"This is not something which can be blamed simplistically on one policy or another, or on failings on the part of one or even a group of individuals. There was an institutional culture in which the business of the system was put ahead of the priority that should have been given to the protection of patients and the maintenance of public trust in the service.

"Standards and methods of ensuring compliance were not focussed on the effect of service deficiencies on patients There was a tolerance of poor standards and the consequent risk to patients. Agencies frequently failed to share their knowledge with each other.

"We need common values, shared by all, putting patients and their safety first; we need, a commitment by all to serve and protect patients and to support each other in that endeavour, and to make sure that the many committed and caring professionals in the NHS are empowered to root out any poor practice around them. These values need to be the principal message of the NHS constitution, to which all staff must commit themselves".

Robert Francis QC's public inquiry report into Mid-Staffs is now online here.

My thoughts and observations will be added throughout the day (as its 290 recommendations will take a little time to digest), but here are a few starters.

Many of the recommendations are deeply sensible, as is the tone of his report.

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Click here for details of 'Francis is coming. Look busy!', the new issue of subscription-based Health Policy Intelligence.

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For a brief overview, Robert Francis QC's press statement is a good place to start.

The full report report shows wisdom and understanding. It is long, complex and detailed. And it starts, rightly, from the point that this is an everybody-in-the-NHS thing, and it is also a culture thing.

This is smart. It will annoy those who wanted his report to call for Sir David Nicholson's head on a plate.

Yet I think Robert Francis QC has been shrewd and subtle. By locating so much of the necessary change in issues of culture, above all he asks the question whether current system leaders can deliver this change.

It will force current system leaders to ask themselves that question.

The report is also keenly aware of the risks of near-instant obsolescence, save at a superficial level: its first points are about ensuring Francis-centricity (which effectively means 'safe-and-compassionate-basic-care-centricity) is built in as an ongoing and annually-reported function of the whole system. (A bit like quality reports, but meaningful this time.)

It also notes wryly that "Professor Brian Jarman pointed out in his evidence to this Inquiry that at the Bristol Inquiry, in which he was a member of the inquiry panel, there were 120 mentions of the word 'hindsight' in the evidence. The Bristol Inquiry Report contained a section on hindsight. In the Foreword, the panel expressed the hope that the disaster that had been uncovered there would not be repeated

"Unhappily, the word 'hindsight' occurs at least 123 times in the transcript of the oral hearins of this inquiry and 'benefit of hindsight' 378 times".

Some context
On the train in this morning, I hit Twitter with the following few thoughts about context and meaning.

An NHS Chief Anthropologist would be more useful than a Chief Inspector of Hospitals: the underlying problems of the NHS are about culture and power. By itself, appointing a Chief Inspector of Hospitals will change nothing. The problems are about culture: the cocktail of power & incentives.

There was negligent and unsafe care elsewhere at individual and ward level. But why did Mid-Staffs have so much and so bad?

Lousy care is probably not uncommon in the residential care market too. This is not an NHS-only issue.

When we need healthcare (which is mercifully rarely, for most of our lives), we're vulnerable and afraid and don't know the system. Is that understood? Remembering that we patients are scared when we're sick may be asking a lot of staff for whom seeing sick people is (and must be) routine. That's the humanity Mid-Staffs lost.

Changing regulation
While Francis wisely promises to eschew structural redisorganisation (indeed, fingering it as causative of problems), he does suggest that regulation needs to change. He calls for the CQC to be an activist inspector:

"Fundamental standards must be policed by the Care Quality Commission. It is this inquiry’s firm conclusion that physical inspection by well qualified, trained and experienced hospital inspectors is the most effective means of monitoring compliance with standards in hospitals.

"Regulation would also be more effective if compliance with fundamental standards and requirements for clinical and corporate governance and finance control, were regulated by one organisation. The CQC should regulate all these matters together rather than responsibility being divided between CQC and Monitor. The CQC would also be expected to intervene where necessary to protect patients from non-compliance with the fundamental standards".

