optical express, bristol clinic newapproachcomprehensive ... ·...

This report describes our judgement of the quality of care at this location. It is based on a combination of what wefound when we inspected and a review of all information available to CQC including information given to us frompatients, the public and other organisations

Mental Health Act responsibilities and Mental Capacity Act and Deprivation of LibertySafeguardsWe include our assessment of the provider’s compliance with the Mental Capacity Act and, where relevant, MentalHealth Act in our overall inspection of the service.

We do not give a rating for Mental Capacity Act or Mental Health Act, however we do use our findings to determine theoverall rating for the service.

Further information about findings in relation to the Mental Capacity Act and Mental Health Act can be found later inthis report.

OpticOpticalal ExprExpress,ess, BristBristolol ClinicClinicQuality Report

CastlemeadLower Castle StBristolBS1 3AGTel: 0800 023 2020

Date of inspection visit: 10 May 2018Date of publication: 13/09/2018

1 Optical Express, Bristol Clinic Quality Report 13/09/2018

Letter from the Chief Inspector of Hospitals

Optical Express Bristol Clinic provides laser eye surgery for adults who pay privately for their care and treatment. No NHSfunded work is completed at this clinic. Optical Express Bristol Clinic (hereafter known as ‘the clinic’) is operated byOptical Express (Gyle) Limited (hereafter known as ‘Optical Express’). The regulated activities at this location arediagnostic 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 Expressoptical practice. The service was registered in 2003 and was in two other sites prior to the opening of the clinic inDecember 2015. The service provides refractive eye laser surgery and intraocular lens surgery for day case adultpatients. 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 intravenoussedation. Refractive eye laser surgery is undertaken using topical anaesthesia. The clinic provides refractive laser eyesurgery approximately five days a month and intra-ocular lens surgery approximately eight days a month. On the day ofsurgery, 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 theBristol clinic. A separate team of optometrists and patient advisors in the general optometric service see surgerypatients for pre-surgery consultations, and aftercare appointments as part of the refractive eye surgery and intraocularlens surgery pathways.

Patients could refer themselves to the clinic for initial consultation. Patients are accepted for surgery if they meetadmissions 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 atotal of 1313 intraocular lens implant/exchange procedures were undertaken. There were 155 Class 3b lasercapsulotomies completed. A Class 3b laser capsulotomy is a non-invasive laser procedure which eliminates thecloudiness 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 theinspection 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 theysafe, effective, caring, responsive to people's needs, and well-led? Throughout the inspection, we took account of whatpeople 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 legalduty to rate these services. We highlight good practice and issues that service providers need to improve and takeregulatory 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.

Summary of findings


• There were systems to ensure that lasers were used safely. The environment was designed and maintained for theuse of lasers. Staff were trained to operate lasers. Staff were aware of protocols for safe use of lasers and followedthese consistently.

• Patients undergoing laser refractive eye surgery had opportunity for appropriate pre-operative assessment anddiscussion 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 andcompetency checks.

• Leaders monitored the treatment outcomes of individual surgeons working at the Bristol clinic and these comparedfavourably to the averages within the company. Changes to treatment decisions were investigated and learning wasshared.

• 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 statethat marking must be performed by the surgeon or a nominated deputy who will be present during the procedure.

Summary of findings


• There was a risk that optometrists were not up to date with safety systems and processes. Optometrists were notrequired 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 monthspreceding our inspection, 25% of surgeon consent appointments were carried out less than seven days prior to theday of treatment. This did not comply with the Royal College of Ophthalmology professional standards for refractivesurgery.

• Patient’s privacy was compromised because the clinic did not provide patients with lockable storage to store theirpersonal belongings during surgery.

• We were not assured that the service risk register identified and mitigated risks to the service using effectivegovernance processes. Not all risks were identified in a risk assessment, such as the overdue service of the Class3b laser equipment.

• Not all processes of governance were transparent. We were told about mechanisms for review and oversight ofclinical practice and protocols that were in addition to the international medical advisory board. However, we couldnot be assured of these processes during the 12 months preceding our inspection because these meetings were notrecorded 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 itshould make other improvements, even though a regulation had not been breached, to help the service improve. Wealso issued the provider with two requirement notices that affected the refractive eye service. Details are at the end ofthe report.

Amanda StanfordDeputy Chief Inspector of Hospitals (South)

Summary of findings


Our judgements about each of the main services

Service Rating Summary of each main service

Refractive eyesurgery

We regulate this service but we do not currently have alegal duty to rate it. We highlight good practice andissues that service providers need to improve and takeregulatory action as necessary.

Summary of findings


Contents

PageSummary of this inspectionBackground to Optical Express, Bristol Clinic 8

Our inspection team 8

Information about Optical Express, Bristol Clinic 8

The five questions we ask about services and what we found 9

Detailed findings from this inspectionOutstanding practice 30

Areas for improvement 30

Action we have told the provider to take 31

Summary of findings


Optical Express Bristol

Services we looked atRefractive eye surgery;

OpticalExpressBristol


Background to Optical Express, Bristol Clinic

Optical Express Bristol is operated by Optical Express(Gyle) Limited. The clinic primarily served thecommunities of the South West. It also accepted patientreferrals from outside this area.

The service provided refractive eye surgery for adultpatients who paid privately for their care and treatment.No NHS funded work was completed at the clinic. Nochildren were treated at the clinic and staff advisedpatients not to bring children to the clinic. There were noovernight facilities.

At the time of our inspection, intraocular lens surgery wascarried out using sub-tenon anaesthesia and in mostcases, intravenous sedation. Refractive laser eye surgerywas undertaken using topical anaesthesia. All patientactivity was carried out at the clinic premises.

At the time of our inspection, the surgery manager wasgoing through the process of becoming the registeredmanager and was supported in this role by the surgicalservices manager. The service had not been inspectedpreviously.

Our inspection team

The team that inspected the service comprised a CQClead inspector and a specialist advisor. The inspectionteam was overseen by an inspection manager and theHead of Hospital Inspection.

Information about Optical Express, Bristol Clinic

Optical Express –Bristol is situated on the ninth floor of amulti-occupied building in the city centre of Bristol. Theclinic is part of a nationwide chain Optical Express (Gyle)Limited that specialises in private refractive laser eyesurgery and lens replacement surgery. The clinic wascommissioned in 2015.

There were 2500 surgical procedures carried out duringthe 12 months preceding our inspection. No patientsstayed overnight at the facility.

During the inspection, we visited the clinic and spokewith 12 staff and four patients. During our inspection, wereviewed five sets of patient records.

There were no special reviews or investigations of theservice ongoing by the CQC at any time during the 12months before this inspection. The service had notpreviously been inspected.

In the 12 months preceding our inspection, there hadbeen no never events or serious incidents reported. Never

events are serious, largely preventable patient safetyincidents, which should not occur if the availablepreventative measures have been put into place byhealthcare providers.

There were three permanent members of staff, includingthe registered manager, employed in the surgery team atthe Optical Express Bristol clinic. All other staff includingthe surgeon, registered nurses, operating departmentpractitioners, optometrists and patient advisors were partof a regional team. The accountable officer for controlleddrugs (CDs) was the surgical services manager.

Services provided at the clinic under service levelagreement:

Clinical and non-clinical waste removal

Decontamination

Laser protection service

Summaryofthisinspection

Summary of this inspection


The five questions we ask about services and what we found

We always ask the following five questions of services.

Are services safe?We do not currently have a legal duty to rate termination ofpregnancy, cosmetic surgery service, refractive eye surgery, dialysis,and hyperbaric oxygen therapy services where these services areprovided as an independent healthcare single speciality service.

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 theduty of candour

• The surgery team took steps to reduce risk to patients duringsurgery. This included use of the World Health Organisationsafer 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 equipmentthoroughly. Waste was managed safely.

• Staff kept comprehensive records about patient care. Recordswere stored securely.

• There were systems to ensure that lasers were used safely. Theenvironment was designed and maintained for the use oflasers. Staff were trained to operate lasers. Staff were aware ofprotocols for safe use of lasers and followed these consistently.

• Staff followed best practice guidelines when handlingmedicines including cytotoxic medicines. Medicines werestored securely and medicines stock was managed safely.

• Patients were assessed for their suitability for surgery usingcurrent treatment criteria. There were adequate systems forfollow up of post-surgery patients.

However, we found the following issues that the service providerneeds to improve:

• The safety of the Class 3b laser could not be assured becausethe routine service was 15 months overdue.

