Quality Assessment for Blood Screening Laboratories in Australia and the Asian Pacific. Darren Jardine and Staff of the National Serology Reference Laboratory, Australia

NRL’s Roles The functions that NRL performs are preventative against Poor testing Poor use of tests Poor safety in laboratories Waivering public confidence Blood wastage

NRL’s Quality Assurance Methods Reference testing Testing strategy development Education programmes Quality Management Delivers reports and programmes to generate quality in laboratories Evaluations of Test Kits Kit performance monitoring Methods: EQAS QC Specificity monitoring Batch monitoring

Quality Assurance of NAT for Blood Screening Laboratories. Established NRL methods adopted for NAT. Methods selected were Quality Control (QC). External Quality Assessment Scheme (EQAS) 25 laboratories participating 14 laboratories using the Chiron TMA assays 10 laboratories using the Roche AmpliScreen assays 1 laboratory using an in-house HCV RT PCR

1. External control samples 2. Include in all test runs 3. Collect the data 4. Analyze the data 5. Monitor variation 6. If variation identified investigate QC Process The QC Process

Quality Control Programme for Chiron TMA Assay Introduced 2001 Laboratories test a variety of QC samples Quality Control Programme for Roche AmpliScreen Assays Introduced 2002 Laboratories test a single multimarker QC sample

EDCNet Internet-based QC monitoring system Laboratories submit data into ‘live’ database graphically displays data in charts instantaneous and confidential Inter- and intra-laboratory variation monitors performance of instruments, reagents and operators NRL application ( Facilitating a QC programme in real time

VQC Viral NAT Run Controls Secondary working reagents calibrated against WHO international standards >30,000 results Twenty-five laboratories Australia, New Zealand, SE Asia and Europe.

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Summary Evaluates precision AND accuracy Allows trends and shifts to be detected Provides the opportunity for preventative action to be taken when results are outside expected limits QC programmes

Summary Provides international comparisons of QC sample results Are fully integrated supplying QC sample, software and QA advice Continually monitor test system performance EDCNet