We spoke with four patients attending appointments at the service on the day of our visit. They told us they were happy with the care and treatment provided. Everyone told us their privacy and dignity had been respected by staff. Patients had received clear information and explanations of care and confirmed that the risks and benefits of different treatments had been explained to them. As one patient said, “they are very clear about risk factors, you know what is suitable for you and what is not.”

Patients told us they considered the service was clean and hygienic. There were effective systems in place to reduce the risk of infection. There had been no post-operative infections in the last year.

Staff received appropriate professional development to enable them to provide safe and effective care and treatment to patients. There was an effective system in place for assessing and monitoring the quality of the service.

We visited this service on 5 February 2013. We looked at the care and treatment records of people who use the service. We also spoke with people who use the service. We spoke with members of staff and looked at staff records held on site.

Patients we spoke with told us that they were very pleased with the service and said that the staff had taken time to "explain everything.” Patient’s told us that they were pleased with the quality of the post operative services available. Patients told us that the staff were very caring and that they felt that they had been made to feel comfortable.

Optegra London is an eye hospital located in North London. It is part of a nationwide company, Optegra UK Limited, which has seven hospitals and three outpatient clinics in the UK. The hospital provides services to adults over 18 only.

The hospital was opened in 2012 within a purpose-built day case facility. The hospital is set over two-floors and has three consulting rooms, a reception area, four diagnostic rooms, two operating theatres, a treatment room and pre and post-operative areas.

Services provided include refractive eye surgery, ocular plastic, retinal diagnostic, general surgical services and ophthalmic disease management. During the 12 months prior to our inspection, the hospital recorded 1,156 surgical procedures. Of these 70% were for cataract surgery, 12% laser, 11% refractive lens exchange and small number (approx. 7%) of other procedures including age related macular degeneration (AMD) injections, vitrectomy and eyelid surgery for non-cosmetic reasons.

During the 12 months prior to our inspection the hospital recorded 2,406 outpatients appointments with the majority of these patients (66%) seen for follow-up after surgery. Others were seen for an initial consultation with the optometrist or for diagnostic tests including glaucoma and cataract screening. Patients receiving AMD injections were also seen in the outpatients department.

We inspected this service using our comprehensive inspection methodology. We have reported our inspection findings against the two core services of Surgery and Outpatients. We carried out the announced part of the inspection on 8 and 9 August 2017, along with unannounced visits to the hospital on 16 and 21 August 2017.

To get to the heart of patients’ experiences of care and treatment, we ask the same five questions of all services: are they safe, effective, caring, responsive to people's needs, and well-led? Where we have a legal duty to do so we rate services’ performance against each key question as outstanding, good, requires improvement or inadequate.

Throughout the inspection, we took account of what people told us and how the provider understood and complied with the Mental Capacity Act 2005.

The main service provided by this hospital was surgery and outpatients. Where our findings on surgery – for example, management arrangements – also apply to other services, we do not repeat the information but cross-refer to the surgery core service.

We rated this service as requires improvement overall because:

• We found that the provider was not effectively managing medicines in order to provide safe care and treatment to patients.

• We found there was no risk assessment, policy or procedure for safe use for use of Mitomycin. Mitomycin is an anti-cancer medication, although ophthalmology is not one of its licensed uses, it is used for clinical procedures including refractive eye surgery and glaucoma. This medication poses a risk to staff and patients, if not handled safely. Staff we spoke with did not demonstrate they were aware of these risks.

• We were not assured systems were in place to protect patients from potential risks after administration of medicines in the hospital. The process for recording medicines to be given to patients preoperatively and on discharge was not clear, presenting a risk that medicines may be given to patients incorrectly. Prescriptions concerning eye drops did not contain information regarding the quantity to be administered; therefore, staff could not make this decision safely.
• The provider did not ensure that staff responsible for the management and administration of medication were suitably trained and competent. Medicines were being administered by staff without any written prescription or patient specific direction. This was a risk to patient safety as patients were receiving medicines from staff who were not competent in their administration.

• Not all staff had completed basic life support training. This meant that patients could be at risk in the event of a medical emergency.
• We were not assured that processes to ensure informed consent was obtained from patients were effective. Most patients were not provided with enough relevant information about their procedure or treatment to allow them to understand the potential risks and complications and to make an informed decision. Patient records did not contain key information detailing what discussions had taken place with patients about the possible outcomes or complications of surgery.
• We were told patients were not given any written information on the procedure they would be having and there were no written records to evidence patients were aware of the likely outcomes of their surgery.
• We found that there was no process in place to review staff competencies or to ensure that they worked within the scope of their qualifications and competence. The hospital director told us that there was no review process in place. There was no formalised competency assessment process to ensure staff had the adequate skills and knowledge to care for patients in the pre-assessment and recovery area of theatres. This meant that patients were at risk of being exposed to individuals who may not be appropriately qualified or otherwise not fit, to carry out their role.
• We were not assured that there were effective processes in place to assess, monitor and mitigate the risks relating to the health, safety and welfare of service users and others. Systems to identify, record and control risks were not well embedded.

