AC-2024-LON-001142 - [2025] EWHC 2015 (Admin)

After IP1’s registration, it fell within the (geographic) responsibility of Amanda Lyndon, CQC’s deputy director of operations within the Midlands. Ms Lyndon had extensive experience carrying out inspections for CQC and had previously been a registered nurse, working within both the NHS and private sector. The CQC tries to inspect new providers within a year of registration, and it was determined that IP1 should be inspected after nine months.

As the relevant deputy director, Ms Lyndon had oversight of the assessment process, but Ms Huntley was the lead assessor, working in a team with CQC’s national professional advisor, medicines manager, senior specialist, the registration manager, and with support from an expert by experience representative from CQC’s LGBT network. The inspection assessment was undertaken using the same five key questions as for the registration assessment.

In the current proceedings, the claimants’ concerns have focused on the issue of patient safety. As such, it is helpful to consider the inspection assessment with reference to the question: is the service safe? This was addressed by reference to the quality statements that are then set out (and further elaborated upon) under each question within the assessment framework, directed to: learning culture; safe systems, pathways and transitions; safeguarding; involving people to manage risks; safe environments; safe and effective staffing; infection prevention and control; and medicines optimisation. Also relevant, under the question: is the service effective?, the quality statements include “delivering evidence-based care and treatment”, which means that “people receive care, treatment and support that is evidence-based and in line with good practice standards”.

Ms Huntley has explained that, in approaching this assessment, she made sure to read the Cass Review final report, and the most up-to-date NHS commissioning policies and service specifications, along with other guidance and information; she also read the information that CQC held about IP1 at that time. In addition to following CQC’s standard procedures (which included reviewing all IP1’s policies and procedures), the assessment team also directly observed patient consultations, which enabled them to:

“... witness how consent was obtained in practice; including seeing and understanding how the risks (including known unknown risks) are explained to service users. It would also allow us to observe if fertility preservation was being discussed in a meaningful manner and allow us to see if the consultation was holistic and person-centred. Many of these were key elements that the Cass Report raised as important, as well as being areas of concern for people who have strong views about this service type.” (Ms Huntley’s witness statement at [15])

Ms Huntley’s statement provides a full account of the investigation assessment and the inquiries undertaken. In summary, Ms Huntley (assisted by others in the assessment team) observed three patient consultations, attended a MDT meeting (which involved an independent child psychiatrist (Dr Adams) who attended when a patient was under 18) during which patients for referral to IP1 were discussed, and spoke with two patients and their families, as well as to Dr Kelly, Mr Carruthers, and to IP1’s administrator. In addition, questionnaires were completed by three health professionals selected at random from Kelly Psychology, and by 15 patients and their families, some of which were followed up with telephone calls to discuss the results (in fact the report records that the team spoke with 21 patients and their families). A random selection of individual patient records was reviewed by both Ms Huntley and the CQC’s medicines manager, who also spoke to the independent pharmacist dispensing IP1 prescriptions, and Ms Huntley spoke directly with a visiting mental health nurse who attended all initial face-to-face appointments to ensure patients had any mental health support they needed, and was able to satisfy herself that there was liaison with patients’ GPs. A further interview with Dr Kelly and Mr Carruthers was separately conducted by Dr Tim Ballard, focusing on the clinical aspects of the service, during which the Cass Review’s findings were discussed, and details provided of IP1’s process of auditing patient outcomes and of sharing of information with GPs, with a view to entering shared care arrangements.

Given the focus on the role of IP1’s MDT, and whether this could rationally be considered to be broadly aligned with the NHS national MDT, it is helpful to set out Ms Huntley’s evidence on this point in more detail.

Ms Huntley has confirmed her familiarity with the 21 March 2024 policy, and the requirement that the suitability of the individual receiving the hormone treatment must be agreed by the national MDT. She has explained how she was able to satisfy herself as to the extensive process of psychological assessment that all patients have to undergo before being referred for consideration by IP1, with no referral being made unless the individual has a confirmed diagnosis of gender dysphoria and the clinician considers this to be the best course of action. Aware that the IP1 MDT was unlikely to be identical to the NHS MDT, Ms Huntley explains how she was assured by the IP1’s requirement that there would then be a MDT for every patient referred (including those over 18), which would include IP1’s nurse consultant, clinicians from Kelly Psychology, and an independent paediatric psychiatrist (for under 18s), and that all decisions must be reached by consensus. Given: the requirement for MDT agreement to the acceptance of any referral; the involvement (in the case of under 18s) of an independent psychiatrist, not concerned with the patient’s care planning; and having regard to the open and detailed discussions she had herself witnessed at the MDT, Ms Huntley’s judgement was that IP1’s practice was sufficiently aligned with the NHS.

Ms Huntley also details how she (and the other members of the assessment team) satisfied themselves that all the other eligibility and readiness criteria in the 21 March 2024 policy were being properly considered, with IP1’s operating procedure expressly stating that the referral criteria would be in line with that policy.

After the assessment was complete, Ms Huntley collated the evidence, analysed it, and produced a draft assessment report which was then considered and approved by senior and other colleagues, and was reviewed by Ms Kirton de Ortega, as head of the CQC’s Cass oversight group. The assessment report was published on 4 December 2024, rating IP1 as “outstanding” overall, as it had achieved “outstanding” ratings for four of the key questions (well-led; responsive; effective; caring); for safe, the service was rated “good” (i.e. performing well and meeting expectations).