Regulatory compliance in Clinical Laboratory Genetics: the Australian Scene
The Australian Government Department of Health and Ageing undertakes a range of activities relating to the delivery of pathology services in Australia. The National Pathology Accreditation Advisory Council (NPAAC) advises the government on matters relating to the accreditation of pathology laboratories. NPAAC plays a key role in ensuring the quality of Australian pathology services and is responsible for the development and maintenance of accreditation policies, standards and guidelines for pathology practices. Audits against these standards and guidelines are conducted by the National Association of Testing Authorities, Australia (NATA). NATA is the Australian Government-endorsed provider of accreditation for laboratories. It is also a peak authority in Australia for the accreditation of inspection bodies and proficiency testing programs.
NATA accreditation provides formal recognition of the competence and reliability of testing laboratories. To maintain this recognition, laboratories are re-evaluated every 3 years by NATA to ensure their continued compliance with requirements and maintenance of operation standards. Laboratories are also required to participate in relevant proficiency testing programs between reassessments, as a further demonstration of technical competence. In addition, key laboratory staff members are required to have appropriate qualification/certification in the relevant field of expertise.
Clinical laboratory genetics is relatively new in Australian pathology. NPAAC have developed guidelines specific for cytogenetics (released 2001) and molecular genetic testing laboratories (released in 2000); both are currently being revised to more comprehensive versions. All cytogenetics laboratories and most molecular genetic laboratories have NATA accreditation. Personnel certification through the Human Genetics Society of Australasia has been in place for cytogenetics since 1985, and certification in molecular genetics started in 2004.