A. Is the clinical workforce sufficient in number, training and productivity to deliver a safe and effective service?

A1. “Each Provider will have: A nominated Senior Clinical Lead, who has the key leadership role for the service overall. The Senior Clinical Lead must demonstrate evidence of appropriate experience and expertise in specialised gender dysphoria practice; significant management experience; and significant evidence of continued professional development.”

Senior Clinical Lead’s job plan, identifying roles and PAs allocated to Clinical Lead role; 

Evidence of continued professional development. 

Discussion with Senior Clinical Lead. 

Evidence of processes in place to map future workforce against population need. 

A2. “A specialist multi-disciplinary team of professionals, with a mix of skills, experience and expertise that is appropriate to ensure the delivery of effective and high-quality services in accordance with the requirements of this service specification.” The MDT must include clinicians with expertise/good professional knowledge in the competencies set out in paragraph 2.4 of the service specification.

WTE clinical staff in the service

Vacant posts in service

Use of locum and agency staff

List of staff including their professional qualifications and who are the Named Professionals and Lead Clinicians; 

Named clinicians with expertise in the competencies set out in paragraph 2.4 of the service specification and description of experience and qualifications.

Interviews with other clinical staff.

Evidence of MDT meetings. 

A3. The service is taking effective steps to reduce staff vacancies, where they exist.

Documented recruitment strategy (may be part of wider document e.g. workforce strategy) 

A4. The service is undertaking effective staff retention initiatives and succession planning.

Documented workforce strategy, including approach to retention and succession planning. 

Anonymised records of staff exit interviews or themes identified from staff exit interviews. 

Staff interviews (former and current) 

A5. All clinical staff receive adequate clinical supervision.

Documented approach to clinical supervision; 

Example of anonymised clinical supervision documentation  

Staff interviews (former and current) 

A6. All clinical staff have job plans identifying roles and contact type.

Current job plans for each clinician, which should show a mix of contact type (e.g. first assessment, second surgical recommendation) depending on discipline and seniority 

Clinical contacts per week in March 2024, for each clinician, broken down by contact type; 

Scheduled time for each contact type. 

Evidence of productivity measures and/or approaches that are in place

B. Does the host organisation have sufficient oversight within a robust clinical governance framework?

B1. “A robust system of clinical governance that ensures, inter alia, all clinical staff are trained in meeting the health needs of trans people and deemed competent to deliver the interventions as per their role” and “have cultural sensitivity”.

Clinical governance organogram; 

Evidence of documented peer-reviewed training approach and framework for training new staff, including sign-off by senior clinician; 

Proportion of eligible clinicians who have registered for the RCP Credential; 

Attendance of clinical members at governance meetings including Morbidity & Mortality and safeguarding. 

Evidence of broader clinical governance framework e.g. policies; adverse incident reporting (and review); complaints reporting (and review); risk register; approach to recording, mitigating and reviewing risks; approach to appraisals; MaST completeness; audit programme and evidence of audits; approach to service review; data collection; and quality improvement.

Interviews with clinical staff to determine whether they feel comfortable and competent regarding clinical practice in the service. How to raise an issue, and how feedback is shared from governance meetings with the teams. 

B2. “A robust system of corporate governance, including a nominated senior manager, that demonstrates effective management, guidance, oversight and accountability by the host organisation (Board level or equivalent)”.

Corporate governance organogram; 

Sample Minutes from Board-level meetings with items referring to the service; 

Corporate risk register including risks within the service; 

Service/Directorate risk register 

Review and discussion of risk register with senior clinical lead and manager.

Separate discussion with Trust CEO, exec lead for the service, Board Chair and non-executive directors, to discuss Board-level engagement and oversight. 

C. Is the service taking effective steps to improve waiting times and waiting experience?

C1. Demand and capacity modelling has been undertaken and used to inform service development.

Demand and capacity modelling and evidence of how it has been used to inform service improvement; 

How are patient cohort numbers reviewed and monitored 

C2. Patients are supported while on the waiting list with harm reviews taking place when required.

Evidence of initiatives to support patients while they are on the waiting list; 

Harm review if any have been undertaken. 

Patient feedback. 

C3. The service has a recovery/action plan describing steps being taken to improve waiting times, with timescales and regular updates on progress.

Recovery/action plan describing steps being taken to improve waiting times, with timescales. Evidence as to how the plan is being implemented, and progress and risks are being monitored, e.g. sitreps, monthly update reports.

Sharing of historic waiting lists to demonstrate effectiveness of previous initiatives to reduce waiting times.

C4. Patients are discharged in a timely way once their pathway is complete.

