We carried out an announced comprehensive inspection at Jenna Clinic on 16 April 2019 as part of our inspection programme and to rate the service.

The clinic provides ultrasound and gynaecology services, assessment for IVF and assessment for plastic surgery. 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 of The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. For example, complementary therapies, including acupressure. These types of arrangements are exempt by law from CQC regulation.

The manager of the clinic 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.

The service proactively gained feedback from patients with regular reports compiled from the surveys. As part of our inspection we reviewed the results of the patient surveys that had been collected over the previous 12 months.

We received eight Care Quality Commission comment cards, and all of these were wholly positive about the care and service and positive outcomes the patients had received.

Our key findings were

:

• We saw there was leadership within the service and the team worked together in a cohesive, supported, and open manner.
• There was an effective system in place for reporting and recording significant events.
• Information about services and how to complain was available and easy to understand.
• The provider was aware of and complied with the requirements of the Duty of Candour.
• All staff had received a Disclosure and Barring Service (DBS) check.
• Risks to patients were assessed and monitored.
• The service held a central register of policies and procedures which were in place to govern activity; staff were able to access these policies easily and all staff had signed each one.
• The service had embedded the system to ensure clinical auditing was completed to achieve quality improvement.
• Staff assessed patients’ needs and delivered care in line with current evidence-based guidance.
• Staff had the skills, knowledge, and experience to deliver effective care and treatment.
• All patients said they were treated with compassion, dignity, and respect and they were involved in their care and decisions about their treatment.
• The service had good facilities and was well equipped to treat patients and meet their needs.
• The service proactively sought feedback from staff and patients, which it acted on. Regular surveys were undertaken, and reports collated from the findings and action taken where required.

Dr Rosie Benneyworth BM BS BMedSci MRCGP

Chief Inspector of Primary Medical Services and Integrated Care

We carried out an announced comprehensive inspection on 11 December 2017 to ask the service the following key questions; Are services safe, effective, caring, responsive and well-led? Due to concerns identified at this inspection, we also carried out an unannounced focussed inspection on 19 December 2017. We found that the clinic was not providing safe, effective or well led services, however they were providing caring and responsive services. Following this inspection, we took urgent action to place conditions on Jenna (UK) Limited to stop them providing regulated activities from the Jenna Clinic based in Peterborough. We also shared our concerns with other regulators.

The conditions placed on Jenna (UK) Limited to stop them providing regulated activities from the Jenna Clinic based in Peterborough ceased to have effect from 21 March 2018. This unannounced focussed inspection took place to ensure that sufficient changes were made in order to meet the relevant regulations.

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 well-led?

We found that this service was 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 Jenna Clinic was meeting the legal requirements and regulations associated with the Health and Social Care Act 2008. At the inspection on 11 December 2017, we found risks relating to good governance and safe care and treatment. Patients were at risk of harm because systems and processes were not in place to keep them safe. The systems and processes in place to ensure good governance were ineffective and did not enable the provider to assess and monitor the quality of the services and identify, assess and mitigate against risks to people using services and others. We served the provider with a letter of intent to take urgent enforcement and giving details of identified risks found during the inspection relating to breaches in regulation. The provider took immediate action and submitted an action plan and agreed to voluntarily suspend providing all services from the Peterborough location.

We carried out an unannounced focussed inspection on 19 December to ensure actions had been taken to address the risks. Following our focussed inspection (19 December 2017) we found additional concerns and risks relating to safe care and treatment and good governance remained. We took urgent action to place conditions on Jenna (UK) Limited to stop them providing regulated activities from the Jenna Clinic based in Peterborough.

The conditions placed on Jenna (UK) Limited to stop them providing regulated activities from the Jenna Clinic based in Peterborough ceased to have effect from 21 March 2018. This unannounced focussed inspection took place to ensure that sufficient changes were made in order to meet the relevant regulations.

The clinic previously provided private GP services to Russian, Lithuanian, Polish and Ukrainian patients. However, follow the period of conditions being placed on the clinic, the provider submitted changes to their registration to stop providing private GP services. They provide ultrasound and gynaecology services, assessment for IVF and assessment for plastic surgery. 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. For example, complementary therapies, including acupressure. These types of arrangements are exempt by law from CQC regulation.

The manager of the clinic 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:

• The scope of the service had been significantly reduced which had allowed for improved management oversight of the service.
• Openness, honesty and transparency were demonstrated when responding to the previous inspection outcome with staff.
• There were positive relationships between staff.
• Structures, processes and systems to support good governance and management were clearly set out, understood and effective.
• Staff had received up-to-date safeguarding and safety training appropriate to their role.
• There were medicines and equipment on site to treat patients in case of an emergency. We found there was a system for the checking of expiry dates of equipment.
• Prescription stationery was stored securely and staff monitored its use.
• Prescribing within the clinic was limited due to the ceasing of GP services. Staff prescribed and gave advice on medicines in line with evidence based guidance.
• Patients’ health was monitored to ensure results of tests were being followed up on appropriately.
• The provider had effective systems in place to maintain a complete safety record, including a legionella risk assessment.
• There was a system for recording, acting on and learning from significant events and incidents. There was a system for receiving and acting on safety alerts.
• Records we viewed showed clinical assessment and treatment was reflective of best practice guidance.
• There was a clear plan in place for quality monitoring and improvement going forward. There was evidence of non-clinical audits.
• We saw that where patients had abnormal test results, there was a system in place to ensure this was followed up by the patient or the regular GP.
• The clinic could evidence working with local midwives as they received referrals for fertility testing.
• Consent forms were available in different languages such as Russian and Lithuanian.
• There was evidence of meetings and these were embedded in to practice every three months.
• There was a focus on continuous learning and improvement within the clinic. For example, receptionists had been trained to carry out phlebotomy.

