UKAS Schedule of Accreditation, Accredited to ISO/IEC 17043:2010, Provider 7833
Markers used to aid the diagnostic process in a variety of settings, including identification of tumours of uncertain lineage, site of origin in metastatic disease.
PURPOSE OF PROGRAMME:
To assess a laboratory's use of general IHC markers with regard to selectivity and sensitivity.
|primary antibodies||Assessments are scored on an arbitrary scale between 4 and 20. Non-submission is scored as 0.|
MATERIAL PROVIDED: Unstained sections from FFPE tumour and/or normal human tissues containing the analyte of interest
DISTRIBUTIONS PER YEAR: 4
SAMPLES PER DISTRIBUTION: Two antigens per assessment run, with one being repeated throughout the year (Gold Standard), and on
FREQUENCY OF DISTRIBUTION: Quarterly
PROGRAMME OF ANALYSIS:
Results are submitted in the form of an IHC slide stained for each of the tested antigens. Participants are also expected to submit an example of their own stained in-house control material appropriate for each tested antigen.
Slides are microscopically assessed by four assessors working independently. Each assessor marks on a scale of 1 to 5, with the final mark being a summation of individual marks.
Assessors whose marks are non-aligned by >1 mark resolve discrepencies in real-time. Assessors are monitored for overall alignment post-assessment. A total score of between 4 and 9 is classified as 'Poor', which highlights a potential issue to the laboratory. Green action-point: two 'Poor' results in a rolling-period of five assessments would result in a laboratory's status being designated as Green (offer to paticipant of assitance to improve). Amber action-point: three 'Poor' results in a rol
Poor performance monitoring applies only to UK clinical laboratories. Performance monitoring is assessed on the UK NEQAS provided material; results on submitted in-house control material are not considered.
PERSISTENT POOR PERFORMANCE:
Red action-point: four 'Poor' results in a rolling-period of five assessments. Participant and Head of Department are notified and invited to contact the Scheme Director to discuss actions to rectify the situation. The Cellular Pathology NQAAP Chair is notified and the performance of the laboratory is referred to that committee for consideration.
Immunocytochemistry & In-Situ Hybridisation
The External Quality Assessment Scheme for Immunocytochemistry was founded in 1985 by Mr Gerry Reynolds at Mount Vernon Hospital, Middlesex. In 1988 the Service was recognised by the UK Department of Health and from that time it became known as the UK National External Quality Assessment Service for Immunocytochemistry (UK NEQAS-ICC and later, when it incorporated in-situ hybridisation methods, as UKNEQAS ICC & ISH).