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

• The current practice with regards to marking of the surgical sitewas not compliant with all relevant guidance including RoyalCollege of Ophthalmologists Theatre Procedures Standards2018. These guidelines state that marking must be performedby the surgeon or a nominated deputy who will be presentduring the procedure.




• There was a risk that optometrists were not up to date withsafety systems and processes. Optometrists were not requiredto complete mandatory training in topics such as infectionprevention and control, moving and handling, conflictresolution, consent, duty of care, equality and diversity, firesafety, health and safety.

Are services effective?We found the following areas of good practice:

• Optical Express had a medical advisory board. Membersreviewed treatment protocols to ensure these were based oncurrent evidence.

• Patients undergoing laser refractive eye surgery hadopportunity for appropriate pre-operative assessment anddiscussion as set out in the General Medical Council Guidancefor doctors who offer cosmetic interventions.

• Staff were supported to maintain up to date clinical skills andcompetencies. Staff participated in appraisals and competencychecks.

• Leaders monitored the treatment outcomes of individualsurgeons working at the Bristol clinic and these comparedfavourably to the averages within the company. Changes totreatment decisions were investigated and learning was shared.

• For intraocular lens surgery, pain was monitored by ananaesthetist who administered sedation as required

• Staff understood and complied with the Mental Capacity Act(2005). Patient consent was checked at every stage of thepatient journey.

However, we also found the following issues that the serviceprovider needs to improve:

• The consent policy did not reflect Royal College ofOphthalmologists 2017standards for a 7-day cooling off periodbetween the initial consent meeting with the surgeon and thefinal consent by the surgeon. Surgeons at the Bristol cliniccompleted 25% of consent appointments less than seven daysprior to the day of treatment.

• Optical Express did not contribute to the Private HealthcareInformation Network (PHIN)

Are services caring?We found the following areas of good practice:

• Surgeons talked to patients throughout their surgery asrecommended in the Royal College of Ophthalmologyprofessional standards for refractive surgery.




• Staff built effective relationships with patients. We observedthat staff listened to patients and gave patients time to askquestions. Patients told us they felt comfortable and safe withstaff.

• Staff gave patients information about what they should expectfrom refractive eye surgery and realistic expectations aboutoutcomes, in line with guidance from the Royal College ofOphthalmologists.

Are services responsive?We found the following areas of good practice:

• The service offered flexibility around appointment times anddates and locations. There was no waiting list for surgery.Surgery was rarely cancelled.

• Treatment rooms and waiting areas were comfortable andspacious and fit for purpose.

• Staff considered the individual needs of patients and thesewere identified on the patient record.

• Interpreter services were available for patients whose firstlanguage was not their first language and for patients who usedsign language to communicate.

• Complaints were investigated promptly.


• Patient’s privacy was compromised because the clinic did notprovide patients with lockable storage to store their personalbelongings during surgery.

Are services well-led?We found the following areas of good practice:

• 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 safety through a programme of internal

audit.• Staff had the information they needed to provide care and

treatment. Electronic records could be accessed at any OpticalExpress clinic.

• Staff told us they felt supported and valued in their work.Leaders were approachable and well respected. Staff felt proudof the service they provided.

• There was a strong mechanism for patient engagementthrough patient experience survey





• We were not assured that the service risk register identified andmitigated risks to the service using effective governanceprocesses. Not all risks were identified in a risk assessment,such as the overdue service of the Class 3b laser equipment.

• The processes of governance were not transparent. We weretold about mechanisms for review and oversight of clinicalpractice and protocols. However, we could not be assured ofthese processes during the 12 months preceding our inspectionbecause some of these meetings were not recorded or madeavailable to the Care Quality Commission.




Detailed findings from this inspection


Safe

EffectiveCaringResponsiveWell-led

Are refractive eye surgery services safe?

Mandatory training

• In the 12 months before our inspection, all permanentstaff employed in the regional surgery team hadcompleted mandatory training in systems and practicesdesigned to keep patients safe. Staff working in theregional surgery team were required to complete anonline training package that covered a range of topicsincluding level two children’s safeguarding and level twoadults safeguarding, conflict resolution, consent, duty ofcare, equality and diversity, fire safety, health and safety,information governance, infection prevention andcontrol, moving and handling. Both surgeons hadcompleted level three safeguarding children training asan optional extra. Bank staff were required to completethe same mandatory training package. Five of the sixbank staff had completed their mandatory training inthe 12 months preceding our inspection.

• There was a risk that staff were not competent to deliveradequate life-saving care for patients in emergencysituations. One of the three staff who assisted theanaesthetists had not completed immediate lifesupport training.The surgical services managerexplained there had been difficulties sourcing thistraining for staff, and going forward they planned for amember of staff to be trained as a trainer. However, aqualified anaesthetist was always available duringsurgery when sedation was used.

• All other surgery team members were required tocomplete basic life support training. All five members ofstaff were compliant with this training.

• Mandatory training requirements for optometrists weredifferent to the surgery team. Optometrists wererequired to complete an annual refresher training forclinical competencies, plus training in the following keytopics: safeguarding vulnerable adults level two,

safeguarding children level two, informationgovernance. All optometrists working on the surgerypathway at the Bristol Clinic were compliant with thesemandatory training requirements.

• However, optometrists were not required to completetraining in conflict resolution, consent, duty of care,equality and diversity, fire safety, health and safety,infection prevention and control, moving and handling.Optometrists’ knowledge of safe systems wasdependent upon reading Optical Express clinicaldirectives such as the professional standards directiveand following guidance issued by the College ofOptometrists such as for infection prevention andcontrol.

Safeguarding

• There were systems and processes to keep patients safeimmediately following their operation. The surgeon wasresponsible for post-operative care. The optometryteam completed follow up care and could accessmedical input as required.

• There were systems to protect vulnerable adults. Therewas a safeguarding policy and this policy conformed tointercollegiate guidance. All staff in the regional surgeryteam were trained in safeguarding vulnerable adult’slevel one and level two, plus safeguarding children levelone and level two. The surgeons were trained insafeguarding children level three although this was nota mandatory requirement.

• All staff we spoke with understood their responsibility torecognise and report safeguarding concerns and knewwhere to go for further advice if a safeguarding concernarose. The registered manager was the safeguardinglead. There had been no safeguarding incidentsreported during the twelve months preceding ourinspection.

• The leaders of the service promoted safety in theirrecruitment practices and ongoing checks. Staff

Refractiveeyesurgery

Refractive eye surgery


suitability for working in the clinic was established atrecruitment and monitored thereafter. We checked avariety of staff files and saw that all relevant documentswere available such as evidence of identification,professional registration and qualifications. We saw thatall staff disclosure and barring checks had beencompleted within the three years preceding ourinspection in accordance with the company policy.

Cleanliness, infection control and hygiene

• Effective systems were in place to prevent and protectpatients from a healthcare-associated infection. Therehad been no reports of healthcare acquired infectiondetected post-surgery during the twelve monthspreceding our inspection.

• There were systems to ensure that the environment andequipment used for patient care were clean. Stafffollowed cleaning schedules and used checklists toevidence that treatment areas were thoroughly cleanedat the end of each day of surgery and then deep cleanedonce per month. Treatment areas were visibly clean anduncluttered. We observed that staff followed infectioncontrol protocols regarding the cleaning of diagnosticequipment between patient uses.

• We saw that staff followed protocols for infectionprevention and control. Protocols reflected the relevantelements of the National Institute for Health and CareExcellence (NICE) guidance regarding surgical siteinfection. Staff wore disposable clothing includinggloves, masks, hats and aprons.

• Staff used effective hand hygiene techniques. Staffwashed their hands thoroughly in accordance with NICEquality standard QS61 Infection Prevention and Control.Hand hygiene audits in the surgery team werecompleted regularly and these showed that effectivehand hygiene measures were used by staff. All staff wereinvolved in the audit process by auditing each otherduring unannounced 20-minute observations of clinicalpractice. Results were consistently very positive.

• Waste was managed according to best practice,segregated and stored in containers in a locked roomwhilst awaiting collection. There was a current servicelevel agreement with a private contractor for thecollection of clinical waste. For intraocular lens surgery,decontamination of surgical instruments was carriedout in accordance with Health Technical Memorandum

(HTM) 01-01 ‘Management and decontamination ofsurgical instruments (medical devices) used in acutecare’. All surgical instruments used for laser refractivesurgery were disposable.

