The 10 day period for commenting on the factual accuracy of draft Care Quality Commission (CQC) inspection reports is a critical phase for health and social care providers, giving a chance to put the record straight on points which are wrong or incomplete and an opportunity to improve draft ratings before the report goes public.
With the CQC having just launched a revamped version of its factual accuracy check guidance, we look at what’s new in the guidance and what impact this might have for providers.
What’s changed?
Overall, the substance of the revised factual accuracy check (‘FAC’) guidance is very similar to the previous version, but it is undoubtedly easier to navigate - not least because it is now in a click-through web-page format which is simpler to find on the CQC website than the previous PDF version.
However, looking at the detail of the revised guidance, it is certainly understandable why many providers may be left feeling that overall the FAC process is becoming more rigid.
Format of response
Perhaps the biggest change relates to the format of providers’ FAC responses, which must now be submitted via the CQC’s new online response form, a link to which will be e-mailed to the registered person along with the draft inspection report.
Whilst the previous guidance ‘strongly recommended’ that the CQC’s FAC form be used, the new requirement to use the online form is framed in stricter terms, with the CQC requiring providers to inform them ‘immediately’ if they are unable to use the online form, adding that it will then consider whether or not to make an exception in that case.
Linked with this, a potentially more controversial change is the introduction of a limit on how much text can be entered onto the form in relation to each point. Presumably in response to concerns raised by providers that a word limit could restrict their ability to challenge reports effectively, the CQC has upped the character limit in an earlier draft from 325 characters (approximately 50 words) to the current 975 characters (approximately 150 words), and has also said that, if providers cannot make their point in one row, they can continue in the row below. Certainly, succinctness is encouraged, making it more important than ever for providers to make effective use of the ability to append/cross-refer to supporting documents.
Timescales
The window for providing an FAC response is as before - i.e. 10 working days. However, because all draft reports will be sent out by e-mail, the timescale is now specified to be 10 working days ‘from the date of the e-mail’, which may help to avoid the uncertainty which has arisen in some cases about when the draft report was actually received and, therefore, when the clock started to run.
Again, the new guidance emphasises that the CQC will enforce this time limit strictly, stating: 'We will not extend the 10-day period unless there are exceptional circumstances'. No examples are given of what those exceptional circumstances might be, but it is vital that providers tell the CQC ‘immediately in writing’ if they are unable to meet the 10 day timescale, otherwise there may be little hope of the CQC exercising its discretion to extend the time.
What can providers challenge?
As before, the potential grounds of challenge are grouped in 3 categories - Category A being typographical/numerical errors, Category B being information in the report which the provider believes to be factually inaccurate and Category C being additional information, available at the time of inspection, which the provider thinks should be included in the report. The description of these categories in the guidance has been simplified, but the substance is much the same.
Related to this, however, it is notable that the previous version of the CQC’s FAC response form included in the annotations to Category B: ‘Challenges to the interpretation/importance attributed to the information should be included here’. There is no such annotation included on the new online form, but this should not necessarily discourage providers from flagging points where they believe that the CQC’s interpretation of the facts is wrong, as opposed to wrongly stating the facts, as this can be a very relevant and important part of the way in which information is presented in the final report.
In relation to providers asking the CQC for information about their findings to help inform the provider response, the new guidance emphasises that, to protect people’s confidentiality, it will not identify people who have shared concerns with them. It also says that the CQC will not release the inspector’s full notes from the inspection, although its stance on this has been softened compared with earlier drafts of the guidance by adding that it will consider requests for extracts of notes about a specific issue if the basis for what the draft report says is unclear.
Post-inspection actions/documents
Whereas the previous version of the guidance focused on the position at the time of the inspection, an important addition to the revised version is an invitation to send the CQC information about action taken since the inspection which addresses concerns the CQC has raised with the provider or included in the draft report (e.g. the example given in the guidance is a safety policy put in place by the provider after inspectors flagged the lack of one).
Whilst the revised guidance makes clear that this new information will not be taken into account when deciding ratings (unless there are ‘exceptional circumstances’, which are not specified), the inspector may decide to amend the draft report to include reference to this new information, plus it could influence the CQC’s decision on whether to take enforcement action against the provider.
It will therefore be crucial for providers to give careful consideration to any improvements which have taken place since the inspection, and how these can be evidenced in documents submitted alongside the FAC response, to ensure that the CQC understands and recognises these changes in the final report.
CQC’s response
As before, the CQC will indicate on the FAC form which of the provider’s points it accepts and which it does not (giving reasons).
The revised guidance also maintains the position that the CQC might change draft ratings if it decides that the evidence on which they are based is inaccurate or incomplete, although a notable addition is the point that the FAC process: '…should not be used to challenge an inspection rating solely because you disagree with it'.
Also as before, the guidance explains that the CQC’s FAC response will be reviewed by another member of CQC staff, who is independent of the original site visit, before being sent to the provider (although the previous, rather complicated, list of examples of who within the CQC could and could not carry out this review is not included in the revised version).
The new guidance is, however, silent on key issues around consistency in the responses to providers, and provides no additional clarity on how the CQC delivers against judicial recommendations around quality assurance and independence at the factual accuracy response review stage. This is likely to be a continued source of frustration for those providers who have found it difficult to persuade the CQC to make changes to the report at the FAC stage and who disagree with the judgements that have been made by inspectors responsible for drafting the report.
Impact?
Providers may feel that, in practice, the revised guidance is unlikely to mean any major changes to how they approach the factual accuracy check process.
With the ‘window’ for raising FAC points continuing to be so tight, however, providers need to take on board the renewed emphasis on the importance of complying with the CQC’s prescribed format and timing for FAC responses.
Providers should also consider how they can maximise the opportunities the process as set out in the revised guidance presents - e.g. by ensuring that the CQC is given full details of actions taken post-inspection, which could end up being reflected in the final report.
However, whilst the streamlined process is helpful, there may be a feeling that - taking into account the limited access to inspection notes, the word limit imposed on FAC submissions and the absence of clarity on ensuring transparency in decision-making - the process is, in reality, becoming more onerous for providers.
How we can help
Our experienced team of healthcare 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:
- Pre-inspection compliance support - e.g. Head Office pre-inspection reports on key risk areas;
- 'Well-led' assessment support, including advice/mock interviews for Board members and senior managers;
- Support with factual accuracy check responses to draft inspection reports, including 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;
- Strategic advice to Boards on the changing regulatory landscape;
- 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 preparing/accompanying Registered Managers and/or nominated individuals at interviews under caution for regulatory breach and defence of criminal prosecutions if charges are brought.
