Q: Can I release the results of genetic tests to the subject?
A: Only if you hold a CLIA certificate that covers the test.
Q: But I'm not offering clinical care, just giving the results of a PCR test for a particular gene mutation or allele. Does CLIA apply?
A: CLIA regulations apply to all laboratories that perform testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention, treatment of disease or the impairment of, or assessment of health. Providing results of genetic testing is a de facto diagnosis and assessment of health.
Q: CLIA offers something called a Certificate of Waiver. Can I get a waiver for my genetic test?
A: No. Genetic tests are classified as "high complexity" and are not eligible for a waiver.
Q: What if I release results of a genetic test without a CLIA certificate?
A: Civil monetary penalties may be levied against the laboratory by the Centers for Medicare & Medicaid Services (formerly HCFA).