The fundamental standards set out in the draft Regulations will apply across the whole health and social care sector from April 2015. The need for new, fundamental, standards was one of the cornerstones of Sir Robert Francis QC's recommendations in the Mid Staffs Inquiry. Robert Francis' findings were that CQC's current Essential standards of quality and safety are unclear and overly bureaucratic. In their place, Robert Francis recommended the introduction of a new set of standards which should be both clear and properly enforced.
Content of the standards
Details of the standards are set out in the draft Regulations. However, some points to note are as follows:
- Person-centred care – the wording of the new standard increases the emphasis on involvement of service users and relatives in decision making and care planning – "enabling and supporting" as opposed to previous "permitting and encouraging". The new standard also includes a requirement for registered providers to encourage people to self-manage their care and treatment.
- Staffing – significantly, the new draft Regulations include a requirement for staff to be "competent" as well as suitably qualified, skilled and experienced. In doing this, the Government acknowledges that the fact that staff have received training does not necessarily mean that they are competent.
- Safeguarding – the requirement makes it clear that service users must be protected from "improper treatment" as well as abuse.
- Good governance – the new draft Regulations include a reference to the need for security of patient/ service user records.
Clarity of standards
The Government states that the fundamental standards are meant to be "common sense statements". However, the need for clarity in the standards is essential not only so providers are clear as to what is required of them, but also to enable CQC to move to swifter enforcement, potentially by prosecution, without the need for service of a prior warning notice. There is a potential for tension therefore between statements which are "common sense" and the need for them to be sufficiently unambiguous to form the basis of a criminal prosecution if required.
It appears, however, that the Government has dramatically improved the clarity of the fundamental standards by removing many of the subjective references to the need of "appropriate steps" from the regulatory requirements. Inevitably, some degree of subjectivity remains, and will require the need for judgments to be made, for instance around what constitutes the "proper and safe" management of medicines required under the new standards. However, further clarity should be provided by the forthcoming CQC guidance on how providers should comply with the regulations.
Enforcement of standards
The Consultation has brought about a shift in the Government's thinking in terms of enforcement of the fundamental standards.
Following the Consultation it is now proposed that, whenever a breach of the regulations constitutes an offence, CQC does not need to serve a warning notice before bringing a prosecution; the Government's previous proposal required warning notices prior to prosecution of some, but not all, fundamental standards.
However, this is not all bad news for providers as, although all fundamental standards can result in 'civil' enforcement action (such as the imposition of conditions of registration) for non-compliance, not all of the standards can lead to a criminal prosecution in the event of a breach. For example, the standard relating to 'Person-centred care', although extended in terms of scope to put greater emphasis on the involvement of service users and/or representatives in care planning, and encouraging people to self-manage their care and treatment, will no longer be an offence if breached. However, the Consultation Response makes the point that a serious failure to meet these requirements would be likely to result in a breach of other fundamental standards' for instance that relating to 'Safe care and treatment' which can lead to prosecution.
There is, however, a third category of standards the breach of which only becomes an offence if that breach results in avoidable harm, or "a significant risk of such harm occurring".
This leads to a confusing picture in terms of methods of enforcement of the standards in that:
- Some standards will not result in prosecution if breached:
- These include the proposed standards in relation to Premises and equipment (although if premises and equipment are unsafe this will be an offence under the standard relating to 'Safe care and treatment'); and the handling of complaints and the operation of effective governance systems
- Significantly, the standards around staffing (and ensuring workers are fit and proper) will also not result in criminal prosecution if breached.
- Standards which will always constitute an offence is breached:
- The only standards included here are the standards around consent to care and treatment and the requirements to supply CQC with information relating to complaints and matters of governance when requested to do so.
- Standards which are offences depending on harm/risk of harm
- These include the key standards of 'Safe care and treatment', 'Safeguarding service users from abuse and improper treatment', and 'Meeting nutritional and hydration needs'.
It seems clear that the removal of warning notices as a pre-requisite for prosecutions will signal greater levels of criminal enforcement for breach of the standards in due course. With this in mind, the clarification of the standards themselves (hopefully to be aided further by CQC's forthcoming guidance) is helpful to providers.
However, the Government's response to the Consultation introduces a new element of uncertainty in terms of whether non-compliance with the particular standard breached is capable of prosecution in the first place:
- Some standards are only capable of 'civil' enforcement;
- Other standards are always capable of prosecution if breached; and
- Others constitute offences, only if the breach leads to avoidable harm or "a significant risk of such harm occurring".
The draft Regulations, therefore, introduce a level of uncertainty in terms of what enforcement action may flow. As such, it is far from clear whether the general intention to bring greater clarity and certainty to regulation of the sector will be achieved.
Suggested course of action
Although the new fundamental standards are meant to be clearer, it is not envisaged that they will increase the burden on providers in terms of the standards of care they are required to deliver. Nevertheless, given the likelihood of increased enforcement, providers should carefully review the standards (and CQC's guidance when available) to satisfy themselves that they comply, and have quality governance systems that properly monitor compliance, with the fundamental standards.
How can Bevan Brittan help?
We can provide assistance and support with:
- Ensuring compliance - through effective policies and procedures and the provision of training
- Monitoring compliance - reviewing and advising on governance and board assurance processes for safety and quality
- Advice and support in handling instances of non-compliance
- Representation in connection with enforcement action