• It was not clear how oversight of risks was being maintained. There was limited evidence of discussion on risk taking place at governance meetings. Of the 37 risks recorded on the hospital’s risk register, 34 did not have an assigned ‘risk owner’ and none of the risks had a recorded next review date. We were not assured that risks were always identified and addressed in a timely way.

• We found that the leadership lacked oversight of the quality and safety of the services provided. There was no internal clinical audit of medications undertaken by staff and therefore no assurance provided that medications were being managed safely and appropriately. Staff told us that they had raised concerns regarding local medicines administration practices but that no action had been taken to address their concerns.

• The leadership was not aware of the training requirements within the organisation's safeguarding policy. The safeguarding lead and the hospital director had not completed the required level of safeguarding training.

• We reviewed other policies and found that many, including the organisation's resuscitation policy and infection prevention and control policies, were not up to date with current legislation or guidelines. This demonstrated a lack of a robust system to review policies and processes to ensure they remain fit for purpose.

• There were often delays due to consultants not arriving on time and clinics over-running. Staff recognised that patients at the end of the session lists could be waiting for long periods. However, the hospital did not collect information on waiting times, although there was an informal system to note delays in flow through the clinics. We were told that work was ongoing to consider how improvements could be made.

• There were no care pathways in place for patients with dementia or learning disabilities. Staff had not had any training in caring for patients with a learning disability or dementia awareness and there was no flagging system in place to identify patients with additional support needs.
• There were no patient leaflets available in the outpatient reception area covering a range of common eye conditions and treatment options. There was no information to advise patients where they could obtain information about their eye conditions and no information on whether these could be provided in alternative formats.

However, we also found areas of good practice:

• We found the leadership team were open and honest about where they felt the hospital needed to improve and responded proactively to the concerns we raised.
• We found a cohesive and supportive leadership team, with well-established members of staff. Staff were complimentary about the support they received from their managers and commented that they were visible and approachable.
• Staff were proud of the organisation as a place to work and spoke highly of the supportive culture. Staff we spoke with were happy with their working environment felt they all worked well together as a team.
• The majority of staff knew the process of reporting and investigating incidents. Staff understood and fulfilled their responsibilities to raise concerns and report incidents as well as near misses and were supported to do so.
• Results from the patient feedback survey undertaken by the hospital indicated patients were satisfied with the care they received.
• Patients were positive about their interactions with staff and the care they received within the department. They told us they were treated with dignity and respect.
• There was evidence of learning from the complaints received from patients and families. We saw that complaints were shared with staff at team meetings. Patients reported that they were satisfied with how to make a complaint and how they were dealt with.
• Staff assessed patient’s needs and delivered care in line with current evidence based guidance and national guidance for best practice. The service audited the outcomes of every patient who had surgery at the service. The service measured outcomes service wide as well as for each individual consultant.

• The hospital had an eye sciences department, whose role was to collate data on refractive lens exchange (RLE), cataract surgery and laser surgery. The eye sciences team collected data for all Optegra hospitals each quarter and presented the data across the UK. Data collected would include operative details; pre-operative, post-operative and clinical outcomes.
• The service provided pre-planned services only. Therefore, they were in control of the numbers of patients they could accommodate at any given period. The service proactively forward planned surgical and clinic sessions and used data to identify number of patients and staffing requirements.
• The service provided a 24-hour helpline for advice to patients outside of normal working hours. Consultants were available during normal working hours to review patients if staff felt medical input was required.
• The environment was clean and well presented, procedures were in place to prevent the spread of infection and equipment was well maintained and appropriate for the service.

Following this inspection, we issued the provider with a Warning Notice for breaches of the Health and Social Care Act 2008 Regulations. We told the provider that it must take action to comply with the regulations by 6 October 2017. We also told the provider that it should make other improvements, even though a regulation had not been breached, to help the service improve. Details are at the end of the report. Following the Warning Notice, CQC returned to the provider on 10 October 2017, to review progress and found that improvements had been made.

Amanda Stanford

Deputy Chief Inspector of Hospitals