It is now more than a year since Robert Francis QC's report into the Mid Staffordshire Inquiry. However, the recommendations he made to the increase: clarity in healthcare standards; openness, transparency and candour; and accountability of senior managers across the health and social care sector are now crystallising as legislation with increasing pace.

Following January's consultation on a new set of Fundamental Standards, the Department of Health has recently issued two new consultations which further extend the obligations of health and social care providers and enhance CQC's powers to take action, at both a corporate and individual level, in the event of failings:

 'Introducing the Statutory Duty of Candour'

 'Consultation on the fit and proper person regulations'

Statutory Duty of Candour

The recommendation for a statutory duty of candour was one of the central points amongst the Robert Francis' 290 recommendations. Although, in the year since the Inquiry report, some aspects of the recommendation (i.e. that the statutory duty should also apply to healthcare professionals) have not been adopted, in other respects the original recommendation has since been amplified. This is particularly the case around the threshold at which the duty to notify service users (or persons lawfully acting on their behalf) is triggered. Robert Francis' original recommendation was for the duty of candour to arise in cases of death or serious injury. However, following the review by Professor Norman Williams and Sir David Dalton, the threshold has been lowered. The draft regulations on the duty of candour also clarify the proposed threshold in relation to adult social care services.

Harm Thresholds

For healthcare providers the draft Regulations adopt the approach suggested by Dalton/Williams so as to include not only cases of death and severe harm, but also "moderate harm" in line with providers' existing contractual duty under the NHS Standard Contract, and also "prolonged psychological harm" (i.e. continuing, or likely to continue, for at least 28 days).

Adult Social Care

Recognising that the National Reporting and Learning System definitions of "severe" and "moderate" harm are terminology aimed at the health sector, the draft Regulations propose a different definition of a "notifiable safety incident" in the social care sector. The aim is to broadly replicate the level of harm which will trigger the duty of candour in healthcare sector. The Regulations do this by adopting the definition of incidents (resulting in death or harm to service users) which currently need to be notified to CQC under the Care Quality Commission (Registration) Regulations.

Nature of the Duty

The nature of the proposed duty is spelt out at regulation 3 of the draft Regulations and is very similar in nature to the obligations on providers under the NHS Standard Contract duty of candour. This includes notifying the service user (or person lawfully acting on their behalf (if they lack capacity)) in person; providing a truthful account of all the facts the service providers knows about the incident; advising on what further enquiries will be carried out; and making an apology which must be "an expression of sorrow or regret in respect of [the incident]". In this respect it is interesting to note that, unlike the NHS contractual duty, the proposed statutory duty requires the apology to be for "the incident", as opposed to the harm caused.

The duty goes on to require the provider to supply the service user/representative with the results of any further enquiries into the incident and to keep records of all correspondence and notifications in person. This emphasises the fact that CQC will, no doubt, during the course of inspections, case track incidents to ensure the overall management has included proper disclosure of information to the service user/ representative.

It should also be noted that, as well as the specific duty of candour to notify the relevant persons when a notifiable safety incident has occurred, the draft Regulations also include a more general obligation on CQC registered persons to "act in an open and transparent way in relation to … service user care and treatment". It is not clear whether this wording is merely creating a convenient 'headline' for the public at large to aid understanding of the duty of candour. However, on the face of it, this creates a wider general obligation to act in open transparent way not limited to situations where particular safety incidents have occurred.

Enforcement

The draft Regulations emphasise CQC will issue guidance to providers on how to comply with the duty of candour and this guidance is awaited.

Registered persons (whether service providers or individual registered managers) who fail to comply with the duty are liable to prosecution and, on a conviction, to an unlimited fine. CQC's guidance on how it will enforce the duty is awaited and it would be anticipated that it will act proportionately in prosecuting cases (Robert Francis suggested that CQC should only resort to prosecution in cases of serial non-compliance or serious of lawful deception). However, there is clearly the potential for serious enforcement action to flow from a failure to observe the duty of candour.  In addition to prosecutions, breach of the duty would (like all CQC registration requirements) provide ground for 'civil' enforcement action by way of imposition of conditions of registration, or suspension or ultimately cancellation of registration.

Fit and Proper Person Test

In a further consultation on the fit and proper person test regulations the Department of Health have signalled a significant change in the level of scrutiny of senior managers across the health and social care sector. 

Under the present system, CQC assess the fitness of 'corporate' providers (i.e. all providers other than individuals or partnerships) by focusing solely on the fitness of the nominated individuals; providers are able to nominate, for themselves, who will be their nominated individual(s) who will usually (although not necessarily) be a director.  Further, under the current regime, when assessing the fitness of the nominated individual, CQC merely consider whether the provider has taken appropriate steps to ensure the nominated individual is of good character, physically and mentally fit, has the necessary qualifications, skills and experience for the role, and can supply requisite information (including a DBS check/full employment history etc.).

In contract, the proposed new "fit and proper person" test will have much wider impact in terms of both the scope of its application and the nature of the test:

Scope of Application

Unlike CQC's current checks against nominated individuals, the new fit and proper person test will apply to all directors and "equivalents". This will include directors of limited companies, executive and non-executive directors of NHS trusts/ foundation trusts, and trustees of charities. (The test will also apply to any sole traders and partners in partnerships registered with CQC).

Nature of the Test

In addition to requirements of good character, qualifications, skills and experience and health, the new test goes further in terms of excluding individuals who are prevented from holding the office (e.g. under a directors' disqualification order) and significantly, excluding people who:

"who have been responsible for, been privy to, contributed to or facilitated any misconduct or mismanagement (whether unlawful or not) in the course of carrying on a regulated activity, or discharging any functions relating to any office or employment with a service provider"

This is a significant restriction and would enable the CQC to deem an individual unfit on the basis of any previous misconduct or incompetence in a previous role for a service provider, even if the individual was working at a more junior capacity at that time.

In addition, the draft Regulations also stipulate that individuals will be deemed "unfit" if they have been sentenced to a minimum of three months imprisonment in the last five years, are on the children's or vulnerable adults barred lists, or on the basis of insolvency. Interestingly, however, for individuals who would otherwise be "unfit" on the basis of a criminal conviction, the Regulations allow applications to be made to CQC for them to be deemed 'fit'. This is significant as a number of providers were concerned that, without that flexibility, former service users (for instance, in drug and alcohol services) would be prohibited from providing a valuable insight and contribution in director roles.

Enforcement

In the event of an individual being considered "unfit", this can result in CQC refusing registration (if the provider is applying for registration) or, if the provider is already registered, the imposition of a condition on the provider's registration requiring their removal from office. In the event of such enforcement action being taken there will be a new right of appeal for the individual director, as well as for the provider organisation.

Conclusion

As can be seen, there are a suite of new enforcement powers being put in place in the wake of the Mid Staffordshire Inquiry. Unlike the consultation on the Fundamental Standards, which were intended to clarify and facilitate the enforcement of, existing requirements, the latest consultations will create new obligations for care providers.  If and when implemented, it will be important for providers to have appropriate procedures and training in place to ensure staff implement the new duty of candour as well as more rigorous systems around board level appointments. We would encourage all providers to review the consultations carefully and consider what they mean for their organisations:

Duty of Candour Consultation

Corporate accountability consultation response