Preparing for the new Care Quality Commission Framework
Later in 2023 the Care Quality Commission (CQC) is set to launch its new single assessment framework for health and adult social care in England. For health and care providers, the regulator’s new approach promises to be ‘dynamic’ and ‘data-led’ – exactly what you’d expect of a modern regulator.
To discuss the new framework, Lockton recently held a webinar in partnership with Mills & Reeve. The recording of that webinar is available here (opens a new window).
The new framework
The foundation of the new framework is a shift towards multi-point assessments, and will become effective later this year. Introducing a dynamic and data-led method of assessment, the new framework will place greater emphasis on people’s experiences of care, and should enhance clarity and transparency around care provision.
Rather than relying upon a single point-in-time rating following an inspection, ratings under the new framework will be updated more regularly, thereby giving a real-time account of a provider’s quality of care. This will be presented via a dynamic and accessible online dashboard.
To achieve this, CQC is shifting away from long narrative-based assessments, replacing these with scores and short statements, with provision and outcomes benchmarked against other comparable care providers. Although CQC’s quality ratings and five key questions (opens a new window) will remain, the existing key lines of enquiry (KLOEs) and prompts will be replaced with a set of 34 ‘quality statements’. In carrying out its assessments, CQC expects a larger volume of data to be collected remotely rather than through on-site visits, although inspection and observation remain a component of the overall assessment service.
To guide its assessments, CQC has set out six categories of evidence, which seek to expand the sources of information upon which assessments are based. These are:
People’s experience
Feedback from staff and leaders
Feedback from partners
Observation
Processes
Outcomes
Providers will be assessed on each of these categories and, in each case, will be awarded a score from 1 to 4, with the former indicating significant shortfalls in the standard of care, and the latter demonstrating an exceptional standard of care.
These scores will then be combined to give an overall result – first, for each quality statement, and then again to give a total score for each of the five key questions. From this, a rating will be generated, which is aggregated once more to give an overall rating for the provider, falling within one of four brackets: Inadequate, Requires Improvement, Good, or Outstanding.
It is hoped that the move to the new framework will give providers greater clarity around CQC ratings, and the steps required to improve a given level of care. Reports should be shorter, simpler, and easier to understand. With assessments carried out in real time, providers should also have more opportunity to improve their ratings in the wake of implemented improvements. This in turn will enhance transparency for members of the public when making decisions about care.
Investigations on the rise
For providers, the new framework constitutes a significant change in the assessment of care. But it isn’t the only shift to occur within the health and social care sector. Since 2016, providers have been subject to an increasing number of CQC investigations, many of which culminate in prosecutions.
Under the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, CQC will pursue civil or criminal enforcement action where appropriate against registered persons for breaches of health and social care law, including failure to provide safe care and treatment resulting in avoidable harm, or a significant risk of exposure to avoidable harm. Prosecutions can be brought against registered providers, individual registered managers, and directors of corporate providers.
To mitigate against the risk of investigation, and subsequent prosecution, providers should take a proactive approach to enhancing their level of care. Typically, the investigation process begins when information is received by CQC, either during the process of an inspection or via an alternative source (e.g. safeguarding, complaints, serious incident), at which point CQC will consider internally whether it warrants investigation. If an investigation is opened, providers will receive an initial communication indicating which offence CQC thinks may have been committed, usually accompanied by a request for further information and, potentially, a request to speak to staff.
Once the information has been considered, where CQC thinks an incident meets the threshold for prosecution, it will write to the provider with:
The offence it thinks has been committed
Evidence that supports its case
Caution
Questions under caution (for corporations, CQC usually invites written representations under caution)
Where cases proceed to court, the conviction rate is extremely high, with the majority of cases difficult to defend. Accordingly, this is the primary opportunity to prevent enforcement action. Providers should seek to answer all questions put by CQC, providing robust evidence of defence, including due diligence taken to provide safe care and mitigate against harm. Unless a document is privileged, it must be disclosed where it has been requested by CQC.
In determining whether to prosecute, CQC will follow the Crown Prosecutors Test. Accordingly, they must consider not only the facts of the case, but also whether there are realistic prospects of success, and whether a prosecution is within the public interest.
