IBMS and NIBSC host successful quality control webinar

The webinar, titled Assay and Device Validation and Verification: ISO15189, was developed to help staff working in clinical laboratories improve their service and meet the requirements for accreditation.

A total of 80 participants attended the two-hour event in which an expert panel of NIBSC scientists and invited guest speakers provided real-world examples of best practice across the areas of cellular pathology, molecular pathology and serology.   

The webinar was chaired by IBMS Company member Rob Anderson, who began the session with an introduction to the NIBSC and the leading role that the institute plays in the field of biological standardisation.

Next, Gavin Dickinson shared his experiences working as a medical laboratory Assessment Manager for the United Kingdom Accreditation Service (UKAS). He offered some valuable insight into what UKAS assessors are looking for during a site visit and also helped to dispel some of the common misconceptions concerning assay and device validation.

This was followed by a presentation from David Padley who addressed the question of when to validate and when to verify. David explained how the described parameters of assays and devices can be used to formulate a good validation and verification plan and reminded the audience to always ‘record, record, record!’

Graham Roberts then spoke about the validation of physiochemical methods using size exclusion HPLC as an example. He outlined the benefit of using run controls in order to identify and resolve potential issues before they develop into more serious problems.

Finally, IBMS Fellow Fiona Denham, Tissue Sciences Quality Manager at Viapath Analytics discussed the validation of qualitative tests. The audience were shown several images of cellular pathology tests accompanied by their corresponding performance criteria. Fiona also highlighted the importance of fully recording every step of the validation method.

The audience were encouraged to take part in polls throughout the webinar and could submit their questions for the 30-minute panel session that closed the event. The questions covered issues such as who is responsible for the validation and verification of assays and devices and what to do in the absence of an international reference standard.

IBMS Deputy CEO Sarah May said:

“This was an excellent webinar and one that many scientists working in quality management would find useful. The discussion of validation and verification of assays can be challenging for some departments, so this learning opportunity was particularly of interest to the audience. We are already looking forward to the next webinar.”

Rob Anderson, Senior Scientist at NIBSC, added:

“This webinar, which represents part of a continued programme between IBMS, UKAS and NIBSC, was a great opportunity to educate and inform scientists about how our standards should be used to assure the quality of patient diagnostics.”

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