S0712B0784A01119 MSP:EJH 06/16/23 #90 A01119
AMENDMENTS TO SENATE BILL NO. 712
Sponsor: SENATOR J. WARD
Printer's No. 784
Amend Bill, page 1, line 6, by inserting after "penalties,""
further providing for definitions and for exemptions and
Amend Bill, page 1, line 7, by inserting after "tests"
and for source plasma donation center
Amend Bill, page 1, lines 11 through 13, by striking out all
of said lines and inserting
Section 1. Section 2 of the act of September 26, 1951
(P.L.1539, No.389), known as The Clinical Laboratory Act, is
amended by adding definitions to read:
Section 2. Definitions.--The following words and phrases
when used in this act shall have the meanings given to them in
this section unless the context clearly indicates otherwise:
* * *
"Plasma." The fluid portion of human blood.
"Plasmapheresis." A procedure in which, during a single
visit to a facility, blood is removed from an individual, the
source plasma is separated from the formed elements and at least
the red blood cells are returned to the donor.
"Source Plasma Donation Center." A facility where plasma is
collected by plasmapheresis and used as source material for
further manufacturing use. The term shall not include single-
donor plasma products intended for intravenous use.
* * *
Section 2. Section 13 of the act is amended to read:
Section 13. Exemptions.--This act shall not include nor
apply to any laboratory or laboratories maintained and operated
by the Federal government; nor to any laboratory or laboratories
maintained and operated purely for research or teaching
purposes; nor to any source plasma donation center.
Section 3. The act is amended by adding sections to read:
Amend Bill, page 2, line 30; page 3, lines 1 and 2; by
striking out "The term includes genetic" in line 30 on page 2
and all of lines 1 and 2 on page 3 and inserting
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Testing or procedures performed for the purpose of screening,
diagnosing, predisposing, managing or treating a physical or
mental condition or disease. The term shall include germline
genetic and genomic testing.
Section 13.4. Source Plasma Donation Center.--
Notwithstanding any other law, a source plasma donation center
may collect source plasma through plasmapheresis if the source
plasma donation center complies with Federal requirements
governing the collection of source plasma and operation of a
clinical laboratory, including laws governing donor screening
and monitoring, staff qualifications, responsibilities,
supervision, training and duties, in a source plasma donation
center and clinical laboratory.
Amend Bill, page 3, line 3, by striking out "2" and inserting
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Amend Bill, page 3, line 5, by striking out "3" and inserting
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