ACCREDITATION STATUS:

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

CLINICAL APPLICATION:

HLA Class I and II associated disease testing

PURPOSE OF PROGRAMME:

To assess participants’ ability to correctly determine disease associated HLA allele families/alleles.

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:

Participating laboratories will be assessed on the alleles reported for each sample and disease.  Assessment will be at the 1st or 2nd field level appropriate to the individual participant’s results for each locus. A reference result will be used for assessment. Reports of groups of alleles must include the reference allele.

PERFORMANCE MONITORING:

Satisfactory performance is obtaining ten samples in agreement with the reference genotype in a year for each disease registered for.

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.