The Electrophysiology department at Moorfields Eye Hospital was granted UKAS accreditation to the IQIPS standard in April 2024. This department sits within the diagnostic and imaging support service, and while it is only one department, it covers six laboratories in the adult clinic, and three additional laboratories in the paediatric clinic. On average the department sees approximately 3000 patients a year, with about 40% of these referrals coming from outside of Moorfields.
Within the department, there are 22 members of staff, led by Professor Anthony Robson and comprising clinical scientists (including consultants, senior and trainees) a technical and systems manager (responsible for all equipment), clinical physiologists, an office manager and support staff. Working within the department is Dr Magella Neveu (Consultant Clinical Scientist and Quality Lead over the course of the accreditation process), who speaks with UKAS about the department’s experience in gaining accreditation.
UKAS accreditation and the IQIPS scheme
Visual electrophysiology is one of the sub specialities that falls within ophthalmic and vision sciences (the other disciplines that fall under this heading being ophthalmic imaging, psychophysical testing and ophthalmic ultrasonography.) These four sub-specialisms underpin the diagnostic processes within ophthalmology.
Ophthalmic and Vision Science is one of the eight physiological sciences that come under the remit of the Improving Quality In Physiological Sciences (IQIPS) standard, which is a professionally developed and led standard, which means it is developed and owned by the professional bodies operating in this sector.
In 2017 UKAS took over management of the IQIPS scheme, at which point UKAS engaged with the main stakeholders in ophthalmic and vision science (professional bodies and patients) such as the Royal College of Physicians and the Accreditation Clinical Advisory Group (ACAG). This engagement led to a scoping exercise in January 2020, then in March 2020 the new version of the IQIPS standard was published with input from ophthalmic and vision science.
The IQIPS standard itself is clearly defined and aligns with the requirements for a high-quality diagnostic service. There are five domains to the IQIPS standard, which are:
Leadership and Management –looks at the structure of the management, governance and leadership within the department and the wider trust.
Clinical –examines how accurate and effective the diagnosis and treatment of patients is within the service.
Patient/Client Experience –ensures that the service is patient-focused and includes appropriate feedback mechanisms from service users.
Safety and Risk Management – ensures that the provider delivers the highest level of safety for all users, through accurate assessment and management of risks.
Facilities and Resource –examines the space the department is working in and the staff available, recruitment and business planning principles for the service.
The journey to accreditation
In July 2020 the department submitted an Expression of Interest to join the ophthalmic and vision science pilot scheme, at which point the department engaged in a full gap analysis. The Quality Manager for the division (Joanne Ball) led this exercise, guiding the department as they worked systematically through each clause in the IQIPS standard to establish where they were currently in relation to where they needed to be to meet the requirements of the standard. The output of this exercise was a roadmap to accreditation. A key objective of which was the adoption of an appropriate QMS, which they began to use for document control and the auditing of non-compliances, meeting management and change control.
In March 2021 the department applied for UKAS accreditation under the IQIPS scheme, and over the next six-to-eight months they had meetings with Laura Booth (Senior Assessment Manager for IQIPS) and the UKAS team to support the department on their journey to accreditation.
The purpose of these meetings was to review where the Moorfields team was in the process and the team found these beneficial because they were encouraged to keep doing what they were doing and, most importantly, not to overcomplicate things. A key consideration was to ensure that everything was documented correctly, and to ensure they were able to demonstrate how the department was meeting processes as laid out in the IQIPS standard.
The department held its first annual management review meeting during which it was decided that they were ready to set a date for the UKAS pre-assessment of the department, which was arranged for January 2023.
Improvement through discovery
Magella explains that one of the big revelations of the gap analysis was not so much a lack of established processes, but a need to formally document these processes in a controlled manner. Once the processes were documented into detailed and comprehensive SOPs, these needed to be controlled and validated along with appropriate training plans, knowledge checks and observation checks. At this point the department also dedicated time to developing and implementing a formal internal audit schedule, management review, change control, and, once all the SOPs were written, they could draft the department overarching quality manual.
All these actions, when viewed all at once, seemed very daunting, but the team pulled together and felt confident that it was a process they were able to engage with. On looking at the gap analysis and the actions that came out of that, the team recognised that the greatest challenge that faced them was resource, particularly the availability of staff, without deflecting from essential clinical activity. To address this challenge, they appointed leads (as well as supporting deputies where possible), which led the overall progress in each area through working groups.
