Education at the heart of EQA

External quality assessment (EQA), also referred to as proficiency testing (PT), has been a central part of laboratory quality assurance for more than half a century. Inter-laboratory comparison exercises in the 1960s demonstrated that there was very poor agreement between UK laboratories for the measurement of key analytes and led to the establishment of the UK National External Quality Assessment Service (UK NEQAS), with the aim of improving laboratory performance through education and the sharing of best practice. Accreditation of EQA schemes to ISO 17043 requires EQA to provide: education for participants, in the form of expert commentary; interpretation of the EQA exercise results; and support to laboratories with unsatisfactory performance.

Regulatory and educational

There are different types of EQA/PT programmes, which fall into two major groups: regulatory and educational, although the two are not necessarily mutually exclusive. Regulatory EQA is generally mandatory and ‘failure’ in such programmes carries a penalty that may include the removal of the licence to practise or provide a service. Because this system is based on penalty for failure, it may have relatively basic acceptable performance standards that are achievable by all but the worst performing participants. An unfortunate consequence of such systems is that they may encourage the laboratory to invest the maximum effort in avoiding failure, which would not be applied to patients’ specimens. Educational EQA programmes, in contrast, do not have the same punitive outcomes, although persistent unsatisfactory performance and a failure to respond appropriately to out-of-consensus results should result in review by the EQA provider and escalation to a national oversight body.

Educational EQA does not have the same ‘pass/fail’ cut off, allowing the EQA  organiser to set the performance limits higher and challenge laboratories harder, provide a wider range of cases and a higher frequency of specimen distribution, but inevitably at a price. There is a risk that laboratories may regard repeated failure in an educational programme as normal or acceptable. Education in EQA also requires a major commitment of EQA staff resources and this is inevitably reflected in the EQA subscription fees.

The recently launched EQA Governance Framework of The Royal College of Pathologists (RCPath) in the UK aims for an effective and harmonised approach to EQA performance oversight that reflects the importance of sharing performance outcomes, especially where method-related concerns exist. The aim is not to prevent laboratories practising (the Governance Framework does not have that remit) but to improve patient care and to learn from patient safety incidents in diagnostic testing.

Getting the most from EQA

The educational impact of EQA extends beyond individual laboratories to professional bodies who wish to understand the limitations of the methods in use, healthcare funders who wish to obtain the best quality results at the lowest cost, and patients who wish to know that their results are correct and have been correctly interpreted. Accreditation bodies should also ensure they have sufficient knowledge of EQA to understand both the limitations and the scope of the EQA programmes utilised by laboratories. EQA providers are in a unique position of capturing data that can inform the shared knowledge of the state of the art in laboratory medicine. The data are powerful, if understood correctly, especially when assessing method-related performance concerns using commutable survey materials. These opportunities do not even touch on the demonstration of professional competency of individual healthcare practitioners, where the challenge includes tailoring assessment systems to fit the knowledge and experience of the practitioner. 

The question arises as to how we demonstrate the effectiveness of educational EQA over a simpler and less expensive regulatory programme. This is an almost impossible question to answer. EQA providers provide education through expert commentaries, scientific papers, webinars, training courses and individual competency assessments. The success of these can be monitored through feedback questionnaires, the performance of laboratories in EQA over time etc. However, the activity is never complete, because of the dynamic nature of diagnostic testing and laboratory staff.

The best EQA provision is a partnership between the laboratory and the EQA provider. External quality assessment is a free lesson and an opportunity to get things wrong without compromising the safety of an individual patient. Inevitably, being out of consensus will require investigation and action in the quality management system but may result in improved testing systems. There are expectations in this partnership from trust on both sides to an expectation of a proactive response by the participant and assistance by the EQA provider, when needed by the laboratory

Education is a powerful weapon. With that in mind, the EQA scheme should not aim to provide comprehensive academic programmes, which are better delivered by those with a different expertise. They should ask how they can demonstrate the effectiveness of their efforts and should ensure that their advice is evidence or guideline based. It may be a controversial statement, but the pressure to make the design of all EQA programmes the same should be resisted. Although there is merit in collaborations between EQA providers to assess performance across national boundaries and global methods, we should value the diversity of provision that allows providers to respond to clinical scenarios, to work in partnership with participants and to push educational boundaries through innovative service provision

Barbara De la Salle PhD