“(e) the need to ensure that action by the Commission in relation to health and social care services is proportionate to the risks against which it would afford safeguards and is targeted only where it is needed … (g) best practice among persons performing functions comparable to those of the Commission (including the principles under which regulatory action should be transparent, accountable and consistent).”
“i) prior to publication, service providers can challenge the factual accuracy and completeness of the evidence and findings on which the ratings are based, as well as the proposed ratings themselves. The service provider has 10 working days in which to review draft reports and submit its comments to the CQC. There is no express provision for the submission of evidence that was not produced at the time of the inspection. ii) after publication, service providers can seek a review of ratings. The Handbook makes it plain that the only grounds for requesting such a review is that CQC did not follow the process of making ratings decisions and aggregating them (i.e. the process set out in the Handbook). Service providers cannot request reviews on the basis that they disagree with the judgments made by CQC, "as such disagreements would have been dealt with through the factual accuracy checks…".”
“If, as in the present case, the CQC did not make the changes which fairness required it to make to the draft report in response to the challenges that were properly raised at the factual accuracy stage, how, if at all, could the Claimant get it to put things right? ”
“I will therefore grant a declaration that there is an obligation on the CQC to carry out an independent [internal] review of a decision made in response to comments in the Factual Accuracy Comments Log, on a request to do so by the inspected entity, if the ground of complaint is that a fact-finding maintained in the draft report is demonstrably wrong or misleading. I deliberately express no view as to whether the right of review would extend to other scenarios.”
“The Defendant says that it is sufficient that an independent reviewer should contribute to the document responding to the service provider's comments before that document is issued, together with the final s.61 report for publication, and before those documents are given to the service provider. On the other hand, the Claimant says that that does not go far enough. They say that, according to the judgment of Andrews J, it is necessary that the service provider should see the response of the inspection team. It can then ask for an independent review, and that review will separately indicate whether any additional changes should or should not be made. In other words, they say, the two responses should not be conflated. I agree with the Claimant that that was what was intended by Andrews J…”
“The service stated that they did not prescribe certain medicines and for some long-term conditions without receiving adequate documentation from the individual’s doctor. However, we found that the service had continued to issue medicines for a particular patient without receiving any clearance from the patient’s own GP or ensuring they had received kidney function tests. We saw no evidence that any information had been requested.” … “We found instances where patients requesting antibiotics for a urinary tract infection, were prescribed antibiotics without a record of the presenting symptoms or past medical history. For example, in one patient record we reviewed, there was no record of any history of past urine infections or if the patient had a recent urine sample tested. However, a prescription was generated for antibiotics for this patient without a record of the clinical decision to prescribe.”
“We reviewed six anonymised medical records which were complete records. We saw that notes were recorded, and the GPs working for the provider had access to all previous notes. However, we saw examples where patient records lacked adequate documentation to support prescribing. Some records lacked a detailed assessment of the patient’s presenting symptoms for example, when prescribing antibiotics. We were told that each clinician was required to complete 25 prescriptions per hour. However, we found in most cases, prescriptions were generated in under 30 seconds and in some instances in 15 seconds. Resulting in instances where prescribing was not in line with the services policy.” … “Before providing treatment, doctors at the service ensured the policy was to ensure there was adequate knowledge of the patient’s health, any relevant test results and their medicines history. We saw examples of patients being signposted to more suitable sources of treatment where this information was not available to ensure safe care and treatment. However, the process relied on the patient providing that information with no further systems in place to verify this with the patients’ own GP.” … “The service identified patients who may need extra support and had a range of information available on the website (or links to NHS websites or blogs). For example, in consultation records, we found patients were given advice on healthy living as appropriate. However, we found that in some instances patients were not sent vital information with their medicines. For example, the information leaflets were missing vital information on safety netting such as depression/suicide risk associated with some medicines used to treat depression. Following our inspection, the provider wrote to us stating they had taken action to correct this.”
“There was evidence of continued issuing of prescriptions for some patients with chronic conditions without assurance that these patients had received adequate monitoring from their own GPs. There were also instances where antibiotics had been prescribed despite a lack of sufficient history. The leaders were not aware of these gaps within their systems and had not undertaken a robust risk assessment to minimise risk for patients whose health required monitoring prior to receiving repeat medicines.”
