Quality Assessment for Blood Screening Laboratories in Australia

Quality Assessment for Blood Screening Laboratories in Australia and the Asian Pacific. Darren Jardine and Staff of the National Serology Reference Laboratory, Australia NRLs NRLs Roles Roles The functions that NRL performs are preventative against Poor testing

Poor use of tests Poor safety in laboratories Waivering public confidence Blood wastage NRLs NRLs Quality Quality Assurance Assurance Methods Methods Evaluations of Test Kits Kit performance monitoring Methods: EQAS

QC Specificity monitoring Batch monitoring Quality Management Reference testing Testing strategy development Education programmes Delivers reports and

programmes to generate quality in laboratories 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

The The QC QC Process Process ss eess oocc PPrr 3. 3. Collect Collect the

the data data 4. 4. Analyze Analyze the the data data CC QQ 1. 1. External External control

control samples samples 2. 2. Include Include in in all all test test runs runs 5. 5. Monitor Monitor variation variation

6. 6. If If variation variation identified identified investigate investigate 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 Facilitating Facilitating aa QC QC programme programme in in real real time 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). 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. hcvspy005 hcvspy005 hcvspy005 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 Summary EDCNet Provides international comparisons of QC sample results Are fully integrated supplying QC sample, software and QA advice Continually monitor test system performance