We carried out an announced follow up inspection on 5 December 2018 to ask the service the following key questions; Are services safe and well-led?

Our findings were:

Are services safe?

We found that this service was providing safe care in accordance with the relevant regulations.

Are services well-led?

We found that this service was providing well-led care in accordance with the relevant regulations.

We carried out this follow up inspection under Section 60 of the Health and Social Care Act 2008 as part of our regulatory functions. 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.

CQC inspected the service on 7 March 2018 and asked the provider to make improvements regarding the management of medicines and governance. We checked these areas as part of this follow up inspection and found they had been resolved.

Well-One Clinic is an Independent Health clinic. The clinic provides general practice, consultation and treatment without accommodation. The provider offers services across a range of areas but in particular in relation to Lyme disease and chronic fatigue.

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 service and these are set out in Schedule 2 of The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. At Well One Clinic a service was provided called RIFE treatment which is short wave therapy delivered by a machine. This was built for the clinic by a PhD scientist following research into the various types of RIFE machines. This service is registered with CQC under the Health and Social Care Act 2008 in respect of the treatment of disease, disorder or injury by, or under the supervision of, a medical practitioner, including the prescribing of medicines. At Well One Clinic the RIFE treatment that is provided is exempt by law from CQC regulation. Therefore, we were not able to inspect the RIFE treatment element of the service.

Dr Beryl Beynon 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:

• Arrangements for the management of medicines kept patients safe.
• Clinical staff maintained the necessary skills and competence to support the needs of patients. Staff were up to date with all required training.
• Systems and processes were in place for managing governance in the service.

There were areas where the provider could make improvements and should:

• Review and improve policies to check they are relevant to the service.
• Review and improve the quality assurance/clinical audit tool so it captures all outcomes for patients.

Professor Steve Field CBE FRCP FFPH FRCGP Chief Inspector of General Practice

We carried out an announced comprehensive inspection on 7 March 2018 to ask the service the following key questions; Are services safe, effective, caring, responsive and well-led?

Our findings were:

Are services safe?

We found that this service was not providing safe care in accordance with the relevant regulations.

Are services effective?

We found that this service was providing effective care in accordance with the relevant regulations.

Are services caring?

We found that this service was providing caring services in accordance with the relevant regulations.

Are services responsive?

We found that this service was providing responsive care in accordance with the relevant regulations.

Are services well-led?

We found that this service was not providing well-led care in accordance with the relevant regulations.

We carried out this inspection under Section 60 of the Health and Social Care Act 2008 as part of our regulatory functions. 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.

Well-One clinic is an Independent Health clinic. The clinic provides general practice, consultation and treatment without accommodation. The provider offers services across a range of areas but in particular in relation to Lyme disease and chronic fatigue.

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 service and these are set out in Schedule 2 of The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. At Well One Clinic a service was provided called RIFE treatment which is short wave therapy delivered by a machine. This was built for the clinic by a PhD scientist following research into the various types of RIFE machines. This service is registered with CQC under the Health and Social Care Act 2008 in respect of the treatment of disease, disorder or injury by, or under the supervision of, a medical practitioner, including the prescribing of medicines. At Well One Clinic the RIFE treatment that is provided is exempt by law from CQC regulation. Therefore we were not able to inspect the RIFE treatment element of the service.

Dr Beryl Beynon 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.

We obtained feedback from patients through 16 completed comment cards and speaking with two patients during the inspection. All the feedback was very positive and patients commented that staff offered excellent care and were supportive and responsive to questions and that they had confidence in the service provided. Patients told us they had no difficulties in arranging a convenient appointment and that staff put them at ease and listened to their concerns.

Our key findings were:

• There was an open and transparent approach to safety and a system in place for reporting and recording incidents. However we found that the systems were not always followed, we saw examples of incidents that had not been reported and investigated.
• Arrangements for the management of medicines at the service did not always keep patients safe. Patients were not informed if a medicine they were prescribed was being used outside of its licence and when patients were prescribed medicines that required monitoring this was not always undertaken.
• Patients reported they were involved in their care and decisions about their treatment.
• Information about services was available and easy to understand.
• All consultation rooms were organised and equipped, with good light and ventilation.
• Clinical staff maintained the necessary skills and competence to support the needs of patients. Staff were not up to date with all required training.
• Staff were aware of current clinical guidelines.
• Staff were kind and caring and put patients at their ease.
• The provider was aware of the requirements of the Duty of Candour.
• Systems and processes were in place for managing governance in the service. However these were not fully implemented and followed.

We identified regulations that were not being met and the provider must:

• Ensure care and treatment is provided in a safe way to patients in respect of the management of medicines

• Establish effective systems and processes to ensure good governance in accordance with the fundamental standards of care

You can see full details of the regulations not being met at the end of this report.

There were areas where the provider could make improvements and should:

• Review arrangements for the provision of medicines and equipment for use in a medical emergency.
• Review the process for confirming parental responsibility when children attend the clinic.
• Review policies to check they are relevant to the service.

When we visited the Well-One clinic patients told us that they were very happy with the treatment and support they had received. One patient told us “The support is invaluable and is as important as the treatment. The staff are respectful and helpful. I can access treatment whenever I need it and it has been adjusted according to my needs. I cannot praise the clinic enough”.

We found that patient files were detailed, up to date and appropriate. The environment was found to be clean and tidy and infection control procedures were being followed.

The staff member employed by the clinic attended training relevant to their role. They were happy with the level of support they received.

There was a feedback process in place to gather information from patients and there was audit and business planning documentation in place. There was a complaint policy in place and this was made known to anyone who accessed the service.

We spoke with one patient of the service and relative of a patient. Both people we spoke with told us they had been asked their consent to treatment. One person told us. “I have been impressed with this service. I have recommended the clinic to other people. They are very honest and thorough.”

We saw that patients' treatment needs were assessed and treatment plans were drawn up with risk assessment in place where needed. We saw evidence that the provider had consulted with other specialists to provide a service which considered patients’ holistic needs. We saw that plans were kept under review to ensure they took account of changing needs.

Patients were protected by the safeguarding policies of the service. Also we saw that all staff had Criminal Records Bureau (CRB) checks in place. (This service is now provided by the Disclosure and Barring Service (DBS) and any updates would be carried out by them.) All staff had completed safeguarding training to ensure patients were protected from harm.

Medicines were safely handled and stored.

We saw recruitment records and staff confirmed they had been recruited according to policy.

We saw that the service had a system in place to regularly monitor and assess the quality of provision. This included patient surveys and internal audits to ensure improvements were identified and carried out.

Although Mrs Colette Beynan is the registered manager she is no longer involved in managing the service.