“The CQC has to operate through taking a sample of cases, given the length of the inspection and the number of other registered providers. The inspection took place over one day and the records were not easy to access through the system. Whilst the sample was relatively small, a very worryingly high proportion of the records examined contained issues: six records were examined in full; and the inspectors had concerns in respect of five of them. As set out above, the CQC was initially minded to issue a warning notice, but, following consideration of the Claimant’s representations, it declined to do so. This bears out the CQC’s balanced and proportionate approach, taking into account the risks presented. Given the CQC’s principal statutory objective to protect the health and welfare of its service-users and its findings in respect of safe prescribing, it is not arguable that the CQC breached s 4(1)(e) of the 2008 Act. ”
“The judgement made cannot possibly be reflective or representative of the Provider as a whole because, at best, it is 0.01% of the records. No reasonable or rational regulator would draw such an overarching conclusion based on such a small sample.” ii) In the witness statement of its clinical lead: “One in ten NHS prescriptions are classified as a prescribing error. It has been estimated that that is nearly 237 million a year at a cost to the NHS of£98 million . We had one out of a possible 60,000 prescriptions from the medical record cohort selected by the inspection team: to rate the service as inadequate based on this one error is a grossly disproportionate response. If this were the case in all inspections then all Service Providers registered with the CQC would be classified as inadequate.” iii) In its amended Statement of Facts and Grounds: “As such, the Defendant’s approach cannot be characterised as proportionate, as the balancing exercise that the Defendant must conduct under s.4(1)(e) used just 6 cases to effectively impose a serious sanction against the Claimant.” iv) In the skeleton argument of Mr Havers KC and Ms McCann: “The Defendant acted disproportionately because it only selected nine records and only reviewed six records as a sample of cases. ….The Defendant’s case is that this approach to the records was reasonable firstly because it only had one day to inspect and did not have easy access through the system and secondly because “while the sample was relatively small, a very worryingly high proportion of the records examined contained issues” … It is submitted that both justifications further evidence the Defendant’s unfair, disproportionate approach. In the context of previous “Good” ratings in 2019, five out of six cases causing concern should have been seen as unrepresentative, warranting wider review and closer scrutiny as the Defendant acknowledged in its FAC response “…we are not saying that six records is representative of the quality of all records but may indicate whether there may be concerns or need to explore further”
“Our records review is a sample size, we are not saying that six records is representative of the quality of all records but may indicate whether there may be concerns or a need to explore further. The report is factually correct in that the six records reviewed had concerns in relation to them and improvements are required to be made. The evidence collected during our inspection process supports the statement in the report you refer to. Therefore, no changes will be made to the final report in relation to your comments in this section.”
“At paragraph 41 of the ASFG, the Claimant suggests that the sample size of records was insufficient. However, even though relatively small sample was taken, we still found problems with over 50% of those records which is a high proportion. It is not unusual on inspection for us not to move on to further records where the initial set of records show this level of concerns.”
“During the factual accuracy period, the provider told us that following our inspection feedback they had on18 May 2022 ceased the prescribing of ramipril, lisinopril and angiotensin-converting enzyme (ACE) inhibitors that require renal and kidney blood tests and Terbinafine which requires a liver blood test.” … “Following our inspection, the provider wrote to us stating they would review the process of antibiotics prescribing to ensure it includes the necessary details prior to prescribing.”
“25. There is a clear and identifiable line of authority in relation to the grant of injunctions to restrain public bodies from publishing decisions or reports, which makes it clear that there are separate public law questions which fall to be considered alongside the ordinary principles of private law injunctions. So far as private law injunctions are concerned, the ordinary test, by reference to American Cyanamid, is whether there is an arguable case for the claimant, and if so, where the balance of convenience lies. In defamation cases, injunctions will rarely be given because of the obligations of freedom of speech, but certainly so where the defendant asserts that he or she intends to justify the truth of what it asserts. However, in the public law field there are additional considerations, as is clear from the authorities which have been put before me. … 28. In the Debt Free Direct Ltd decision, Sullivan J said … in paragraph 24, that there would have, in his judgment, to be "the most compelling reasons to prohibit a public body which is embarked on a quasi-judicial task … from publishing its decision". 29. It is not simply, therefore, that there are all these additional words: "exceptional circumstances", "most compelling reasons", "pressing grounds", "exceptionally strong grounds", which require to be satisfied, but such that it will not be in every circumstance - far from it, that a good arguable case is entitled to be protected by an injunction. 30. Sullivan J gave examples of where there might be extreme circumstances - as he put it, in paragraph 24, "most compelling reasons to prohibit the public body": if for example the public body had engaged in a vendetta against the person the subject of the adjudication or if the adjudication was prompted by a deliberate desire to inflict damage on the reputation of the person criticised. One can think of other examples involving fraud or corruption, or perhaps involving the intention to proceed with a Report which is, and can be shown to be, as on a justification injunction, manifestly untrue or riddled with error. It is never helpful to come up with examples, except suffice it to say that the test of the judge's thermometer, in terms of response to an injunction, will be set and calibrated several degrees higher, so far as looking at the arguability of a case, than it is in this case. 31. Assuming, as I do for the purpose of the injunction, that there is an arguable case on the part of the claimant, and even filtering in the damage which the claimant says it will suffer, which is no different from, and perhaps less serious than, that suffered by the victims of other alleged statements which they seek to restrain, I am entirely satisfied that there are not, in this case "most compelling reasons", "exceptional circumstances", "pressing grounds", or "extreme circumstances", which justify the grant of an injunction.”
“…the case put forward by the Claimant comes nowhere near the threshold required to justify the continuation of the injunction to restrain the publication of the report as it now stands, in accordance with the Commission's statutory duty.”