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This entry was published on 2014-09-22
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SECTION 576-B
Performance of certain clinical laboratory services upon request
Public Health (PBH) CHAPTER 45, ARTICLE 5, TITLE 5
§ 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.