Reference Laboratories

The role of Reference Laboratories

The role of Australian National Reference Laboratories is designed to harmonise with the OIE definitions of a Reference Laboratory (with regional and international responsibilities), as follows:

• to function as a centre of expertise and to facilitate standardisation of techniques relevant to the specified disease(s);
• to store and distribute biological reference products and any other reagents used in the diagnosis and control of the specified disease(s);
• to develop new procedures for the diagnosis, control and exclusion testing of the specified disease(s);
• to gather, process, analyse and disseminate epidemiological data relevant to the specified disease(s);
• to participate in scientific and technical studies in collaboration with other laboratories or organisations;
• to publish and disseminate information on laboratory testing for the specified disease(s);
• to provide scientific and technical training for laboratory personnel in other Australian laboratories

While not all Reference Laboratories may be able to provide all of these functions, the list should act as a guide as to the expectations of a National Reference Laboratory.

Criteria for endorsement as an Australian National Reference Laboratory

To carry out the role requirements as outlined above, an Australian National Reference Laboratory is required to comply with the following:

• Employ scientific staff recognised as experts in the specified disease(s) and have an available range of diagnostic tests for the disease(s), including those not ordinarily available at other Australian laboratories;
• Where appropriate, be able to supply biological reference products and any other reagents used in laboratory testing for the specified disease(s);
• Conduct  research to evaluate new laboratory tests for the specified disease(s) and encourage collaborative studies with other laboratories;
• Evaluate data submitted in support of SCAHLS approval of new commercial test kits for existing laboratory tests, for the specified disease(s);
• Gather, process, analyse and disseminate data relevant to the laboratory aspects of the specified disease(s);
•  Assist the Australian National Quality Assurance Program (ANQAP) to conduct proficiency testing where appropriate.
  

Access to Reference Laboratory Services

Australian National Reference laboratories will provide expertise and services to other Australian and New Zealand laboratories on a cost recovery basis deemed appropriate by that laboratory.

Reporting requirements

All Australian National Reference Laboratories will submit a brief annual report of activities to SCAHLS.  This will include confirmation of expertise, data on testing levels, a summary of research including publications, and a record of training activities.  The report will follow the same format as the annual OIE report.  OIE Reference Laboratories may submit their annual OIE report to SCAHLS rather than prepare an additional report.  In the event of a significant change in the ability of an Australian National Reference Laboratory to meet its requirements (eg. the loss of designated “expert”) the laboratory is required advise SCAHLS of its intentions to retain or relinquish Reference Laboratory status.

SCAHLS review process

SCAHLS will annually review the ability of each Laboratory to meet the requirements of an Australian National Reference Laboratory.  When an Australian National Reference Laboratory fails to meet the requirements or relinquishes its Reference Laboratory status, SCAHLS will require a statement justifying retention of Reference Laboratory status, or invite new tenders respectively.  If new tenders are called, all laboratories (via the Members) will be invited to make submissions.  When there is more than one submission for a given Reference Laboratory SCAHLS members will assess each of the submissions on their merit and vote accordingly.  All aspects of this review will occur “in session”.