N.Y. Public Health Law § 576-b: Performance of certain clinical laboratory services upon request

§ 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.