The area where the provider should make improvements:

• Embed the system to ensure clinical auditing is completed to monitor quality and make improvement.

The Jenna Clinic provided registered services aimed at people who were of Russian, Polish and Lithuanian backgrounds from staff who spoke these languages.The clinic provided advice and support mostly in relation to the health needs of women and children although other health tests were available. We spoke with two people who had used the service and were happy with their experience. While no medicines were stored or supplied from the clinic, patients were supplied with appropriate prescriptions.

The owners of the clinic employed three doctors and a receptionist. When we checked current staff files we found that relevant employment checks had been completed. We found that staff had received training and were knowledgeable about safeguarding procedures and could demonstrate that they knew the appropriate action to take if a concern arose.

There were contracts in place to monitor and maintain items of equipment so that they were safe for use.

No complaints had been received by the service since registration although some letters of thanks had been received from patients who had used the service.

We carried out an announced comprehensive inspection on 11 December 2017 to ask the service the following key questions; Are services safe, effective, caring, responsive and well-led? Due to concerns identified at this inspection, we also carried out an unannounced focussed inspection on 19 December 2017. Following this inspection, we took urgent action to place conditions on Jenna (UK) Limited to stop them providing regulated activities from the Jenna Clinic based in Peterborough. We also shared our concerns with other regulators.

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 not 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 Jenna Clinic was meeting the legal requirements and regulations associated with the Health and Social Care Act 2008. At the inspection on 11 December 2017, we found risks relating to good governance and safe care and treatment. Patients were at risk of harm because systems and processes were not in place to keep them safe. The systems and processes in place to ensure good governance were ineffective and did not enable the provider to assess and monitor the quality of the services and identify, assess and mitigate against risks to people using services and others. We served the provider with a letter of intent to take urgent enforcement and giving details of identified high risks found during the inspection relating to breaches in regulation. The provider took immediate action and submitted an action plan and agreed to voluntary suspend providing all services.

We carried out an unannounced focussed inspection on 19 December to ensure actions had been taken to address the risks. Following our focussed inspection (19 December 2017) we found additional concerns and risks relating to safe care and treatment and good governance remained. We took urgent action to place conditions on Jenna (UK) Limited to stop them providing regulated activities from the Jenna Clinic based in Peterborough.

The clinic provides private GP services to Russian, Lithuanian, Polish and Ukrainian patients. They also provide ultrasound, assessment of children, assessment for IVF and assessment for plastic surgery. 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. For example, complementary therapies, including acupressure. These types of arrangements are exempt by law from CQC regulation.

The manager of the clinic 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.

All of the 19 patient Care Quality Commission comment cards we received were positive about the service experienced. Comments related to the caring nature of the staff and that they would recommend the clinic. Patients spoken with on the day aligned with this view.

Our key findings were:

• Some staff had not received up-to-date safeguarding training relevant to their role. Staff who acted as chaperones had not received appropriate training for the role.
• We found one member of clinical staff did not have an appropriate DBS check, and one member of staff did not have appropriate medical indemnity. This member of staff had arranged appropriate indemnity by our second visit on 19 December 2017.
• Patients were at risk of harm because some clinical staff prescribed medicines to patients and gave advice on medicines which was not always in line with current national guidance or evidence based guidance.
• Patients’ health was not monitored to ensure medicines were being used safely or followed up on appropriately.
• There was no effective tool in place to assess for cardiac risks ensuring patients received appropriate care.
• There was no evidence of quality improvement including audits relating to prescribing. The clinical management team had no oversight of clinical decision making or prescribing and could not effectively monitor outcomes for patients.
• We saw that where patients had abnormal test results, there was no system or process in place to ensure this was followed up by the patient or their regular GP.
• Care records we saw showed that information needed to deliver safe care and treatment was not always available to relevant staff in an accessible way.
• The clinic did not have systems for sharing information with staff and other agencies to enable them to deliver safe care and treatment.
• There were no emergency medicines kept on site in the case of a patient becoming acutely unwell. We found out of date items in a clinical room, including catheters. These were removed and emergency equipment and medicines had been ordered, but had not been received, when we returned on 19 December 2017. Since our second inspection, we have been informed these medicines and equipment have been delivered.
• There were cleaning schedules in place for some, but not all areas of the clinic. This had improved on 19 December 2017.
• There was no legionella risk assessment or on-going monitoring in place at the time of inspection.
• There was no system for recording or acting on significant events. The clinic planned to implement a new system to address this; however there was a lack of understanding of significant events.
• There was a system for receiving safety alerts; however this was ineffective as not all alerts had been recorded and there was no record of any actions taken. There was no system in place to enable staff to search patient records to identify anyone affected by an alert.
• Consent forms were available in different languages.
• All of the 19 patient Care Quality Commission comment cards we received were positive about the service experienced. Patients spoken with on the day aligned with this view.
• The complaint policy and procedures were in line with recognised guidance.

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

• 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.

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:

• Consider the need to have chaperones trained to carry out this role.