§ 576-b. Performance of certain clinical laboratory services upon\nrequest. 1. A clinical laboratory may perform a clinical laboratory\nservice (including accepting a specimen or assignment for examination\nand rendering a report), that it is otherwise allowed to perform, upon\nthe request of the person on whom the service is to be performed and\nrender a report directly to the person, where the service is for the\nsame purpose as a test or collection device that has been approved or\ncleared by the Food and Drug Administration of the United States\nDepartment of Health and Human Services for sale or distribution to the\npublic on a direct or over-the-counter basis without a prescription from\na qualified health care practitioner.\n 2. All services conducted pursuant to this section shall comply with\nthe standards for testing established by the department and with any\nother laws of this state, including requirements for confidentiality and\npre-test and post-test counseling.\n 3. The results of any test conducted pursuant to this section shall be\nprovided only to the person who requested the test. Such results shall\nbe provided in a clear and concise manner that is understandable by lay\npersons and that identifies results indicating the need for referral to\na physician or other qualified health care practitioner.\n 4. Nothing in this section shall authorize a clinical laboratory to\nengage in the practice of any health care profession under title eight\nof the education law. The report issued to a person for a test conducted\npursuant to this section shall contain a clear statement, presented in a\nprominent manner, to the effect that the report should not be viewed as\nmedical advice and is not meant to replace direct communication with a\nphysician or other health care practitioner.\n
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