Measurement Uncertainty
One of the areas that was highlighted by the accreditation process was that of Uncertainty of Measurement. While in a laboratory setting the concept of Measurement Uncertainty is second nature, within physiological sciences it is more of a challenge, and that is because the biggest uncertainty faced by these departments is that of the patient themselves. Elements such as eye closure, blinking, muscle-tension and eye-movement are very difficult to quantify, therefore measuring the uncertainty (which can also vary over the course of one test) is very challenging. Magella describes how the team rose to this challenge by taking advantage of the quieter Christmas period to conduct exercises that would help to identify uncertainty (considering not only patient, but operator, environment and equipment). At the end of this exercise, the department could analyse and interpret the data, taking these findings into account for the measurements that they take.
Audit
It was necessary for the team to create an audit schedule. The COVID-19 pandemic became a blessing in disguise for this purpose, as there were more staff available to support the writing of SOPs. The real challenge came once the pandemic ended, and (like all trusts) they were faced with a significant backlog of clinical work, which impacted the speed of the team’s preparation for UKAS accreditation.
Magella explains that their newly appointed audit lead was invaluable during this process, and that due to her hard work and attention to detail the team was able to complete the challenging audit schedule within the year, as planned.
Training
It was necessary to develop a training matrix, and the Educational Lead took full control of defining training according to roles within the department. This represented a challenge because all the staff had already had training but undocumented within an SOP. Therefore, all staff needed to be trained to the newly written SOPs and have their training signed-off, almost simultaneously.
The on-site assessment and findings
Magella reiterates that the assessment days themselves, taking place on 11 and 12 December 2023, were stressful, but also clarifies that the UKAS team that came on site were very helpful and approachable, and helped them to take things step by step.
Following their assessment, the team were commended for being so patient-focused and placing patient care at the centre of what we do. The UKAS team recognised that the department had established and embedded processes, shown appropriate attention to detail and worked as at team at all levels. The team were particularly delighted hear that some of the areas in which they had excelled were elements that had only been introduced during the process of preparing for accreditation, such as the annual management review, audit and documented training.
At this point in the process the service was made aware that accreditation would be recommended following completion of some close out actions, including non-conformities and recommendations. Once this was done, the grant of accreditation was received in April 2024.
Reflecting on the process, Magella reiterates that the biggest challenge to the department was resource (both time and people), especially at the start of the process. “It is wonderful to have gone through this process and to have been awarded our grant of accreditation, however quality improvement is never a one-off event, it is a continuous process, that all the team are committed to and engaged in.”
Benefits
Skills management
By going through the process of identifying section leads, the department was able to identify skills in other staff members and conduct skills reviews, which helped the team identify how staff can cover when others are absent, safely sharing responsibilities around the team.
Training
Training records can be easily accessed and reviewed by the team, which is especially beneficial when new members of staff join the department.
Document control
The QMS is a very clear, centralised access point for controlled documents, and all users can now be confident that when a member of staff accesses a document, that it is the current version and that they can see clearly when it is due for review.
Patient feedback
The accreditation process has also shown where improvements can be made with regards to taking and recording patient feedback – which has also helped the team to improve the service to patients and is evidenced in the feedback the department has received post-accreditation.
Equipment
Efficiencies have also been identified by the Technical Manager, who uses the QMS to manage equipment. As with all aspects of the accreditation process there was a significant outlay of time at the start of the process, however now anyone within the department can access equipment and calibration information, and the QMS is also used to manage reminders about software updates and calibration.
Change control
The department didn’t previously have a documented process for change control, however now there is a defined, clear, and detailed process of how a significant change is introduced into the service. This was put to the test recently, when the department faced the biggest change since opening 50 years ago, in that a routinely used type of recording, critical to the testing of patients ceased production, requiring the introduction of a completely new type of electrode. The department managed this process completely through the QMS, which helped enormously with what would otherwise have been a highly disruptive process.
Celebrating achievements and looking ahead
Magella describes the day they received their grant of accreditation as a great celebration in the department. Even more so, and largely a result of the accreditation, the team was put forward for (ultimately winning) the ‘team of the year’ award at Moorfields Eye Hospital.
The team are now busy preparing for their annual surveillance visit, coming up in November 2024. In addition to this surveillance visit for the Electrophysiology department, the Ophthalmology and Clinical Support Services Division is also now preparing two further departments for IQIPS accreditation (medical imaging and ophthalmic ultrasound).
A further milestone on the horizon is that the City Road site is relocating to Oriel in Kings Cross in 2027, coinciding with the four-year assessment cycle, which Magella looks forward to as another excellent test of their newly established change management process.