• The laser treatment room complied with Royal Collegeof Ophthalmology Ophthalmic Services Guidance(2013). Laser refractive surgery was performed in anoperating theatre with an airflow system that minimisedthe spread of airborne infection. Intraocular refractivesurgery was performed within a standard ophthalmicoperating theatre. Humidity conditions in the operatingtheatre were maintained consistently within the rangefor safe operation of equipment specified by themanufacturers of the lasers being used. Staff recorded alog of humidity conditions and this was checked as partof the clinic audit. The air handling system wasvalidated in February 2018. Microbiology and air particletesting occurred in November 2017 with satisfactoryresults.

• Clinical staff we spoke with understood the importanceof identifying sepsis and taking prompt action whenrequired. Sepsis is a life-threatening illness caused bythe body’s response to an infection. Optical express hada sepsis awareness protocol for staff in line with NICEguideline NG51 Sepsis Recognition Diagnosis and EarlyManagement. This protocol included identification ofrisk factors and symptoms and referred staff to use theNICE algorithm if a situation arose where they suspecteda patient had sepsis.

Environment and equipment

• There were systems to ensure that equipment used inintra-ocular lens surgery and refractive laser eye surgerywas safe to operate on the day of surgery. Before surgerystarted, the laser technician set up and calibrated theequipment according to the manufacturer’s instructionsand then repeated this process regularly throughout theday of surgery. This process produced data which waschecked by the laser technician against expected rangesto monitor for any discrepancies. The laser technicianemailed the manufacturers engineer at the end of everytreatment day with this data.

• Resuscitation equipment was available and readilyaccessible. Staff checked this equipment prior to everysurgical list for safety and completeness.

• Surgical equipment used for refractive eye laser surgeryand intraocular lens surgery procedures had beenserviced within the twelve months preceding our




inspection. However, the safety of the Class 3b lasermachine could not be assured because the last servicedate was February 2016. This non-invasive lasermachine was used to remedy symptoms of visioncloudiness experienced by some patients afterintraocular lens surgery.

• There were recording systems that allowed details ofspecific implants and equipment to be provided rapidlyto the Medicines and Healthcare Products RegulatoryAgency when needed. Theatre staff attached thepackaging with unique identification label to thepatient’s paper record.

• There was an up to date laser safety policy available forstaff which followed Health and Safety Executiveguidance on Control of Artificial Optical Radiation 2010.The laser protection advisor carried out a site visit andrisk assessment every three years or when newequipment was installed or if a safety incident occurred.The most recent risk assessment was in June 2016 andno further actions were identified to mitigate the risks ofthe laser equipment. The laser protection advisor wasresponsible for revalidating the protocols that stafffollowed in the laser treatment environment (localrules). At the time of our inspection all staff knew whereto find the local rules and had signed to say they hadread the latest version.

• There were systems to ensure that laser safety protocolswere followed during surgical procedures. Theregistered manager was the laser protection supervisorwith overall responsibility for the safety and security ofthe lasers. The laser equipment was operated only byauthorised users as identified in the local rules.

• The treatment area was set up to mitigate the safetyrisks associated with laser treatment and complied withguidance issued by the Medicines and HealthcareProducts Regulatory Agency. The laser controlled areawas clearly defined. Illuminated warning notices wereclearly visible. There was a key pad securing entrance tothe operating theatre. Laser safety of the clinicenvironment was assessed as part of the regular clinicaudit completed monthly.

• There were no facilities for overnight stay and norecovery facilities with level two capacity for patientswho were slow to recover from the effects of sedation orwho experienced medical problems during sedation, asrecommended by the Royal College of Anaesthetists2015. However, in the event of a patient experiencing anadverse reaction to an anaesthetic, the team could

undertake detailed patient observation. Theanaesthetist could provide one to one care, includingfull monitoring, advanced airway resuscitation andimmediate access to appropriate medicines. During the12 months preceding our inspection, there had been noincidents of patients requiring these facilities at thislocation.

Assessing and responding to patient risk

• The team thoroughly assessed the level of risk for eachpatient to ensure their suitability for treatment. Prior tothe day of surgery, patients completed a health andlifestyle questionnaire and optometrists conducted athorough examination of the patient’s visual andlifestyle needs. The optometrist and patient discussedany risk factors such as the existence of diabeticretinopathy or high blood pressure. Some risk factorsresulted in the patient being excluded for surgery, forexample, pregnancy.

• When surgeons made decisions to treat patients, theyfollowed a detailed protocol based on best practice andresearch evidence. This protocol required staff toconsider permanent conditions such as thin corneas,temporary conditions such as breast feeding, andsystemic conditions such as epilepsy, depression,cancer or diabetes. In certain situations, for example if apatient had a history of epilepsy, the surgeon advisedpatients they would need a letter from their GP toconfirm their suitability for surgery.

• Patient risk was reviewed on the day of their surgery.The pre-operative nurse verified all the details of thepreviously identified risks and checked the patientspulse rate, temperature, respiration rate, and bloodpressure to ensure that no further risks had arisen sincethe previous consultation.

• Patients did not receive an assessment of venousthromboembolism and bleeding risk on admission or 24hours after their surgery. However, patients who weretaking blood thinning medicine were required to havean International Normalised Ratio (INR) test completedby their GP before surgery. This test is used to monitorhow well the blood-thinning medicine is working. If thetest result was outside of expected parameters, thepatient’s surgery was postponed.

• The anaesthetist adhered to National Patient SafetyAgency/ Royal College of Anaesthetists ‘Stop before youblock’ protocols. These aim to reduce the incidence of




patients receiving nerve blocks for the wrong side oftheir body. The team checked which eye was to beoperated on prior to the local anaesthetic beingadministered.

• When the surgery team carried out refractive eyesurgery, they followed systems for completing verbalchecks during surgery as recommended by the RoyalCollege of Ophthalmologists standards for refractive eyesurgery. The team marked the surgical site, stated whatrefractive outcome was planned, stated what lensmodel and power was required and confirmed thecorrect lens implant was present in theatre. When thesurgery team carried out intraocular lens surgery, theycompleted the five steps to safer surgery World HealthOrganisation checklist.

• Staff completed several checks to verify the location ofthe surgery site. However, the specific process formarking of the surgical site was not consistent with allprofessional guidelines. The surgical site marking wascompleted by the optometrist, who was not present intheatre during the procedure. This did not comply withthe guidelines of the Royal College of OphthalmologistsTheatre Procedures Standards, February 2018 whichstate that if a nominated deputy completes the marking,that deputy should be present for the duration of thesurgical procedure.

• We saw that all stages of the safer surgery checklist wereincluded in the surgery process. All team members werepresent at the pre-surgery briefing. We saw thatmeasures had been taken to encourage optometristattendance at the post-surgery de-briefing.

• Staff took precautions to mitigate the risk ofcomplications during eye surgery. Staff monitoredpatients receiving intravenous sedation usingrecommended equipment such as pulse oximetry andnon-invasive blood pressure monitoring. Intravenousaccess was available throughout the procedure. Anechocardiogram machine and resuscitation equipmentwas available for use when required. Staff used arecognised system for monitoring the deterioratingpatient. This was the National Early Warning System(NEWS).

• There was a clear and regularly tested pathway toenable the patient to receive appropriate advancedmedical care. If an emergency occurred during surgery,the surgeon was present in theatre throughout thesurgical procedure and the anaesthetist was availablewhen sedation was used. The surgery team knew what

to do if a patient collapsed. The Optical Express protocolstipulated that staff were to telephone for anambulance in the event of a cardiac arrest. This scenariowas practised every three months. The most recentsimulation had highlighted the need to identifyappropriate parking for the ambulance outside of theclinic building and to keep the building managementteam informed of developments.

• Staff took precautions to mitigate the risk ofcomplications following eye surgery. Patients werecarefully monitored to check for any sign ofinflammation, irritation or infection post-surgery. Theteam gave patients an aftercare advice leaflet thatincluded telephone numbers to call if they had concernsor queries post-surgery. The optometrist routinelyreviewed patients the day after their surgery and thenagain at regular intervals until discharge. Theoptometrists told us they felt comfortable to contact thesurgery team with any concerns identified postoperatively. Optometrists could also contact the clinicalservices team for advice.

