Health and social care providers will be acutely aware that poor ratings in CQC inspection reports have the potential to “wreak serious economic and reputational damage”, as was acknowledged by the judge in the recent case of R (on the application of Hexpress Healthcare Limited) v CQC, which looked at the fairness (or otherwise) of the CQC’s approach in a number of respects, including its factual accuracy check process and the reaching of conclusions based on only a very small sample of cases.
In this briefing, we look in more detail at what the court found and what happens next.
What is the case about?
This case involves an online prescribing provider, Hexpress, which is seeking to challenge a CQC inspection report through the courts.
The provider had previously been rated ‘good’ overall but, following some “concerning incidents” in 2021, including two fatal overdoses involving beta-blocker medication, the CQC carried out a comprehensive inspection in May 2022. As part of that inspection, the CQC reviewed 6 patient records and found concerns in relation to 5 of those (for example, antibiotics being prescribed without a record of presenting symptoms or past medical history). The CQC subsequently sent the provider the draft inspection report, which gave an overall rating of ‘requires improvement’, with an ‘inadequate’ rating for the ‘safe’ domain.
In response, the provider submitted its factual accuracy check form raising issues in relation to the draft report, including its view that the size of the sample of medical records reviewed - 6 out of 60,000 records - was so small that no reliable conclusions could be drawn from it.
The CQC then sent the provider its response to the factual accuracy check points along with a record of the internal independent review of that response, plus the final version of the inspection report. The ratings remained unchanged from the draft version.
The provider then applied to challenge the CQC’s report through the courts via judicial review.
What did the court find?
The court’s recent judgment relates to the first stage of the judicial review process, known as the ‘permission’ stage, which involves a judge ruling on whether there are any arguable grounds of challenge which can go forward to a substantive hearing.
The provider put forward 5 grounds of challenge, arguing that the CQC’s approach had been disproportionate and unfair. The court gave permission for one of those grounds of challenge - relating to the size of the sample on which the CQC based its conclusions - to go forward to the next stage, which will be a full judicial review hearing looking at whether the CQC’s approach was fair and lawful in that regard.
Was the CQC’s factual accuracy check process fair?
One of the grounds of challenge which was not put through to full hearing stage, but is useful to highlight, related to whether the CQC’s factual accuracy check process had been fair.
The provider’s argument here centred around the obligation on the CQC - established in the case of R (on the Application of SSP Health Ltd) v CQC back in 2016 - to carry out an independent internal review where the inspection team has decided not to change findings in a CQC report which the provider is maintaining are factually wrong. To comply with this obligation, the CQC now routinely has every factual accuracy check response checked by someone independent of the inspection team before it is sent to the provider. It was argued by the provider in the Hexpress case, however, that rolling the inspection team’s factual accuracy check response and the independent check of that response all into a single stage is not what was envisaged by the court in the SSP case and is unfair because it does not give the provider an opportunity to submit a reply to the inspection team’s initial response before an independent reviewer gets involved.
The judge rejected this ground of challenge, finding that the CQC’s “condensed” factual accuracy check process is fair and therefore lawful, particularly because the factual accuracy check process is about “errors of primary concrete fact, and not about value judgments on those primary facts”.
Could the CQC fairly rely on such a small sample size?
The one ground of challenge which the judge did allow through to substantive hearing stage centred on the question of whether the CQC acted disproportionately by using only 6 medical records as its sample.
The provider’s position was that no reliable conclusions could be drawn from reviewing a sample of only 6 out of 60,000 records (representing 0.01% of all records). The CQC argued in response that it had to operate through taking a sample of cases, given the length of the inspection and the number of other registered providers.
As the judge put it, the key question here is: “…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?”. Whilst the judge did not reach any conclusions on this question (that will be for the judge at the substantive judicial review hearing), he did rule that it is an arguable ground of challenge and, as such, permission was granted for this issue to go to full hearing when 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”.
What about publication of the CQC’s report now?
The provider in this case asked the court to grant an injunction preventing the CQC from publishing the inspection report pending the substantive judicial review hearing.
However, the judge refused to do so, pointing to the very high threshold for such an injunction in this scenario and concluding: “I cannot say that the facts of this case, even taken at their highest, 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.” Whilst, therefore, the provider can flag up that its legal challenge is going ahead following the court’s decision that there is an arguable case to take forward, the report itself can now be made public.
What next?
This case can now proceed to a substantive judicial review hearing on the issue of whether the CQC could fairly reach generalised conclusions based on such a small sample of records.
The judge has given 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.
Comment
This case reminds us of the very high threshold for any attempt to prevent or delay publication of a CQC report, notwithstanding the serious economic and reputational damage that a report which is not accepted by the provider may cause, and also the limited scope of the factual accuracy process in respect of errors of concrete fact only, and not an opportunity to challenge judgments made by CQC inspectors This underlines the importance of being able to demonstrate quality and safety standards during the inspection process itself, proactive preparation for CQC inspection and robust management of the inspection and FACACC process.
The CQC is currently in the process of developing its regulatory approach and this includes reviewing the factual accuracy challenge process. There is opportunity for providers (or any members of the public) to provide their views via a CQC survey which importantly includes a question as to whether, under the revised process, comments should be accepted by the CQC in relation to judgments and decisions, as well as factual accuracy of fact. If this were to be included in a revised scheme, this would represent a significant shift and present substantially more opportunity for constructive challenge but, unless and until this change comes to fruition, the importance of careful and robust inspection preparation will remain.
How we can help
Our experienced team of health and social care regulatory lawyers work with organisations across the independent and public sector to provide advice and support on the full range of issues that CQC regulation brings with it, including:
- Support with factual accuracy check responses to draft inspection reports, such as working with in-house teams on which issues to include and how best to evidence them;
- Advice on process flaws which may open the way to judicial review challenge if the factual accuracy process does not resolve the provider’s concerns;
- Representations about Warning Notices, Notices of Proposal and appeals to the First Tier Tribunal about Notices of Decision;
- Advice and support during CQC investigations, including responding to questions under caution (whether in writing or by personal attendance at interviews) for regulatory breach and defence of criminal prosecutions if charges are brought, including advice to registered provider organisations and also individual registered managers and nominated individuals;
- Board support in preparation for well-led scrutiny and inspection.
