Public Inquiry Recommendations

F1 Accepted

Mid Staffs Inquiry (2013)

Implementing the recommendations

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 …

- The government published "Hard Truths: the Journey to Putting Patients First" (Cm 8777) in November 2013, responding to all 290 Francis recommendations. Volume 2 …

F2 Accepted

Mid Staffs Inquiry (2013)

Putting the patient first

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 …

- The NHS Constitution for England was revised in 2013 and again on 27 July 2015, incorporating updated values including "patients come first in everything …

F3 Accepted

Mid Staffs Inquiry (2013)

Clarity of values and principles

The NHS Constitution should be the first reference point for all NHS patients and staff and should set out the system's common values, as well as the respective rights, legitimate …

- The NHS Constitution for England, first published in 2009 under the Health Act 2009, sets out patients' rights, staff rights, and the values of …

F4 Accepted

Mid Staffs Inquiry (2013)

Clarity of values and principles

The core values expressed in the NHS Constitution should be given priority of place and the overriding value should be that patients are put first, and everything done by the …

- The NHS Constitution for England states "patients come first in everything we do" as the opening principle under the value "Working together for patients" …

F5 Accepted

Mid Staffs Inquiry (2013)

Clarity of values and principles

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 …

- The NHS Constitution for England includes a section titled "Staff: your responsibilities" which states that staff should aim to "provide all patients with safe …

F6 Accepted

Mid Staffs Inquiry (2013)

Clarity of values and principles

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

- The Handbook to the NHS Constitution for England was revised on 27 July 2015, providing "greater detail on the rights and pledges contained in …

F7 Accepted in Part

Mid Staffs Inquiry (2013)

Clarity of values and principles

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 …

- The NHS Constitution for England states that staff should "follow all guidance, standards and codes relevant to your role" and that staff have "a …

F8 Accepted

Mid Staffs Inquiry (2013)

Clarity of values and principles

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 …

- The NHS Constitution for England states it applies to "private and voluntary sector providers supplying NHS services" and covers staff "whether in public, private …

F9 Accepted in Part

Mid Staffs Inquiry (2013)

Fundamental standards of behaviour

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.

- The NHS Constitution for England states that staff have "a duty to accept professional accountability and maintain the standards of professional practice as set …

F10 Accepted in Part

Mid Staffs Inquiry (2013)

Fundamental standards of behaviour

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 …

- The NHS Constitution for England states that staff should "follow all guidance, standards and codes relevant to your role, subject to any more specific …

F11 Accepted

Mid Staffs Inquiry (2013)

Fundamental standards of behaviour

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 …

- 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 …

F12 Accepted

Mid Staffs Inquiry (2013)

Fundamental standards of behaviour

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 …

- The statutory duty of candour was introduced through Regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, requiring registered …

F13 Accepted

Mid Staffs Inquiry (2013)

The nature of standards

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 …

- 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 …

F14 Accepted in Part

Mid Staffs Inquiry (2013)

The nature of standards

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 …

- Regulation 17 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 establishes a fundamental standard for "Good governance," requiring providers to …

F15 Accepted in Part

Mid Staffs Inquiry (2013)

The nature of standards

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 …

- Regulation 17 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 requires providers to have systems and processes that enable them …

F16 Accepted

Mid Staffs Inquiry (2013)

Responsibility for setting standards

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 …

- 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 …

F17 Accepted in Part

Mid Staffs Inquiry (2013)

Responsibility for setting standards

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 …

- NHS England (formerly the NHS Commissioning Board) publishes quality standards and commissioning guidance. The NHS Outcomes Framework set out national outcome goals for the …

F18 Accepted

Mid Staffs Inquiry (2013)

Responsibility for setting standards

It is essential that professional bodies in which doctors and nurses have confidence are fully involved in the formulation of standards and in the means of measuring compliance.

- NICE involves professional bodies, clinical experts and patient representatives in the development of guidelines and quality standards through its established guideline development process, including …

F19 Not Accepted

Mid Staffs Inquiry (2013)

Gaps between the understood functions of separate regulators

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.

- The government did not accept the recommendation for a single regulator combining financial and quality oversight. Hard Truths (November 2013) stated that CQC and …

F20 Accepted in Part

Mid Staffs Inquiry (2013)

Responsibility for regulating and monitoring compliance

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 …

- CQC is responsible for monitoring and enforcing compliance with the fundamental standards set out in the Health and Social Care Act 2008 (Regulated Activities) …

F21 Accepted in Part

Mid Staffs Inquiry (2013)

Responsibility for regulating and monitoring compliance

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. …

- CQC has a statutory duty under the Health and Social Care Act 2008 to assess whether providers are meeting the fundamental standards, and its …

F22 Accepted in Part

Mid Staffs Inquiry (2013)

Responsibility for regulating and monitoring compliance

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 …

- 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 …

F23 Accepted

Mid Staffs Inquiry (2013)

Responsibility for regulating and monitoring compliance

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 …

- 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 …

F24 Accepted

Mid Staffs Inquiry (2013)

Responsibility for regulating and monitoring compliance

Compliance with regulatory fundamental standards must be capable so far as possible of being assessed by measures which are understood and accepted by the public and healthcare professionals.

- CQC's five key questions — Safe, Effective, Caring, Responsive, and Well-led — are designed to be understood by the public and professionals. CQC publishes …

F25 Accepted

Mid Staffs Inquiry (2013)

Responsibility for regulating and monitoring compliance

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 …

- 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 …

F26 Accepted

Mid Staffs Inquiry (2013)

Responsibility for regulating and monitoring compliance

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 …

- 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 …

F27 Accepted

Mid Staffs Inquiry (2013)

Responsibility for regulating and monitoring compliance

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, …

- 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 …

F28 Accepted

Mid Staffs Inquiry (2013)

Sanctions and interventions for non-compliance

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 …

- The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, Regulation 22, created a criminal offence where a registered person fails to comply …

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 …