We carried out an announced comprehensive inspection on 14 November 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 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 and to follow up on the warning notice issued during the March 2018 comprehensive inspection.

CQC inspected the service on 7 and 22 March 2018 and asked the provider to make improvements regarding the way safe care and treatment was provided to patients.

We checked these areas as part of this comprehensive inspection and found this had been resolved.

Previously the provider had not:

• Ensured that prescription only medicines and Enzyme Potentiated Desensitisation (EPD) were legally authorised by an appropriate practitioner.
• Monitored the temperatures of the fridges to ensure they were working correctly.
• Comprehensively risk assessed the laboratory area.
• Completed the actions required from the fire risk assessment from February 2017.
• Calibrated equipment.
• Reviewed a policy detailing the environment that allergy vaccines should be stored in (including room and fridge temperature control) and the shelf life of allergy vaccines made.

At this inspection we found:

• The doctors were prescribing medicines and Enzyme Potentiated Desensitisation (EPD) as legally required.
• Fridge temperatures were being monitored to ensure they were working correctly.
• There was a comprehensively risk assessed for the laboratory area which included infection control.
• The actions required from the fire risk assessment from February 2017 had been completed with the exception of one action. The provider had organised a further fire risk assessment for further guidance.
• All equipment had been calibrated.
• There was a policy detailing the environment that allergy vaccines should be stored in and the shelf life of allergy vaccines made.

The Burghwood Clinic is situated in a converted building which has been refurbished specifically in an environmentally friendly fashion. There are two consulting rooms, two clinical rooms for skin testing and intravenous infusions and a client waiting area. The premises also includes an administration office, a manager’s office and a laboratory. There is disabled access and parking is also available.

The service investigates and aims to identify dietary, environmental or nutritional factors related to health problems. It also offers advice and treatment, including dietary modification and desensitisation. The service also manufactures, supplies and administers vaccines and intravenous infusions to patients.

At the time of our inspection this service was 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 general 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. Services are provided to patients regardless of where they live. Patients who are seen in the clinic, but do not reside in England are out of CQC scope of registration.

At the time of the inspection The Burghwood Clinic did not have a 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:

• Staff had the relevant skills, knowledge and experience to deliver the care and treatment offered by the clinic.
• All vaccines were being manufactured by the doctor as required by The Medicines and Healthcare products Regulatory Agency (MHRA).
• The clinic had good facilities, and was well equipped, to treat patients and meet their needs.
• Assessments of a client’s treatment plan were thorough with a full health history assessment taking place before treatment options were discussed.
• Patients received full and detailed explanations of any treatment options.
• The service encouraged and valued feedback from patients and staff.
• The service had systems in place to identify, investigate and learn from incidents relating to the safety of patients and staff members.
• There were processes in place to safeguard patients from abuse.
• There was an infection prevention and control policy; and procedures were in place to reduce the risk and spread of infection.

• However, staff mandatory training and administration staff appraisals were overdue
• Some risk assessment had been completed but documents reviewed did not always show evidence of this.
• Some risk assessment and the review of some policies were overdue.

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

• Ensure persons employed in the provision of the regulated activity receive the appropriate support, training, professional development, supervision and appraisal necessary to enable them to carry out the duties.
• 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 and implement any findings from the Legionella risk assessment.

Professor Steve Field CBE FRCP FFPH FRCGPChief Inspector of General Practice

We carried out an announced comprehensive inspection on 7 and 22 March 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.

The Burghwood Clinic is an independent health clinic which specialises in the investigation and treatment of food and environmental intolerances and problems associated with the immune system. The clinic provides guidance and a range of treatments and tests to help identify the cause of food and environmental intolerances.

The service is provided by two doctors, two nurses, two laboratory technicians, reception and administration staff and a practice manager.

The practice manager is also 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 received feedback from five clients about the clinic. All replies were very positive. Comments included excellent personal care. Clients felt staff were friendly, knowledgeable and professional.

Our key findings were:

• Staff had the relevant skills, knowledge and experience to deliver the care and treatment offered by the clinic.
• The service was offered on a private, fee paying basis but had a small number of referrals from GP practices.
• The clinic had good facilities, and was well equipped, to treat clients and meet their needs.
• Assessments of a client’s treatment plan were thorough with a full health history assessment taking place before treatment options were discussed.
• Clients received full and detailed explanations of any treatment options.
• The service encouraged and valued feedback from clients and staff.
• Feedback from clients was positive.
• The service had systems in place to identify, investigate and learn from incidents relating to the safety of clients and staff members.
• There were processes in place to safeguard clients from abuse.
• There was an infection prevention and control policy; and procedures were in place to reduce the risk and spread of infection.
• However, the risk assessment including the infection control risk, was not comprehensive for the laboratory area.
• The clinic had not fully completed the actions required from the fire risk assessment from February 2017.
• The clinic had not calibrated the equipment used to ensure it was working correctly.
• There was no policy on the stability of allergy vaccines made and the correct environment that these should be stored in.
• Vaccines, which were prescription only medicines, were not being prescribed as required by an appropriate practitioner such as a doctor or a nurse independent prescriber.
• Fridge temperatures were not always being monitored to ensure they were working correctly.

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

• Ensure care and treatment is provided in a safe way to patients

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 the risk assessment for the products used for cleaning as required by Control of Substances Hazardous to Health Regulations 2002.
• Review and implement any findings from the booked Legionella risk assessment and review the frequency of further assessments required.
• Review the frequency of health assessments being reviewed and recorded within clients notes and the frequency of individual client consent forms being completed.