Robert Francis QC's report into the Mid-Staffordshire NHS Foundation Trust Public Inquiry was heralded as the 'NHS event of 2013'.  However, this description may be wrong on both counts:

  • Although the setting for the Inquiry's findings was an NHS acute trust, and some details of the responses will be applicable just to the NHS, the main themes of the response to the Inquiry are applicable to providers, commissioners, and regulators right across the independent health and adult social care sector; and
  • It seems clear that the events at Mid-Staffordshire, and the response to the same, will shape the arena of quality governance for many years to come.

The scale of the Inquiry and the wide-ranging nature of its 290 recommendations make it difficult to envisage an area of quality governance which has not been touched by the Francis effect. The Inquiry's report in February sparked a multitude of reviews and reports in response.  In addition to the responses of the individual regulators, the central Government response, itself, included:

  • Patients First and Foremost:  The initial Government Response
  • The Keogh Review – into quality of care and treatment provided by 14 Hospital Trusts in England
  • The Cavendish Review – into Healthcare Assistants and Support Workers in the NHS and Social Care Settings
  • A Promise to Learn – A Commitment to Act:  Improving the Safety of Patients in England (the Berwick Review)
  • A Review of the NHS Hospitals Complaints System – by Rt. Hon Ann Clwyd MP and Professor Tricia Hart
  • Challenging Bureaucracy – led by the NHS Confederation
  • The Report by the Children and Young People's Health Outcomes Forum

These reviews conclude with 'Hard Truths' – the Government's recent response to the Inquiry.  In terms of tracking the developments under the wide range of recommendations made by Robert Francis, volume 2 of the Hard Truths response provides a helpful summary on a recommendation-by-recommendation basis.
 
In the spirit of retrospectives and 'round robins' at this time of year, any attempt to distil the key messages from this plethora of material is almost impossible.  However, if one had to sum up the main thrust of the outcome of the Inquiry in a single phrase, you could do far worse than "Openness, Transparency and Candour".

The Candour Landscape

There is massive focus on the current proposals to introduce a statutory duty of candour which will be enforced by CQC.  However, this new statutory duty is just one part of a wider landscape of "Openness, Transparency and Candour" which providers in all sectors will need to embrace as a key response in the on-going management of their quality governance procedures.  It is worth reminding ourselves what these phrases mean, as defined in Robert Francis' Report:

  • "Openness"  - enabling concerns to be raised and disclosed freely without fear, and for questions to be answered;
  • "Transparency"  - allowing true information about performance and outcomes to be shared with staff, patients and public.
  • "Candour"  - ensuring the patients harmed by a healthcare service are informed of the fact and that an appropriate remedy is offered, whether or not a complaint has been made or a question asked about it.

The three concepts are inextricably linked and all will have a vital part in moving the quality agenda forward.

Openness

The importance of openness within organisations can be seen as underpinning a number of initiatives resulting from the Inquiry.  For instance:

Complaints – Ann Clwyd's and Professor Hart's review, as accepted by the Government's response, means that providers need to ensure they do more both to facilitate the making of complaints and to review complaints data as a source for learning and future improvement.  The practical steps the Government wish to be taken include:

  • having a sign in every ward and clinical setting providing patients with information about:
  1. how they can complain to the hospital when things go wrong
  2. who they can turn to for independent local support if they want, and where to contact them
  3. their right to complain to the Parliamentary Health Service Ombudsman if they remain dissatisfied, and how to contact her
  4. how to contact their local Healthwatch.
  • boards needing to consider both the "narrative and not just the numbers" in relation to complaints, and publishing information on complaints on a quarterly basis including "the number of complaints received as a percentage of patient interventions; the number of complaints the hospital has been informed have subsequently been referred to the Ombudsman; and the lessons learned and improvements made as a result of complaints".

Raising concerns and whistleblowing – a key priority for all providers is to ensure they have robust and effective procedures in place to encourage staff to raise concerns, and to thoroughly investigate such concerns and learn lessons where appropriate.  CQC has made it clear in their 'A New Start' consultation that, in considering whether organisations are "well-led" (one of their new five Key Questions), it will judge organisations based on their ability to promote an open, fair and transparent culture. 

"Gagging" clauses – there is now clear guidance that confidentiality and non-disparagement clauses in contracts and compromise agreements with staff should contain explicit wording clarifying that such provisions on no account prevent staff raising patient safety concerns by way "a protected disclosure in the public interest".

