Before Christmas, the Administrative Court made a ruling, in a judicial review challenge (brought by Hexpress Healthcare Limited) against a CQC inspection report, which will have significance as CQC moves towards implementing its new Single Assessment Framework in 2023.
The case considered two important issues regarding CQC’s processes for inspection and assessment of services and the bringing of challenges against inspection reports.
Factual Accuracy Challenge Process
The case reviewed the development of CQC’s processes for dealing with factual accuracy challenges, which had previously been considered by the courts in challenges brought by SSP Healthcare and Babylon Healthcare Limited.
In the SSP case (in 2016), the court had declared that providers should have a right to request CQC to carry out an independent review of factual accuracy challenges in circumstances where the findings in the inspection report remained “demonstrably wrong or misleading”.
Following the SSP case, CQC changed its Factual Accuracy process to include an independent review of the inspection team’s response to the provider’s factual accuracy challenges before that response is sent back to the provider.
The central issue considered in the Hexpress case, however, was whether the provider should have the right to reply to CQC’s factual accuracy challenge response in order to request CQC to carry out an independent review of that response. This has been previously considered in the Babylon Healthcare case where the court held that providers should be able to see CQC’s initial response before having a right to request an independent review.
However, in the Hexpress case, Mr Justice Mostyn concluded that it is acceptable for the independent review to be incorporated into CQC’s initial response, and that the provider should not have a further right to request an independent review upon receipt of that response. Mr Justice Mostyn concluded:
“What has the provider lost if the process is thus condensed? All that has been lost is that the reviewer will not see the “reply” of the provider …. Frankly, I cannot see that as a great loss which justifies such a prolongation of the procedure. I remind myself that we are talking here about errors of primary concrete fact, and not about value judgments on those primary facts. Those errors will have been clearly pointed out in the initial FAC request by the provider. They will either be right or wrong. If the alleged errors are rejected by the inspection team they will have had to have done so for good reasons, referable to hard objective evidence. It is hard to see what the reply can contribute further to the debate.”
There is an assumption in this conclusion that, if findings in the draft report are demonstrably wrong, and if the provider’s Factual Accuracy challenge points that out (sometimes with accompanying evidence), CQC’s Factual Accuracy process (including the involvement of an independent reviewer) will correct the factual inaccuracy. Whilst that assumption may appear, in theory, to be logical, it does require CQC to act reasonably and transparently. Unfortunately, experience shows that, in practice, CQC will not infrequently maintain factual findings in the draft report (in the face of clear evidence to the contrary provided as part of a factual accuracy challenge) and/ or will maintain challenged judgements by relying on new factual findings which were not previously set out in the draft report and which the provider may not agree (but has not been given an opportunity to challenge).
The Hexpress ruling is disappointing given that, as Andrews J stated in the SSP case “there is little point in giving someone an opportunity to make factual corrections, if there is no procedural mechanism for safeguarding against an unfair refusal to make them.”
It is for these reasons that it is important that the provider should be able to see CQC’s response to a challenge before being able to call for an independent review of the report prior to publication. The Hexpress ruling suggests that the only option for providers, when receiving such a response to a factual accuracy challenge, is to seek judicial review. This is unwelcome as such action is expensive and time consuming and, therefore, not a viable option for many providers. As Mr Justice Mostyn acknowledged in his judgment, inspection reports have “the potential to wreak serious economic and reputational damage” on services and it is essential, therefore, that the processes have appropriate safeguards in place to ensure that they are accurate.
As CQC finalises its new Single Assessment Framework over the coming months, one of the remaining pieces of the jigsaw to be put in place is the process for providers to check and challenge the factual accuracy of its assessments and reports. It will therefore be essential that the new process is fair to providers and that, when subsequently implementing that process, CQC acts reasonably and with transparency in response to the challenges providers raise.
Inspection and Assessment Process - Sample Size
The Hexpress case also highlighted an important issue about CQC’s inspection and assessment process, and the evidence base upon which it draws conclusions.
Hexpress Healthcare is an online medication prescribing service, and, at the time of inspection, CQC had a number of concerns regarding the service’s processes for prescribing medication. These concerns were based to a large extent upon CQC’s review, at the time of inspection, of a sample of medical records from the service. However, out of approximately 60,000 medical records available, the inspection only actually reviewed six medical records, albeit that five of these six sets of records raised concerns.
The provider therefore brought a judicial review challenge that it was disproportionate for CQC to make judgements regarding the safety of the service (resulting in findings of breaches of the Regulations and negative ratings) based on such a small sample size (comprising 0.01% of all available patient records) and asserted that no reliable conclusions could be drawn from such a sample.
CQC defended its approach, highlighting that it has to operate through taking a sample of cases, and although it accepted the sample was relatively small, CQC justified its findings on the basis that “a very worryingly high proportion of the records examined contained issues [of concern]”.
Mr Justice Mostyn stated that it is a valid question whether, in using such a small sample, CQC had conducted a fair analysis. He accepted, however, that it may be that, given the resources available to CQC and its duty to protect the public, there is no other way for it to form an evidence base from which to extrapolate conclusions.
Mr Justice Mostyn did not have to determine this substantive issue, as the matter for him was whether to give permission for the challenge to go to trial. He accepted, however, that the small sample size was an arguable ground of challenge to the validity of generalised conclusions being drawn, and therefore gave permission for the case to proceed to a full hearing on this ground.
This issue will now proceed to a full judicial review hearing, and it will be a matter for the trial judge to balance issues of the fairness of CQC making judgements upon such a small sample size, against the resources, available to CQC, and its duty to protect the health, safety and welfare of the public.
It will be of great interest to see how this argument pans out as this will also have an impact upon the evidence base CQC relies upon to make its judgements in its new Single Assessment Framework due to be implemented in 2023.