ACCREDITATION STATUS:

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

CLINICAL APPLICATION:

Pharmacogenetic-related HLA Class I and II testing.

PURPOSE OF PROGRAMME:

To assess participants’ ability to correctly determine pharmacogenetic related HLA 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:

The consensus HLA status of each sample is determined by at least 75% of laboratories agreeing on the presence or absence of a relevant HLA allele for each drug. A reference result will be used for assessment for samples failing to reach the 75% consensus level.

PERFORMANCE MONITORING:

Satisfactory performance is making ten sample reports in agreement with the consensus/reference HLA type in a year per drug that they have 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.