Quality Assessment for Blood Screening Laboratories in Australia and the Asian Pacific.

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

2. 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

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

4. 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

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

6. 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

7. Facilitating a QC programme in real time • 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 (https://www.nrlqa.net).

8. 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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11. Summary QC programmes • 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

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