ACCREDITATION STATUS:

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

CLINICAL APPLICATION:

HLA typing

PURPOSE OF PROGRAMME:

To assess participants' ability to correctly determine HLA alleles to the 2nd or 3rd field level

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. Participants will only be assessed on those alleles that appear in the IMGT/HLA database update from the April two years prior to start of the Scheme

PERFORMANCE SCORING:

The consensus full HLA genotype is determined by at least 75% of laboratories agreeing each allele. A "blank" forms part of the assessment if at least 75% of laboratories report a single allele at a locus. A reference result will be used for assessment for samples failing to reach the 75% consensus level.

PERFORMANCE MONITORING:

Satisfactory performance is obtaining nine or more full HLA genotypes in agreement with the consensus/reference genotypes 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.