NRL Quality Assurance Programme
The National Serology Reference Laboratory, Australia was established in 1985, as part of the Australian Government's HIV/AIDS Strategy, to deal with evaluation of HIV tests and interpretation of HIV test results. Based on this initial success the NRL developed a national HIV quality assurance programme, working together with other laboratories to achieve high quality HIV testing results with only rare controversies over diagnostic results. The NRL's quality assurance methodologies have since been refined and applied to HTLV and HCV serology (1993 and 1995 respectively) as well as to HIV and HCV Nucleic Acid Testing (1996 and 1998 respectively).
The NRL has continued to expand its programmes and services. A tertiary reference testing service has been instituted to provide adjudication on controversial HIV and HTLV diagnoses. A reference testing service is also available for HCV. A Quality Management System has been developed and certified/accredited to ISO 15189 and ISO9001 standards. The External Quality Assessment Schemes meet ISO Guide 13. Personnel have acted as consultants and trainers in Australian and overseas laboratories. Laboratory evaluations of new or modified HIV and HCV test kits have been contracted to the NRL by the Therapeutic Goods Administration (TGA). The NRL has been a WHO Collaborating Centre since 1985 and it is also nominated as an Australian Centre of Excellence.
During recent years, the NRL has examined how best to serve the quality assurance needs of retrovirus and hepatitis testing laboratories in Australia and overseas. As a result of these deliberations, the NRL Quality Assurance Programme has been developed – combining all of the NRL's programmes and services into one comprehensive package. This programme provides a "one-stop-shop" for laboratory quality assurance, enabling participants to monitor their performances and maintain and/or improve their standards.
Whilst visiting the NRL, an international guest was quoted as saying "It was great seeing your operation during my visit. Your group certainly punches above its weight! I was surprised that the government does not give more resources, given the amount you have to do."
Objectives of the Programme
The NRL Quality Assurance Programme has been designed to provide participating laboratories with the means to ensure accurate and efficacious serology.
Components of the programme
Features of the Programme
· Comprehensive – combines evaluations, monitoring, QC, EQAS, TRT, consulting, training and Internet access in one complete programme
· Confidential – unique laboratory ID numbers are used for all communication, data entry and reporting
· Cost Effective – systems are free of charge or provided at a competitive rate.
· Efficient – samples are aliquotted and shipped ready for use, and data entry is electronic.
· Recognised – nationally and internationally respected, and developed by experienced professionals
· Extensive – systems available for HIV, HCV, HTLV and HBsAg serology, as well as for HIV, HCV and HTLV Nucleic Acid Testing, Chlamydia trachomatis, HBV
· Personalised – individual virus systems allow for subscription to appropriate combinations of QA programs
· Independent – source of expert impartial adjudication and information on serology and laboratory quality assurance and management
· Regular – frequent distribution of QC samples and EQAS panels allow regular monitoring of laboratory procedures