The Department of Health's recent consultation 'Introducing Fundamental Standards' marks the most concrete step to date in the introduction of the new standards regime to apply across the health and social care sector in the wake of the Mid Staffs Inquiry.  It is important for all providers and commissioners to review the consultation. The deadline for responding is 4 April 2014.

One of the key aims of Robert Francis' recommendations in the Mid Staffs Inquiry was to simplify the framework of standards applicable across the sector.  Whilst the Government and CQC accepted Robert Francis' call for the introduction of a set of Fundamental Standards below which care should never fall, it was initially proposed that these would be supplemented by a set of 'expected standards' also to be enforced by the regulator.  It is therefore welcome that the latest consultation makes it clear that the proposals for a separate set of 'expected standards' has now been abandoned and the regulations will focus, instead, upon a single set of Fundamental Standards.  There will, however, be further requirements to be imposed in the form of the new statutory duty of candour and the Fit and Proper Persons requirement for directors of provider organisations.

Clarity of standards

Robert Francis criticised the current standards as being "over-bureaucratic" and the Department of Health's Impact Assessment accompanying the latest consultation acknowledges that the current regulations "remain unspecific and unclear".

The need for clarity in the standards is essential to ensure that providers, staff, service users and their carers are clear what needs to be done to meet standards, and when they are breached.  This is also essential in terms of the proposed changes in enforcement.  It is proposed that CQC will have the power to prosecute for failures to meet the new Fundamental Standards without the need to serve a prior warning notice; this means that providers at risk of prosecution will need to be clear as to precisely what outcomes are required, and what conduct could result in prosecution, from the outset. 

However, the consultation acknowledges that, in order to simplify the wording of the regulations themselves, it is necessary to use language that can be interpreted subjectively.  This creates a tension with the need for clarity, on the part of providers, as to exactly what outcomes are required, and what conduct may result in enforcement.  It is therefore essential that CQC's guidance, which will underpin the regulations, makes it absolutely clear how CQC will judge breaches.  This guidance is still awaited but is anticipated in the near future.

Burdens of the revised standards

The Department of Health are keen to stress, in the Consultation and accompanying Impact Assessment, that, overall, the introduction of the new standards, with clearer obligations on providers, should reduce the burden of regulation.  Whilst the wording of the regulations will be clearer, there will be no change in the scope of requirements on providers.  Nevertheless, the Department acknowledges there is a risk that the deterrent effect of the regulations being easier to enforce, could lead to even compliant providers taking unnecessary action beyond what is required to meet the standards. 

The Department also acknowledge that it will take time for providers to read, absorb, discuss and communicate the new regulatory requirements to staff.  It also acknowledges that the cost of understanding and cascading the revised requirements could be significantly higher in providers, such as the NHS, with large numbers of staff and complex management systems covering a wide variety of services. 

However, the Impact Assessment envisages that the simplified nature of requirements should reduce the amount of time involved in training new staff and in preparing for inspections.  It states that, on balance, the costs savings arising to businesses are likely to outweigh the costs associated with the introduction of the new standards.  However, in carrying out these calculations, the Department have not taken into account the fact that some providers may wish to change their quality governance systems, and the data they collect, in order to be "better aligned to proving compliance against the revised regulations".  In our view, providers would be well advised to review the data they collect, as part of their quality management systems, to ensure these are properly aligned with the new standards, particularly given that one of the standards, itself, relates to 'Good Governance' and will presumably be assessed by CQC and rated in relation to the question of whether the service is "well-led".

On a positive note, the Department's Impact Assessment notes there could be a potential benefit for providers, by reducing the duplicative burden (in terms of inspection and information requests) of local authority contract monitoring over time.  This will, however, require local authorities to have confidence in CQC's new model for assessing standards.

The content of the Fundamental Standards

The content of the proposed Fundamental Standards is set out in draft regulations annexed to the consultation.  As intended, the proposed regulations are shorter and simpler than the existing regulations:  the format is that each regulation has a 'headline' outcome which must be met, supported by a small number of other steps which providers are required to take to comply with that outcome.

We would encourage all providers to review the detail of the draft regulations and consider what these mean for their organisation.  However, we set out a few thoughts on some points below:

  • General – the regulations acknowledge that not each of the requirements will be applicable to each registered service:  for instance, the requirement around meeting nutritional needs may be outside of the control of providers of certain community services.
  • Person-centred care – it is proposed that the need to provide person-centred care will be a free-standing regulatory requirement in its own right:  this is a departure from the current regulations which seek to achieve this by way of requirements across a number of different areas (e.g. care planning, consent, risk taking, equipment, and medicines management).
  • Reasonable practicability – the proposed regulations impose a requirement on providers to take reasonably practicable steps to enable service users to make decisions relating to their care and treatment, and in terms of making reasonable adjustments for staff and service users' needs.  The regulations make it clear that, in any prosecution under the regulations, the onus would be on the provider to prove that it was not reasonably practicable to have done more to comply with the requirement.
  • Complaints – in line with the increasing focus on the importance of managing complaints, and using these as a source of learning, the proposed regulations include an explicit requirement for each complaint to be "appropriately investigated and [have] appropriate action … taken in response".
  • Recruitment of staff – the draft regulations include two interesting proposals in terms of ensuring fitness of staff:
    1. Firstly, amongst the information which the regulations state "must be available in relation to each … person employed" is included "satisfactory evidence of conduct in previous employment concerned with the provision of services relating to (a) health or social care, or (b) children or vulnerable adults".  This does, therefore, beg a considerable question as to how providers can recruit staff with no previous experience in the care sector but who, otherwise, may be excellent candidates.
    2. The draft regulations include an express requirement on providers to inform professional regulators (such as the GMC, NMC and the Health and Care Professions Council) where staff members are no longer considered to be "fit and proper".  This test incorporates not only issues of good character and physical and mental health, but also ensuring the staff have the necessary "qualifications, skills and experience" for their role.

Enforcement and penalties

It has been expected, ever since the Mid Staffs Inquiry report, that the new standards would enable CQC to take enforcement action without the need for service of a prior warning notice.  However, a further escalation of the impact relates to the level of penalties courts can impose on conviction.  Whilst not limited to the Fundamental Standards regime alone, wider changes being introduced to court sentencing powers mean that conviction for breach of the Fundamental Standards will, in due course, be subject to a possible unlimited fine.  At present, prosecution for failure to comply with the CQC registration requirements is subject to a maximum fine of £50,000 and this, in itself, represents a substantial increase from the fine of £2,500 which was the maximum penalty for breach of the regulations under the Care Standards Act up until 2010.


As can be seen, the implications for failures to comply with the new Fundamental Standards are becoming more serious both in terms of the speed with which enforcement action can be taken and the penalties which can be imposed.  In view of this, we would encourage all providers to closely review the detail of the draft Fundamental Standards, respond to the Consultation if necessary, and consider the extent to which their internal quality governance systems are aligned with the requirements of the new proposed standards.

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