576-b. Performance of certain clinical laboratory services upon request. 1. A clinical laboratory may perform a clinical laboratory service (including accepting a specimen or assignment for examination and rendering a report), that it is otherwise allowed to perform, upon the request of the person on whom the service is to be performed and render a report directly to the person, where the service is for the same purpose as a test or collection device that has been approved or cleared by the Food and Drug Administration of the United States Department of Health and Human Services for sale or distribution to the public on a direct or over-the-counter basis without a prescription from a qualified health care practitioner.
2. All services conducted pursuant to this section shall comply with the standards for testing established by the department and with any other laws of this state, including requirements for confidentiality and pre-test and post-test counseling.
3. The results of any test conducted pursuant to this section shall be provided only to the person who requested the test. Such results shall be provided in a clear and concise manner that is understandable by lay persons and that identifies results indicating the need for referral to a physician or other qualified health care practitioner.
4. Nothing in this section shall authorize a clinical laboratory to engage in the practice of any health care profession under title eight of the education law. The report issued to a person for a test conducted pursuant to this section shall contain a clear statement, presented in a prominent manner, to the effect that the report should not be viewed as medical advice and is not meant to replace direct communication with a physician or other health care practitioner.
Last modified: February 3, 2019