Accreditation

Classification of Human Genetic Testing - 2007 Edition

This is a publication of the National Pathology Accreditation Advisory Council which is managed by the Australian Government Department of Health and Ageing. It has been prepared for laboratories as a guide to when patients would benefit from pre-test counselling.

Results from genetic tests can have serious social and personal implications. For some time now, pathology laboratories have suggested that guidance should be available to their staff and requesters as to when patients would benefit from pre-test counselling.

DNA testing is already categorised into two levels of testing in the Laboratory Accreditation Standards and Guidelines for Nucleic Acid Detection and Analysis. Supplementary information on decision making regarding pre-testing counselling is now being included.

This new document is a supplementary guide to “Laboratory Accreditation Standards and Guidelines for Nucleic Acid Detection and Analysis (2006)” and provides additional information about aspects of the standards and guidelines. Nucleic acid tests are performed to determine the presence of infectious diseases in blood and tissue samples as well as to diagnose human genetic diseases.

This supplementary guidance expands the existing two Levels of testing and allows the requesting practitioner and laboratory staff to know what counselling a patient should require. The majority of requests for genetic testing for diagnostic or medical screening purposes will be Level 1. These tests require the usual degree of pre-test advice and consent. A Level 2 test requires professional genetic counselling and consent.

It is proposed that the next time the full document is reviewed this guide will be incorporated in the appendix of the document.

Classification of Human Genetic Testing - 2007 Edition (PDF 69 KB)
Classification of Human Genetic Testing - 2007 Edition (Online)

This document came into effect on 1 January 2008.

The document linked to this page is in PDF format. If you are unable to view it, please contact the NPAAC Secretariat and a copy will be sent to you.