9.0 Quality Assurance of HCV Testing

For more information and background on HCV IVD regulation and quality assurance, refer to the TGA.

9.1 Laboratories

Laboratories that perform HCV testing:

• must be NATA accredited for medical testing;⁴⁷
• must participate in an external quality assessment scheme (EQAS);⁴⁸
• must comply with the National Pathology Accreditation Advisory Council (NPAAC) standards;⁴⁹ and
• should contribute testing statistics to National Serology Reference Laboratory (NRL) to ensure the completeness of test denominator data.¹⁷

9.2 Pre-marketing quality assurance of HCV IVDs.

The TGA has regulatory responsibility for IVDs through the Therapeutic Goods Act 1989 (the Act) and its associated regulations.⁵⁰

9.3 Post-marketing quality assurance of HCV IVDs

IVD manufacturers, sponsors and the TGA have responsibility for post-market monitoring of the IVDs. Corrective action must be initiated by the manufacturer and sponsor of an IVD in consultation with the TGA. This must occur as soon as practicable after becoming aware of information relating to any adverse events, malfunction or deterioration in the performance, or inadequacy in the design production and labelling of an IVD. Users are encouraged to report any issues with an IVD to the sponsor and the TGA. Reports to the TGA can be submitted through the TGA’s Incident Reporting Investigation Scheme (IRIS).  https://www.tga.gov.au/medical-device-incident-reporting-investigation-scheme-iris