ACCREDITATION STATUS:

UKAS Schedule of Accreditation, Accredited to ISO/IEC 17043:2010 Provider 8351

CLINICAL APPLICATION:

HLA Antibody Specification

PURPOSE OF PROGRAMME:

To assess the laboratory's ability to determine the component HLA specificity or specificities in the antisera using all methods the laboratory employs for clinical samples.

ANALYTES:

PROGRAMME OF ANALYSIS:

Results should be submitted via online data entry. Results are expected to be returned within the specified reporting period (please refer to results deadline for each distribution on the UK NEQAS for H&I website or Participants Manual). The majority of UK NEQAS for H&I schemes are assessed on a consensus basis, therefore samples are distributed with the assigned value not being determined. Where a reference result is used, this testing is performed alongside or after the close of the EQA scheme. For these reasons UK NEQAS for H&I is unable to disclose results early.

DATA ANALYSIS:

Qualitative analysis.

PERFORMANCE SCORING:

Class I and Class II IgG specificities will be assessed independently. Consensus presence of a specificity is determined by at least 75% of laboratories agreeing the specificity. Consensus absence of a specificity is determined by at least 95% of laboratories agreeing the absence of the specificity

PERFORMANCE MONITORING:

Satisfactory performance is testing ten serum samples and getting at least 75% of specificities in agreement with the consensus findings in a year.

PERSISTENT POOR PERFORMANCE:

Laboratories not meeting the Satisfactory Performance criteria are deemed to have Unsatisfactory Performance and must complete a root cause, corrective and preventative action form.