• After-care arrangements included access to specialistmedical input if required. Post-operative follows upappointments were scheduled for the morning to allowtime for staff to arrange suitable urgent medical followup for patients if the need arose. There was anemergency support system for urgent cases where theclinical services team co-ordinated care between thesurgeon and optometrist and co-ordinated externalreferrals to another consultant or laboratory serviceswhen required.

• There had been two incidents when a patient wasrequired to return to the operating theatreunexpectedly. One of these patients required the lens tobe repositioned; the other patient required the cornealflap to be repositioned. There were no lasting negativeeffects from these additional procedures.

Nurse staffing

• There were sufficient staff to meet patients’ needs.Managers at Optical Express used a staffing tool thathad been approved by their medical advisory board.This tool calculated the number of staff and rolesrequired for each surgery list according to the tasks tobe undertaken. Staffing numbers and skill mix compliedwith the Royal College of Ophthalmology guidance onstaffing in ophthalmic theatres.




• There were no surgery team shift changes during thesurgery day.

• In the surgery team, there were three members of staffpermanently employed based at the Bristol location;this was the registered manager plus a nurse and anoperating department practitioner. All other staffpresent in the surgery team on treatment days weremade up of a combination of the remaining twopermanent members of staff based elsewhere in theregion plus seven bank staff.

• There was an effective system for engaging staff at shortnotice from other clinics to cover sickness or annualleave. Staff absence was escalated to a scheduling teamat the central office who could access the staff databasefor the region. This database included permanentmembers of staff in the south west surgery team as wellas long established ‘bank’ staff that were frequently androutinely included on the surgery staffing lists. Coverwas always provided for staff absences.

• There were systems to ensure that staff travellingbetween different bases were familiar with safetyprocesses. All protocols were standardised throughoutthe company and staff felt at ease travelling to othersites to assist with surgery in their role. Staff werefamiliar with the teams in other sites and identified noconcerns with this pattern of work. The laser protectionadvisor was available to all staff by telephone if requiredduring normal working hours.

Medical staffing

• Patients received care from experienced andappropriately qualified medical staff. There were no staffworking under practising privileges at the clinic. Therewere two surgeons directly employed by Optical Expresswho completed all surgical procedures plus pre-surgeryconsent consultations and follow up consultations asrequired. Both surgeons were on the General MedicalCouncil specialist register in Ophthalmology.

• Intravenous sedation was administered by theanaesthetist who was employed by an agency. Localanaesthetic blocks were performed by the anaesthetist.

• There was a service level agreement for the laserprotection service. A laser protection advisor visitedevery three years to complete a risk assessment. Clinicstaff could telephone the laser protection advisor foradvice when required.

• In an emergency, medical staffing was available. Thesurgeon was present throughout the surgical procedure.

The anaesthetist was available in an adjoining roomwhenever a patient had sedation for the surgicalprocedure. If a patient required further medical input,for example if the patient had a cardiac arrest, staff usedthe resuscitation equipment available on site and calledfor an ambulance to take the patient to the emergencydepartment of a nearby hospital.

Records

• There were safe systems for storing records. Electronicrecords were password protected and paper recordswere stored in filing cabinets in a locked filing room. Nopaper records were left unattended at the time of ourinspection. On the day of treatment, the informationfrom the paper record was entered onto the electronicfile. At the end of surgery, staff securely packaged paperrecords and an optical express courier visited twice dailyto transport the records to the external archive facility.The archivist confirmed receipt of all listed records byemail.

• There were systems to ensure that staff followed bestpractice with regards to record keeping. Patientdocumentation was audited every three months by thesurgical services manager. This audit had not identifiedany recurring concerns for the Bristol clinic during thetwelve months preceding our inspection. The registeredmanager audited record keeping as part of the monthlyclinic audit. No concerns were identified through thisprocess. The clinical services team auditeddocumentation as part of the review of complex cases.We saw that staff in the clinical services team emailedoptometrists individually to provide feedback onspecific records which did not meet the requiredstandard.

• Patient records were completed in accordance with theGeneral Medical Council Guidance for doctors who offercosmetic surgery. We reviewed five sets of patientrecords. We saw that records contained patientidentification, relevant assessments and consentdocuments as well as details of the surgery undertakenand medicines prescribed.

• Records were maintained each time a laser wasoperated. We saw that staff inputted acontemporaneous record of laser operations for everypatient. This aspect of laser safety was audited as part




of the clinic audit completed monthly by the registeredmanager. Completion of this assessment was audited aspart of the records audit every three months. No notableconcerns were identified by this audit process.

• Staff shared details of the surgery with the patient’s GPwhen patients gave permission for them to do so.Patients could choose whether to give permission forthe clinic to contact their GP regarding the treatmentthey received at the clinic. If necessary staff askedpatients to contact their GP directly when further clinicalinformation was required, such as internationalnormalized ratio (INR) results for patients taking bloodthinning medication. The treatment pathway wassuspended pending receipt of the relevant information.After treatment, staff gave each patient relevantinformation to share with their GP if they chose to do so.

Medicines

• There were effective systems for the management ofmedicines. There was a current and comprehensivepolicy for the management of medicines which servedas a guideline for staff to follow. The policy included theordering, receipt, prescribing, administering, dispensing,storing and disposal of medicines, emergencymedicines, reporting of drug errors and adversereactions plus the training and competency of staff.

• There had been no reported medicines incidents duringthe 12 months preceding our inspection. Medicinesmanagement was audited as part of the clinic auditcompleted by the registered manager every month. Nonotable concerns had been identified as part of thisaudit process.

• Staff stored medicines safely and securely within lockedcabinets or fridges. Staff monitored and recorded thetemperature of fridges using thermometers thatidentified minimum and maximum temperature ranges.There were clear instructions for staff to follow in theevent of temperature recordings not being withinexpected ranges.

• We checked five patient records and saw that staffclearly documented patient’s allergies in the prescribingdocument.

• There was an emergency stock of medicines availablecontaining treatment for anaphylactic shock, diabeticcoma, adrenaline, aspirin, antihistamines, a spareinhaler for asthmatic patients and portable oxygen forpatients feeling feint. These medicines were within theirexpiry dates.

• Nurses participated in the dispensing of eye drops. Themedicines policy included instructions for safedispensing. None of the medicines being dispensedrequired re-constitution. All dispensing was checked bya second member of staff to mitigate risk of error.Nursing competency checks included safe dispensingmethods.

• The use of cytotoxic medicines was well managed.There was a policy and procedure to guide staff. Risksassociated with the use of this medicine were identifiedwithin a risk assessment and actions were taken toprotect the safety of patients and staff. For example, thesurgeon took responsibility for prescribing the cytotoxicmedicines and these were ordered as a pre-preparedsolution specifically for each patient as required. Thesemedicines were stored in secure, rigid containers in afridge. These medicines were collected in sealed purplecytotoxic waste bins by the waste contractors. Therewas no spillage kit for cytotoxic waste but the policyclearly outlined the procedure for staff to follow in theevent of spillage.

Incidents

• There had been no serious incidents and no neverevents during the 12 months preceding our inspection.A never event is a serious incident that is whollypreventable as guidance, or safety recommendationsproviding strong systemic protective barriers, areavailable at a national level, and should have beenimplemented by all providers.

• Staff in the surgery team and the optometry teamunderstood their responsibilities to raise concerns andknew how to record safety incidents. This included theneed to report suspected or actual ocular injury to theiremployer and to the laser protection advisor. Therewere four incidents reported at the Bristol clinic duringthe twelve months preceding our inspection.

• All incidents in the surgery team were investigated bythe surgical services manager. There were no themesevident from the four incidents reported during the 12months prior to our inspection. This process includedchecking the onward patient pathway to ascertain if anyharm or detriment to treatment resulted from theincident. There had been no incidents of suspected oractual ocular injury reported.

• The surgical services manager demonstrated awarenessof potential triggers for a duty of candour notificationwhere applicable. All staff we spoke with were clear




regarding their responsibilities for duty of candour.There was a duty of candour policy in place since 2015.The duty of candour is a regulatory duty that relates toopenness and transparency and requires providers ofhealth and social care services to notify patients (orother relevant persons) of certain ‘notifiable safetyincidents’ and provide reasonable support to thatperson. There had been no incidents that met thethreshold for the duty of candour in either the surgeryteam or optometry team.

