Public Inquiry Recommendations

F29 Accepted

Mid Staffs Inquiry (2013)

Sanctions and interventions for non-compliance

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, …

- Regulation 22 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 created an offence where failure to comply with a fundamental …

F30 Accepted

Mid Staffs Inquiry (2013)

Interim measures

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 …

- 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 …

F31 Accepted

Mid Staffs Inquiry (2013)

Interim measures

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 …

- 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 …

F32 Accepted

Mid Staffs Inquiry (2013)

Interim measures

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 …

- CQC has statutory powers to take urgent action to protect patients, including imposing urgent conditions on registration, urgent suspension, or urgent cancellation under sections …

F33 Accepted in Part

Mid Staffs Inquiry (2013)

Interim measures

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.

- 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 …

F34 Accepted in Part

Mid Staffs Inquiry (2013)

Interim measures

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.

- Where CQC places a provider in special measures following an "Inadequate" rating, NHS England (and previously NHS Improvement) provides oversight and performance management support …

F35 Accepted

Mid Staffs Inquiry (2013)

Need to share information between regulators

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 …

- 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 …

F36 Accepted

Mid Staffs Inquiry (2013)

Use of information for effective regulation

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 …

- 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 …

F37 Accepted

Mid Staffs Inquiry (2013)

Use of information about compliance by regulator from: Quality accounts

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 …

- 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, …

F38 Accepted

Mid Staffs Inquiry (2013)

Use of information about compliance by regulator from: Complaints

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 …

- Regulation 16 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 requires providers to establish and operate an accessible complaints system, …

F39 Accepted in Part

Mid Staffs Inquiry (2013)

Use of information about compliance by regulator from: Complaints

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

- 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 …

F40 Accepted

Mid Staffs Inquiry (2013)

Use of information about compliance by regulator from: Complaints

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

- 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 …

F41 Accepted in Part

Mid Staffs Inquiry (2013)

Use of information about compliance by regulator from: Patient safety alerts

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 …

- The National Patient Safety Agency (NPSA) was abolished in June 2012. Its patient safety functions were transferred to NHS England (then the NHS Commissioning …

F42 Accepted

Mid Staffs Inquiry (2013)

Use of information about compliance by regulator from: Serious untoward incidents

Strategic Health Authorities/their successors should

- Strategic Health Authorities were abolished on 1 April 2013 under the Health and Social Care Act 2012. Their functions relating to oversight of NHS …

F43 Accepted

Mid Staffs Inquiry (2013)

Use of information about compliance by regulator from: Media

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

- The government stated in Hard Truths (November 2013) that regulators should be alert to information from all sources, including media reports, about the organisations …

F44 Accepted in Part

Mid Staffs Inquiry (2013)

Use of information about compliance by regulator from: Media

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 Care Quality Commission (Registration) Regulations 2009, Regulations 16 and 18, require providers to notify CQC of deaths and other serious incidents (SI 2009/3112, …

F45 Accepted in Part

Mid Staffs Inquiry (2013)

Use of information about compliance by regulator from: Inquests

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

- 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 …

F46 Accepted

Mid Staffs Inquiry (2013)

Use of information about compliance by regulator from: Quality and risk profiles

The Quality and Risk Profile should not be regarded as a potential substitute for active regulatory oversight by inspectors. It is important that this is explained carefully and clearly as …

- CQC replaced the Quality and Risk Profile with its Insight model, which uses a wider range of intelligence sources and indicators to monitor provider …

F47 Accepted

Mid Staffs Inquiry (2013)

Use of information about compliance by regulator from: Foundation trust governors and scrutiny committees

The Care Quality Commission should expand its work with overview and scrutiny committees and foundation trust governors as a valuable information resource. For example, it should further develop its current …

- CQC engages with local Healthwatch organisations (the successors to Local Involvement Networks established under the Health and Social Care Act 2012) as part of …

