KING'S BENCH DIVISION
ADMINISTRATIVE COURT
Strand, London, WC2A 2LL |
||
B e f o r e :
sitting as a Judge of the High Court
____________________
THE KING (ON THE APPLICATION OF SEABROOKE MANOR LIMITED) |
Claimant |
|
- and – |
||
THE CARE QUALITY COMMISSION |
Defendant |
____________________
VICTORIA BUTLER COLE KC and ARIANNA KELLY (instructed by The Care Quality Commission, Legal Services ) for The Care Quality Commission
Hearing dates: 25 June 2024 and 27 June 2024
____________________
Crown Copyright ©
HHJ WALDEN-SMITH:
Introduction
(i) That the CQC's policy recommends that an individual's medicine care plan should include how medicines should be administered covertly and that the CQC guidance goes beyond NICE (National Institute for Health and Care Excellence) guidance and is irrational and/or lacking cogent evidential underpinning;
(ii) That the CQC's finding that Seabrooke Manor "Requires Improvement" in the safe key question is not rational or lawful;
(iii) That the CQC's finding that Seabrooke Manor "Requires Improvement" in the well-led key question is not rational nor lawful;
(iv) That the CQC's finding that the overall rating "Requires Improvement" cannot be supported if any of the Grounds 1-3 succeed as the overall rating is dependent upon the individual findings.
The Inspection and Report
(i) Resident CB's PRN protocol was amended as the PRN protocol first seen by the inspection team did not contain the correct information. This was altered on 13 June 2023 and submitted by the Claimant as part of the Factual Accuracy Check submissions in August 2023.
(ii) Resident HN's PRN protocol was also amended on 13 June 2023 as it was noted by Ms Charlesworth to be nearly identical to CB's PRN protocol. This amended protocol was submitted with the Factual Accuracy Check submissions in August 2023.
(iii) Resident GC's covert medication plan suggested that the medication could be mixed with tea, which was not in fact a suitable course to take as the tea could denature the medication. Tea was crossed through and porridge used in its stead. While a document dated 17 May 2023 was submitted with the Factual Accuracy Check submissions, the CQC do not accept that was the document provided in the course of the Inspection.
Legal Framework
"What it [the CQC] cannot do is make adverse findings that something does not exist if the regulated body tells it that it does, and it does nothing to test that assertion. That would be tantamount to finding that the complainant is lying without taking any steps, let alone reasonable steps, to ascertain whether what it has said is true."
The Challenge
"The reasons for a decision must be intelligible and they must be adequate. They must enable the reader to understand why the matter was decided as it was and what conclusions were reached on the "principal important controversial issues", disclosing how any issue of law or fact was resolved. Reasons can be briefly stated, the degree of particularity required depending entirely on the nature of the issues falling for decision. The reasoning must not give rise to a substantial doubt as to whether the decision-maker erred in law, for example by misunderstanding some relevant policy or some other important matter or by failing to reach a rational decision on relevant grounds. But such adverse inference will not readily be drawn. The reasons need refer only to the main issues in the dispute, not to every material consideration. They should enable disappointed developers to assess their prospects of obtaining some alternative development permission, or, as the case may be, their unsuccessful opponents to understand how the policy or approach underlying the grant of permission may impact upon future such applications. Decision letters must be read in a straightforward manner, recognising that they are addressed to parties well aware of the issues involved and the arguments advanced. A reasons challenge will only succeed if the party aggrieved can satisfy the court that he has genuinely been substantially prejudiced by the failure to provide an adequately reasoned decision." (per Lord Brown in South Bucks DC v Porter (No 2) [2004] UKHL 33
Ground One
"Policy
The medicine policy should include a clear explanation of your covert medicines process. The policy should be specific and up to date. Your staff must read, understand and follow the policy"
The CQC contends that the policy is logical and sensible, but the Claimant avers that the CQC has a far stricter policy when it comes to records, requiring that all relevant information be contained in the care plan:
"Records
Include in a medicine care plan
…
- How medicines will be administered covertly."
It is the Claimant's contention that this is a change from the general requirements in the policy and goes beyond the NICE guidelines. The Claimant contends that the CQC is acting irrationally to impose the requirement as effectively a mandatory requirement so that an absence of compliance is considered as threatening the safety of the patient. The Claimant contends that there is no rational or sufficient reason advanced for such a restrictive policy which it says goes beyond the NICE guidance without identifying any inconsistency.
" Covert administration is only likely to be necessary or appropriate where:
- A person actively refuses their medicine and
- That person is assessed not to have the capacity to understand the consequences of the refusal. Such capacity is determined by the Mental Capacity Act 2005 and
- The medicine is deemed essential to the person's health and well-being"
"Care home providers should ensure that medicine administration records (paper-based or electronic) include
- The full name, the date of birth and weight (if under 16 years or where appropriate, for example, frail older residents) of the resident
- Details of any medicines the resident is taking, including the name of the medicine and its strength, form, does, how often it is given and where it is given (route of administration)
- Known allergies and reactions to medicines or their ingredients, and the type of reaction experienced
- When the medicine should be reviewed or monitored (as appropriate)
- Any support the resident may need to carry on taking the medicine (adherence support)
- Any special instructions about how the medicine should be (such as before, after or with food).
Ground Two
"In line with the guidance above, information was missing for GC, MA, MY and VF regarding how each individual medicine should be given. For example, crushed, dissolved in water, what to mix a liquid with. All medicines should be reviewed by a pharmacist and written information must be provided as to how each medicine should be given e.g. crushed and given in a spoonful of yoghurt. Any medicines not given as per the manufacturers licence are being given off licence so the patient information leaflet would not apply. Please see additional professional advance here."
"On the paperwork reviewed for GC it stated risperidone (liquid) should be given with tea or juice. Risperidone must not be given in tea as it denatures the active ingredient. This was discussed with the clinical lead. On the records provided as part of this FAC submission this entry has been overwritten with the word porridge."
"Care home providers should ensure that medicines administration records (paper-based or electronic) include:
- the full name, date of birth and weight (if under 16 years of where appropriate, for example, frail older residents) of the resident
- details of any medicines the resident is taking, including the name of the medicine and its strength, form, dose, how often it is given and where it is given (route of administration)"
and then said "this to us seems to demonstrate that MARS should be clear about how to administer a medicine". The CQC cannot be legitimately criticised for this determination.
(1) the CQC had not been provided with the November 2021 care plan for GC until the second pre-action protocol letter and therefore it is not an error for the CQC to not have taken that care plan into account; the Claimant further contends that the CQC was wrong to criticise the Claimant for a breach of NICE Guideline 1.2.5, the error was only with respect to the particular point (it should have been 1.5.2) not the substance;
(2) the Claimant criticises the CQC for failing to note that MY was no longer on regular covert medication by 13 June 2023, however the notes record that the staff at the care home notified the inspection team that MY was on covert medication and the CQC was entitled to rely upon that information.
Ground Three
Ground Four
Conclusion