PRINTER'S NO. 2211
THE GENERAL ASSEMBLY OF PENNSYLVANIA
HOUSE BILL
No.
1795
Session of
2023
INTRODUCED BY GERGELY, BRIGGS, MADDEN, FRANKEL, SANCHEZ,
BRENNAN, GIRAL, HILL-EVANS, ROZZI, DALEY AND DONAHUE,
OCTOBER 25, 2023
REFERRED TO COMMITTEE ON HEALTH, OCTOBER 25, 2023
AN ACT
Amending the act of September 26, 1951 (P.L.1539, No.389),
entitled "An act defining clinical laboratory; regulating the
operation of the same; requiring such laboratories to obtain
permits, and to be operated under the direct supervision of
qualified persons; imposing certain duties upon the
Department of Health; and providing penalties," further
providing for definitions and for exemptions.
The General Assembly of the Commonwealth of Pennsylvania
hereby enacts as follows:
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
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the red blood cells are returned to the donor.
"Source plasma donation center." A facility where plasma is
collected by plasmapheresis and used as a source material for
further manufacturing use. The term does 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]:
(1) Any laboratory or laboratories maintained and
operated by the Federal government[; nor to any].
(2) Any laboratory or laboratories maintained and
operated purely for research or teaching purposes.
(3) Any source plasma donation center that performs only
hematocrit and total protein donor eligibility tests.
Section 3. This act shall take effect in 60 days.
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