F48 Accepted in Part

Mid Staffs Inquiry (2013)

Use of information about compliance by regulator from: Foundation trust governors and scrutiny committees

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 …

- NHS foundation trust governors have a statutory duty under the Health and Social Care Act 2006 (as amended by the Health and Social Care …

F49 Accepted

Mid Staffs Inquiry (2013)

Enhancement of monitoring and the importance of inspection

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 …

- 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 …

F50 Accepted

Mid Staffs Inquiry (2013)

Enhancement of monitoring and the importance of inspection

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

- The government stated in Hard Truths (November 2013) that CQC would place far greater emphasis on inspection, with the appointment of Chief Inspectors of …

F51 Accepted

Mid Staffs Inquiry (2013)

Enhancement of monitoring and the importance of inspection

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 …

- The government stated in Hard Truths (November 2013) that CQC would develop specialist inspection teams led by trained inspectors, including clinicians, other experts, and …

F52 Accepted

Mid Staffs Inquiry (2013)

Enhancement of monitoring and the importance of inspection

The Care Quality Commission should consider whether inspections could be conducted in collaboration with other agencies, or whether they can take advantage of any peer review arrangements available.

- CQC conducts Joint Targeted Area Inspections (JTAIs) alongside Ofsted, HMICFRS, and HM Inspectorate of Probation. These unannounced joint inspections evaluate the multi-agency response to …

F53 Accepted

Mid Staffs Inquiry (2013)

Care Quality Commission independence strategy and culture

Any change to the Care Quality Commission's role should be by evolution – any temptation to abolish this organisation and create a new one must be avoided.

- The government stated in Hard Truths (November 2013) that it would retain CQC and reform it rather than replace it, consistent with this recommendation …

F54 Accepted

Mid Staffs Inquiry (2013)

Care Quality Commission independence strategy and culture

Where issues relating to regulatory action are discussed between the Care Quality Commission and other agencies, these should be properly recorded to avoid any suggestion of inappropriate interference in the …

- 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 …

F55 Accepted

Mid Staffs Inquiry (2013)

Care Quality Commission independence strategy and culture

The Care Quality Commission should review its processes as a whole to ensure that it is capable of delivering regulatory oversight and enforcement effectively, in accordance with the principles outlined …

- 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 …

F56 Accepted

Mid Staffs Inquiry (2013)

Care Quality Commission independence strategy and culture

The leadership of the Care Quality Commission should communicate clearly and persuasively its strategic direction to the public and to its staff, with a degree of clarity that may have …

- CQC published a series of "A fresh start" strategy documents in October 2013 setting out its new approach to regulation and inspection by sector, …

F57 Accepted

Mid Staffs Inquiry (2013)

Care Quality Commission independence strategy and culture

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 …

- CQC developed "Intelligent Monitoring" reports from March 2014, which brought together over 150 indicators for acute NHS trusts to help identify where risks to …

F58 Accepted

Mid Staffs Inquiry (2013)

Care Quality Commission independence strategy and culture

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 …

- 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 …

F59 Accepted in Part

Mid Staffs Inquiry (2013)

Care Quality Commission independence strategy and culture

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 …

- 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 …

F60 Accepted in Part

Mid Staffs Inquiry (2013)

Consolidation of regulatory functions

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 Fit and Proper Person Requirement (Regulation 5 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014) came into force in …

F61 Not Accepted

Mid Staffs Inquiry (2013)

Consolidation of regulatory functions

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 …

- The government did not merge the system regulatory functions of Monitor and CQC as Francis recommended. Instead, it maintained CQC as an independent quality …

F62 Accepted

Mid Staffs Inquiry (2013)

Improved patient focus

For as long as it retains responsibility for the regulation of foundation trusts, Monitor should incorporate greater patient and public involvement into its own structures, to ensure this focus is …

- Monitor merged with the NHS Trust Development Authority to form NHS Improvement on 1 April 2016. NHS Improvement subsequently merged into NHS England from …

