2022 New York Laws
PBH - Public Health
Article 5 - Laboratories
Title 5 - Clinical Laboratory and Blood Banking Services
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.