The New Fundamental Standards
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.
Details of the standards are set out in the draft Regulations. However, some points to note are as follows:
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.
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:
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:
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.
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.
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