Duties of Candour

Although the Government has not adopted Robert Francis' recommendation that there should be a statutory duty of candour on registered medical practitioners and registered nurses, preferring to rely upon enhanced professional duties in this respect (see below), much attention has been focussed on the adoption of the recommendation for a statutory duty of candour on providers (recommendation 181). 

This duty will be introduced as a regulatory requirement on all providers registered with CQC and draft regulations are expected in January 2014.  It is likely that the regulations will enable CQC to bring a prosecution for breach of the statutory duty without the need for a prior warning notice and, in line with other CQC requirements, prosecutions can also be brought against directors or other senior officers within providers if the breach of duty occurs with their consent or connivance, or due to neglect on their part.  CQC will, no doubt, set out an enforcement policy clarifying how they will use the power of prosecution.  It remains to be seen whether CQC's exercise of the power of prosecution will be used, as Robert Francis recommended (recommendation 184) "in the last resort in cases of serial non-compliance or serious or wilful deception". 

However, the introduction of the statutory duty of candour needs to be viewed in the context of wider, already existing, duties of candour:

Contractual duty – all providers of NHS services have already been subject to a contractual duty of candour (Service Condition 35 of the NHS Standard Contract) since 1 April 2013.  A provider's duty under the contract is triggered whenever a Reportable Patient Safety Incident occurs or is suspected.  The contractual duty requires providers to notify the service user/ someone acting lawfully on their behalf "as soon as practicable, but in any event within 10 Operational Days".  Such notification should include the provision of all facts the provider knows about and an appropriate apology, which is defined as "a sincere expression of sorrow or regret given verbally and in writing, for the harm that has resulted from the incident".  The duty also requires providers to keep the service user or representative updated as the investigation into the incident proceeds, and to provide them with a copy of the investigation report.  If a provider fails to comply with the contractual duty, the Co-ordinating Commissioner must notify CQC and the provider can be required to publish details of their failure "prominently" on their website.

Professional duties – in conjunction with the statutory and contractual duties of candour on providers as organisations, the Government's response to the Inquiry reinforces the need for professional regulators to review their codes of conduct with regard to obligations around candour.  The Government's response also makes it clear that providers should strengthen their policies on appraisal to increase the emphasis on issues of candour, openness and transparency in local appraisals and performance arrangements.

There is a concern, however, that there may be differing thresholds amongst these various duties of candour.  The existing contractual duty is triggered by "Reportable Patient Safety Incidents" which are defined, under the contract, as being those which result in moderate or severe harm.  Robert Francis' initial recommendation was that the statutory duty should be limited to cases of death or serious injury.  However, the Government has requested David Dalton and Professor Norman Williams to report by the end of the year on whether the threshold for the statutory duty should be reduced to cover moderate harm; it would appear to make sense to align the statutory duty with that under the existing contractual duty. 

However, the Government's latest response appears to leave room for inconsistencies when considering the professional duties.  The Government states, in Hard Truths, that the professional regulators should agree consistent approaches "across doctors and nurses and other health professionals to be candid with patients when mistakes occur whether serious or not".  However, the Government's response goes on to state "the professional regulators will develop new guidance to make it clear professionals' responsibility to report 'near misses' for errors that could have led to death or serious injury, as well as actual harm, … and will review their professional codes of conduct to bring them into line with this guidance".  There is, therefore, the potential for health professionals to be under a professional duty to report incidents, and even near misses, to patients in situations where the providers' contractual and statutory duties are not engaged.  Providers will need to monitor developments in professional codes of practice closely and be aware of this situation.

In terms of the practicalities around ensuring an appropriate level of candour in response to incidents, providers are recommended to have close regard to the previous NPSA guidance 'Being Open' as recommended by Robert Francis (recommendation 180).

Transparency

In addition to issues of candour, relating to disclosure of information regarding incidents to patients/representatives, providers also need to have regard to increasing duties of transparency in terms of information being shared with wider groups of patients, staff, the public and other stakeholders.

