S T A T E O F N E W Y O R K
________________________________________________________________________
7820
2009-2010 Regular Sessions
I N A S S E M B L Y
April 24, 2009
___________
Introduced by M. of A. ROSENTHAL -- read once and referred to the
Committee on Health
AN ACT to amend the public health law, in relation to clinical laborato-
ries and biological data analysis
THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
BLY, DO ENACT AS FOLLOWS:
Section 1. Section 576-b of the public health law, as added by chapter
572 of the laws of 2002, is amended to read as follows:
S 576-b. Performance of certain clinical laboratory services upon
request. 1. (A) 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 Depart-
ment 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.
(B) IN ADDITION TO ANY CLINICAL LABORATORY SERVICE AUTHORIZED UNDER
PARAGRAPH (A) OF THIS SUBDIVISION, A CLINICAL LABORATORY MAY PERFORM A
CLINICAL LABORATORY SERVICE (INCLUDING ACCEPTING A SPECIMEN OR ASSIGN-
MENT 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 FOR PERSONAL GENOMICS OR BIOLOGICAL DATA COLLECTION.
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] (A) EXCEPT AS PROVIDED IN PARAGRAPH (B) OF THIS SUBDIVISION,
THE results of any test conducted pursuant to this section shall be
EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
[ ] is old law to be omitted.
LBD11161-01-9
A. 7820 2
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.
(B) WHERE A CLINICAL LABORATORY PERFORMS A CLINICAL LABORATORY SERVICE
AS PROVIDED FOR IN THIS SECTION, AND WHERE SUCH SERVICE IS FOR PERSONAL
GENOMICS OR BIOLOGICAL DATA COLLECTION, WHEN DIRECTED BY THE PERSON
REQUESTING SUCH SERVICE, A CLINICAL LABORATORY MAY SEND THE RESULTS OF
THE SERVICE TO AN ENTITY FOR BIOLOGICAL DATA ANALYSIS SERVICES. SUCH
BIOLOGICAL DATA ANALYSIS SERVICES SHALL NOT BE CONSIDERED A CLINICAL
LABORATORY SERVICE UNDER THIS ARTICLE. THE RESULTS OF ANY BIOLOGICAL
DATA ANALYSIS SERVICES SHALL BE PROVIDED IN A CLEAR AND CONCISE MANNER
THAT IS UNDERSTANDABLE BY LAY PERSONS, AND SHALL BE SENT DIRECTLY TO THE
PERSON REQUESTING SUCH ANALYSIS.
4. Nothing in this section shall authorize a clinical laboratory, OR
AN ENTITY PROVIDING BIOLOGICAL DATA ANALYSIS SERVICES, to engage in the
practice of any health care profession under title eight of the educa-
tion 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.
S 2. This act shall take effect immediately.