmes accessible to ward managers, including the Edward Jenner programme (leadership foundations), the Mary Seacole programme (first-time leaders), and the Rosalind Franklin programme (senior clinical leaders). These provide leadership development resources as Francis recommended (NHS Leadership Academy Programmes, NHS England).
- There is no national regulatory requirement that ward nurse managers operate in a purely supervisory capacity. Implementation varies by trust, with staffing pressures meaning ward managers in many organisations continue to carry a clinical caseload alongside supervisory duties. The National Quality Board's "Developing Workforce Safeguards" (2018) recommends that organisations review skill mix and supervisory arrangements but does not mandate a supervisory-only model (Developing Workforce Safeguards, National Quality Board, 2018).
Healthcare providers (Primary)
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F196
Accepted
Nurse leadership
Recommendation
The Knowledge and Skills Framework should be reviewed with a view to giving explicit recognition to nurses' demonstrations of commitment to patient care and, in particular, to the priority to be accorded to dignity and respect, and their acquisition of … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation and stated that the NHS Knowledge and Skills Framework would be reviewed to give explicit recognition to compassionate care and leadership skills (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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).
Department of Health and Social Care (Primary)
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F197
Accepted in Part
Nurse leadership
Recommendation
Training and continuing professional development for nurses should include leadership training at every level from student to director. A resource for nurse leadership training should be made available for all NHS healthcare provider organisations that should be required under commissioning … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation and committed to making leadership training available at all levels of nursing (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- The NHS Leadership Academy provides a tiered suite of leadership programmes open to nurses at every career stage: the Edward Jenner programme (free, open-access, for those new to leadership), the Mary Seacole programme (for first-time leaders, CMI-accredited), and the Rosalind Franklin programme (for mid-to-senior clinical staff, CMI-accredited) (NHS Leadership Academy Programmes, NHS England).
- The NMC's 2018 Standards of Proficiency for Registered Nurses include leadership and management as one of the seven platforms, requiring newly qualified nurses to demonstrate leadership competencies at the point of registration (Future Nurse: Standards of Proficiency for Registered Nurses, NMC, 2018).
- NMC Revalidation, launched April 2016, requires 35 hours of CPD every three years, which can include leadership development activities. The Edward Jenner programme specifically supports NMC revalidation CPD requirements (NMC Revalidation, NMC, April 2016; NHS Leadership Academy).
- The Health and Care Act 2022 established Integrated Care Boards from July 2022, whose commissioning arrangements include workforce development requirements. ICBs have responsibilities for population health workforce planning, including supporting leadership development in provider organisations (Health and Care Act 2022).
NHS (Primary)
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F198
Accepted
Measuring cultural health
Recommendation
Healthcare providers should be encouraged by incentives to develop and deploy reliable and transparent measures of the cultural health of front-line nursing workplaces and teams, which build on the experience and feedback of nursing staff using a robust methodology, such … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation and stated that healthcare providers should develop transparent measures of cultural health on front-line wards (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
Healthcare providers (Primary)
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F199
Accepted
Key nurses
Recommendation
Each patient should be allocated for each shift a named key nurse responsible for coordinating the provision of the care needs for each allocated patient. The named key nurse on duty should, whenever possible, be present at every interaction between … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation and committed to ensuring every hospital patient has a named nurse responsible for coordinating their care (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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).
Healthcare providers (Primary)
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F200
Accepted in Part
Key nurses
Recommendation

Consideration should be given to the creation of a status of Registered Older Person's Nurse.

Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) stated that it would ask Health Education England and the NMC to consider whether a specialist status for older person's nursing should be developed (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- Lord Willis's "Raising the Bar: Shape of Caring" review (March 2015) did not recommend the creation of a Registered Older Person's Nurse status. The review focused instead on broader educational reforms and the development of the nursing associate role (Raising the Bar: Shape of Caring, HEE, March 2015).
- The NMC register currently includes four fields of practice for nursing: adult, children's, learning disabilities, and mental health. No fifth field for older person's nursing has been added. The NMC has not consulted on or proposed the creation of a Registered Older Person's Nurse annotation or field of practice (NMC Registration, NMC).
- No further published evidence has been identified of progress towards the creation of a Registered Older Person's Nurse status since 2015.
NMC (Primary)
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F201
Accepted
Strengthening the nursing professional voice
Recommendation

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".

Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) noted that this recommendation was addressed to the Royal College of Nursing and stated that the government expected the RCN to consider it (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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).
F202
Accepted
Strengthening the nursing professional voice
Recommendation
Recognition of the importance of nursing representation at provider level should be given by ensuring that adequate time is allowed for staff to undertake this role, and employers and unions must regularly review the adequacy of the arrangements in this … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation and stated that adequate time for staff representation at provider level should be ensured by employers and unions (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
Healthcare providers (Primary)
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F203
Accepted
Strengthening the nursing professional voice
Recommendation

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.

Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation and stated that a forum for directors of nursing from NHS and independent sector organisations should be established to coordinate nursing leadership (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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).
Department of Health and Social Care (Primary)
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F204
Accepted in Part
Strengthening the nursing professional voice
Recommendation

All healthcare providers and commissioning organisations should be required to have at least one executive director who is a registered nurse, and should be encouraged to consider recruiting nurses as non-executive directors.

Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation and stated that all healthcare provider organisations should have at least one executive director who is a registered nurse (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- NHS provider governance codes require trusts to have a board-level Director of Nursing or Chief Nurse. The NHS Foundation Trust Code of Governance states that the board should include executive directors with appropriate professional and clinical expertise, and the vast majority of NHS trusts have an executive Director of Nursing on their board (NHS Foundation Trust Code of Governance, NHS England).
- The Health and Care Act 2022, which established Integrated Care Boards from July 2022, requires each ICB to have a Director of Nursing as part of its minimum board membership. This ensures nursing representation at commissioner level as well as provider level (Health and Care Act 2022, s.14Z25).
- The Fit and Proper Person Requirement (Regulation 5 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014) requires directors of registered providers to meet fitness criteria. The Kark Review (2019) recommended strengthening this test, and the government accepted the recommendations in principle (Kark Review of FPPT, DHSC, 2019; Government Response, DHSC, 2023).
Healthcare providers (Primary)
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F205
Accepted in Part
Strengthening the nursing professional voice
Recommendation
Commissioning arrangements should require the boards of provider organisations to seek and record the advice of its nursing director on the impact on the quality of care and patient safety of any proposed major change to nurse staffing arrangements or … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation and stated that boards should seek and record the advice of their nursing director on staffing changes (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- NICE published "Safe staffing for nursing in adult inpatient wards in acute hospitals" (SG1) on 15 July 2014, providing an evidence-based framework for determining safe nurse staffing levels. The guidance stated that nursing directors should have a central role in staffing decisions (Safe Staffing Guidance SG1, NICE, July 2014).
- The National Quality Board published "Developing Workforce Safeguards" in 2018, which requires provider boards to receive a report on staffing capacity and capability at least every six months and to review staffing information alongside quality and outcomes data. The guidance requires boards to have processes to ensure the nursing director's advice on staffing is sought and recorded (Developing Workforce Safeguards, National Quality Board, 2018).
- The Nurse Staffing Levels (Wales) Act 2016 established a statutory duty on NHS bodies in Wales to calculate and maintain nurse staffing levels, representing the first nurse staffing legislation in Europe. No equivalent legislation has been introduced in England, where the approach remains guidance-based through the National Quality Board framework (Nurse Staffing Levels (Wales) Act 2016).
- CQC inspections assess whether providers have adequate staffing levels under the "safe" key question and whether there is effective board-level oversight of staffing under the "well-led" key question, including the role of the nursing director in staffing decisions (CQC Inspection Framework, CQC).
Commissioners (Primary)
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F206
Accepted
Strengthening the nursing professional voice
Recommendation
The effectiveness of the newly positioned office of Chief Nursing Officer should be kept under review to ensure the maintenance of a recognised leading representative of the nursing profession as a whole, able and empowered to give independent professional advice … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation and stated that the effectiveness of the Chief Nursing Officer role would be kept under review (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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).
Department of Health and Social Care (Primary)
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F207
Accepted in Part
Strengthening identification of healthcare support workers and nurses
Recommendation

There should be a uniform description of healthcare support workers, with the relationship with currently registered nurses made clear by the title.

Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation in principle, noting the importance of clear identification of healthcare support workers (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- The Cavendish Review (July 2013) recommended that healthcare support workers who complete the proposed Certificate of Fundamental Care should be entitled to use the title "Nursing Assistant," establishing a clear relationship with registered nurses (Review of Healthcare Assistants and Support Workers in NHS and Social Care, Camilla Cavendish, July 2013).
- NHS Supply Chain, in conjunction with NHS England, announced 15 national colourways for clinical roles in September 2023, assigning healthcare assistants a lilac uniform with navy trim, distinct from registered nurses' hospital blue with navy trim (NHS Supply Chain, National Healthcare Uniform, September 2023).
- The Nursing Associate role, regulated by the NMC from January 2019 under the Nursing and Midwifery (Amendment) Order 2018 (SI 2018/838), created a bridging role between HCAs and registered nurses, partially clarifying the relationship between unregistered and registered clinical staff (NMC, Nursing Associates, January 2019).
- No uniform national title for healthcare support workers has been mandated; role titles vary between trusts (e.g. healthcare assistant, healthcare support worker, nursing assistant, clinical support worker), and adoption of the national colourways remains voluntary at trust level.
Department of Health and Social Care (Primary)
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F208
Accepted in Part
Strengthening identification of healthcare support workers and nurses
Recommendation

Commissioning arrangements should require provider organisations to ensure by means of identity labels and uniforms that a healthcare support worker is easily distinguishable from that of a registered nurse.

Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation in principle, agreeing that healthcare support workers should be visually distinguishable from registered nurses (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- NHS England published "Uniforms and Workwear: Guidance for NHS Employers" on 2 April 2020, setting out principles for uniform policies including the need for patients to identify staff roles clearly (NHS England, Uniforms and Workwear Guidance, April 2020).
- NHS Supply Chain announced 15 national colourways in September 2023: healthcare assistants and support workers are assigned lilac with navy trim, while registered nurses wear hospital blue with navy trim, with embroidered names, job titles, and NHS logos (NHS Supply Chain, National Healthcare Uniform, September 2023).
- Adoption of the national colourways by individual NHS trusts is voluntary; NHS England's guidance states that trusts should set uniform policies but does not mandate a specific colour scheme. Implementation varies across the NHS, with some trusts adopting the national scheme and others retaining local uniform policies.
- The recommendation called for commissioning arrangements to require visual identification; NHS standard contracts do not contain specific uniform requirements for distinguishing HCAs from registered nurses, leaving implementation to provider-level policy.
Commissioners (Primary)
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F209
Not Accepted
Registration of healthcare support workers
Recommendation
A registration system should be created under which no unregistered person should be permitted to provide for reward direct physical care to patients currently under the care and treatment of a registered nurse or a registered doctor (or who are … Read more
Published evidence summary
- The government explicitly rejected this recommendation in "Hard Truths" Volume 2 (Cm 8777, November 2013), one of only nine Francis recommendations not accepted. The government stated that statutory regulation of healthcare support workers "would not add sufficiently to the general assurance provided by the CQC" and considered it too bureaucratic and expensive (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- Instead of statutory registration, the government adopted a package of alternative measures: a voluntary Code of Conduct for Healthcare Support Workers (published March 2013 by Skills for Care and Skills for Health), the Care Certificate (launched April 2015), and reliance on existing CQC provider registration and DBS barring mechanisms.
- The Cavendish Review (July 2013), commissioned by the Secretary of State, had its terms of reference expressly exclude consideration of statutory regulation, and its training-focused recommendations were adopted as the government's alternative approach (Review of Healthcare Assistants and Support Workers in NHS and Social Care, Camilla Cavendish, July 2013).
- Robert Francis publicly criticised the rejection, stating: "Without any registration system or its equivalent, I believe the public will be at risk." He noted that taxi drivers and security guards face stricter registration requirements than healthcare assistants caring for vulnerable patients.
- The Professional Standards Authority accredits approximately 28 voluntary registers for unregulated health practitioners, but there is no PSA-accredited register for healthcare support workers or healthcare assistants specifically (Professional Standards Authority, Accredited Registers programme).
- Healthcare support workers in England remain unregistered as of March 2026. The Nursing Associate role (NMC-regulated from January 2019) creates a separate registered role but does not constitute registration of HCAs themselves.
Department of Health and Social Care (Primary)
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F210
Accepted
Code of conduct for healthcare support workers
Recommendation

There should be a national code of conduct for healthcare support workers.

Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation and acted on it prior to publication of the full response (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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).
Department of Health and Social Care (Primary)
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F211
Accepted
Training standards for healthcare support workers
Recommendation

There should be a common set of national standards for the education and training of healthcare support workers.

Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
Department of Health and Social Care (Primary)
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F212
Not Accepted
Training standards for healthcare support workers
Recommendation
The code of conduct, education and training standards and requirements for registration for healthcare support workers should be prepared and maintained by the Nursing and Midwifery Council after due consultation with all relevant stakeholders, including the Department of Health, other … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) rejected this recommendation, as a consequence of rejecting F209 (statutory registration of healthcare support workers). Since the government did not accept that HCAs should be registered, it followed that the NMC would not be given responsibility for maintaining a register, code of conduct, or training standards for this workforce (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- Instead, responsibility for the Code of Conduct and training standards was given to Skills for Care and Skills for Health (non-statutory sector skills bodies) rather than the NMC. The Code of Conduct was published in March 2013 and the Care Certificate launched in April 2015, both maintained by these bodies rather than a statutory regulator.
- The NMC was given regulatory responsibility for the new Nursing Associate role from January 2019 under the Nursing and Midwifery (Amendment) Order 2018 (SI 2018/838), but this is a separate, higher-level role requiring a two-year foundation degree — not regulation of healthcare support workers as Francis envisaged (NMC, Nursing Associates).
- The Professional Standards Authority's accredited voluntary registers programme does not include a register for healthcare support workers, and there is no regulatory body with oversight of HCA conduct, education, or training standards in the way Francis recommended for the NMC (Professional Standards Authority, Accredited Registers).
- The recommendation that the NMC should prepare and maintain HCA standards after consultation with relevant stakeholders has not been implemented; the NMC's remit remains limited to registered nurses, midwives, and nursing associates.
NMC (Primary)
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F213
Not Accepted
Training standards for healthcare support workers
Recommendation
Until such time as the Nursing and Midwifery Council is charged with the recommended regulatory responsibilities, the Department of Health should institute a nationwide system to protect patients and care receivers from harm. This system should be supported by fair … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) rejected this recommendation, stating that existing safeguards — particularly the Disclosure and Barring Service (DBS) barring mechanisms and CQC provider regulation — were sufficient to protect patients without a dedicated HCA barring system (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- Healthcare support workers in regulated activity are subject to Enhanced DBS checks with Adults' Barred List checks, and employers are legally required to carry these out before engagement. The DBS maintains adults' and children's barred lists under the Safeguarding Vulnerable Groups Act 2006, and individuals can be placed on barred lists without a criminal conviction using the civil standard of proof.
- However, the DBS operates as a negative check (barring known unfit individuals) rather than the positive registration and barring system Francis recommended. Francis noted in his report: "Should a healthcare support worker be dismissed by an employer for being unfit to undertake this form of work, there is no system which prevents the worker being re-engaged by another employer" unless a formal DBS referral has been made.
- There is no nationwide system equivalent to NMC fitness-to-practise proceedings for healthcare support workers. The recommendation envisaged a system with fair due process for dismissed HCAs — the DBS barring process does include a representations stage, but it is not equivalent to a professional regulatory hearing.
- The gap identified by Francis remains: an HCA dismissed for poor care can seek employment elsewhere provided no DBS referral is made. NHS Employers guidance encourages trusts to make DBS referrals where appropriate, but referral rates vary and there is no mandatory reporting mechanism specific to HCAs.
Department of Health and Social Care (Primary)
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F214
Accepted
Shared training
Recommendation
A leadership staff college or training system, whether centralised or regional, should be created to: provide common professional training in management and leadership to potential senior staff; promote healthcare leadership and management as a profession; administer an accreditation scheme to … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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).
F215
Accepted
Shared code of ethics
Recommendation

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.

Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
Department of Health and Social Care (Primary)
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F216
Accepted
Leadership framework
Recommendation
The leadership framework should be improved by increasing the emphasis given to patient safety in the thinking of all in the health service. This could be done by, for example, creating a separate domain for managing safety, or by defining … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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).
F217
Accepted in Part
Common selection criteria
Recommendation

A list should be drawn up of all the qualities generally considered necessary for a good and effective leader. This in turn could inform a list of competences a leader would be expected to have.

Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- The NHS Leadership Competency Framework (LCF) for board members, published 28 February 2024 and effective from 1 April 2024, defines competencies across six domains: driving high-quality and sustainable outcomes; setting strategy and delivering long-term transformation; promoting equality and inclusion; providing robust governance and assurance; creating a compassionate culture; and building trusted relationships with partners and communities (NHS England, NHS Leadership Competency Framework, February 2024).
- The LCF must be incorporated into all NHS board member role descriptions, recruitment processes, and annual appraisals from 1 April 2024, establishing the list of competences a leader is expected to have as Francis recommended.
- The earlier Healthcare Leadership Model (2013) set out nine behavioural dimensions of leadership applicable at all levels, providing a predecessor competency framework. The LCF builds on this for board-level leaders specifically.
- The revised Fit and Proper Person Test framework (effective 30 September 2023) incorporates standard competencies for all board directors, reinforcing the requirement for leaders to demonstrate specific qualities and competences (NHS England, FPPT Framework, September 2023).
F218
Accepted
Enforcement of standards and accountability
Recommendation
Serious non-compliance with the code, and in particular, non-compliance leading to actual or potential harm to patients, should render board-level leaders and managers liable to be found not to be fit and proper persons to hold such positions by a … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation and introduced the Fit and Proper Person Test (FPPT) as CQC Regulation 5 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, effective from 27 November 2014 (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
CQC (Primary)
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F219
Accepted in Part
A regulator as an alternative
Recommendation
An alternative option to enforcing compliance with a management code of conduct, with the risk of disqualification, would be to set up an independent professional regulator. The need for this would be greater if it were thought appropriate to extend … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) noted this recommendation as an alternative to F218 and indicated it would proceed with the Fit and Proper Person Test approach rather than a full independent regulator (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- Francis presented this as an alternative option: rather than the FPPT disqualification route in F218, an independent professional regulator for healthcare managers could enforce a code of conduct. He noted the need for this would be greater if regulation extended beyond directors to a wider range of managers.
- The government's consultation "Leading the NHS" (November 2024–February 2025) considered three options: voluntary accreditation, statutory barring with professional register, or full statutory regulation. The consultation response (July 2025) chose the middle option — a statutory barring system operated by the HCPC, rather than full statutory professional regulation (Leading the NHS: Consultation Response, DHSC, July 2025).
- The statutory barring mechanism will apply to board-level leaders and their direct reports, with the HCPC empowered to bar individuals for serious misconduct. This is closer to the FPPT-plus-disqualification model in F218 than the full independent regulatory model in F219.
- Francis's suggestion that regulation might extend to a wider range of managers has not been adopted; the proposed barring system is limited to senior leaders. The consultation also invited views on a professional duty of candour for NHS managers.
Department of Health and Social Care (Primary)
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F220
Accepted in Part
Accreditation
Recommendation
A training facility could provide the route through which an accreditation scheme could be organised. Although this might be a voluntary scheme, at least initally, the objective should be to require all leadership posts to be filled by persons who … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation in principle (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- The NHS Leadership Academy offers structured development pathways including nationally recognised programmes (Edward Jenner, Mary Seacole, Nye Bevan) that provide a route to leadership accreditation. The Nye Bevan Programme prepares senior leaders for board roles and has developed over 1,000 senior leaders (NHS Leadership Academy).
- The NHS Leadership Competency Framework (effective 1 April 2024) defines six competency domains that must be incorporated into all board member recruitment processes and annual appraisals, functioning as an accreditation requirement for board-level roles (NHS England, NHS Leadership Competency Framework, February 2024).
- However, the accreditation scheme remains voluntary in the sense that there is no mandatory qualification or licence required to hold a senior NHS leadership post. The revised FPPT framework (September 2023) incorporates competency standards into director assessments, but this is a fitness test rather than a positive accreditation requirement.
- Francis envisaged a progression from voluntary to mandatory accreditation for all leadership posts. While the infrastructure exists through the Leadership Academy and competency framework, a formal requirement that all leadership posts be filled by accredited persons has not been established.
F221
Accepted
Ensuring common standards of competence and compliance
Recommendation
Consideration should be given to ensuring that there is regulatory oversight of the competence and compliance with appropriate standards by the boards of health service bodies which are not foundation trusts, of equivalent rigour to that applied to foundation trusts. Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
CQC (Primary)
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F222
Accepted
General Medical Council Systemic investigation where needed
Recommendation

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.

Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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).
GMC (Primary)
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F223
Accepted in Part
Enhanced resources
Recommendation
If the General Medical Council is to be effective in looking into generic complaints and information it will probably need either greater resources, or better cooperation with the Care Quality Commission and other organisations such as the Royal Colleges to … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- A formal GMC-CQC Joint Operational Protocol governs bilateral 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. An emerging and urgent concerns protocol allows ad hoc bilateral sharing outside routine channels (CQC-GMC Joint Operational Protocol).
- The Medical Profession (Responsible Officers) Regulations 2010 require every designated body (including NHS trusts, Royal Colleges, and other healthcare organisations) to appoint a responsible officer who has a statutory duty to report fitness to practise concerns to the GMC, systematising the flow of information from employers and professional bodies.
- The draft GMC Order 2026 (consultation launched March 2026) includes provisions requiring information sharing with the PSA when requested, further strengthening the regulatory information ecosystem (Reforming the General Medical Council Legislative Framework, DHSC, March 2026).
- The cooperation framework Francis recommended between the GMC, CQC, and Royal Colleges is now established through formal protocols and statutory duties, providing the GMC with multiple information channels beyond individual complaints.
GMC (Primary)
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F224
Accepted
Information sharing
Recommendation

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.

Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
GMC (Primary)
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F225
Accepted
Peer reviews
Recommendation
The General Medical Council should have regard to the possibility of commissioning peer reviews pursuant to section 35 of the Medical Act 1983 where concerns are raised in a generic way, in order to be advised whether there are individual … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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).
GMC (Primary)
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F226
Accepted in Part
Nursing and Midwifery Council Investigation of systemic concerns
Recommendation
To act as an effective regulator of nurse managers and leaders, as well as more front-line nurses, the Nursing and Midwifery Council needs to be equipped to look at systemic concerns as well as individual ones. It must be enabled … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- The NMC's current legislation dates from 2001 and its fitness to practise framework is focused on individual registrants, not systemic or organisational concerns. The NMC does not have explicit statutory powers to investigate systemic failings in organisations — the gap Francis identified remains in the legislative framework (NMC, Why We Need Regulatory Reform).
- The NMC has established closer working relationships with CQC through information sharing agreements. The NMC's Employer Link Service facilitates communication between the NMC and healthcare providers, receiving 1,152 requests for advice about fitness to practise concerns in 2024/25 (NMC, Employer Link Service).
- The UK government intends to bring forward legislation to modernise the NMC's legislative framework during this parliamentary term, using the General Medical Council Order 2026 as a blueprint with bespoke changes for each regulator. Proposed reforms include enhanced data-sharing capabilities and improved fitness to practise processes emphasising learning over blame (Written Question 85142, 27 October 2025).
- No specific timeline has been published for when NMC reform legislation will be laid. Until then, the NMC's ability to look at systemic concerns and work closely with systems regulators in the manner Francis recommended remains constrained by its existing legislative framework.
NMC (Primary)
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F227
Accepted in Part
Nursing and Midwifery Council Investigation of systemic concerns
Recommendation
The Nursing and Midwifery Council needs to have its own internal capacity to assess systems and launch its own proactive investigations where it becomes aware of concerns which may give rise to nursing fitness to practise issues. It may decide … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- The NMC's registrar has the power to refer cases for investigation without a formal third-party complaint, which Francis noted should make legislative change unnecessary. However, the NMC's fitness to practise processes remain structured around individual registrant concerns rather than proactive organisational investigations.
- The NMC does not currently have its own internal capacity to assess systems in the manner Francis recommended — it relies on information from CQC, employers, and the public to identify individual fitness to practise concerns, rather than launching independent systemic investigations into organisations.
- The NMC Council approved a £30 million, 18-month improvement plan to address operational backlogs, targeting a two-month screening average in 2025/26 and a seven-month investigation average in 2026/27. This addresses administrative capacity but does not constitute the systemic investigation capability Francis envisaged (NMC, Fitness to Practise Improvement Plan).
- Legislative reform is anticipated: the government intends to modernise the NMC's legislative framework during this parliamentary term, using the GMC Order 2026 as a blueprint. Whether the new framework will include explicit powers for proactive systemic investigations by the NMC has not been confirmed (Written Question 85142, 27 October 2025).
NMC (Primary)
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F228
Accepted
Administrative reform
Recommendation
It is of concern that the administration of the Nursing and Midwifery Council, which has not been examined by this Inquiry, is still found by other reviews to be wanting. It is imperative in the public interest that this is … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation as urgent (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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).
NMC (Primary)
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F229
Accepted
Revalidation
Recommendation
It is highly desirable that the Nursing and Midwifery Council introduces a system of revalidation similar to that of the General Medical Council, as a means of reinforcing the status and competence of registered nurses, as well as providing additional … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
NMC (Primary)
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F230
Accepted
Profile
Recommendation
The profile of the Nursing and Midwifery Council needs to be raised with the public, who are the prime and most valuable source of information about the conduct of nurses. All patients should be informed, by those providing treatment or … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
NMC (Primary)
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F231
Accepted
Coordination with internal procedures
Recommendation
It is essential that, so far as practicable, Nursing and Midwifery Council procedures do not obstruct the progress of internal disciplinary action in providers. In most cases it should be possible, through cooperation, to allow both to proceed in parallel. … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
NMC (Primary)
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F232
Accepted
Employment liaison officers
Recommendation
The Nursing and Midwifery Council could consider a concept of employment liaison officers, similar to that of the General Medical Council, to provide support to directors of nursing. If this is impractical, a support network of senior nurse leaders will … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
NMC (Primary)
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F233
Accepted
For joint action Profile
Recommendation
While both the General Medical Council and the Nursing and Midwifery Council have highly informative internet sites, both need to ensure that patients and other service users are made aware at the point of service provision of their existence, their … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
GMC (Primary)
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F234
Accepted
Cooperation with the Care Quality Commission
Recommendation
Both the General Medical Council and Nursing and Midwifery Council must develop closer working relationships with the Care Quality Commission – in many cases there should be joint working to minimise the time taken to resolve issues and maximise the … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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).
GMC (Primary)
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F235
Accepted in Part
Joint proceedings
Recommendation
The Professional Standards Authority for Health and Social Care (PSA) (formerly the Council for Healthcare Regulatory Excellence), together with the regulators under its supervision, should seek to devise procedures for dealing consistently and in the public interest with cases arising … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation in principle (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- The Professional Standards Authority (PSA) has developed its Right-touch regulation framework (originally 2010, updated 2015, most recently updated 2025) to promote consistent, proportionate approaches across the healthcare regulators under its oversight (PSA, Right-touch Regulation, 2025).
- The PSA has advocated for a shared independent tribunal service for adjudication on fitness to practise cases across all healthcare regulators, and for reducing the number of regulators (currently 10). The PSA has stated that "creating a single regulator would be the best way to deal with problems in the current system" but acknowledges there may not be appetite for such a change (PSA, Right-touch Reform).
- The Health and Care Act 2022 includes powers (Section 121) for the Secretary of State to merge or abolish healthcare professional regulators and to move professional groups out of statutory regulation, providing a legislative basis for consolidation. However, these powers have not been exercised to date.
- Under the draft GMC Order 2026, the PSA will receive new powers to challenge interim decisions by the Medical Practitioners Tribunal Service, and regulators will be required to share information with the PSA. However, a common independent tribunal to determine fitness to practise issues across all healthcare professions, as Francis recommended, has not been established. The regulatory landscape remains fragmented across 10 separate regulators.
F236
Accepted
Identification of who is responsible for the patient
Recommendation

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.

Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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).
Healthcare providers (Primary)
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F237
Accepted
Teamwork
Recommendation
There needs to be effective teamwork between all the different disciplines and services that together provide the collective care often required by an elderly patient; the contribution of cleaners, maintenance staff, and catering staff also needs to be recognised and … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
Healthcare providers (Primary)
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F238
Accepted
Communication with and about patients
Recommendation
Regular interaction and engagement between nurses and patients and those close to them should be systematised through regular ward rounds: All staff need to be enabled to interact constructively, in a helpful and friendly fashion, with patients and visitors. Where … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
Healthcare providers (Primary)
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F239
Accepted
Continuing responsibility for care
Recommendation
The care offered by a hospital should not end merely because the patient has surrendered a bed – it should never be acceptable for patients to be discharged in the middle of the night, still less so at any time … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
Healthcare providers (Primary)
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F240
Accepted
Hygiene
Recommendation

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.

Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
Healthcare providers (Primary)
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F241
Accepted
Provision of food and drink
Recommendation

The arrangements and best practice for providing food and drink to elderly patients require constant review, monitoring and implementation.

Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
Healthcare providers (Primary)
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F242
Accepted
Medicines administration
Recommendation
In the absence of automatic checking and prompting, the process of the administration of medication needs to be overseen by the nurse in charge of the ward, or his/her nominated delegate. A frequent check needs to be done to ensure … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
Healthcare providers (Primary)
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F243
Accepted
Recording of routine observations
Recommendation
The recording of routine observations on the ward should, where possible, be done automatically as they are taken, with results being immediately accessible to all staff electronically in a form enabling progress to be monitored and interpreted. If this cannot … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
Healthcare providers (Primary)
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F244
Accepted
Common information practices shared data and electronic records
Recommendation
There is a need for all to accept common information practices, and to feed performance information into shared databases for monitoring purposes. The following principles should be applied in considering the introduction of electronic patient information systems: Patients need to … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
NHS (Primary)
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F245
Accepted in Part
Board accountability
Recommendation

Each provider organisation should have a board level member with responsibility for information.

Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- All NHS organisations are required to appoint a Senior Information Risk Owner (SIRO) at board or governing body level. The SIRO has executive-level responsibility for the organisation's information risk policy, accountability for information risk across the organisation, and a duty to ensure staff understand their personal responsibility for safeguarding and sharing information appropriately. SIROs must produce annual reports to their boards (NHS England Digital, Data Security and Protection Toolkit).
- In addition to the SIRO, organisations must appoint a Caldicott Guardian (a senior person responsible for protecting patient information confidentiality) and a Data Protection Officer under UK GDPR. These roles are embedded at board or senior level.
- The DSPT requirement ensures board-level engagement with information governance: organisations must demonstrate that their board receives regular information governance reports and that a named senior individual takes responsibility for information risk.
- The NHS Leadership Competency Framework (effective 1 April 2024) includes "providing robust governance and assurance" as one of its six domains, within which information governance and data quality are expected competencies for board members (NHS England, NHS Leadership Competency Framework, February 2024).
Healthcare providers (Primary)
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F246
Accepted
Comparable quality accounts
Recommendation
Department of Health/the NHS Commissioning Board/regulators should ensure that provider organisations publish in their annual quality accounts information in a common form to enable comparisons to be made between organisations, to include a minimum of prescribed information about their compliance … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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."
Department of Health and Social Care (Primary)
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F247
Accepted
Accountability for quality accounts
Recommendation

Healthcare providers should be required to lodge their quality accounts with all organisations commissioning services from them, Local Healthwatch, and all systems regulators.

Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
Healthcare providers (Primary)
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F248
Accepted
Accountability for quality accounts
Recommendation

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.

Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation in principle (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
Healthcare providers (Primary)
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F249
Accepted in Part
Accountability for quality accounts
Recommendation
Each quality account should be accompanied by a declaration signed by all directors in office at the date of the account certifying that they believe the contents of the account to be true, or alternatively a statement of explanation as … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation in part (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- The NHS (Quality Accounts) Regulations 2010 require "a written statement, at the end of Part 1, signed by the responsible person for the provider that to the best of that person's knowledge the information in the document is accurate." For corporate bodies, the responsible person is the most senior employee (NHS (Quality Accounts) Regulations 2010, SI 2010/279).
- However, Francis recommended that the declaration should be signed by "all directors in office at the date of the account," with individual directors required to provide an explanation if they are unable or refuse to sign. The regulations require only the most senior employee's signature, not all directors collectively.
- The Care Act 2014 (Sections 92-94) created personal liability for directors: where the offence of supplying false or misleading information was committed with the consent or connivance of, or was attributable to the neglect of, a director, manager, secretary or similar officer, that individual is personally liable for the same penalties (Care Act 2014, s.94).
- This personal liability provision partially addresses the accountability gap, but the collective director declaration and individual opt-out mechanism Francis recommended has not been implemented in the Quality Accounts regulations.
Healthcare providers (Primary)
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F250
Accepted in Part
Accountability for quality accounts
Recommendation
It should be a criminal offence for a director to sign a declaration of belief that the contents of a quality account are true if it contains a misstatement of fact concerning an item of prescribed information which he/she does … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- The Care Act 2014, Part 2, Sections 92-94 implemented this recommendation. Section 92 provides that a care provider commits an offence if it supplies, publishes, or otherwise makes available information of a specified description that is required under an enactment or other legal obligation and that information is false or misleading in a material respect. A defence exists if the provider took all reasonable steps and exercised all due diligence (Care Act 2014, s.92).
- Section 93 sets penalties on conviction: on summary conviction, a fine; on indictment, up to two years' imprisonment or a fine or both. Courts may also impose remedial orders and publicity orders.
- Section 94 provides personal liability for directors, managers, secretaries, or similar officers where the offence was committed with their consent or connivance, or was attributable to their neglect. The same penalties apply to individuals as to the corporate body.
- The False or Misleading Information (Specified Care Providers and Specified Information) Regulations 2015 brought these provisions into force, specifying that the covered information includes Quality Accounts, cancer waiting times, maternity data sets, and core commissioning data sets. Guidance on the offence was published by DHSC in February 2015 (The False or Misleading Information Offence: Guidance, DHSC, February 2015).
Department of Health and Social Care (Primary)
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F251
Accepted in Part
Regulatory oversight of quality accounts
Recommendation
The Care Quality Commission and/or Monitor should keep the accuracy, fairness and balance of quality accounts under review and should be enabled to require corrections to be issued where appropriate. In the event of an organisation failing to take that … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation in principle (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- CQC does not directly review or audit individual Quality Accounts in the manner Francis envisaged. CQC uses data from Quality Accounts as one of many sources within its CQC Insight monitoring tool to inform inspection decisions, but it does not provide a formal statement or review of individual Quality Accounts or require corrections to be issued (CQC, Using Data to Monitor Services).
- The former requirement for Monitor (later NHS Improvement) to oversee Quality Reports from foundation trusts has been withdrawn. NHS foundation trusts no longer produce a separate Quality Report as part of their annual report (NHS England, Quality Accounts Requirements).
- Integrated Care Boards have assumed responsibilities for the review and scrutiny of Quality Accounts, providing oversight but without the specific power to require corrections that Francis recommended for CQC or Monitor.
- The Care Act 2014 false information offence (Sections 92-94) provides a legal remedy where Quality Accounts contain materially false or misleading information, but this is a criminal prosecution route rather than the administrative correction mechanism Francis proposed.
CQC (Primary)
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F252
Accepted
Access to data
Recommendation

It is important that the appropriate steps are taken to enable properly anonymised data to be used for managerial and regulatory purposes.

Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
Department of Health and Social Care (Primary)
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F253
Accepted
Access to quality and risk profile
Recommendation
The information behind the quality and risk profile – as well as the ratings and methodology – should be placed in the public domain, as far as is consistent with maintaining any legitimate confidentiality of such information, together with appropriate … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
CQC (Primary)
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F254
Accepted
Access for public and patient comments
Recommendation
While there are likely to be many different gateways offered through which patient and public comments can be made, to avoid confusion, it would be helpful for there to be consistency across the country in methods of access, and for … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
NHS England (Primary)
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F255
Accepted
Using patient feedback
Recommendation

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.

Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
NHS England (Primary)
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F256
Accepted
Follow up of patients
Recommendation

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.

Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) noted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
Healthcare providers (Primary)
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F257
Accepted in Part
Role of the Health and Social Care Information Centre
Recommendation
The Information Centre should be tasked with the independent collection, analysis, publication and oversight of healthcare information in England, or, with the agreement of the devolved governments, the United Kingdom. The information functions previously held by the National Patient Safety … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation in principle (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- The Health and Social Care Information Centre (HSCIC) was established on 1 April 2013 as an Executive Non-Departmental Public Body under the Health and Social Care Act 2012, with statutory duties for the independent collection, analysis, and publication of healthcare information in England. It was rebranded as NHS Digital in July 2016 (NHS Digital).
- The patient safety reporting functions previously held by the National Patient Safety Agency (NPSA) were transferred — initially to NHS England's patient safety team rather than to the Information Centre as Francis recommended. These functions are now part of the Learn from Patient Safety Events (LFPSE) service within NHS England.
- NHS Digital was merged into NHS England on 1 February 2023, at which point it ceased to exist as a separate arms-length body. NHS England became the custodian of national health and social care datasets and the single body responsible for digital technology, data, and health service delivery (NHS England, NHS Digital Merger, February 2023).
- Francis's key concern was independence: the Information Centre should independently collect and publish healthcare information. The merger into NHS England means the data functions are no longer held by a separately governed, independent body — they sit within the same organisation responsible for commissioning and delivering NHS services, raising questions about the independence of data publication that Francis emphasised.
F258
Accepted
Role of the Health and Social Care Information Centre
Recommendation

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.

Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
F259
Accepted
Role of the Health and Social Care Information Centre
Recommendation

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.

Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
F260
Accepted in Part
Information standards
Recommendation
The standards applied to statistical information about serious untoward incidents should be the same as for any other healthcare information and in particular the principles around transparency and accessibility. It would, therefore, be desirable for the data to be supplied … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- The National Reporting and Learning System (NRLS) was the longstanding national system for reporting patient safety incidents. It was decommissioned on 30 June 2024 and replaced by the Learn from Patient Safety Events (LFPSE) service, which can be used by all organisations registered with an ODS code including primary care (NHS England, LFPSE).
- LFPSE uses standardised categories and severity classifications for recording patient safety events, providing a more comprehensive national dataset than its predecessor. Data is collected by NHS England and is used for national analysis and learning.
- The Patient Safety Incident Response Framework (PSIRF), which replaced the previous Serious Incident Framework from autumn 2023, changed the approach from mandatory investigation of defined categories to locally-determined proportionate responses. This represents a shift from standardised statistical reporting of serious incidents to a more flexible, learning-focused model.
- Francis recommended that statistical information about serious untoward incidents should meet the same transparency and accessibility standards as other healthcare information, and that data should be supplied to and processed by the Information Centre. While LFPSE centralises patient safety event data within NHS England, the transition from NRLS to LFPSE and from the SI Framework to PSIRF means the statistical landscape for serious incidents is evolving. There is no single nationally agreed statistical metric (such as a rate per 1,000 admissions) that all trusts must report against for serious incidents.
F261
Accepted
Information standards
Recommendation

The Information Centre should be enabled to undertake more detailed statistical analysis of its own than currently appears to be the case.

Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
F262
Accepted
Enhancing the use analysis and dissemination of healthcare information
Recommendation
All healthcare provider organisations, in conjunction with their healthcare professionals, should develop and maintain systems which give them: Effective real-time information on the performance of each of their services against patient safety and minimum quality standards; Effective real-time information of … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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).
Healthcare providers (Primary)
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F263
Accepted
Enhancing the use analysis and dissemination of healthcare information
Recommendation

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.

Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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).
Healthcare providers (Primary)
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F264
Accepted
Enhancing the use analysis and dissemination of healthcare information
Recommendation

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.

Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
Royal Colleges (Primary)
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F265
Accepted
Enhancing the use analysis and dissemination of healthcare information
Recommendation
The Department of Health, the Information Centre and the Care Quality Commission should engage with each representative specialty organisation in order to consider how best to develop comparative statistics on the efficacy of treatment in that specialty, for publication and … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
Department of Health and Social Care (Primary)
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F266
Accepted
Enhancing the use analysis and dissemination of healthcare information
Recommendation
In designing the methodology for such statistics and their presentation, the Department of Health, the Information Centre, the Care Quality Commission and the specialty organisations should seek and have regard to the views of patient groups and the public about … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
Department of Health and Social Care (Primary)
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F267
Accepted
Enhancing the use analysis and dissemination of healthcare information
Recommendation

All such statistics should be made available online and accessible through provider websites, as well as other gateways such as the Care Quality Commission.

Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
Healthcare providers (Primary)
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F268
Accepted
Resources
Recommendation

Resources must be allocated to and by provider organisations to enable the relevant data to be collected and forwarded to the relevant central registry.

Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
Healthcare providers (Primary)
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F269
Accepted
Improving and assuring accuracy
Recommendation

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.

Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
Healthcare providers (Primary)
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F270
Accepted
Improving and assuring accuracy
Recommendation
There is a need for a review by the Department of Health, the Information Centre and the UK Statistics Authority of the patient outcome statistics, including hospital mortality and other outcome indicators. In particular, there could be benefit from consideration … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
Department of Health and Social Care (Primary)
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F271
Accepted
Improving and assuring accuracy
Recommendation
To the extent that summary hospital-level mortality indicators are not already recognised as national or official statistics, the Department of Health and the Health and Social Care Information Centre should work towards establishing such status for them or any successor … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
Department of Health and Social Care (Primary)
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F272
Accepted
Improving and assuring accuracy
Recommendation
There is a demonstrable need for an accreditation system to be available for healthcare-relevant statistical methodologies. The power to create an accreditation scheme has been included in the Health and Social Care Act 2012, it should be used as soon … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
Department of Health and Social Care (Primary)
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F273
Accepted in Part
Information to coroners
Recommendation
The terms of authorisation, licensing and registration and any relevant guidance should oblige healthcare providers to provide all relevant information to enable the coroner to perform his function, unless a director is personally satisfied that withholding the information is justified … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- The statutory duty of candour, introduced via Regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, requires healthcare providers to be open and transparent with patients and families when things go wrong. It applied to NHS trusts from November 2014 and all CQC-registered providers from April 2015 (CQC, Regulation 20: Duty of Candour).
- The Coroners and Justice Act 2009 establishes a duty on registered medical practitioners to notify the senior coroner of deaths. Healthcare providers are legally required to cooperate with coroner investigations. Failure to comply with a coroner's request for information without reasonable excuse is a contempt of court.
- The Caldicott 2 review (published April 2013) introduced the seventh Caldicott principle: "The duty to share information can be as important as the duty to protect patient confidentiality." An eighth principle was added in 2020: "Inform patients and service users about how their confidential information is used" (Caldicott Review, DHSC, April 2013; NDG, 8th Caldicott Principle, December 2020).
- These provisions collectively establish that healthcare providers must provide relevant information to coroners, patients, and families, with openness prioritised over any perceived institutional interest.
Healthcare providers (Primary)
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F274
Accepted
Information to coroners
Recommendation
There is an urgent need for unequivocal guidance to be given to trusts and their legal advisers and those handling disclosure of information to coroners, patients and families, as to the priority to be given to openness over any perceived … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
Department of Health and Social Care (Primary)
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F275
Accepted in Part
Independent medical examiners
Recommendation

It is of considerable importance that independent medical examiners are independent of the organisation whose patients' deaths are being scrutinised.

Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- The statutory medical examiner system commenced on 9 September 2024 under the Coroners and Justice Act 2009 (as amended by the Health and Care Act 2022). From this date, all deaths in England and Wales not investigated by a coroner must be reviewed by an NHS medical examiner (Death Certification Reform, DHSC).
- Medical examiners are independent of the clinical teams whose patients' deaths they scrutinise. They are senior doctors (with at least five years post-registration experience) employed by NHS trusts but exercising their medical examiner function independently of the trust's management. The National Medical Examiner's guidance emphasises this independence as a core principle of the role.
- Dr Alan Fletcher was appointed as the first National Medical Examiner for England and Wales in March 2019, overseeing the non-statutory rollout from April 2019 and the subsequent statutory implementation (NHS England, Medical Examiner System).
- The system was initially rolled out non-statutorily from April 2019, with NHS England asking all trusts to establish Medical Examiner Offices. The move to statutory footing in September 2024 completed the implementation, directly fulfilling Francis's recommendation that medical examiners should be independent of the organisations being scrutinised.
Department of Health and Social Care (Primary)
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F276
Accepted
Independent medical examiners
Recommendation

Sufficient numbers of independent medical examiners need to be appointed and resourced to ensure that they can give proper attention to the workload.

Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
Department of Health and Social Care (Primary)
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F277
Accepted
Death certification
Recommendation

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.

Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
Department of Health and Social Care (Primary)
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F278
Accepted
Death certification
Recommendation
It should be a routine part of an independent medical examiners's role to seek out and consider any serious untoward incidents or adverse incident reports relating to the deceased, to ensure that all circumstances are taken into account whether or … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
Healthcare providers (Primary)
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F279
Accepted
Death certification
Recommendation

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.

Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
Healthcare providers (Primary)
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F280
Accepted
Appropriate and sensitive contact with bereaved families
Recommendation
Both the bereaved family and the certifying doctor should be asked whether they have any concerns about the death or the circumstances surrounding it, and guidance should be given to hospital staff encouraging them to raise any concerns they may … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
Healthcare providers (Primary)
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F281
Accepted
Appropriate and sensitive contact with bereaved families
Recommendation

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.

Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
Department of Health and Social Care (Primary)
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F282
Accepted
Information for and from inquests
Recommendation

Coroners should send copies of relevant Rule 43 reports to the Care Quality Commission.

Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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).
Coroners (Primary)
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F283
Accepted
Information for and from inquests
Recommendation

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.

Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
F284
Accepted
Appointment of assistant deputy coroners
Recommendation

The Lord Chancellor should issue guidance as to the criteria to be adopted in the appointment of assistant deputy coroners.

Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
F285
Accepted
Appointment of assistant deputy coroners
Recommendation

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.

Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
F286
Accepted
Impact assessments before structural change
Recommendation
Impact and risk assessments should be made public, and debated publicly, before a proposal for any major structural change to the healthcare system is accepted. Such assessments should cover at least the following issues: What is the precise issue or … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation in principle (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
Department of Health and Social Care (Primary)
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F287
Accepted
Impact assessments before structural change
Recommendation
The Department of Health should together with healthcare systems regulators take the lead in developing through obtaining consensus between the public and healthcare professionals, a coherent, and easily accessible structure for the development and implementation of values, fundamental, enhanced and … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
Department of Health and Social Care (Primary)
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F288
Accepted
Clinical input
Recommendation

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.

Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
Department of Health and Social Care (Primary)
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F289
Accepted
Experience on the front line
Recommendation
Department of Health officials need to connect more to the NHS by visits, and most importantly by personal contact with those who have suffered poor experiences. The Department of Health could also be assisted in its work by involving patient/service … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
Department of Health and Social Care (Primary)
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F290
Accepted
Experience on the front line
Recommendation
The Department of Health should promote a shared positive culture by setting an example in its statements by being open about deficiencies, ensuring those harmed have a remedy, and making information publicly available about performance at the most detailed level … Read more
Published evidence summary
- The government's response in "Hard Truths" (Cm 8777, November 2013) accepted this recommendation (Hard Truths: the Journey to Putting Patients First, DHSC, November 2013).
- 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.
Department of Health and Social Care (Primary)
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