  • All providers registered with CQC are already subject to certain requirements of transparency in terms of the need to notify incidents and other events to CQC (via the NRLS system for the NHS).  However, even some of these existing requirements may have increased significance in the new regulatory landscape.  For instance, it is already a requirement for all registered providers to notify CQC of any event which threatens to prevent on-going compliance with registration requirements including "an insufficient number of suitably qualified, skilled and experienced staff".  This notification obligation will perhaps increase in significance in a new landscape where, at least for the NHS, providers will be required, from April 2014, to publish their required nursing and midwifery staff levels (using appropriate evidence based tools) and whether they are meeting these.
  • A further step in terms of promoting transparency can be found in the introduction of the new offence of providing 'False or Misleading Information'.  A clause in the Care Bill currently passing through Parliament will make it an offence for care providers to supply information of a specified description, where that information is required under a legal obligation, if the information is false or misleading in a material respect.  The Government has signalled that their current intention is to limit this offence to providers (which is likely to include independent sector providers) of secondary NHS care and to restrict its impact to information such as mortality rates and patient level information on outpatient, elective and A&E activity.  However, from the drafting of the clause there is clearly the potential for the remit of this offence to be extended, in due course, to the provision of false or misleading information in other situations, including supplying information in response to a request by CQC.  The Government has made it clear, in Hard Truths, that they will consult on whether the False or Misleading Information offence should also be extended to information in quality accounts.  Again, it is envisaged that directors and senior officers may be prosecuted for consent, connivance or neglect and that sentences will include an unlimited fine and/or up to two years imprisonment, in addition to the making of remedial and publicity orders.
  • In addition, the Government's response, in Hard Truths, identifies a range of further measures by which data relating to provider performance and outcomes will be put into the public domain;
    • Quality accounts – the Government has responded to calls by Robert Francis and Sir Bruce Keogh for the contents of quality accounts to be extended in order to provide a more comprehensive and balanced assessment of quality.  The Government states that NHS England will review quality accounts before the 2014/15 cycle "to ensure that they give patients appropriate information regarding the services they use, and that they add value to the quality assurance infrastructure used by trusts, local and national organisations".  The Government has indicated that new guidance on the contents of quality accounts will be issued in March 2014.  This guidance will also be relevant for independent sector providers of NHS services.
    • The Government in its Hard Truths response, maps out the timetable for further publication of data regarding performance and outcomes, pointing out that:
  1. NHS England has already published clinical outcomes by consultant for 10 medical specialities and began to publish data on the friends and family test.  These apply equally to the independent sector providers.
  2. since October 2013 CQC has published is surveillance data for all acute trusts – the surveillance monitoring of other sectors will be published in due course as CQC introduces its new approach on a phased basis (e.g. CQC proposes to publish surveillance data for the adult social care sector from April 2014 and for the independent acute healthcare sector from July 2014). 
  3. CQC and NHS England are to develop a dedicated hospital safety website drawing together information including "staffing, pressure ulcers, healthcare associated infections and other key indicators, where appropriate at ward level" from June 2014.

Inquest Disclosure - the issue of transparency also impacts upon how providers should disclose information in the course of an inquest.  Robert Francis stated, at recommendation 274, that there is an urgent need for unequivocal guidance to be given to "those handling disclosure of information to Coroners, patients and families, as to the priority to be given to openness over any perceived material interest".  Robert Francis' examination of the issue of disclosure in the course of inquests centred mainly on the case of John Moore-Robinson in which a critical report prepared by the consultant A&E surgeon was withheld from the Coroner on legal advice. 

The Government, in its response, stated that it accepts Robert Francis' recommendation and indicated that this has been put into effect by provisions in Schedule 6 to the Coroners and Justice Act 2009 (which came into force on 25 July 2013) which makes it an offence "to do anything that is intended to have the effect of (a) distorting or otherwise altering any evidence, document or other thing that is given, produced or provided for the purpose of an investigation … (b) preventing any evidence, document or other thing from being given, produced or provided for the purposes of such an investigation, or to do anything that the person knows or believes is likely to have that effect".  

In addition Schedule 6 also makes it an offence for any person "(a) intentionally to suppress or conceal a document that is, and that the person knows or believes to be, a relevant document, or (b) intentionally to alter or destroy such a document".

Conclusion

It is clear that openness, transparency and candour will be the cornerstones on which providers need to build their quality governance structures.  However, although greater scrutiny by the regulators, and tougher sanctions in these areas, increase the potential for organisations to face penalties if they get things wrong on these issues, providers should seize the opportunity to enhance openness, transparency and candour, as a fundamental step on the road to improving patient safety and quality of care.