F63 Accepted

Mid Staffs Inquiry (2013)

Improved transparency

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

- 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 …

F64 Not Accepted

Mid Staffs Inquiry (2013)

Authorisation of foundation trusts

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 …

- The government did not transfer the foundation trust authorisation process to CQC as Francis recommended. Instead, it maintained separate roles: CQC assessed quality and …

F65 Accepted

Mid Staffs Inquiry (2013)

Quality of care as a pre-condition for foundation trust applications

The NHS Trust Development Authority should develop a clear policy requiring proof of fitness for purpose in delivering the appropriate quality of care as a pre-condition to consideration for support …

- The NHS Trust Development Authority, established in 2012, oversaw NHS trusts that had not achieved foundation trust status. The TDA merged into NHS Improvement …

F66 Accepted

Mid Staffs Inquiry (2013)

Improving contribution of stakeholder opinions

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 …

- The government stated in Hard Truths (November 2013) that it would strengthen the foundation trust application process, including stakeholder consultation (Hard Truths Vol 1, …

F67 Accepted

Mid Staffs Inquiry (2013)

Focus on compliance with fundamental standards

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 …

- The NHS Trust Development Authority oversaw NHS trusts and was responsible for supporting and assessing potential foundation trust applicants. The TDA merged into NHS …

F68 Accepted

Mid Staffs Inquiry (2013)

Focus on compliance with fundamental standards

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 …

- Strategic Health Authorities were abolished on 1 April 2013 under the Health and Social Care Act 2012. Their performance management functions transferred to the …

F69 Accepted

Mid Staffs Inquiry (2013)

Focus on compliance with fundamental standards

The assessment criteria for authorisation should include a requirement that applicants demonstrate their ability to consistently meet fundamental patient safety and quality standards at the same time as complying with …

- The NHS provider licence, which replaced foundation trusts' Terms of Authorisation from 1 April 2013, includes Condition FT4 (Governance) requiring providers to demonstrate clear …

F70 Accepted

Mid Staffs Inquiry (2013)

Duty of utmost good faith

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 …

- 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 …

F71 Accepted

Mid Staffs Inquiry (2013)

Role of Secretary of State

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 …

- The foundation trust application pipeline was effectively closed by 2014, with most applications paused or deferred. No further trusts were authorised as foundation trusts …

F72 Accepted

Mid Staffs Inquiry (2013)

Assessment process for authorisation

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 …

- The foundation trust application pipeline was effectively closed by 2014. No published evidence has been identified that a specific requirement for full physical inspection …

F73 Accepted

Mid Staffs Inquiry (2013)

Need for constructive working with other parts of the system

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 …

- 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 …

F74 Accepted

Mid Staffs Inquiry (2013)

Enhancement of role of governors

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 …

- Monitor published "Your Statutory Duties: A Reference Guide for NHS Foundation Trust Governors" in August 2013, updated November 2013. This guide sets out governors' …

F75 Accepted in Part

Mid Staffs Inquiry (2013)

Enhancement of role of governors

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 …

- Section 151 of the Health and Social Care Act 2012 strengthened the role of councils of governors. New paragraph 10C inserted into Schedule 7 …

F76 Accepted

Mid Staffs Inquiry (2013)

Enhancement of role of governors

Arrangements must be made to ensure that governors are accountable not just to the immediate membership but to the public at large – it is important that regular and constructive …

- 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 …

F77 Accepted

Mid Staffs Inquiry (2013)

Enhancement of role of governors

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 …

- NHS Providers (formerly the Foundation Trust Network) operates the GovernWell programme, established in 2013, providing national training and support for NHS foundation trust governors. …

F78 Accepted

Mid Staffs Inquiry (2013)

Enhancement of role of governors

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 …

- Section 39A of the National Health Service Act 2006 (inserted by the Health and Social Care Act 2012) provides for a panel to consider …