The Department of Health and Social Care has launched a consultation on proposed changes to the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 which would impact on the scope of regulation by CQC.

As well as a proposed technical change removing an expiry date in the Regulations and replacing it with an obligation for the Secretary of State to keep the appropriateness of the Regulations under review, the consultation proposes two substantive changes:

  • Firstly, extending the regulation of healthcare provision at sporting and cultural events; and
  • secondly, imposing an obligation on providers in mental health services to notify CQC of all forms of restrictive practice.

Regulation of Healthcare at Sporting and Cultural Events

Currently, the provision of healthcare services which would otherwise fall within the regulated activity of ‘Treatment of disease, disorder or injury ’ is exempt from registration by CQC if it:

  • is at a sports ground or facility and is solely for the benefit of people taking part in, or attending, sporting events; or
  • is treatment (other than First Aid) under temporary arrangements to deliver health care to people taking part in, or attending, sporting or cultural events.

In short, the proposed amendment will require the registration of healthcare providers providing treatment to people participating in, or attending, sporting or cultural events.

There will still be some aspects of healthcare provided at sporting and cultural events which will remain unregulated as:

  • any treatment of professional sports people provided under arrangements made by their employer; and
  •  transporting patients solely within the confines of sites used for sporting or cultural events;

will remain outside of the scope of registration.

In addition, the provision of First Aid will continue to be exempted from the need for registration.

Assuming that the amendments are passed, providers of services at sporting and cultural events may need to seek clarity as to the boundary between services which are First Aid (and therefore exempt from registration) and those services which fall within the definition of ‘treatment’ under the Regulations, and may therefore be subject to the requirement for registration and ongoing monitoring by the regulator.

Notification of Restrictive Practices

DHSC is also consulting on introducing a new obligation on mental health providers registered with CQC to notify CQC within 72 hours of the use of any physical, mechanical or chemical restraint or isolation (including seclusion and segregation) of any patient being assessed or treated for a mental disorder in a mental health unit.

Such notifications would ensure that CQC becomes aware of all instances of restrictive practice at a much earlier stage, rather than having to await publication of the Mental Health Services Data Set, which, in any event, provides limited information in services with very low numbers of such practices.  CQC would then be able to take a view, in the light of the information received as to whether to carry out an inspection or take enforcement action in the event that safety concerns were raised.

The proposal is that the information which providers will need to notify to CQC will be based on data they will be required to record in any event when the Mental Health Units (Use of Force) Act 2018 is brought into force, including:

  •  the reason for the use of force
  •  the place, date and duration of the use of force
  • the type, or types of force used on the patient
  •  name of the patient on whom force was used
  • the relevant characteristics of the patient (if known)
  • whether the patient has a learning disability or autistic spectrum disorder
  • whether the patient died or suffered any serious injury as a result of the use of force
  • any efforts made to avoid the need for use of force on the patient

DHSC’s proposal is to introduce the notification obligation with effect from April 2025.

The consultation closes on 21 June 2024 and providers are encouraged to submit their comments on the proposals before then.

If you wish to discuss any of the issues related to this consultation, or CQC regulation more generally, please contact Carlton Sadler or Siwan Griffiths.

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