In this update we look at the recent Court decision in R (on the application of Hexpress Healthcare Limited) v CQC. The case is a reminder both of how difficult it is for care providers to successfully challenge the findings of CQC reports, and why the Courts consider it appropriate that this should remain the case.
Summary
The reasoning behind the Court's judgement acknowledges that the CQC's resources are limited and the inspection process is inherently limited in nature. An entire service is reviewed on the basis of limited evidence and cannot realistically be comprehensive. A review that provides a snapshot in time serves to assess an ongoing service, where documents are reviewed and samples must be assessed in lieu of the whole. Given the CQC's resource constraints, the CQC makes its findings from constrained data sets to inform judgments.
However, in this particular case, the Court decided that Hexpress should have the opportunity to make put forward its argument that the CQC had gone too far by providing a rating based on a review of just six patient records plucked from a total of sixty thousand held by Hexpress. Hexpress was granted permission by the Court to make its case in full at a subsequent hearing. It is important to note that this result simply leaves the question open: the subsequent hearing may rule that the sample size was entirely appropriate in the case in question.
The result of the full hearing will be of interest to healthcare providers across the country.
Factual Accuracy Check and Rating Review Processes: the odds
The Care Quality Commission ("CQC") is entrusted by Parliament with the responsibility of ensuring the protection of the health, safety and welfare of those who use health and social care services. The CQC is legally obliged to publish the reports of its assessments, which may have significant reputational and financial consequences for those organisations which are the subject of inspection. Where a provider disagrees with a report, it may challenge the CQC's findings via the CQC's factual accuracy check and rating review processes.
Data published by the CQC demonstrates that as of 31 December 2019 (latest published dataset), the odds of success at the rating review stage are low. Of 970 total rating reviews requested, fewer than 3% resulted in a change to the ratings, either to a specific or overall service rating. 72% of rating reviews submitted were closed having failed to set out proper grounds for review.
This dataset is not the focus of this piece, but it does provide some interesting further insights. The great majority (79%) of rating review processes submitted relate to adult social care services. Reviews relating to hospital care are the least common but are the most successful, with a 16% success rate in increasing the rating attributable to a particular element of care.
Judicial Review: A high bar
Providers that are dissatisfied with the CQC's conduct of the factual accuracy check and rating review process may go a step further and review the lawfulness of the CQC's decision via the judicial review process.
Hexpress Healthcare Limited (the "Provider") brought such a judicial review case. The initial stage of the case has now completed, with the Court granting permission for the Provider to proceed with one of the grounds of challenge brought, relating to the proportionality of the approach taken by the CQC.
Background: R (on the application of Hexpress Healthcare Limited) v CQC (Hearing date 15 November 2022)
The Provider prescribed medication for over 60 conditions via an online service requiring the patient to fill in a set of medical conditions. Based on information provided by the patient, the presenting symptoms and past medical history, one of the Provider’s doctors would prescribe medication where appropriate.
The Provider’s Inspection in 2019 achieved a ranking of ‘Good’. Between April 2021 and August 2021, five incidents took place in relation to the service, two of which resulted in fatal overdoses of propranolol. The CQC undertook an inspection, examining a sample of medical records. The CQC randomly selected nine to review out of 60,000 medical records but due to technical reasons, they were only able to sample six records (representing 0.01% of patients). Out of those six records, five presented concerns.
The CQC provided its draft report to the Provider, rating the service as Requiring Improvement, with the safety element rated as being inadequate.
The Provider submitted a response at the factual accuracy check stage and the CQC confirmed that its ratings would not be changed as a result of the Provider's submission.
The Provider issued an application to judicially review the findings and seek an interim injunction restraining the CQC from publishing the report pending further order.
The five grounds of challenge
i) The CQC failed to give reasons for departing significantly from its findings in earlier inspection reports.
ii) The CQC acted disproportionately, and thereby breached s.4(1)(e) of the 2008 Act, by using only six medical records as its sample.
iii) The CQC failed to independently review the factual accuracy check response, which was procedurally unfair.
iv) The CQC irrationally assessed the safety of the provider’s services as inadequate.
v) The final report contained errors of fact or else gives undue weight to irrelevant factors.
The Court rejected four of these five grounds, but granted permission to proceed on the basis of the second. The Court's explanation provides valuable insight and is worth reading in full:
"The approach of the CQC gives rise to a number of questions. Are such responses entirely consistent with the laws of probability? Would a sample size of 6 out of 60,000 be regarded as statistically significant? In using such a small sample did the CQC conduct a fair analysis? If not, has that principle been sacrificed on the altar of CQC’s limited resources?
It seems to me that the key question is this: whether adopting a common-sense point of view or a legal point of view, can a generalised criticism that the provider’s standard of safety is “inadequate”, or that its standards of effectiveness and leadership “require improvement”, logically and fairly be extrapolated from six medical records out of 60,000?
I do not doubt that there would be resource implications if the CQC’s inspection teams had to review hundreds of medical records on every inspection such as this. The answer to the questions might be, therefore, that given the resources available to the CQC, and the duty imposed on it to protect the public, there is no other way of forming an evidence base from which to extrapolate conclusions, notwithstanding that the result of the ratings and of the report could have very serious implications for the provider. Further, for all I know, it may be commonly accepted that where, as here, a regulator is concerned with safety, a statistical approach is not appropriate. I read no evidence and heard no argument about the accepted alternative modes of proof used by such regulators when identifying systemic issues of concern.
In my judgment the invalidity of generalised conclusions being drawn from such a limited sample is an arguable ground of challenge, and I therefore grant permission under Ground 2. I emphasise that all I am deciding is that the challenge is arguable. It will be for the trial judge to balance individual fairness against the resources of the guardian of the public’s health, safety and welfare. I hope that the questions I have posed above will be answered.
I will give permission to both parties to adduce expert statistical evidence at the substantive hearing and to the CQC to adduce evidence as to the resource implications of having to use significantly larger samples on inspections or assessments."
The Court also rejected the request for an interim injunction, confirming that the CQC could publish the report. The case did not "come close to demonstrating the exceptionally strong grounds needed to prevent a public body from publishing a report that Parliament has required it to publish".
The full judgment can be read here.
More information
The Healthcare team at Burges Salmon can advise care providers on CQC compliance matters, including factual accuracy checks, ratings reviews and judicial review processes.
Article written by Patrick Parkin, Sam Charkham and Jess King.