• Staff told us that learning was identified and shared withthe regional surgery team following the investigation ofincidents. We saw that it was normal practice forlearning from incidents to be shared at the pre-surgerybriefing. There was evidence that incidents werediscussed at team meetings and learning was shared.For example, following an incident of surgicalequipment failure, the minutes showed that this hadbeen discussed and action taken to ensure the serialnumber of failed equipment was logged prior toreturning the item to the manufacturer.

• Incidents reported by the optometry team wereinvestigated centrally by the clinical services team. Twotypes of optometry incidents were routinely reported.Firstly, when the surgeon recommended a treatmentoption that was not the option recommended by theoptometrist, this was reported and investigated andindividual learning was fed back to the optometrist byemail.

• Secondly, when patients presented at the Bristol clinicwith post-surgery complications, these wereinvestigated by the clinical services team. Due to thenature of the business, it was unrealistic to expect theservice to track whether patients presented at otherhealthcare facilities for treatment of infection followingsurgery at the Bristol clinic.

• Optometrists used a grading system to classify thesecomplications. Optometrists reported patientcomplications to the clinical services team whoprovided advice and guidance regarding the mosteffective way to treat these patients. Part of this clinicalreview also involved an audit of the patient pathway bythe clinical services team in conjunction with themedical director and the clinical services director.

• If an optometrist identified that a further surgicalprocedure might be needed to rectify an unresolvedcomplication, the clinical services director, medical

director and operating surgeon reviewed theoptometrist recommendation. Optometrists andsurgeons discussed learning from clinical cases at athree-monthly regional face to face meeting thatincluded presentation of actual complex case studies.

• The surgical services manager reviewed all NationalPatient Safety Alerts (NPSA) and forwarded these to staffwhen appropriate. Every three months the surgicalservices manager sent a summary of alerts thatincluded a breakdown of their relevance to the clinic.For example, the regional surgery team were required tobe extra vigilant regarding the use of the manualresuscitation system following the release of a medicaldevice alert.

Major Incident awareness

• The service used a variety of methods to monitor safety.The surgical services manager evaluated all incidentsreported, checked staff competencies and auditedcompliance with safety policies. At a local level, the lasertechnician monitored the safety of laser equipmentused in intraocular lens surgery and refractive laser eyesurgery by carrying out system checks on surgery days.

• Patient safety was maintained if surgical equipmentfailed. Intra-ocular lens surgery and refractive laser eyesurgery did not proceed if laser equipment was notfunctioning or did not calibrate successfully. Lasermachines cut off automatically if the data inputted bythe laser technician was out of the expected range.Laser technicians contacted experts in the clinicalservices team for immediate advice over the telephoneand had the option of contacting the manufacturer if aproblem could not be resolved. Patients were offeredsurgery at alternative clinic locations or alternativesurgery dates.

• Laser treatment was not compromised if power failedmid-treatment. Laser equipment was fitted with anuninterruptible power supply sufficient to complete asurgical procedure, as recommended by the RoyalCollege of Ophthalmologists 2017. There was a policy toguide staff in the event of mains service failure. Thosepatients whose surgery had not started would bere-scheduled for another surgery date. Post-operativecare would be rescheduled at an alternative clinic.

• The service did not benchmark safety performance ofthe Bristol Clinic in comparison to other clinics. Thesafety performance of individual surgeons wasbenchmarked across the company.




Are refractive eye surgery serviceseffective?

Evidence-based care and treatment

• Staff followed evidence based protocols for treatment.Optical Express had an international medical advisoryboard (IMAB) made up of international refractive surgeryexperts. They met annually over several days to considernew research evidence, technologies and guidelines forbest practice such as the Royal College ofOphthalmology Standards for refractive surgery. TheIMAB used this evidence together with the OpticalExpress outcomes data to review the clinical protocolsof the company. For example, the suitability guidanceand treatment criteria clinicians used to make decisionsto treat patients.

• Patients had their needs assessed and their careplanned and delivered in line with evidence basedguidance and standards. All surgeons and heads ofdepartment plus the medical director and the clinicalservices director were members of the medical advisoryboard (MAB). This was an open meeting for discussion ofthe IMAB recommendations during which changes wereagreed to treatment criteria or protocols or decisionsmade to introduce new technology.

• The medical advisory board set standards for allsurgeons and optometrists. These standards were inline with national guidance such as NICE guidance onphotorefractive surgery, Royal College ofOphthalmology Standards for Laser Refractive Surgeryand Royal College of Surgeons’ Professional Standardsfor Cosmetic Surgery.

• The service complied with NICE InterventionalProcedures Guidance IPG164 Photorefractive (laser)surgery for the correction of refractive errors. Forexample, patients understood the potential benefitsand risks of their surgical procedure by watching aninformation video. This was then followed up duringconsent discussions with the optometrist and surgeon.

• Staff ensured that patients undergoing laser refractiveeye surgery had opportunity for appropriatepre-operative assessment and discussion as set out inthe General Medical Council Guidance for doctors whooffer cosmetic interventions.

Nutrition and hydration

• Staff gave patients appropriate advice regarding what toeat and drink prior to their surgery.

• Staff gave patients hot or cold drinks and biscuitsfollowing their surgery

Pain relief

• The clinic ensured that patients were given adequatepain relief. Dependent upon the type of surgery, theteam used either topical or sub tenon anaesthesia toensure that patients did not experience pain duringsurgery.

• The team could monitor the patient’s pain throughoutthe procedure because patients were fully consciousand responsive.

• Staff informed patients about the expected level of painduring and after the surgery. Nurses advised patientshow to manage their pain after surgery by taking theirpreferred choice of simple analgesia.

Patient outcomes

• Optical Express used data to monitor the efficacy andsafety of treatment. Outcome data was collected forevery treatment undertaken including long term followup. Optical Express compared their outcomes with thedata in the National Ophthalmic Database. Thiscomparison provided a means of benchmarking thetreatment outcomes of individual surgeons.

• The management team closely monitored the individualperformance of surgeons who worked at the Bristolclinic. An annual audit of the individual surgeon’soutcomes was made available to the registeredmanager. These included for example total number oftreatments, mean age and gender, pre-operativemeasurements of the eye, treatment types, one-monthpost treatment distance vision for different types ofvision correction, one-month post treatment refractivepredictability, attempted versus achieved results,efficacy, safety, surgeon safety and efficacy over time,estimated enhancement rate and complications.

• Specific data for the treatment outcomes obtained atthe Bristol clinic was not available because OpticalExpress monitored outcomes according to individualsurgeons rather than locations. The outcomes data forthe surgeons operating at the Bristol clinic were similarto the outcomes data for other surgeons working forOptical Express.

• At a corporate level, there were systems to ensure thatclinicians made safe and effective decisions around




patient care. Quality and compliance officers completedchecks of every patient record two days prior to surgery.All action points raised from these checks were emailedto the registered manager to action.

• If a patient presented for surgery and on examination,the surgeon disagreed with the clinicalrecommendation of the optometrist, this resulted in thesurgeon completing a ‘non-treatment form’. Thistriggered a review by the clinical services director whoexamined the clinical reasoning of both the optometristand surgeon. Any learning from this review was sharedwith the relevant clinician. If an optometrist graded apatient with a complication post-surgery, this triggereda review of the patient journey by the clinical servicesteam in conjunction with the medical director and theclinical services director.

• The average rate of complications for treatments carriedout in Optical Express clinics was 1%. The rate ofcomplications for the surgeons who worked at theBristol clinic was lower (better) than the average forOptical Express.

Competent staff

• There were systems to ensure staff in the surgery teamwere competent to carry out their role. Four of the fivepermanent staff working in the South West regionalteam had completed an appraisal during the 12 monthspreceding our inspection. The remaining appraisal wason hold to enable a new manager to complete this as atraining exercise. The surgical services manager checkedthe skills competencies of all staff in the surgery teamevery three years. This included competencies toadminister cytotoxic medicines.

• The competence of surgeons was assured before theywere permitted to perform eye surgery independently.The medical director and clinical services directorcompleted the induction of all surgeons. This processincluded detailed information about the procedures;clinical suitability guidance; policies and procedures;diary and patient management systems; protocols andpathways. Surgeons then shadowed the medicaldirector or a senior surgeon and attended training withthe laser manufacturer which included a period ofsupervised practice. The surgeon was required toundertake a number of procedures under the

supervision of the medical director or senior surgeonfollowing their training before they were entered ontothe list of authorised users. This list was kept underreview by the surgical services manager.

