20 March 2023
During a routine inspection
This service is rated as Requires improvement overall.
The key questions are rated as:
Are services safe? – Requires improvement
Are services effective? – Good
Are services caring? – Good (carried over from previous inspection)
Are services responsive? – Good (carried over from previous inspection)
Are services well-led? – Requires improvement
We previously carried out a comprehensive inspection of The Cooden Medical Group on 5 July 2022. We identified breaches of regulation 12 (Safe care and treatment) and regulation 17 (Good governance) of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 and issued requirement notices. The service was rated as requires improvement for providing safe and well-led services and good for providing effective, caring and responsive services. The service was rated as requires improvement overall.
We carried out this announced comprehensive inspection of The Cooden Medical Group on 20 March 2023 under Section 60 of the Health and Social Care Act 2008. This inspection was planned to check whether the service was meeting the legal requirements and regulations associated with the Health and Social Care Act 2008. At this inspection we checked that the service was providing safe, effective and well-led services. Our ratings of good for caring and responsive services are carried over from the previous inspection.
How we carried out the inspection:
This inspection was carried out in a way which enabled us to spend a minimum amount of time on site.
This included:
- Speaking with staff in person, on the telephone and using video conferencing.
- Requesting documentary evidence from the provider.
- A site visit.
We carried out an announced site visit to the service on 20 March 2023. Prior to our visit we requested documentary evidence electronically from the provider. We spoke to staff on the telephone and using video conferencing prior to and following our site visit.
The Cooden Medical Group is an independent service led by the medical director, a consultant interventional radiologist. The service specialises in the provision of minimally invasive varicose vein treatments, performed under local anaesthetic and ultrasound guidance, including radio-frequency ablation and foam sclerotherapy. The service also provides practising privileges to a range of consultants and a GP with special interests, who work under the governance of The Cooden Medical Group to deliver services in women’s health, dermatology, minor surgical procedures, such as lesion excision and upper blepharoplasty (to remove excess skin or fat from the eyelids), and a sub-contracted NHS commissioned vasectomy service. The provider had recently ceased providing musculoskeletal (MSK) and joint injection services from a London-based satellite clinic. Varicose vein treatments are also provided from a satellite location in Kent, on one half-day session per month.
This service is registered with CQC under the Health and Social Care Act 2008 in respect of some, but not all, of the services it provides. There are some exemptions from regulation by CQC which relate to particular types of regulated activities and services, and these are set out in Schedule 1 and Schedule 2 of The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. The Cooden Medical Group provides a range of non-surgical aesthetic interventions, for example, cosmetic botox injections, dermal fillers and skin rejuvenation treatments, which are not within CQC scope of registration. Therefore, we did not inspect or report on these services.
The Cooden Medical Group is registered with the Care Quality Commission to provide the following regulated activities: Treatment of disease, disorder or injury, Diagnostic and screening procedures and Surgical procedures.
The medical director is the 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.
Our key findings were:
- There were safeguarding systems and processes to keep people safe. However, some staff had not completed training in the safeguarding of children and vulnerable adults at an appropriate level to support their role, in line with current guidance.
- There were processes in place for the training and performance review of staff.
- There were improved processes for ensuring recruitment checks of clinical consultants were undertaken. However, there was a lack of recruitment records for one lead member of staff.
- Arrangements for chaperoning were displayed. However, the offer and attendance of a chaperone was not recorded within the patient’s clinical record.
- There were appropriate arrangements to manage medical emergencies and suitable emergency medicines and equipment in place.
- Medicines requiring refrigeration were stored safely. Policies and processes to support the administration of local anaesthesia, including the management of local anaesthetic toxicity, had been reviewed.
- There were governance and monitoring processes to ensure the safety of premises at the provider’s main location, including improvements to fire safety processes. However, there was a lack of monitoring of the premises and safety arrangements at satellite locations.
- Best practice guidance was followed in providing treatment to patients. For example, varicose vein treatments were offered in line with NICE guidance; excised lesions were routinely sent for histological review.
- There were some processes to assess the risk of, and prevent, detect and control the spread of infection. However, some staff immunisations were not monitored in line with current guidance.
- Policies provided up to date, relevant and sufficient information, to provide effective guidance to staff.
- Planning had been undertaken to develop an enhanced programme of clinical governance processes, including development of a Medical Advisory Committee, but not yet fully implemented.
- There was some monitoring of clinical record keeping however, outcomes had not always been shared with clinicians or acted upon.
- Incident recording forms did not always clearly capture the nature of the incident or learning outcomes.
- Staff dealt with patients with kindness and respect and involved them in decisions about their care.
- Staff worked well together as a team and felt supported to carry out their roles.
- The service encouraged and valued feedback from patients and staff. Feedback from patients was positive.
The areas where the provider must make improvements as they are in breach of regulations are:
- Ensure care and treatment is provided in a safe way to patients.
- Establish effective systems and processes to ensure good governance in accordance with the fundamental standards of care.
(Please see the specific details on action required at the end of this report).
The areas where the provider should make improvements are:
- Review processes to ensure the offer and attendance of a chaperone is recorded within the patient’s clinical record.
- Promote the full completion of incident recording forms and monitor compliance.
- Develop equipment servicing schedules, for treatment couches and ultrasound equipment.
- Continue to monitor hot water temperatures and respond to temperatures which fall outside of the required range, to reduce the risks associated with Legionella bacteria.
Dr Sean O’Kelly BSc MB ChB MSc DCH FRCA
Chief Inspector of Hospitals and Interim Chief Inspector of Primary Medical Services