11.0 Quality Assurance of HBV Testing

Posted in: HBV

11.1 Laboratories

Laboratories that perform HBV testing and claiming Medicare Benefits:

  • must be accredited for medical testing in accordance with the National Pathology Accreditation Advisory Council (NPAAC) standards;
  • should contribute testing statistics to National Serology Reference Laboratory (NRL) to ensure the completeness of test denominator data;
  • must be enrolled, participate and demonstrate acceptable performance continually in appropriate external quality assurance programs (EQAS);
  • should report any adverse events to both the IVD sponsor and the TGA.

11.2 Pre-market quality assurance of HBV in-vitro diagnostic devices

The TGA has regulatory responsibility for IVDs through the Therapeutic Goods Act 198914 and Therapeutic Goods (Medical Devices) Regulations 2002. For regulation of HBV IVDs refer to the TGA website.

11.3 Post-market monitoring and quality assurance of HBV in-vitro diagnostic devices

IVD manufacturers, sponsors and the TGA have the responsibility for post-market monitoring of the IVDs. The manufacturer and sponsor must inform the TGA of all reportable adverse events. Corrective action must be initiated by the manufacturer and sponsor of an IVD in consultation with the TGA. This action 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. Laboratory users are encouraged to report any adverse event to the TGA through the Medical Device Incident Reporting & Investigation Scheme as well as the sponsor of the IVD.