• The medical director monitored the ongoingcompetence of surgeons by their clinical outcomes,which were benchmarked within the company. Theprovider ensured they had opportunity to completeadequate continuing professional development for thepurposes of revalidation. Both surgeons held evidenceof an established refractive surgery practice. Surgeonswere required to provide evidence of their annualappraisal and this was available for both surgeons whoworked at the Bristol location.

• All staff operating laser equipment were trained in thisrole. All staff completed the laser core of knowledgetraining day. The laser technician was certified by thelaser manufacturer following a one-week course in theuse of the lasers and associated equipment. Lasertechnicians participated in a review of theircompetencies every three years. Optical Expressemployed senior refractive trainers who carried out thelaser competency assessments locally and supportedtechnicians and laser protection supervisors to ensurethey remained skilled.

• The clinical competencies of optometrists were up todate. Regional optometry development managers wereresponsible for inducting, training, developing,supporting and completing the appraisals ofoptometrists. Competencies of the optometry teamwere reviewed annually during the appraisal process. Alloptometrists working at the Bristol location hadreceived an appraisal in the twelve months precedingour inspection.

• Optometrists who treated eye surgery patients weretrained to complete the additional clinical tasks of thesurgery pathway, including the management ofpost-operative side effects and complications of eyesurgery. These optometrists participated in a two-weektraining course that included an introduction to clinicalgovernance processes, the electronic record system,and the patient pathway, the interpretation ofdiagnostic instruments plus practical observations ofclinical practice.

Multidisciplinary working

• Multidisciplinary working outside of the team wasdependent upon patient choice. At their initial




consultation, patients were encouraged to give consentto sharing of information with their GP. For thosepatients who consented, a treatment summary wasautomatically generated by the electronic recordssystem and sent to the GP when the final appointmentwas recorded by the clinician. All patients were given acopy of their treatment summary on discharge.

• For some high-risk patients, the team insisted thatpatients asked their GP for a letter confirming theirhealth status prior to surgery going ahead.

Seven-day services

• The clinic did not operate a seven-day service.

Health promotion

• The clinic provided a service for refractive eye lasersurgery and intraocular lens surgery only. These servicesdid not include general health promotion based uponthe national priorities to improve the health of thepopulation.

• Staff empowered patients to manage their own healthand to take responsibility for their aftercare. Staffadvised patients how they could help to achieve thebest outcome during the procedure, as recommendedin the Royal College of Ophthalmology standards forrefractive eye surgery. Staff advised patients how to lookafter their eyes in the weeks following surgery to get thebest outcomes for their surgery. Staff encouragedpatients to attend regular vision check-ups post-surgery.

• Nurses supported patients to be independent byteaching them to administer their own medicinesfollowing surgery.

Consent and Mental Capacity Act

• Staff understood and complied with the Mental CapacityAct 2005. All staff in the surgery team had completed amandatory training module on consent which includedinformation on the Mental Capacity Act 2005. Onlypatients who could give informed consent wereaccepted for surgery. Patients who were requestingsurgery received a pre-operative assessment andthorough discussion of their needs with both theoptometrist and the surgeon. Staff gave detailed verbaland written information about all risks, benefits, realisticoutcomes and costs of treatments. Patients wereoffered a range of options for treatment as alternativesto refractive eye surgery. Staff showed patients a videothat explained the recommended surgery

• Staff ensured that patients continued to give informedconsent as they progressed along the surgery pathway.Patients were given opportunities to change their mind.There were no time limited deals offered. Staff gavepatients information to take home to read includingwritten information about treatment options and apaper copy of the consent form. The printed consentform clearly explained the risks of using cytotoxicmedicines in refractive eye surgery. Patient advisors,optometrists, surgeons and nursing staff all checkedpatients consent at every stage of the assessment andtreatment process. Patients were offered translationservices if they did not understand English.

• Staff ensured that patients had capacity to give consentfor surgical procedures. Assessment of capacity toconsent began with the patient’s self-assessment in thehealth questionnaire. This asked patients to declare anymental health conditions that affected their ability tounderstand. During the initial consultation, theoptometrist assessed the patients understanding of thelimitations and benefits of treatment, and if any doubtsregarding capacity were noted, the patient was steeredtoward a less invasive treatment option such ascorrective eye wear. Any concerns that arose from thehealth questionnaire or from the optometrist’sassessment triggered a letter to the patients GP.Surgeons made the final decision whether a patient hadthe mental capacity to consent to treatment. Thisassessment was recorded in the patient’s electronicrecord.

• The consent process was completed by the surgeon;patients were given a choice of either face to face orover the telephone consultation. High risk categories ofpatients were excluded from telephone consultations.During the six months preceding our inspection, 69% ofconsent consultations were carried out over thetelephone.

• The Optical Express consent policy did not followguidelines published by the Royal College ofOphthalmology. Potential patients were given aminimum of three days ‘cooling off’ period betweenagreeing to go ahead with the procedure and surgerybeing performed. The Royal College of Ophthalmologyrecommends a minimum cooling off period of sevendays between the procedure recommendation and




surgery. In exceptional circumstances, where aone-week cooling off period is impractical, the reasonsfor this should be agreed with the patient anddocumented in the medical record.

• During the six months preceding our inspection, OpticalExpress data showed 25% of surgeon consentappointments were carried out less than seven daysprior to the day of treatment. The surgical servicesmanager explained that Optical Express were in theprocess of changing the electronic system. Theamended version would ensure that staff could onlybook consent appointments more than seven days priorto surgery.

Are refractive eye surgery servicescaring?

Compassionate care

• Staff respected the identity and dignity of patients. Staffused eye contact when speaking to patients. Weobserved that staff introduced themselves to thepatient. Staff communicated with patients in arespectful and considerate manner. Duringconsultations, staff explained the reasons for asking forpersonal information.

• Surgeons talked with patients during surgery, explainingto patients what sensations they were likely toexperience during surgery. This complied with the RoyalCollege of Ophthalmology professional standards forrefractive surgery.

Emotional support

• When patients expressed anxiety regarding their surgeryor tests, staff in the optometry team were kind andpatient, and gave verbal reassurance.

• Staff gave extra time to patients with emotional needs. Ifappropriate for the patient, a staff member wasallocated to sit with the patient during surgery to holdtheir hand. Patients could request a chaperone for anyconsultation as per the company policy.

Understanding and involvement of patients andthose close to them

• Staff supported patients to understand relevanttreatment options including benefits, risks and potentialconsequences in order to make informed choices. We

observed face-to face consultations and saw that staffgave patients ample time to ask questions. Patients toldus they felt comfortable asking questions and staff triedwherever possible to make them feel at ease.

• At various stages of the treatment journey, we observedstaff patiently explaining written information andchecking patients understanding, for example, prior toconsent, during the consultation process, and duringthe medicines talk.

• We saw that staff gave patients written informationabout what to expect during surgery. Following theirpre-operative optometrist assessment, the optometristsgave patients a written report that included details oftheir eye health, prescription and diagnostics, therecommended treatment, surgeon details and full costof treatment.

Are refractive eye surgery servicesresponsive to people’s needs?

Service delivery to meet the needs of local people

• The facilities and premises were designed andmaintained for the service delivered. The clinic waseasily accessible from the town centre and close topublic transport links. Waiting areas were comfortable.Treatment areas were spacious. Treatment rooms werearranged to facilitate ease of patient movement alongthe surgery pathway.

• The team tried, wherever possible to provide continuityof care. For example, a patient would be seen by thesame surgeon and the same optometrist throughouttheir patient journey. The need for continuity wasidentified in a clinical directive.

• The surgeon delegated routine review appointments tothe optometrists. The optometrists followed clinicaldirectives to ensure their practice complied with theRoyal College of Ophthalmologists professionalstandards.

Meeting people’s individual needs

• Staff were considerate of patient’s individual needs.Following the patient’s initial consultation, staff in theoptometry service used the free text section on thepatient’s electronic medical record to flag any additional




requirements to the surgery team. On the day of ourinspection we observed that staff were sensitive to theneeds of a patient with hearing difficulties. There was aportable hearing loop available.

• Some adjustments were made to ensure that peoplewith impaired mobility were given equal access to careand treatment. We saw that a patient with back painwas offered an alternative method of surgery whichmeant that they were not required to lie completely flatand still. This was discussed in advance at thepre-surgery team briefing.

• Some reasonable adjustments had been made toensure that language was not a barrier to treatment forpatients whose first language was not English. Anexternal interpreter service was available for patientswhose first language was not English and for patientswho used British sign language as a means ofcommunication. Patients were not required to pay forthe cost of this service.