Evidence of discharge information and signposting. 

Patient feedback.

Case notes 

D. Is the process of clinical diagnostic assessment robust and meaningful?

D1.  The clinical approach to assessment and treatment is holistic and individualised, takes account of complexity, alternative diagnoses and the risk of diagnostic overshadowing, makes no presumptions about whether or not individuals referred to the service experience gender dysphoria as part of their incongruence, and makes no presumptions about a patient’s treatment goals or about patients based on gender stereotypes or on their gender identity (for example if they are nonbinary).

Detailed assessment framework; 

MDT meeting terms of reference; 

MDT attendance records. 

Staff interviews describing clinical approach to diagnostic assessment; 

Case notes

D2. “Information from the referrer and the initial consultation, together with any investigation results, will be reviewed and further explored with the individual. Diagnostic coding will be discussed and agreed with the individual. The individual’s treatment goals will be discussed and agreed. A general assessment of capacity to consent to treatment will be made.”

Detailed assessment framework covering the elements described in the specification. 

Case notes

D3. “The majority of individuals will have two core assessment consultations”. “A minority of individuals have complex or additional needs such that more than two core assessment consultations may be appropriate.”

Detail of any audits completed showing numbers of patients who require more than two core assessment consultations. 

Case notes

D4. The service uses a robust, documented approach for identifying and assessing cases where individuals may have complex or additional needs.

Documented protocol for identifying and assessing complex cases 

Staff interviews describing clinical approach to complex cases 

D5. Initial assessment consultation will be “conducted by a regulated health professional”. The diagnostic assessment consultation will be “conducted by a medical practitioner or clinical or counselling psychologist”.

Standard operating procedure 

Case notes 

D6. Intimate physical examination is “not a routine part of the assessment process”.

Standard operating procedure including informed consent to intimate physical examination. 

Staff interviews describing process regarding intimate physical examination 

Case notes

D7. If the diagnosis is that the individual does not have gender incongruence/dysphoria the Provider will “advise the individual and referrer on alternative services that might meet the individual’s health and well-being needs”.

Example anonymised referral letter 

Standard operating procedure 

Case notes

E. Is there robust and safe clinical decision-making throughout the service’s pathway?

E1. A decision to initiate or recommend a medical intervention is made within a clinically appropriate framework. All patients recommended for a medical intervention will have a formal diagnosis of gender incongruence/dysphoria. “A written treatment plan, with indicative timelines, will be discussed and agreed with the individual”.

Documented framework/standard operating procedure 

Case notes 

E2. Endocrine interventions may be recommended “where they are essential for the purpose of harm reduction and where they are in the individual’s best interests for reducing gender dysphoria”. There must be evidence of “persistent, well documented gender dysphoria”.

Treatment guidelines, including contraindications to endocrine treatment and process followed in cases where contraindications are present 

E3. The process of obtaining informed consent must “enable the individual to make informed decisions about the treatment options, benefits, material risks, and the alternatives to the treatments proposed (including the option of having no treatment). Individuals must be given sufficient time to reflect on the clinical advice and the potential treatment options before deciding what is best for them.”

Standard operating procedure; 

Treatment pathway documentation 

The clinical pathway is for patients; 

Case notes

E4. Where loss of fertility is likely, patients must be given information on the options for conservation of reproductive potential.

Patient information leaflets 

Case notes

E5. Individuals are supported to minimise health risk factors before a recommendation for hormone therapies is made, e.g. smoking cessation and BMI, including an individualised discussion of risk, possible adverse effects and possible impacts on final treatment outcome.

Patient information leaflets; 

Referral pathways to support reduction of health risk, e.g. smoking cessation, weight loss

Case notes

E6. For patients who are placed on a medical pathway, there is appropriate ongoing support.

Protocol for ongoing support during medical pathway 

Case notes 

Current planned and actual caseloads of each clinician; 

Job plans 

Staff interviews for opinions on whether caseloads are safe and appropriate 

E8. Waiting times between appointments for patients on the open caseload are clinically safe and appropriate.

Median waiting time between first and second assessment; 

Median waiting time between follow-up appointments; 

Median waiting time between first and second surgical recommendation appointments; 

Standard Operating Procedures providing guidance to clinicians and administrative staff about the appropriate timing of appointments, including risk assessments and approach to complexity; 

Support and contact advice available for patients between appointments 

Staff interviews for opinions on whether waiting times between appointments are safe and appropriate; 

Case notes

E9. Patients “will be allocated a ‘Named Professional’ for the duration of the episode of care. This will be a regulated health professional who will act as the individual’s primary ‘point of contact’ with the service”. “The frequency of contact should be determined according to individual need, though usually the minimum frequency of contact will be every six months.”

