Optical Express Bristol Clinic provides laser eye surgery for adults who pay privately for their care and treatment. No NHS funded work is completed at this clinic. Optical Express Bristol Clinic (hereafter known as ‘the clinic’) is operated by Optical Express (Gyle) Limited (hereafter known as ‘Optical Express’). The regulated activities at this location are diagnostic and screening procedures; and treatment of disease, disorder or injury; and surgical procedures.

The clinic is situated on the 9th floor of a multi-occupied office building. The clinic area is shared with an Optical Express optical practice. The service was registered in 2003 and was in two other sites prior to the opening of the clinic in December 2015. The service provides refractive eye laser surgery and intraocular lens surgery for day case adult patients. There are no inpatient facilities. No children are treated at the clinic.

Intraocular lens surgery is carried out using sub-tenon anaesthesia. At this clinic, most patients received intravenous sedation. Refractive eye laser surgery is undertaken using topical anaesthesia. The clinic provides refractive laser eye surgery approximately five days a month and intra-ocular lens surgery approximately eight days a month. On the day of surgery, the patients are treated by a regional surgery team who move between all locations within the South West, dependent on demand at the various locations. The registered manager and two other staff members are based at the Bristol clinic. A separate team of optometrists and patient advisors in the general optometric service see surgery patients for pre-surgery consultations, and aftercare appointments as part of the refractive eye surgery and intraocular lens surgery pathways.

Patients could refer themselves to the clinic for initial consultation. 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 the 12 months preceding our inspection, a total of 1187 refractive eye surgery procedures were undertaken and a total of 1313 intraocular lens implant/exchange procedures were undertaken. There were 155 Class 3b laser capsulotomies completed. A Class 3b laser capsulotomy is a non-invasive laser procedure which eliminates the cloudiness that occasionally interferes with a patient's vision after cataract / lens replacement surgery.

We inspected this service using our comprehensive inspection methodology. We carried out the announced part of the inspection on 10 May 2018. There was no unannounced inspection.

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

At the time of our inspection, we had a legal duty to regulate refractive eye surgery services, but we did not have a legal duty to rate these services. 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 report incidents and safeguarding concerns. Incidents were investigated thoroughly.
• Staff we spoke with understood their responsibilities under the duty of candour
• The surgery team took steps to reduce risk to patients during surgery. This included use of the World Health organisation safer surgery checklist and the Royal College of Anaesthetists ‘Stop before you block’ procedures.
• Staff followed protocols for infection prevention and control. We saw that staff washed their hands and cleaned equipment thoroughly. Waste was managed safely.
• Staff followed best practice guidelines when handling medicines including cytotoxic medicines. Medicines were stored securely and medicines stock was managed safely.
• Staff kept comprehensive records about patient care. Records were stored securely.
• There were systems to ensure that lasers were used safely. The environment was designed and maintained for the use of lasers. Staff were trained to operate lasers. Staff were aware of protocols for safe use of lasers and followed these consistently.
• Patients undergoing laser refractive eye surgery had opportunity for appropriate pre-operative assessment and discussion as set out in the General Medical Council Guidance for doctors who offer cosmetic interventions.
• Staff were supported to maintain up to date clinical skills and competencies. Staff participated in appraisals and competency checks.
• Leaders monitored the treatment outcomes of individual surgeons working at the Bristol clinic and these compared favourably to the averages within the company. Changes to treatment decisions were investigated and learning was shared.
• For intraocular lens surgery, pain was monitored by an anaesthetist who administered sedation as required.
• Staff understood and complied with the Mental Capacity Act. Patient consent was checked at every stage of the patient journey.
• Patients were assessed for their suitability for surgery using current treatment criteria. There were adequate systems for follow up of post-surgery patients.
• Staff used evidence based criteria to assess patient suitability for treatment. There was a clear procedure for obtaining patient consent. There were adequate systems for follow up of post-surgery patients.
• All clinical protocols, directives and patient information were reviewed at the annual medical advisory board meeting.
• Surgeons talked to patients throughout their surgery as recommended in the Royal College of Ophthalmology professional standards for refractive surgery.
• Staff built effective relationships with patients. We observed that staff listened to patients and gave patients time to ask questions. Patients told us they felt comfortable and safe with staff.
• Staff gave patients were appropriate information about what they should expect from refractive eye surgery and realistic expectations about outcomes, in line with guidance from the Royal College of Ophthalmologists.
• The service offered flexibility around appointment times and dates and locations. There was no waiting list for surgery. Surgery was rarely cancelled.
• Treatment rooms and waiting areas were comfortable and spacious and fit for purpose.
• Staff considered the individual needs of patients and these were identified on the patient record.
• Interpreter services were available for patients whose first language was not their first language and for patients who used sign language to communicate.
• Staff told us they felt supported, and valued by their peers and their managers. Staff enjoyed their work. Leaders were well respected and there was a clearly defined leadership structure.
• There were several mechanisms for communication between the senior management team and the staff treating patients.
• Leaders monitored quality and safety through internal audit and investigation of incidents. The surgical services manager had recently recruited a member of staff responsible for monitoring safety in theatres.
• Staff had the information they needed to provide care and treatment. Electronic records could be accessed at any Optical Express clinic.
• Staff told us they felt supported and valued in their work. Leaders were approachable and well respected. Staff felt proud of the service they provided.
• There was a strong mechanism for patient engagement through patient experience survey

We found the following issues that the service provider needs to improve:

• Not all staff who assisted the anaesthetists had completed immediate life support training.

• The current practice with regards to marking of the surgical site was not compliant with all relevant guidance including

  Royal College of Ophthalmologists Theatre Procedures Standards, February 2018

  . These guidelines state that marking must be performed by the surgeon or a nominated deputy who will be present during the procedure.

• There was a risk that optometrists were not up to date with safety systems and processes. Optometrists were not required to complete mandatory training in topics such as infection prevention and control, moving and handling, conflict resolution, consent, duty of care, equality and diversity, fire safety, health and safety.
• The safety of the Class 3b laser machine could not be assured. The last service date was February 2016.
• Optical Express did not submit data to the Private Healthcare Information Network (PHIN).
• The consent policy did not reflect Royal College of Ophthalmologists 2017 standards for a seven-day cooling off period between the initial consent meeting with the surgeon and the final consent by the surgeon. In the 12 months preceding our inspection, 25% of surgeon consent appointments were carried out less than seven days prior to the day of treatment. This did not comply with the Royal College of Ophthalmology professional standards for refractive surgery.
• Patient’s privacy was compromised because the clinic did not provide patients with lockable storage to store their personal belongings during surgery.
• We were not assured that the service risk register identified and mitigated risks to the service using effective governance processes. Not all risks were identified in a risk assessment, such as the overdue service of the Class 3b laser equipment.
• Not all processes of governance were transparent. We were told about mechanisms for review and oversight of clinical practice and protocols that were in addition to the international medical advisory board. However, we could not be assured of these processes during the 12 months preceding our inspection because these meetings were not recorded or made available to the Care Quality Commission.

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 two requirement notices that affected the refractive eye service. Details are at the end of the report.

Amanda Stanford

Deputy Chief Inspector of Hospitals (South)