• Some adjustments were made for patients with eyesightdifficulties. Some written patient information wasavailable in large font, such as the laser surgery termsand conditions document, the reposition, removal and/or replacement of an ophthalmic device informedconsent document and the reflection period addenduminformed consent document. The aftercare informationleaflet included photographs to aid understanding.

Access and flow

• Access to the service was timely and flexible. There wasno waiting list for refractive eye surgery. Patients wereoffered an appointment on the next planned surgicallist.

• Staff at the Bristol clinic were flexible with appointmenttimes to meet the needs of patients who had far totravel. If the surgery dates at the Bristol clinic were notconvenient, dates at other clinics nationwide wereoffered. The option of telephone appointment with thesurgeon for the consent process was popular withpatients who told us they were pleased to reduce theirtime spent travelling to appointments.

• The rate of cancellations of surgery was low at 7%.Reasons for cancellations were varied including patientchoice, equipment failure, clinical changes orcomplications.

• The team tried to minimise the time that patients spentin clinic on their day of treatment. Patient arrival timeswere staggered to coincide with their allotted surgery

time. Patients were encouraged to go for a walk in thecity centre if their surgery start time was delayed.Patients we spoke with told us they had waited longerthan expected on the day of their surgery. However, thesubjective results of the patient experiencequestionnaire completed during the 12 monthspreceding our inspection indicated that patients at theBristol clinic felt they had spent less time waiting thanthe average time indicated on this survey. The clinic didnot objectively monitor the length of time that eachpatient waited on the day of their surgery.

Learning from complaints and concerns

• Complaints were investigated by the clinical servicesteam. There were seven complaints received by theBristol clinic during the 12 months preceding ourinspection. Neither of these complaints were upheld byOptical Express. The surgical services manageridentified themes from complaints. Most complaintsrelated to patients being dissatisfied with their visualoutcome following surgery or the charges forenhancement procedures. Patients were kept informedregarding the outcome of these investigations.

• Teams learned from complaints and shared this learningwith other teams. For example, when a patient wasdissatisfied with their surgery experience, this wascommunicated to the optometry store manager toensure that staff adopted a sensitive approach to thepatient on their follow up appointment.

Are refractive eye surgery serviceswell-led?

Leadership

• There were clearly defined systems of leadership for allstaff working at the clinic. Clinical leadership of thesurgery pathway was divided between two separateclinical governance structures and centrally supportedby the clinical services team. The link between bothleadership structures was the clinical services directorand the medical director. All staff we spoke to were clearhow the leadership structure worked.

• There was strong clinical leadership of the surgery team,provided by the surgical services manager who wasresponsible for all the surgery teams nationwide. Thesurgical services manager was supported in this role bythe clinical services team, the medical director and




clinical services director. The registered manager wasresponsible for day to day coordination of the clinic.This person was new in post and the surgical servicesmanager was supporting them whilst they becamefamiliar with the requirements of the role.

• Clinical leadership of the optometrists was provided bya regional optometry development manager who hadoversight of the training and development andcompleted optometrist appraisals. The optometrydevelopment manager was supported in this role by theclinical services team and the medical director.

• Clinical leadership of the surgeons was theresponsibility of the medical director and the clinicalservices director. They were supported in this role by themedical advisory board who were guided by theinternational medical advisory board.

• Leaders had identified challenges to the quality of theservice, such as the need for theatre protocols tobecome embedded. The leadership team hadappointed to a new role created to lead safety initiativeswithin theatres. The intention was for this member ofstaff to play a key role in monitoring the safety of surgerythrough observation and real-time interactions withteams. The plan was for this staff member to initiallyfocus on embedding the world health organisation safersurgery checklist within all surgery teams. Staff in thesurgery had participated in a development workshopwhich encouraged good safety practice within theatres.

• We saw that leaders were visible and approachable.Staff from both teams told us they had confidence andtrust in the leadership team, and described the surgicalservices manager as ‘knowledgeable’ and ‘responsive’.

Vision and strategy

• There was a vision and mission statement for thecompany. The mission was to grow and develop thenetwork of clinics globally and provide the highestquality science based technology, superior productsand services that enhance people’s lives. This was to beachieved by fostering a work environment that valuesand rewards integrity, respect and performance. Somestaff were familiar with the values. However, thesevalues were not developed in collaboration with staff,people who use the services, or external partners.

• The strategy for the Bristol clinic was determined at acorporate level. The strategy was not available as awritten document for the inspection and we were notable to consider progress against the delivery of the

strategy or to evaluate how robust or realistic thisstrategy was. However, we were told the plan was tointroduce bilateral surgery procedures and this was dueto commence in the next 2-3 months. The service hadalso appointed a new refractive eye laser surgerymanager lead based in Cardiff who would also provideleadership for the Bristol clinic.

• The leadership had taken account of the Royal Collegeof Ophthalmology Professional Standards for RefractiveSurgery. Leaders had made amendments to theprotocols around consent, specifically the requirementfor a seven day ‘cooling off’ period’ in order to align withbest practice.

Culture

• All staff told us they felt respected, supported andvalued. All staff told us they were proud of the servicethey provided for patients and proud to work for thecompany. Staff participated in appraisals. We saw therewere opportunities for career development as staff werepromoted to more senior roles within the company.Members of staff told us they could access advice andguidance when they needed to.

• The culture of the service was focused on workingtogether to provide the best possible care for patients.The patient experience was very important to the team.

• In surgery briefings, we observed a non-hierarchicalstructure where staff of all grades could speak up.During theatre we saw that staff worked together in acooperative and appreciative way.

• In the minutes of local team meetings, we saw thatwhen staff raised concerns, these were addressed. Forexample, in February the team had raised a securityissue regarding workmen cutting through the clinic toaccess toilets on the floor below. The surgical servicesmanager supported staff to speak directly to theworkmen and building manager and advised staff howto escalate this further if necessary.

• Leaders took a personal interest in the safety andwell-being of staff. At this location, there had been noreason for leaders to take action regarding behaviourthat was inconsistent with the values of the company.

Governance

• There were three levels of clinical governance forum forthe reviewing of surgical ophthalmic procedures.

• There was an independent medical advisory board(IMAB) that consisted of experts in the field of




ophthalmic surgery. We saw the latest minutes of theIMAB dated April 2018. This forum met once a year toreview surgical ophthalmic procedures in line with thelatest evidence base for treatment including clinicalresearch, published guidelines, and Optical Expressdata. This group also reviewed all clinical directives andinformation given to patients.

• There was a medical advisory board (MAB) that metonce per year. We were told that members of this forumdiscussed the recommendations of the IMAB andconsidered how policies and protocols might need to bereviewed or amended. However, we could not beassured of this process because the latest minutes ofthe MAB submitted as part of the inspection processwere dated September 2015.

• The surgical services manager participated in a monthlyclinical governance committee teleconference. Thisforum consisted of the medical director, the responsibleofficer, the refractive operations manager, the clinicaldirector and the surgical services manager. The surgicalservices manager told us this meeting was a forum toraise location specific issues and trends identifiedacross locations in the surgery and optometry teams, forexample, from incidents or audits and to address safetyor quality concerns raised by teams. However, we couldnot be assured of this process because the clinicalgovernance committee teleconference had not beenrecorded since April 2017.

• Staff were informed of changes to clinical protocols by aclinical directive that was communicated by email twicea week for three consecutive weeks. Staff were requiredto respond to the clinical services team within one weekto confirm that they had read, understood and intendedto comply with the contents of the directives.

• There were systems to provide operationalmanagement of staff when working at the Bristol clinic.The optometry store manager was responsible for theroutine operational management of the optometryteam who carried out pre-surgery consultations andpost-surgery follow ups in the optometry store. Thesurgery manager was responsible for routineoperational management of the regional surgery staffwhen they were working at the Exeter clinic and thesmooth running of the clinic that day.

• The safety and quality of the patient journey wasmonitored effectively. There was a central clinicalservices team responsible for the monitoring of variousaspects of clinical governance across the entire patient

pathway. This included specific members of staff wholooked at complaints management, cancellations, thegovernance of optometrists, changes in policies andprocesses. All policies and procedures for the lasersurgery service were reviewed during the 12 monthspreceding our inspection.