However, providers should be aware that the above process is not ubiquitous. Unlike other regulators, CQC has a maximum of three years to prosecute for an offence from the date upon which it was committed, and a maximum of 12 months from the point at which it has gathered ‘sufficient evidence’. When these deadlines approach, CQC has been known to skip the initial communication or request for information, instead proceeding directly to questions under caution.
Sentencing and fines
Where a prosecution is successful, sentencing is subject to circumstance. Fines are unlimited, but will generally be calculated using the following process:
Determine the offence category – including culpability (deliberate or indeliberate breach), seriousness of harm risked, likelihood of harm, number of individuals exposed to risk of harm, and whether actual harm was caused
Identify the fine starting point and range – for organisations, determined in proportion to annual turnover for the last three years, adjusted in relation to aggravating or mitigating factors
Is the proposed fine proportionate to the overall means of the organisation? – must have real economic impact in order to ‘bring home’ the need to comply to management or shareholders
Other factors – e.g. impact on ability to improve care, impact on staff, impact on service users, or guilty plea (if given at earliest opportunity, will ensure a 1/3rd reduction in fine)
Executing best practice with regards to the provision of care is the most reliable way for providers to reduce the likelihood of causing harm. Preparing in advance for inspections or investigations, and demonstrating a willingness to co-operate with CQC, will also help to mitigate against prosecutions.
Recommendations for providers:
Upon being alerted to an investigation, get advice early – it will be privileged
All correspondence or documents created will potentially be evidence – do so with that in mind
Following a complaint or incident, take measures to ensure there are no wider safety or quality issues
During inspections, be present and inquisitive
Provide evidence not assertion
Note what you are told – and play it back to the inspection team
Follow up queries in writing with evidence
Insurance considerations
Upon becoming aware of a CQC investigation, providers will typically be required under the conditions of their insurance policy to notify either their broker or insurer.
In doing so at the earliest opportunity, providers will be able to take advantage of the help available from their insurers to prepare for the investigation process. This may include guidance around the disclosure and submission of evidence, privileged information, and the implementation of improvements to address safety or quality issues.
Once CQC have confirmed they are considering a prosecution, insurers will usually appoint a panel law firm to support providers through the process, especially as staff will be interviewed (possibly under caution). The outcome of any prosecution is likely to have a direct impact on inquests and/or increase the likelihood of a civil claim being presented by the injured party, their family, or representatives.
Insurance coverage varies dependant on the type of cover being purchased. However, policies covering Public Liability / Medical Malpractice (PL/MM) should provide an indemnity for legal defence costs in connection with a prosecution (including an appeal against a conviction) for an act or offence committed or alleged to have been committed during the policy period.
On the other hand, providers should beware of the fact that Public Liability (PL)/Medical Malpractice (MM) policies do not provide cover for fines or penalties of any kind. There will also be a policy limit for the total spend on legal defence costs in connection with regulatory investigations during any one policy period.
It is also important to note that directors can also be held personally liable for failures within care homes, with claims levied against corporate entities in addition to individuals (for matters beyond the scope of PL/MM). Directors & Officers (D&O) insurance may offer cover for defence costs of both civil and criminal cases, but should be reviewed carefully with brokers or insurers to check extensions and exclusions relating to malpractice or any allegations of abuse.
In all cases, adopting a proactive approach and engaging with your brokers or insurers early on is key. Depending on the circumstances that prompted the CQC’s involvement, insurers may consider support at an earlier stage than notice of prosecution, with the intention of avoiding getting to prosecution stage and therefore containing and controlling costs.
For further information, please contact:
Duncan Astill, Partner, Regulatory, Public and Commercial Disputes, Mills & Reeve
T: +44 (0)1223 222477
E: duncan.astill@mills-reeve.com (opens a new window)
Alex Titmarsh, Account Director, Lockton
T: +44 (0)7435969344
E: alex.titmarsh@lockton.com (opens a new window)
Wendy Moule, Healthcare Claims Consultant, Lockton
T: +44 (0)7415 722783
