Pennsylvania Act 2024-6 — CLINICAL LABORATORY ACT - DEFINITIONS AND EXEMPTIONS

Act text

Session of 2024

No. 2024-6

HB 1795

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:

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"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 a source material for further manufacturing use. The term does not include single donor plasma products intended for intravenous use.

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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.

APPROVED--The 15th day of April, A.D. 2024.

JOSH SHAPIRO