![Page 1: Quality Assessment for Blood Screening Laboratories in Australia and the Asian Pacific. Darren Jardine and Staff of the National Serology Reference Laboratory,](https://reader036.vdocuments.site/reader036/viewer/2022062401/5a4d1b577f8b9ab0599a9c7b/html5/thumbnails/1.jpg)
Quality Assessment for Blood Screening Laboratories in Australia and the Asian Pacific.Darren Jardine and Staff of the National Serology Reference Laboratory, Australia
![Page 2: Quality Assessment for Blood Screening Laboratories in Australia and the Asian Pacific. Darren Jardine and Staff of the National Serology Reference Laboratory,](https://reader036.vdocuments.site/reader036/viewer/2022062401/5a4d1b577f8b9ab0599a9c7b/html5/thumbnails/2.jpg)
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
![Page 3: Quality Assessment for Blood Screening Laboratories in Australia and the Asian Pacific. Darren Jardine and Staff of the National Serology Reference Laboratory,](https://reader036.vdocuments.site/reader036/viewer/2022062401/5a4d1b577f8b9ab0599a9c7b/html5/thumbnails/3.jpg)
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
![Page 4: Quality Assessment for Blood Screening Laboratories in Australia and the Asian Pacific. Darren Jardine and Staff of the National Serology Reference Laboratory,](https://reader036.vdocuments.site/reader036/viewer/2022062401/5a4d1b577f8b9ab0599a9c7b/html5/thumbnails/4.jpg)
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
![Page 5: Quality Assessment for Blood Screening Laboratories in Australia and the Asian Pacific. Darren Jardine and Staff of the National Serology Reference Laboratory,](https://reader036.vdocuments.site/reader036/viewer/2022062401/5a4d1b577f8b9ab0599a9c7b/html5/thumbnails/5.jpg)
1. External control samples1. External control samples2. Include in all test runs2. Include in all test runs
3. Collect the data3. Collect the data4. Analyze the data 4. Analyze the data
5. Monitor variation 5. Monitor variation 6. If variation identified6. If variation identified investigate investigate
QC Process
QC ProcessThe QC Process
![Page 6: Quality Assessment for Blood Screening Laboratories in Australia and the Asian Pacific. Darren Jardine and Staff of the National Serology Reference Laboratory,](https://reader036.vdocuments.site/reader036/viewer/2022062401/5a4d1b577f8b9ab0599a9c7b/html5/thumbnails/6.jpg)
Quality Control Programme for Chiron TMA Assay
Introduced 2001Laboratories test a variety of QC samples
Quality Control Programme for Roche AmpliScreen Assays
Introduced 2002Laboratories test a single multimarker QC sample
![Page 7: Quality Assessment for Blood Screening Laboratories in Australia and the Asian Pacific. Darren Jardine and Staff of the National Serology Reference Laboratory,](https://reader036.vdocuments.site/reader036/viewer/2022062401/5a4d1b577f8b9ab0599a9c7b/html5/thumbnails/7.jpg)
EDCNet Internet-based QC monitoring systemLaboratories submit data into ‘live’ database
graphically displays data in chartsinstantaneous and confidentialInter- and intra-laboratory variationmonitors performance of instruments, reagents and operators
NRL application (https://www.nrlqa.net).
Facilitating a QC programme in real time
![Page 8: Quality Assessment for Blood Screening Laboratories in Australia and the Asian Pacific. Darren Jardine and Staff of the National Serology Reference Laboratory,](https://reader036.vdocuments.site/reader036/viewer/2022062401/5a4d1b577f8b9ab0599a9c7b/html5/thumbnails/8.jpg)
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.
![Page 9: Quality Assessment for Blood Screening Laboratories in Australia and the Asian Pacific. Darren Jardine and Staff of the National Serology Reference Laboratory,](https://reader036.vdocuments.site/reader036/viewer/2022062401/5a4d1b577f8b9ab0599a9c7b/html5/thumbnails/9.jpg)
hcvspy005
hcvspy005
![Page 10: Quality Assessment for Blood Screening Laboratories in Australia and the Asian Pacific. Darren Jardine and Staff of the National Serology Reference Laboratory,](https://reader036.vdocuments.site/reader036/viewer/2022062401/5a4d1b577f8b9ab0599a9c7b/html5/thumbnails/10.jpg)
hcvspy005
![Page 11: Quality Assessment for Blood Screening Laboratories in Australia and the Asian Pacific. Darren Jardine and Staff of the National Serology Reference Laboratory,](https://reader036.vdocuments.site/reader036/viewer/2022062401/5a4d1b577f8b9ab0599a9c7b/html5/thumbnails/11.jpg)
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
![Page 12: Quality Assessment for Blood Screening Laboratories in Australia and the Asian Pacific. Darren Jardine and Staff of the National Serology Reference Laboratory,](https://reader036.vdocuments.site/reader036/viewer/2022062401/5a4d1b577f8b9ab0599a9c7b/html5/thumbnails/12.jpg)
Summary
Provides international comparisons of QC sample results
Are fully integrated supplying QC sample, software and QA advice
Continually monitor test system performance
EDCNet