ACCREDITATION STATUS:

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

CLINICAL APPLICATION:

HLA antibody detection

PURPOSE OF PROGRAMME:

To assess participants' ability to correctly determine the presence of HLA antibodies using all 'screening' 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:

Participating laboratories will be assessed on the antibody class or classes they designate at registration. The consensus findings for Class I and Class II antibodies are determined separately. Consensus positivity or negativity of each sample is determined by at least 75% of laboratories agreeing on the presence or absence of Class I or Class II antibody. Samples failing to reach the 75% consensus level will not be assessed. The reports of participants registered for Class I and II assessment must be in agreement with the consensus Class I and Class II findings on a serum to achieve an ‘Acceptable’ classification.

PERFORMANCE MONITORING:

Satisfactory performance is making 80% of reports on all sera in agreement with the consensus Class I or both the consensus Class I and Class II antibody 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.