On the day of our inspection we met four people who were planning to undergo treatment at the clinic. We also called four people about the treatment they had at the clinic and the aftercare they received.

Every person we spoke with had positive experiences of the treatment and the way they were supported to make a decision about whether to have it, or not. Examples of comments people told us included, “it has been really informative. They explained both options, they gave me all the details I needed”, “I have found them brilliant”, and “the optometrist is really friendly and easy to talk to, they have really put me at my ease".

People were properly supported and given the necessary information so that they were able to make an informed decision about having treatment at the clinic.

People received support and treatment from staff who were suitably qualified to provide them with an effective service.

The quality of the treatment and overall experience people who used the service was checked and monitored. When improvements were identified action was taken to ensure that were put in place.

One person who had used the service told us "I knew about the treatment but they asked whether I needed time to make a decision. They took my wellbeing into consideration and went through everything." Another person said "I thought they were excellent. I was really impressed with what they said about risks."

We were shown a consent form, which required the person receiving treatment to sign each section, to signify that they had been informed of that particular issue or risk, and that they agreed to proceed. "They went through absolutely everything." one person who had used the service told us. "There was no pressure and I felt really comfortable with my treatment."

We were shown the corporate policy related to 'Vulnerable Adult Protection' and we spoke with staff about their understanding of the expectations for safeguarding people. Although there had been no allegations of abuse it was clear, from the responses, that staff knew what to do, if this was to occur.

People who had used the service told us that they were confident that there were enough qualified, skilled and experienced staff. One person told us "Their mannerisms and calmness were enough."

We were shown a corporate review of information from surveys of people who had used the service. This identified information regarding the Bristol clinic. Overall 80% had stated that they would 'recommend the service.' The provider had systems in place to make service changes based on feedback and investigations.

We visited the Optimax Laser Eye Clinic - Bristol on 10 February 2012. We met and talked with three people who were visiting the service either for a procedure or a post-procedure follow-up appointment.

People told us that they felt that the service had given them realistic expectations about the outcome of the corrective surgery. People said that they were given clear information about the risks and rewards of the surgery. We were told that the costs of the procedure were made clear to people. No one that we talked with said that they felt pressurised to agree to the procedure and were given time to make the decision.

One person that we talked with said that the staff appeared "rushed" and the waiting area was not as calm as was expected. This person had met with the surgeon and had to have their scans repeated as staff had not been able to provide the surgeon with the original scans. The scans were repeated, however, without delay or inconvenience.

The three patients that we talked with said that they had been asked to and had provided their written consent. They said that they had been told that they were able to withdraw their consent at any time. Each person had completed a health questionnaire and felt that the questions asked were not inappropriate and gave the staff the right degree of important information.

We looked at five sets of patient notes on our visit. We checked the service for inspection prevention and control procedures. We asked the clinic manager to tell us how the organisation assessed and monitored the quality and safety of the service. We talked with staff about training and support to carry out their roles.

Optimax Laser Eye Clinics – Bristol provides laser eye surgery for adults who pay privately for their care and treatment. No NHS funded work is completed at this clinic. Optimax Laser Eye Clinic Bristol (hereafter known as ‘the clinic’) is operated by Optimax Clinics Limited (hereafter known as ‘Optimax’). The service provides refractive eye surgery for day case adult patients. There are no inpatient facilities. All surgery is carried out using topical anaesthesia. Refractive eye surgery is undertaken on two days per month.

All patient activity is part of a surgery pathway, several elements of which occur prior to the day of surgery. This includes initial measurements and topography scans with the patient advisor, optometrist assessment, patient advisor consultation to explain fees and terms/conditions, and surgeon assessment. On the day of surgery the patients are seen by the surgeon for a pre-surgery review and by the optometrist for a post-operative check. The patient advisor explains to patients about their take home medication and repeats their topography and biometry tests. One to four days after the surgery, patients are seen by the optometrist or the surgeon for a review, and then the optometrist reviews the patient at intervals of one to three months until the episode of care was completed, approximately six months post-surgery.