Mmm. If CQC takes over financial regulation, then Monitor is orphaned from its role in the ongoing oversight of foundation trusts, and will sit merely as an economic sector regulator with a remit over competition (and of course co-operation).

The Prime Minister announced in his Commons statement that the Government will formally respond in full next month, but said (continuing Jeremy Hunt's theme) that "Today when a hospital fails financially its Chair can be dismissed and the Board suspended. But failures in care rarely carry such consequences ... We will create a single failure regime where the suspension of the Board can be triggered by failures in care, as well as failures in finance.

"We will put the voice of patients and staff at the heart of the way hospitals do business ... from this year every patient, every carer, every member of staff will be given the opportunity to say whether they would recommend their hospital to their friends or family. This will be published and the Board will be held to account for their response. Put simply, where a significant proportion of patients or staff raise serious concerns about what is happening in a hospital, immediate inspection will result and suspension of the hospital board may well follow".

Blimey: this is an epic change. Turbo-charging the Friends And Family Test (on whose limitations I wrote here) is clearly intended to act as a sword of Damocles.

The PM has also made a smart (or well-advised) move to ask "Don Berwick – who has advised President Obama on this issue – to make zero harm a reality in our NHS". Nobody stands a better chance of commanding a hearing than The Don.

Accountability
The PM also said that "We expect hospitals to take disciplinary action against staff who abuse their patients. We expect professional regulators to strike off doctors and nurses who seriously breach their professional codes. And we expect the justice system to prosecute those suspected of criminal acts whether in a hospital or anywhere else.

"The Health and Safety Executive also needs to explain their decisions not to prosecute in specific cases. Indeed Robert Francis makes a very strong argument that the Health and Safety Executive is too distant from hospitals and not the right organisation to be focusing on healthcare. So we will look very closely at his recommendation to transfer the right to conduct criminal prosecutions away from the Health and Safety Executive to the Care Quality Commission.".

Riiiight.

The NMC bit is ever-so-slightly top-down - although probably necessary, but a bit of a political irony.

Also on the top-down front, the PM also calls for "a hospital inspections regime that doesn’t just look at numerical targets but examines the quality of care and makes an open, public and explicit judgement. So I have asked the Care Quality Commission to create a new post – a Chief Inspector of Hospitals to take personal responsibility for this task.

"In the meantime I have asked the NHS Medical Director – Professor Sir Bruce Keogh – to conduct an immediate investigation into the care of hospitals with the highest mortality rates and to check that urgent remedial action is being taken.".

How is the Chief Inspector of Hospitals (see my comment above on the need for a Chief Anthropologist) to measure caring? What's the validated caring index?

And where is our evidence that the CQC will be good at deciding what meets the burden of proof to move forwards to criminal prosecution?

Robert Francis' press statement also says, "in all walks of life the buyer wants to ensure that he gets what he pays for. Health should be no different. Therefore commissioners of healthcare services must be required to develop and require compliance with other standards – which I have called enhanced quality standards - of quality, effectiveness and other requirements over and above the fundamental standards. As the buyer of these services on our behalf commissioners must ensure that these enhanced standards are delivered by their providers. In this way the role of the regulator and commissioners responsibility would be simplified and clarified".

Minimum "clear, fundamental" quality standards will be set out, in collaboration with NICE and consulted on with patients, and Francis suggests "any organisation unable consistently to comply should be prevented from continuing a service which exposes patients to risk. To cause death or serious harm to a patient by non-compliance with fundamental standards should be a criminal offence".

Duty of candour
Francis also calls for a statutory duty of candour. His statement says "A common culture of serving and protecting patients and of rooting out poor practice will not spread throughout the system without insisting on openness, transparency and candour everywhere in it. A duty of candour should be imposed and underpinned by Statute and the deliberate obstruction of this duty should be made a criminal offence.

"Every provider trust must be under an obligation to tell the truth to any patient who has or may have been harmed by their care".