Process for allocation of named worker; 

Process of informing patient who named contact is and how to contact; 

Patient information leaflet 

Feedback from patients; 

Case notes

E10. “A registered medical practitioner or clinical or counselling psychologist will be appointed as ‘Lead Clinician’ for individuals who progress to a planned intervention on the NHS care pathway.”

Process for assigning Lead Clinician

Number of patients on caseload for each Lead Clinician 

Case notes

E11. There is robust clinical governance supporting decisions for appointments to be remote or face-to-face.

Documented protocol for decision-making around remote or face-to-face appointments 

Case notes

E12. “The Provider will make available specific psychological interventions that are adapted to the needs of the individual based on psychological assessment and collaborative formulation.”

Documentation of psychological interventions available. 

Case notes

F. Is the process of clinical assessment for referral for suitability for surgery robust and thorough?

F1. The clinical approach to assessment of suitability for surgery is holistic and individualised, takes account of complexity, and makes no presumptions about the best treatment pathway for any individual, keeping open the possibility that there may be no benefit to medical intervention for that individual.

Detailed framework for assessment of suitability for surgery.

Documentation on training for referrers, including the identification and assessment of stability of mental health disorders and consideration of differential diagnoses.

Evidence of discussions with patients around potential restrictions to surgery (e.g. BMI), or where desired procedures are not covered by the surgical service specification.

Evidence that the service collects and reviews patient’s hormone levels prior to referral for surgery.

Staff interviews describing clinical approach to assessment for surgery; 

Case notes 

F2. “Before a referral for surgery is made, the Lead Clinician will meet with the individual to review current treatment interventions, and to assess the individual’s needs and readiness for the surgical intervention.” Where loss of fertility is likely, patients must be given information of the options for conservation of reproductive potential.

Patient information leaflets 

Case notes 

F3. “A referral for genital surgery requires two letters of referral: one from a Lead Clinician, the other from a similarly qualified and experienced professional not directly involved in the individual’s care and able to form an independent opinion; at least one letter of referral must be from a Registered Medical Practitioner with expertise in gender dysphoria.”  “A referral for mastectomy and reconstruction of the chest requires one letter of referral from a Lead Clinician.”

Standard operating procedure

Case notes 

F4. The letters of referral for genital surgery confirm evidence of 12 continuous months of hormone therapy and evidence of 12 continuous months of living in a gender role that is congruent with their gender identity; this must not entail a requirement for the individual to conform to externally imposed or arbitrary preconceptions about gender identity and presentation.

Standard operating procedure 

Case notes 

G. Are patients discharged in a timely way, with support offered to their GP?

G1. Individuals will be discharged from the care of the Provider “when the individual and Lead Clinician agree that treatment for gender dysphoria is complete, and not less than six months after completion of the last planned intervention”.

Discharge protocol 

Case notes 

G2. “At discharge the Lead Clinician will provide advice to the individual’s GP on long-term health maintenance and screening.”

Anonymised example letters to GPs from different lead clinicians at the service 

Audit of time taken to inform GP and for relevant clinical information to be sent to GPs.

Evidence that information re: long-term health maintenance and screening is shared with patients.

Inquire about discharge process when meet members of team; 

Case notes 

G3. The service shares learning around detransition / retransition / regret.

Any existing process for collecting and sharing data and learning internally and with other services around detransition / retransition / regret; 

Any data collected on incidence of detransition / retransition / regret 

Process for sharing learning around this data, internally and with other services 

H. Does the service collaborate with Primary Care and other stakeholders in a timely and effective way?

H1. The service supports patients whose GPs decline to prescribe recommended endocrine treatment to ensure the problem is resolved.

Standard operating procedure 

Staff interviews; 

Case notes

H2. The service provides patient’s GPs with clear guidance on prescribing and monitoring through shared care agreements (as per Appendix K in service specification)

Anonymised example letters to GPs from different lead clinicians at the service 

Case notes

H3. The service provides clear routes for GPs and other external stakeholders to contact the service and responds in a timely way.

Evidence of where contact route is publicised, e.g. letter proformas, website. 

Any evaluation undertaken of stakeholders’ ease of contacting the service  

I. Does the service have effective management that uses data and patient and staff feedback to improve the service?

I1. The service enacts learning as appropriate from patient deaths and other adverse incidents.

