We inspected this service using our comprehensive inspection methodology. We carried out an announced inspection on 28 November 2017. We carried out a re-inspection on 19 April 2018 which was unannounced. Optical Express Chelmsford is operated by Optical Express Limited. Optical Express is a nationwide company offering general optometric services. The Chelmsford clinic provides intra-ocular refractive lens surgery for adults aged 18 years and above. Patients are self-referring and self- funded. The clinic is based on the ground floor of a multipurpose building in Chelmsford.

The clinic was registered in July 2014 but ceased operating in December 2015 due to a drop in demand. The clinic re-registered and re-opened in August 2017.

The clinic provides services approximately four days a month but does not have set surgery days. The clinic does not have any resident staff members. The clinic is staffed on surgery days with Optical Express employees from across the organisation and regions.

The clinic has pre-screening amenities, a dirty utility room, consultation rooms, an anaesthetic room, a laser room, operating theatre and a post-operative room. The service shares premises and optical equipment with an Optical Express practice.

During our inspection on 28 November 2017, we visited the theatre, laser room, anaesthetic room, pre and post-operative rooms, dirty utilities and examination rooms. We spoke with seven members of staff, including the ophthalmologist (surgeon), anaesthetist, registered nurses, health care assistant and surgical services manager. We spoke with five patients. During our inspection, we reviewed four sets of patient records and the staff personal files of five of the staff present on the day of our inspection including registered nurses and the surgeon.

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.

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.

On our November 2017 inspection we found the following issues that the service provider needed to improve:

• Patients’ observations, such as oxygen saturations and pulse rate, were not recorded during the surgical procedure.
• Prescription medicines to take home, consisting of eye drops and oral medication, were supplied by a registered nurse without being prescribed by the doctor or anaesthetist.
• Registered nurses were supplying prescription medicines without having assessed competencies to meet this extended role.
• Anaesthetic and medicated eye drops were stored loosely in the anaesthetic fridge without original sterile packaging. This meant that sterility was compromised and efficacy could not be assured, as no expiry data information was evident.
• Patients having received intravenous sedation were required by staff to walk from the theatre corridor to the recovery room. These patients were not offered a wheelchair for the transfer which was not in line with the providers policy.
• The World Health Organisation (WHO) and five steps to safer surgery checklist was not used appropriately. All sections of the form were completed before the surgeon had commenced scrubbing for the procedure.
• Effective infection control practices and processes were not in place, which posed a risk to patients from healthcare associated infection.
• Resuscitation equipment storage was not secure. Equipment and emergency medicine was accessible to staff and patients.
• Processes to ensure equipment was in date and ready for use were not always effective.
• The service was not complying with national guidance.

However, we also found the following areas of good practice:

• The service managed patient safety incidents well. Staff recognised incidents and reported them appropriately.
• Surgical outcomes were audited and benchmarked across the organisation.
• Staff kept appropriate records of patients’ care and treatment. Records were clear, up-to-date and available to all staff providing care.
• Patients could access the service and the booking system was efficient and easy to use.
• Patients we spoke with were positive about the care provided by staff.
• Patients were offered consultations and follow up appointments at other Optical Express Limited clinics to ensure patients were treated at their preferred location.
• The service had a weekly staff recognition scheme.

• On 6 December 2017 we sent the provider a letter setting out the significant concerns that we had identified on the November 2017 inspection. The letter detailed that we would have to take urgent action unless the provider immediately addressed the risks we had identified. In response, On 7 December 2017 the provider decided to voluntarily suspend surgical services at the clinic with immediate effect and submitted an action plan to address the concerns prior to recommencing services at the Chelmsford site.

  This action negated the requirement for CQC to take urgent enforcement action as major safety concerns and risks for patients were addressed by Optical Express suspending services at Chelmsford. Since 7 December 2017, CQC has been closely monitoring actions taken and reviewing progress. On 12 January 2018, we received written confirmation that the service intended to continue the suspension until 5 February 2018 to allow them to ensure all areas of their action plan had been addressed. On 17 January 2018 the service submitted documents that supported their compliance with their action plan. On 5 February the service re-instated surgery services at the Chelmsford location with increased presence from the registered manager.

  We inspected the service on 19 April 2018. We solely inspected the areas of concern which we had identified in our letter to the service on 6 December 2017. These concerns lay in the safe and well led domains of our inspection key lines of enquiry. The inspection looked at whether the patient safety concerns had been addressed and whether the new processes and policies put in place had been embedded.

  On our inspection on 19 April 2018 we found the following improvements at the service:

• New processes had been introduced and embedded in the service to ensure that patient’s observations were monitored during surgery.
• Nurses had completed dispensing competencies to meet the requirements of this extended role.
• Medicines and consumable equipment was found to be in date.
• Patients were assisted to the recovery room post-operatively by using a wheelchair in all cases to prevent the risk of patients falling.
• The adapted World Health Organisation (WHO) and five steps to safer surgery checklist was fully implemented and all staff were engaged in the process.
• Infection prevention and control risks had been addressed.
• Emergency medicine was now securely stored.
• The service had improved staffing levels and was now compliant with national guidance.

• 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. Details are at the end of the report.

  Heidi Smoult

  Deputy Chief Inspector of Hospitals