Patients self-refer for treatment. Patients are accepted for surgery if they meet admissions criteria and if the optometrist and surgeon agree that surgery is a viable treatment option. During April 2016 to March 2017, there were a total of 508 surgical operations, and 1459 aftercare appointments.

We inspected this service using our comprehensive inspection methodology. We carried out the announced part of the inspection on 30 November and 01 December 2017. There was no unannounced visit.

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 patient's needs, and well-led? Throughout the inspection, we took account of what patients told us and how the provider understood and complied with the Mental Capacity Act 2005.

We regulate refractive eye surgery services, but we do not currently have a legal duty to rate them. We highlight good practice and issues that service providers need to improve and take regulatory action as necessary.

We found the following areas of good practice:

• Staff knew how to raise concerns and report incidents. Incidents were investigated and action was taken to mitigate risks identified through incident reporting. Staff understood the key concepts of duty of candour.
• Staff were up to date with most mandatory training. Relevant staff required to complete laser core of knowledge training had done this within the 12 months preceding our inspection.
• Staff followed protocols to prevent and protect patients from health-care associated infections. There had been no infections reported during the 12 months preceding our inspection.
• Protocols for safe use of lasers were consistently followed by staff
• Records were complete and contemporaneous and stored securely.
• Staff followed safe systems for the management of medicines including the use of cytotoxic medicines.
• Patients underwent thorough assessment prior to the surgeon’s decision to treat. Patients were carefully monitored post-surgery and had access to expert advice outside of working hours.
• Clinicians planned and delivered evidence based care. The medical advisory board set standards and protocols in line with national guidance.
• Patients received thorough pre-operative assessment and care. Post-surgery complications were monitored closely and investigated.
• Staff followed evidence based protocols for treatment. Treatment outcomes were carefully monitored via a patient satisfaction survey and a yearly audit of individual surgeon outcomes.
• Staff had adequate awareness of laser protection protocols. Staff employed at the clinic were supported to meet their competencies and received a yearly appraisal.
• The processes for seeking patient consent were followed in line with best practice and legislation.
• Patients told us they felt comfortable with staff. Feedback from patients was positive about the way staff cared for them.
• Patients were encouraged to ask questions. Staff took time to explain the expected outcomes and limitations of surgery in a way that patients understood.
• There was a culture of honesty regarding costs of treatment.
• There was flexibility within the company to offer patients a choice of location and dates and times of appointments. Waiting times, delays and cancellations were minimal.
• The registered manager understood the challenges to good quality care at this location. The leaders of the service discussed quality at local and corporate level.
• Staff felt able to raise concerns and these concerns were taken seriously.
• Audits were regularly undertaken and action plans were completed. Identified risks were investigated and mitigated.
• The registered manager was visible and approachable for staff and for patients. Staff told us they enjoyed their work and felt valued in their role.

We found the following areas that the provider needed to improve:

• There was a risk of cross infection because some equipment and facilities were not designed to minimise the risk of infection.
• Staff compliance for training in safeguarding adults level two was low at 50%
• The clinic did not contribute data to the Private Healthcare Information Network (PHIN).
• The premises and facilities did not always meet the needs of the service being delivered. Patients were required to ascend and descend stairs immediately post-surgery. The waiting area did not protect the privacy and confidentiality of patients.
• Patients who required sign language or foreign language interpreters were required to pay for this themselves.
• There was no documented strategy for the Bristol location.
• There had been no staff survey in the 12 months preceding our inspection. Team meetings were recorded but did not show a clear and complete record of discussions, outstanding actions from previous meetings were not reviewed.

Following this inspection, we told the provider that it must take some actions to comply with the regulations and that it should make other improvements, even though a regulation had not been breached, to help the service improve. We also issued the provider with one requirement notice that affected Optimax Laser Eye Clinic –Bristol. Details are at the end of the report.

Amanda Stanford

Deputy Inspector of Hospitals