OPINION EQA – past, present and future?


In 1977 the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) defined the objectives of External Quality Assessment (EQA) as to: provide a measure of the quality of a test; supplement internal quality control procedures; provide a measure of the ‘state of the art’ of a test; obtain consensus values when true values are unknown; investigate factors in performance (methods, staff etc.); and, act as an educational stimulus to improvement in performance. When I started in pathology, over 40 years ago, the majority of tests were manual. Computers and automation were in their infancy, we had just integrated a Commodore PET computer with our Technicon AA2 analyser, we were still manually plotting our Levey-Jennings and Cusum IQC on paper charts that covered the entire corridors outside the laboratory, and EQA reports were paper-based, posted between participant and provider. Regional EQA schemes were already established with UK NEQAS at the Wolfson Laboratories in Birmingham, and Weqas at the University Hospital of Wales in Cardiff, both initiated in the late 1960s. The UK NEQAS and Weqas schemes were free to participating laboratories, the money top-sliced by the Department of Health and the Welsh Office, respectively, until April 1993. After this date, the money was devolved to hospital laboratories, allowing freedom of choice for their EQA provider.


By the millennium, we had four major clinical chemistry EQA providers in the UK, the previously government- sponsored programmes, UK NEQAS and Weqas, and two commercial providers, the Randox International Quality Assessment Scheme (RIQAS) and Murex Quality Assessment Programme, the latter providing very different designs. An oversight committee was established in the early 1990s, the Joint Working Group for Quality Assurance (JWG), the membership of which was nominated by the professional bodies, and accountable to The Royal College of Pathologists (RCPath). Until 1997 they had the role of ‘recognising’ EQA providers along with an advisory role for laboratories on poor EQA activity.


In 1996 Clinical Pathology


Accreditation (CPA) took over the accreditation function, leaving the JWG with the watchdog and advisory role of poor performance monitoring. The accreditation function was later undertaken by UKAS after the publication


of ISO 17043:2010 Conformity assessment – General requirements for proficiency testing.


Over the past two decades some EQA schemes have changed markedly in terms of their objectives, depth and breadth of programmes provided, and in the design of the programmes. Designs are no longer confined to the simple statistical peer-review assessment of analytical performance, with a number of EQA programmes providing assessment of the total testing process including the pre- and post-analytical phases and audits. Improvements in the assessment of the analytical phase includes evaluation of trueness using target values assigned with high order reference methods, utilising performance criteria that are clinically (rather than statistically) appropriate for the test, and the use of commutable and clinically challenging samples.


Assessment of EQA data is undertaken in a timely manner with data uploaded either via web portals or through database integration and the use of electronic EQA reports. A wealth of additional information can be provided to participants with direct links to the EQA databases providing rich data for troubleshooting. Education, performance surveillance, troubleshooting, quality improvement and method vigilance reporting are now major components of an EQA service. It is therefore appropriate that the 1977 objectives are broadened to include these additional ‘must haves’ with post- market vigilance and the monitoring of harmonisation strategies becoming even more important with the transition from IVDD98/79/EC to IVDR 2017/746, and the requirement for UK Conformity Assessment (UKCA) to be in place in the UK from January 2023. The impact of these new regulations requires a transformation of the diagnostic sector and requires regulatory infrastructures that are ‘ready for business’. Healthcare delivery is changing, the pandemic accelerated the pace for adoption of point-of-care testing (POCT), digital technology and the ‘digital first’ model of care, with a health service offering an option for richer face-to- face consultations with clinicians where patients want or need it. Patients will be increasingly cared for in their own homes, with diagnostics being provided with POCT devices, and people will be encouraged to stay well, to recognise important symptoms early, and to manage their own health, guided by


WWW.PATHOLOGYINPRACTICE.COM SEPTEMBER 2022 About Annette Thomas


Annette Thomas is a consultant clinical biochemist at Cardiff and Vale University Health Board with over 40 years’ experience in laboratory medicine, over 20 years of which have been as Director of Weqas, an International EQA provider and Reference Measurement Laboratory. Annette is the National Point of Care (POCT) Clinical Lead for Wales, representing POCT in government advisory committees, and chairs the Wales POCT Strategic Board and the POCT Delivery Group. She is a member of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Task Force on Global Lab Quality, and past chair of the IFCC Committee on Analytical Quality.


wearables and digital tools. Healthcare is facing the challenge of


transforming into a data-driven science, with artificial intelligence in digital imaging in pathology and radiology already a reality. Many of these new and emerging digital healthcare technologies rely on the ability to collect, store, access and share diagnostic, medical and other health-related data, and will require more from our healthcare scientists to monitor and interpret these data. With an increase in patient-centred digital diagnostics, where does that leave EQA? Providers need to consider how to meet these challenges: for POCT they need to ensure that the performance meets the clinical utility of the test and the needs of the patient; that governance processes are robust; that the full diagnostic patient pathway is mirrored; and, that the integrity of the data in this data-driven world is not compromised. Consideration will also need to be given to matrix issues such as the design of EQA for implanted devices, and the appropriateness and stability of the samples, if at all needed. The design of EQA must ‘keep up’ with the times – with greater use of informatics and the sharing of data.


Annette Thomas FIBMS MRSB CSci CBiol


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