Consent and Genetics Counselling for genetic testing

According to the Laboratory Accreditation Standards and Guidelines for Nucleic Acid Detection Techniques (National Pathology Accreditation Advisory Council) genetic testing is classified as

• Class A: diagnostic tests and
• Class B: predictive, carrier and prenatal tests.

Class A diagnostic genetic tests require verbal consent of the individual being tested and do not require pre-test genetic counselling for genetic disease. Test results are accessible by the doctors providing patient care.

Class B tests include presymptomatic tests for untreatable adult onset conditions (predictive testing), prenatal and some carrier tests for autosomal recessive or X-linked conditions.

Tests in this class require

• formal consent from the individual being tested
• pre and post-test counselling
• confidentiality procedures
• coordination between  the laboratory and clinicial geneticists or other referring clinicians.

The responsibility for ensuring informed consent, the provision of appropriate pre- and post-test counselling and ensuring patient confidentiality lies with the referring clinician.

For Class B tests, if the laboratory has reasonable grounds for believing that informed consent may not have been given and pre- and post-test genetic counselling may not have been arranged, laboratory staff will contact the referring clinician to ensure that informed consent is obtained prior to laboratory testing. Alternatively, the patient can be referred to the South Australian Clinical Genetics Service.

The laboratory does not provide genetic testing for any patient-initiated service which is not referred from a clinical service.

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