In April 2021, the East Kent Hospitals University NHS Foundation Trust pleaded guilty to failing to provide safe care and treatment to a newborn baby and his mother, which resulted in the infant dying seven days after a Caesarean birth.  The Care Quality Commission (CQC) brought the prosecution following an inquest into the death of the infant.  What was unique about this case is that it marks the first time the watchdog has prosecuted a regulated provider for a clinical failure as opposed to a health and safety breakdown.

The fact that the CQC has extended its scope for prosecution into clinical failure means those regulated by the watchdog must have a clear understanding of how it operates and its enforcement powers.

What is the CQC?

The CQC is an independent body that regulates a broad range of services that the general public rely on, including:

• Hospitals.
• Adult social care providers.
• Mental health and community health services.
• GP practices.
• Health and social care in prisons and young offenders’ institutions.
• Primary care dental services.

The regulator’s two primary purposes are:

• To protect people who use the above-regulated services from harm and the risk of harm, and to ensure they receive health and social care services of an appropriate standard, and
• To hold providers and individuals to account for service failures.

Can the CQC prosecute people?

The CQC has the power to bring enforcement action against an individual if:

• They breach the conditions of their registration.
• The offence has been linked to or caused by their negligence.
• Bringing a prosecution is in the public interest.

What is the process the CQC will follow if they are required to investigate a regulated service or person?

If required to make an enforcement decision, the CQC will use a four-step process:

• Initial assessment – a Management Review Meeting (MRM) will be held to consider the case.  Most cases will then progress to a focused inspection or standard direct checks.  However, if the matter is serious enough, the process of collecting evidence for a potential prosecution will begin.
• Legal and evidential review – the CQC will carefully examine the evidence it has gathered and check it was obtained, recorded, and logged in accordance with statutory guidance. 
• Tests to assess appropriate enforcement action – inspectors will consider the following in order to decide what type of enforcement action to take:
  • The seriousness of the concerns.  Here, inspectors must determine whether there is evidence of systematic failings in the quality of care or management, resulting in the same issues happening again.
  • Is there evidence of multiple or regular breaches?  A positive answer is likely to result in harsher enforcement action and may also result in criminal prosecution being pursued.
• Final decision – A further MRM is held where a final decision on the enforcement action to take will be made.  This is done with reference to the priorities set by CQC’s Board and agreed in the CQC’s business plan.

What enforcement action can the CQC take against a regulated body or individual?

Several enforcement action routes are available to the CQC, including:

• Simple cautions – these are given in situations where there is enough evidence to prosecute but it is believed that improvements can be made, and the provider is prepared to take action to remedy failings.  If the breach does not greatly affect service users, a caution is likely to be given.    Although the provider does not have to accept the caution, the CQC can consider prosecution if acceptance is refused.
• Fixed Penalty Notices – as with cautions, there is no obligation to pay a Fixed Penalty Notice; however, failure to do so may result in a prosecution being brought.  If a breach occurs across a sector, multiple providers can be issued with a Fixed Penalty Notice.
• Prosecution – this will be considered in cases where multiple breaches have occurred, avoidable harm was caused to the service user, and/or the provider has acted deceitfully or withheld information.

Civil enforcement powers can also be used, including:

• Imposing, varying, or removing conditions of registration.
• Suspending registration.
• Cancelling registration.
• Urgent procedures for cancelling registration, suspending registration, or imposing or varying conditions.

The following special measures can also be imposed:

• A direction that changes must be made within a certain timeframe to ensure inadequate care does not continue.
• Coordination with other regulators.

Can enforcement measures be appealed?

If a registered body or person disagrees with a CQC enforcement measure, it or they can appeal to the First-tier Tribunal (Care Standards).

Appeals must be lodged within 28 days of the service of a:

• Decision notice.
• Notice imposing, varying, or removing conditions using the urgent procedures.
• Court Order cancelling a registration using urgent procedures.

There is no right of appeal concerning warning notices, penalty notices, or criminal convictions.

Final words

A CQC prosecution can have serious consequences for a registered provider’s or person’s professional reputation and ability to deliver care in their sector.  The key to mitigating the risk of persecution and media interest is to instruct a lawyer who has expertise in regulatory investigations and prosecutions. If you are facing a CQC prosecution, please contact me urgently.

Tanveer Qureshi specialises in white-collar crime and regulatory investigations and prosecutions. If you require legal representation, please contact Tanveer directly at tqureshi@4-5.co.uk or via his chambers, 4-5 Gray’s Inn Square.