Nobody in their right mind could argue with a word of that. It does raise interesting legal questions about what will happen in relation to commercial confidentiality with non-NHS providers of care: it could clearly conflict with the duty of candour.

Francis goes on to hit a pair more sixes with the following: "so-called 'gagging clauses' which might prevent a concerned employee or ex-employee raising honestly held concerns about patient safety should be banned. Trusts must be open and honest with regulators. It should be an offence deliberately to give them misleading information".

Francis has done his bit. Now it's the NHS's turn
I copy a medium-sized list of the key recommendations below - but really, it's a case of reading the whole report. (Race you to the end!)

And the report is not the final word on the matter. Rather, it is the start of a process of change that the NHS needs to do to itself. It cannot and will not be done by a more activist CQC, legal duty of candour, minimum or enhanced quality standards or any other component. The components are tools.

The issue for the NHS is to develop an open, honest, self-critical, learning and peer-reviewing culture. The best trusts have been doing this for some time.

Francis gives the service a set of tools to reduce the extent to which such self-improving reforms are optional in the not-best trusts.

It's over to the service now. Good luck and as the French say, bon courage: it'll hurt, but it'll also make the NHS a better place to work and to receive care.

Robert Francis QC's summary of recommendations (from press statement)
First, a structure of clearly understood fundamental standards and measures of compliance, accepted and embraced by the public and healthcare professionals, with rigorous and clear means of enforcement: we need a list of standards, about patient safety, the effectiveness of treatment, and basic care - the requirements we will all agree should be in place to permit any hospital service to continue.

These standards should be defined by what patients and the public want and are entitled to, and what healthcare professionals agree can be delivered.

Non-compliance with these fundamental standards cannot be tolerated. Any organisation unable consistently to comply should be prevented from continuing a service which exposes patients to risk. To cause death or serious harm to a patient by non-compliance with fundamental standards should be a criminal offence. Standard procedures, guidance and assessment tools designed to enable organisations and individuals to comply with fundamental standards in different clinical settings should be produced by the National Institute of Clinical Excellence (NICE), with the help of relevant professional and patient organisations. These should include guidance on staffing. Individuals should be supported to report non-compliance or matters which might prevent compliance to their organisations. They should be protected when they do this.

Fundamental standards must be policed by the Care Quality Commission. It is this inquiry’s firm conclusion that physical inspection by well-qualified, trained and experienced hospital inspectors is the most effective means of monitoring compliance with standards in hospitals.

Regulation would also be more effective if compliance with fundamental standards and requirements for clinical and corporate governance and finance control, were regulated by one organisation. The CQC should regulate all these matters together rather than responsibility being divided between CQC and Monitor. The CQC would also be expected to intervene where necessary to protect patients from non-compliance with the fundamental standards.

In all walks of life the buyer wants to ensure that he gets what he pays for. Health should be no different. Therefore commissioners of healthcare services must be required to develop and require compliance with other standards – which I have called enhanced quality standards - of quality, effectiveness and other requirements over and above the fundamental standards. As the buyer of these services on our behalf commissioners must ensure that these enhanced standards are delivered by their providers. In this way the role of the regulator and commissioners responsibility would be simplified and clarified.

 Secondly, openness, transparency and candour throughout the system: A common culture of serving and protecting patients and of rooting out poor practice will not spread throughout the system without insisting on openness, transparency and candour everywhere in it.

A duty of candour should be imposed and underpinned by Statute and the deliberate obstruction of this duty should be made a criminal offence.
o Openness means enabling concerns and complaints to be raised freely and fearlessly, and questions to be answered fully and truthfully;
o Transparency means making accurate and useful information about performance and outcomes available to staff, patients, the public and regulators.
o Candour means informing any patient who has or may have been avoidably harmed by a healthcare service of that fact and a remedy offered where appropriate, regardless of whether a complaint has been made or a question asked about it.

Every provider trust must be under an obligation to tell the truth to any patient who has or may have been harmed by their care. It is not in my view sufficient to support this need by a contractual duty in commissioning arrangements. It requires a duty to patients, recognised in statute, to be truthful to them. It requires staff to be obliged by statute to make their employers aware of incidents in which harm has or may have been caused to patients so they can take the necessary action.

