Informed Consent Compliance Form printable pdf download

Informed Consent Compliance

for Germline Genetic Testing

Name of Practice_______________________________________________________________

Practice Address_______________________________________________________________

Date ___ /___ /______ Account Number_____________________________________________

Lab__________________________________________________________________________

I,__________________________________________ (physician name), acknowledge that:

•

Prior to ordering genetic testing on the patient listed below, I have obtained a signed, written consent

form from the patient (or their authorized representative) as required by applicable state law and/or

regulations; and

•

I will maintain all written consent forms as part of the patient file and make them available to

Athena Diagnostics upon reasonable request.

Patient Name__________________________________________________________________

DOB ___ /___ /______ Gender M/F Collection Date ___ /___ /______

Tests Ordered______________________________________________________________

Signature of medical practitioner___________________________________________

NPI___________________________________________________

Background

Some state laws require that individuals (or their authorized representative) provide written

informed consent to the physician ordering germline genetic testing and/or releasing test results.

The individual (or authorized person) must sign and date a consent form that includes:

•

Statement of test purpose and description

•

Statement that prior to testing, the physician ordering the test discussed with the individual the

reliability of positive/negative test results and the level of certainty that a positive result for the

disease or condition serves as a predictor of such disease

•

Statement that the physician informed the individual about availability and importance of

further testing, physician consultation and genetic counseling, and provided written information

identifying a genetic counselor or medical geneticist

•

General description of each disease or condition for which a test is ordered

•

The name of the person or persons to whom the test results may be disclosed

This signed consent form should accompany test order and patient specimen UNLESS TEST ORDER CONSENT HAS BEEN SIGNED.

For internal use only. Accession number _____________________________

Attestation of Informed Consent – December 2014

Informed Consent Compliance Form