IMMUNOLOGY
John Ringrow, UKAS Senior Assessment Manager. The scientific sessions were chaired throughout the day by Professor Berne Ferry and Dr Sadia Noorani. Right: Discussion opportunities with colleagues.
aggressive disease with a poor prognosis. It is important to differentiate RCD subtypes, and treatment and prognosis is different for each type.
Accreditation with UKAS This session focused on the ever-topical subject of United Kingdom Accreditation Service (UKAS) accreditation. The first speaker, John Ringrow (Senior Assessment Manager, UKAS) discussed the transition from Clinical Pathology Accreditation (CPA) to ISO 15189 standards. John began by talking about the differences found between CPA and UKAS. The main differences were identified by gap analysis prior to UKAS beginning its assessments. The four key gaps identified were verification/validation, traceability, uncertainty of measurement, and clinical staff competence. John reported that to date 290 visits had taken place and that UKAS is on course to complete all initial visits to all laboratories by March 2018. The next speaker, Ravina Hira-Kazal,
shared her laboratory’s experience of a UKAS visit. She commented that the non- conformances received were mainly related to the four key gaps discussed previously by John. She shared some of her laboratory’s non-conformances and how these were resolved. Ravina also gave some useful advice to anyone undergoing inspection – scrutinise all standard operating procedures (SOPs) and manufacturers’ product inserts to ensure that you are doing what you/they say you should do. She also recommended that for in-house assays it is beneficial to keep written procedures as simple as possible, as you must do (and be able to justify) everything that is written in the procedure. She ended her talk by sharing her personal pre-inspection checklist, which includes carrying out observational audits on all SOPs, ensuring all documents are ‘controlled’ and can be found on the quality management system. Her final piece of advice was “expected to learn new things about your laboratory during the inspection”. The final speaker on the subject of
accreditation was Steve Rimmer, who spoke THE BIOMEDICAL SCIENTIST AUGUST 2016
‘The Autoimmune Focus meeting covered various subjects in the field of clinical immunology and the presentations stimulated interesting questions and comments from the audience’
about his directorate’s approach to the process. He began by reiterating that there are many differences between CPA and UKAS, and he suggested reading the ISO guidelines, not just 15189, but also those additional guidelines referred to in the standards, so that it is clear what is expected of you. He advised that preparation was key and should cover all documentation within the laboratory, staff training/competences, and equipment maintenance/calibration documentation. He stated that audit was invaluable in highlighting any non- conformances pre-inspection, and pointed out that any internal non-conformances that have been raised and have in place a timeframe for resolving them cannot be raised as a non conformance by UKAS. He discussed the differences found between the
a
first all-encompassing visit – describing it as a helicopter view of the laboratory – and the subsequent surveillance visits that focus in depth on certain areas.
Antinuclear antibodies Dr Eckart Mummert then talked about adding value in antinuclear antibody (ANA) testing. He pointed out that ANAs can be found in around 20% of healthy individuals, and therefore this causes many false-positive ANA results. This is particularly problematic as the majority of ANA requests received in the laboratory come from primary care where the prevalence and pretest probability of systemic autoimmune rheumatic disease (SARD) is particularly low. False-positive ANAs result in increased
healthcare costs due to unnecessary referrals and follow-up testing, as well as worry and anxiety to the patent. Therefore, it would be beneficial to reduce the number of false- positive results obtained. Both Dr Eckart and Dr Sadia Noorani discussed DFS70 antibody testing, which may be of use in reducing the incidence of false-positive ANA results. Named after their HEp-2 pattern (dense fine speckled), DFS70 antibodies produce a speckled pattern on HEp 2 cells that cannot easily be differentiated from true ANA staining. A number of studies have found that DFS70 antibodies are present in various
b
Examples of true-positive immunofluorescence antinuclear antibody screening results on HEp-2 cells: a) centromere pattern; b) nucleolar pattern.
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