The deliberate obstruction of the performance of these duties and the deliberate deception of patients in this regard should be criminal offences.

So called “gagging clauses” which might prevent a concerned employee or ex employee raising honestly held concerns about patient safety should be banned. Trusts must be open and honest with regulators. It should be an offence deliberately to give them misleading information. Information provided to the public about performance should be required to be balanced, truthful and not misleading by omission. Quality accounts should be independently audited. The CQC should be responsible for policing these obligations.

 Thirdly, improved support for compassionate caring and committed nursing: proper standards of nursing care lie at the heart of what is required to protect patients when in hospital. The majority of nurses are compassionate, caring and committed. They should be given effective support and recognition, and be empowered to use these qualities to maintain standards. Entrants to the profession should be assessed for their aptitude to deliver and lead proper care, and their ability to commit themselves to the welfare of their patients. Training standards need to be created to ensure that qualified nurses are competent to deliver compassionate care to a consistent standard and their training must incorporate the need to experience hands-on patient care. Named clinicians should be responsible for the welfare and care of each patient in hospital.

Healthcare support workers are a highly important but insufficiently valued part of the workforce: they provide most of the hands on care for elderly and vulnerable patients. They need the help of consistent training, and standards of performance. Patients are not currently adequately protected from those who are unfit to do this work. The time has come in for healthcare support workers to be regulated by a registration scheme enabling those who should not be entrusted with the care of patients to be prevented from being employed to do so. This needs to be supported by common training standards and a code of conduct.

No-one should have hands-on care of patients unless properly trained and registered. Patients and the public are entitled to greater clarity about the status of those who provide direct physical care to them.

Nursing needs a stronger voice. This can be achieved by strengthening nursing representation in organisational leadership, enhancing the links with their professional regulators, better appraisal, and encouraging strong nursing leadership at ward level. I would like to see more recognition of the extremely important role nursing plays in the care of older patients by the creation of a new registered status as a registered older person’s nurse. I would like their profession to consider how greater authority can be brought to their representative voice.

 Fourthly strong and patient centred healthcare leadership: leadership generally in the NHS is under challenge and needs more effective support. The necessary culture will only flourish if leaders reinforce it every day in every part of the service. A NHS leadership staff college could be created, offering all potential and current leaders the chance to share in a form of common training designed to equip them to exemplify and implement the common culture. They should be supported by a common code of ethics and conduct for all leaders and senior managers.

The public are entitled to expect leaders to be held to account effectively when they have not applied the core values of the Constitution, or are otherwise shown to be unfit for the role.

Currently leaders who are registered as doctors or nurses can be disciplined by a regulator for failing to protect patients. Other leaders cannot.

A more level playing field would enhance leadership teamwork and increase the public’s confidence in the NHS. It should be possible to disqualify those guilty of serious breach of the code of conduct or otherwise found unfit from eligibility for leadership posts. This will require a registration scheme and a requirement that only fit and proper persons are eligible to be directors of NHS organisations. While this regulatory function could be performed by an existing regulator, the need for a separate entity for this purpose should be kept under review.

 Finally, accurate, useful and relevant information: information is the lifeblood of an open transparent and candid culture. All professionals, individually and collectively, should be obliged to take part in the development, use and publication of more sophisticated measurements of the effectiveness of what they do, and of their compliance with fundamental standards. Patients, the public, employers, commissioners and regulators need access to accurate, comparable and timely information. Improvements are needed in the core information systems for the collection of data about patients, both to support their individual treatment and the accurate collation of information for statistical purposes. Difficulties in achieving this are no excuse for inaction.

The Information Centre for Health and Social Care has an important role to play in this field. Boards must be accountable for the presentation to the public of balanced and candid information about their trusts’ compliance with fundamental standards. It should be a criminal offence to be a party to a wilful or reckless false statement as to compliance with safety or fundamental standards.