Description of all Serious Incidents/ Patient Safety Incident Response Framework (PSIRFs) Apr 2022 – Mar 2024, including all deaths by suicide of patients on the waiting list or under the service’s care; 

Trust’s Learning from Deaths policy and service’s compliance with policy; 

Regulation 28 reports Apr 2022 – Mar 2024; 

Sample of papers from Morbidity and Mortality meetings; 

Papers/Minutes demonstrating that learning from the above is being implemented as part of a clear strategy to identify and implement lessons learned; 

Governance structure identifying escalation of Serious Incidents and Mortality and Morbidity discussions. 

I2. Patients have opportunities to provide feedback, which is used to improve patient experience.

Evidence of accessible, transparent and inclusive mechanisms offered to allow patients to provide feedback; 

Evidence of service user engagement activities within the last 12 months that informed service improvements; 

Evidence of change in practice following patient feedback. 

Patient feedback

I3. Staff have opportunities to provide feedback on the service, which is used to improve clinical practice and patient experience.

Evidence of mechanisms offered to allow staff to provide feedback, including any concerns around clinical practice; 

Access to Freedom to Speak Up (FTSU) guardians; 

Any FTSU concerns relating to the service. 

Staff interviews 

I4. Arrangements are in place to ensure that all complaints and concerns raised by service users are acknowledged, investigated and responded to promptly.

Evidence of complaints process being clearly publicised to patients; 

Number of complaints received between 1 Jan 2023 and 31 Dec 2023; 

The number of the above that received a written response; 

Median time between receipt and written response; 

Themes in the complaints identified by the service; 

Actions taken in response to complaints 

Patient feedback

I5. The service has “systems that demonstrate how Providers use audit, data management and analysis, service reviews (including peer reviews) and other intelligence to evaluate effectiveness and drive ongoing service improvement”; and “collaborate in sharing best practice” and benchmarking.

Evidence that IT systems used by service are capable of extracting data for audits; 

Named lead in service for clinical audit and evidence of protected time for this role; 

Minutes of meetings between April 2022 and March 2024 where outcomes of audits were presented; 

Evidence of how Providers have used audit, data management and analysis and service reviews to drive service improvement between April 2022 and March 2024; 

Active participation in sharing best practice between April 2022 and March 2024; 

Collection of patient compliments and how feed back to staff. 

Meet audit lead and discuss progress and challenges 

I6. The service collaborates in the “development of research and innovation”, including participation in “national and international research projects to increase the evidence base”. The service “ensures close links with other expert centres at national and international levels”.

Documented approach for continuous professional development; 

Evidence of active participation (at service level) in approved research projects between April 2022 and March 2024, e.g. research meeting minutes; 

List of relevant peer reviewed papers with staff named as authors published between April 2022 and March 2024; 

Named collaborative projects with named partners between April 2022 and March 2024 and learning adopted/shared. 

J. Does the service have adequate administrative support and processes?

K. Does the service manage transfers from other services?

J1. The service has a robust and fair process for accepting and rejecting referrals, including self-referrals. “Providers will not be unnecessarily prescriptive about the information to be included with the referrals (including insistence on use of template forms)”.

Information required from referrer

Number of referrals rejected/accepted January – March 2024 and the reason for each 

Process for managing referrals, including criteria for accepting and rejecting. 

J2. “The Provider will acknowledge the referral in writing with the referrer and individual within 14 days.”

Any audit data relating to acknowledgement

Case notes

J3. The service has “sufficient” administrative “support for efficient and timely delivery of services”.

WTE administrative staff in establishment;

Identify vacant posts in establishment, non substantive posts and use of locum/agency. 

Check when speaking to staff at visit. 

J4. Time taken to respond to referrals and letters following appointments is appropriate.

Any audit carried out to review waiting times and letters following appointment 

Case notes

K1. The service facilitates safe, well-planned and timely transfers from children and young people’s gender services.

Compliance with national protocol for transfer of patients from children and young people’s gender services; 

Evidence of joint working with children and young people’s services; 

Key worker allocation during the transfer between services. 

Transfer from children and young people’s service and the approach taken by the service to be discussed at the visit; 

Evidence of literature provided to young person and parent/carers relating to the transfer to the adult service; 

Case notes

K2. Transfers to and from other adult gender dysphoria services are managed in accordance with requirements in the service specification. “Individuals will be offered a single ‘induction’ consultation by the receiving provider during which the diagnostic assessment and treatment plan will be reviewed and, unless there are compelling clinical reasons (these must be carefully explained to the individual), the receiving provider will continue the previously agreed care plan.” “Individuals accepted for transfer of care will not be re-assessed unless there are compelling clinical reasons.”

Accordance with requirements in the service specification.

A discussion of what works well and challenges would take place at the visit; 

Case notes