• The two surgeons who performed surgery at the Bristolclinic were on the General Medical Council SpecialistRegister in Ophthalmology and held current indemnityinsurance. Surgeons were not permitted to invite visitingsurgeons into the theatre.

Managing risks, issues and performance

• The registered manager was supervised by the surgicalservices manager who was part of the senior leadershipteam, which included the medical director. In this sense,the registered manager had a direct route to and fromthe senior decision makers of the organisation.

• We were told that the surgical services managerescalated concerns at the clinical governancecommittee and informed the registered manager of theoutcomes of these discussions. However, we could notbe assured of this process because the clinicalgovernance committee teleconference had not beenrecorded since April 2017.

• Leaders used internal audit processes to monitor staffcompliance with safety protocols. The registeredmanager repeated a clinic audit every month. Thisincluded infection control, decontamination, airhandling, incident and complaints management,patient satisfaction, record keeping, personnel,maintenance of equipment, personnel, emergencyequipment, medicines management, laser safety,quality management and health and safety.

• The registered manager reported the results of theseaudits to the surgical services manager, who monitoredcompliance and checked results to identify trendsacross locations. We checked the last three audits andsaw that only minor issues were identified with norecurrent themes or trends. Action plans were recordedand all identified actions were completed.

• The surgical services manager took action to managesurgical risks. For example, low levels of legionella hadbeen detected during water safety checks. To addressthis, staff were reminded about the water flushingprotocol and the pipes were lagged to reduce heattransfer




• The local risk register was a collection of riskassessments rather than a live tool to monitor currentrisks to patient care or service delivery. In mostcircumstances where risk to the health and safety ofstaff or patients was identified, such as needle stickinjury or power failure during treatment, the surgicalservices manager completed a risk assessment andidentified ways to reduce or manage the risk. Staffsigned to say that they had read the risk assessmentand understood the required actions to take. Forexample, risk assessments for the Control of Substanceshazardous to health (COSHH) were completed in March2018. All hazardous substances were stored innon-patient areas in rooms secured by key pad.

• However, the surgical services manager was aware ofother live risks to patient care that were not riskassessed or recorded on the risk register. Theseincluded the lack of availability of external training forimmediate life support and the delayed routinemaintenance of the Class 3b laser. The lack ofavailability of external training for immediate lifesupport was being addressed. The intention was for thenew theatre lead to be trained to act as ‘secondfacilitator’ for these courses. However, the delayedroutine maintenance of the Class 3b laser was notidentified on the regular clinic audit, had not been riskassessed and was not actively mitigated.

• We were told that financial processes and dataregarding current and future performance weremonitored at a corporate level by the seniormanagement team. However, the service did notprovide evidence of senior management meetings sowe could not be assured of these processes.

Managing information

• Staff had the information they needed to provide careand treatment to patients. All information wasaccessible to the surgery team in paper or electronicformat. Prior to the surgery date, the clinical servicesteam checked the electronic files of all patientsscheduled to attend the clinic. This was to ensure thatall necessary documentation and pre-surgical actionshad been completed, for example, GP letter received ifnecessary.

• The system for storing individual patient records wasaccessible to staff who needed this information. Theclinic used a password protected electronic patientrecord system. Different grades of staff could view,

access and add records which were appropriate to theirrole at any of the Optical Express locations. Theelectronic record included details of any unexpectedevents occurring during surgery. The optometrist couldaccess both the paper copy and the electronic recordduring their initial aftercare appointment.

• Data management was monitored at a corporate level.There had been no incidents related to data security atthis location during the 12 months preceding thisinspection.

Engagement

• The service proactively sought and acted upon theviews and experiences of patients. Patients routinelycompleted the patient experience questionnaire aftertheir initial consultation, 24 hours following their surgeryand three months following surgery.

• Results of the 2017 patient experience questionnaireshowed patients gave positive feedback about theirexperience at the clinic. All patients said the surgeryteam made them feel at ease, that staff explained thepost-operative eye drop regime and aftercare processclearly and effectively, and that patients were satisfiedwith the warmth and friendliness of the surgeon. Onmost parameters, patients at the Bristol clinic scoredtheir levels of satisfaction with their vision higher(better) than the average score for Optical Express. Forintraocular lens surgery, 100% of patients at the Bristolclinic indicated they would recommend visioncorrective surgery to their friends and relatives. Forrefractive laser eye surgery, this score was 99%. This wasbetter than the average score companywide.

• At a corporate level, a range of strategies were used tofoster goodwill and commitment from staff. All staffwere invited to an annual event hosted by the chiefexecutive. Once a month staff received an electronicmagazine. Every week the chief executivecommunicated to staff by email. Once a week, staffcould nominate a colleague who had shownexceptional commitment to their work, and winnersreceived generous prizes.

• Local staff engagement in the surgery team wasproactive. Staff in the regional surgery team were invitedto attend monthly team meetings. One member of thesurgical services management team joined staff at this




meeting. Managers encouraged staff to raise concernsand contribute ideas for improvement. For example,staff decided that a sign for the disabled toilet would bebeneficial.

• There were no forums where staff or patients or patientrepresentatives were involved in shaping the planningand delivery of services and/or the shaping of theculture of the organisation.

Learning, continuous improvement and innovation

• Patient advisors scanned all patients who wereassessed for refractive eye surgery using a diagnostictechnology that produced a three-dimensional map ofeach eye. The laser followed this personalised ‘map’ toallow treatment to be custom-fitted to the exactspecification of each eye with microscopic accuracy.

• There had been no internal or external reviews of theservice at this location during the 12 months precedingour inspection




Areas for improvement

Action the provider MUST take to improve

• Ensure that all laser equipment is regularly servicedaccording to manufacturer’s instructions.

• Records must be maintained in relation to themanagement of the service. Records shoulddemonstrate when the quality and safety of the serviceis assessed, monitored or improved.

Action the provider SHOULD take to improve

• The consent policy should reflect Royal College ofOphthalmologists 2017 for a seven-day cooling offperiod between the initial consent meeting with thesurgeon and the final consent by the surgeon.

• The clinic should consider setting up forums wherestaff or patients or patient representatives can beinvolved in shaping the planning and delivery ofservices and/or the shaping of the culture of theorganisation.

• The clinic should provide lockable storage for patientsto store their personal belongings during their surgery

• The risk register should be an accurate reflection of therisks to the service.

• In accordance with the Royal College of Anaesthetists‘Guidelines for the Provision of Anaesthesia Services(GPAS) Guidelines for the Provision of OphthalmicAnaesthesia Services’ 2018, all members of clinicalstaff working within the recovery area should becertified immediate-life-support providers andmandatory training should be provided.

• The provider should review the mandatory trainingoffered to optometrists to ensure that this reflects therequirement for staff to have up to date knowledge ofsafety systems and processes, i.e. that personsproviding care or treatment have the skills to do sosafely; persons employed by the service provider in theprovision of a regulated activity must receive suchappropriate support and training to enable them tocarry out the duties they are employed to perform

• The provider should ensure that current practice withregards to the surgical site marking is compliant withall relevant clinical and professional guidelines.

Outstandingpracticeandareasforimprovement

Outstanding practice and areasfor improvement


Action we have told the provider to takeThe table below shows the legal requirements that were not being met. The provider must send CQC a report that sayswhat action they are going to take to meet these requirements.

Regulated activity

Diagnostic and screening procedures

Surgical procedures

Treatment of disease, disorder or injury

Regulation 15 HSCA (RA) Regulations 2014 Premises andequipment

All premises and equipment used by the service providermust be

(e) Properly maintained.

The routine service of the Class 3b laser was overdue by15 months.

Regulated activity

Diagnostic and screening procedures

Surgical procedures

Treatment of disease, disorder or injury

Regulation 17 HSCA (RA) Regulations 2014 Goodgovernance

Systems or processes must enable the registered person,in particular, to-

Assess, monitor and improve the quality and safety ofthe services provided in the carrying on of the regulatedactivity

d) maintain securely such other records as are necessaryto be kept in relation to-

(ii) the management of the regulated activity

The clinical governance committee meetings had notbeen recorded since April 2017. The most recent minutesof the Medical Advisory Board were September 2015.

Regulation

Regulation

This section is primarily information for the provider

Requirement noticesRequirementnotices


Action we have told the provider to takeThe table below shows the legal requirements that were not being met. The provider must send CQC a report that sayswhat action they are going to take to meet these requirements.

This section is primarily information for the provider

Enforcement actionsEnforcementactions


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