Save Minds Operational Base

Updated 2 September 2022

This service is provided by Save Minds Limited.

Save Minds Limited is registered and the following address. This is the location where our inspection was carried out:

Aura Centre

Charlbert Street

London

NW8 7BT

The service website: https://saveminds.co.uk

Save Minds Limited is registered to provide the following regulated activities:

• Treatment of disease, disorder or injury
• Diagnostic and screening procedures

Save Minds Operational Base provides assessment and treatment to adults who have treatment resistant depression, anxiety and post-traumatic stress disorder. The treatment involves using a controlled drug called Ketamine that is passed into a person’s blood stream via an intravenous infusion. This is known as Ketamine infusion therapy. The treatment is delivered to a patient in a clinical setting and the patient is closely monitored throughout treatment and for a period of time after treatment before being discharged.

An experienced consultant anaesthetist ran the service and delivered the Ketamine infusion therapy. The doctor was supported by external psychiatrists who assessed patients’ mental health and their suitability for treatment. Patients were required to complete several assessments prior to treatment including a mental and physical health assessment. Since the service opened in 2020 the service had treated 112 patients.

The evidence base for this type of treatment mainly originates from clinical studies carried out in the United States of America. However, UK based researchers along with an NHS trust in Oxford offer the same treatment as part of a clinical research programme. The consultant anaesthetist had links with the clinicians who ran the research programme.

The service registered with the CQC in November 2020 and has not been inspected before. The service employed a consultant anaesthetist and a chief operating office. The consultant for this service was a sole practitioner. This meant they did not have a team of colleagues who were employed by the service to provide support and oversight of their work. However, the service did have a medical advisory board in place that provided external scrutiny and the lead consultant attended annual appraisals that included a review of their clinical practice.

Save Minds Operational Base opened when an assessment or treatment was booked in. The clinic was based within a dental practice and had access to their clinic rooms between 8am and 7.30pm Monday to Friday and 9am to 3pm on a Saturday. The service was closed on a Sunday.

How we inspected this service

During the inspection visit to the service, the inspection team:

• spoke with four patients who had used the service
• reviewed 10 feedback forms
• spoke with the registered manager and chief operating officer
• reviewed six treatment records
• checked how medicines were managed
• reviewed two employment records for the employed members of staff and four board members
• reviewed information and documents relating to the operation and management of the service

To get to the heart of patients’ experiences of care and treatment, we always ask the following five questions:

• Is it safe?
• Is it effective?
• Is it caring?
• Is it responsive to people’s needs?
• Is it well-led?

These questions therefore formed the framework for the areas we looked at during the inspection.

Updated 2 September 2022

This service is rated as Good overall.

The key questions are rated as:

Are services safe? – Good

Are services effective? – Good

Are services caring? – Good

Are services responsive? – Good

Are services well-led? – Good

We carried out a short notice announced comprehensive inspection at the registered location of Save Minds Operational Base on 14 July 2022 as part of our inspection programme.

Save Minds Operational Base provides a consultant led outpatient service that assesses and treats patients who are treatment resistant to depression, anxiety and post-traumatic stress disorder. The treatment involves an intravenous infusion using a controlled drug called Ketamine. Patients that approached the service required this type of treatment as other treatments had not been successful in the past.

The consultant anaesthetist was a sole practitioner who led the service but also performed additional roles including chief executive officer and registered manager. A registered manager is a person who is registered with the Care Quality Commission to manage the service. Like registered providers, they are ‘registered persons’. Registered persons have legal responsibility for meeting the requirements in the Health and Social Care Act 2008 and associated Regulations about how the service is run. The report will refer to this individual as the ‘consultant anaesthetist’.

We reviewed a sample of the feedback forms that the provider had collated since opening the service. Comments were positive and described the service as being excellent. All patients said that they would recommend the clinic. Patients we spoke with were complimentary about the service. They described the consultant anaesthetist as being supportive and made them feel at ease. Patients told us that the treatment had vastly improved their quality of their life.

Our key findings were:

• The service provided safe care and treatment. The provider ensured that patients had access to comprehensive assessments for both their mental and physical health prior to treatment.
• Staff understood their responsibilities to manage a medical emergency. The consultant anaesthetist had been appropriately trained in life support through their role in the NHS and had access to emergency equipment on-site.
• The service safely managed medicines. The consultant anaesthetist prescribed and administered medicines to patients in line with legal requirements and current national guidance.
• Staff supported patients to make informed decisions about treatment. The service ensured that patients were given information that included how the treatment works, the rates of success and the costs involved. Patients we spoke with told us that they were given enough time to ask questions before they committed to starting treatment.
• The service used technology to improve treatment and to support patient experience. The provider used a mood monitoring application to track patients’ mood during and after treatment. This enabled the service to assess the effect of treatment on patients.
• There was a focus on continuous learning and improvement. The provider had plans in place to use treatment data collected to write a research paper that would be published in a peer review academic journal.
• Access into the service was easy. The provider’s website clearly set out how patients could contact the service. The service responded promptly to enquiries and ensured patients were seen in a timely manner.
• The provider had effective governance systems in place that monitored the quality and safety of the service. The consultant anaesthetist recognised the importance of external review and scrutiny and had set up a medical advisory board that met on a quarterly basis. Board members were clinicians.

However:

• Record keeping was not always consistent. Correspondence containing information sent from the service to a patient or other healthcare professionals was not always recorded within the patient’s individual electronic record. This meant that the patient records may not always include the most up to date information, which could lead to the patient not receiving safe care and treatment.
• The provider had not completed a Disclosure and Barring Service (DBS) check for a new member of staff prior to employment commencing. One member of staff had not been DBS checked before they had started their role in 2021. The provider could not be assured that the staff member was suitable to the role without knowing if they had a criminal background. At the time of inspection, the provider told the CQC the DBS check had been applied for.
• The provider did not have an exemption certificate in place for the denaturing process that is required before a controlled drug is disposed of. The denaturing process changes the formula of the drug and ensures that it cannot be retrieved or recovered in the waste chain. Whilst there are no risks to patients and their wellbeing, this is a legal requirement under the Misuse of Drugs Regulations 2001. At the time of inspection, the provider confirmed that they would apply for the exemption certificate immediately.
• The service did not have a robust system in place for checking a patient’s identity before commencing treatment. Although the consultant anaesthetist required patients to confirm their name, date of birth and address prior to treatment, patients were not required to show photographic ID. This increased the risk of the service treating a person who is not suitable for treatment. At the time of inspection, we raised this concern to the consultant anaesthetist. The consultant anaesthetist confirmed that the service would introduce photographic ID checks immediately.

The areas where the provider should make improvements are:

• The provider should ensure that correspondence sent from the service to individual patients and to other healthcare professionals is clearly recorded within the electronic record system.
• The provider should ensure that a Disclosure and Barring Service (DBS) check is completed prior to any member of staff commencing employment.
• The provider should ensure that the service applies for an exemption certificate that covers the denaturing process for controlled drugs before they are disposed of.
• The provider should ensure that there is a robust system in place for verifying a patient’s identity when they attend the clinic and before commencing treatment.

Jemima Burnage

Interim Deputy Chief Inspector of Hospitals (mental health)