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 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

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

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

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

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