S T A T E O F N E W Y O R K
________________________________________________________________________
9915
I N A S S E M B L Y
February 27, 2020
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Introduced by M. of A. GOTTFRIED -- read once and referred to the
Committee on Health
AN ACT to amend the public health law, in relation to source plasma
donation centers
THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
BLY, DO ENACT AS FOLLOWS:
Section 1. Section 571 of the public health law is amended by adding
two new subdivisions 2-a and 2-b to read as follows:
2-A. "SOURCE PLASMA DONATION CENTER" MEANS A FACILITY WHERE SOURCE
PLASMA IS COLLECTED BY PLASMAPHERESIS. "SOURCE PLASMA" MEANS THE FLUID
PORTION OF HUMAN BLOOD COLLECTED BY PLASMAPHERESIS AND INTENDED AS
SOURCE MATERIAL FOR PLASMA PROTEIN THERAPIES. "SOURCE PLASMA DONATION
CENTER" SHALL NOT INCLUDE SINGLE DONOR PLASMA PRODUCTS INTENDED FOR
INTRAVENOUS USE.
2-B. "PLASMAPHERESIS" MEANS A PROCEDURE IN WHICH, DURING A SINGLE
VISIT TO THE FACILITY, BLOOD IS REMOVED FROM AN INDIVIDUAL, THE SOURCE
PLASMA SEPARATED FROM THE FORMED ELEMENTS, AND AT LEAST THE RED BLOOD
CELLS ARE RETURNED TO THE DONOR.
§ 2. The public health law is amended by adding a new section 575-a to
read as follows:
§ 575-A. SOURCE PLASMA DONATION CENTERS. 1. A SOURCE PLASMA DONATION
CENTER MAY COLLECT SOURCE PLASMA THROUGH PLASMAPHERESIS, AND MAY EMPLOY
A PERSON TO PERFORM TOTAL PROTEIN TESTS USING DIGITAL REFRACTOMETERS, IF
THE SOURCE PLASMA DONATION CENTER AND SUCH PERSON COMPLY WITH ALL THE
REQUIREMENTS OF FEDERAL LAW AND REGULATIONS GOVERNING THE COLLECTION OF
SOURCE PLASMA, INCLUDING, BUT NOT LIMITED TO, LAWS GOVERNING STAFF
SUPERVISION, TRAINING, AND DUTIES, INCLUDING REQUIREMENTS FOR PERFORMING
TOTAL PROTEIN TESTS USING DIGITAL REFRACTOMETERS IN A SOURCE PLASMA
DONATION CENTER.
2. THE COMMISSIONER MAY MAKE REASONABLE ADDITIONAL REGULATIONS GOVERN-
ING SOURCE PLASMA DONATION CENTERS, INCLUDING REQUIREMENTS FOR REGISTRA-
TION AS A SOURCE PLASMA DONATION CENTER AND PAYMENT OF A REASONABLE
REGISTRATION FEE. RULES AND REGULATIONS APPLICABLE TO SOURCE PLASMA
DONATION CENTERS SHALL BE CONSISTENT WITH THIS SECTION.
EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
[ ] is old law to be omitted.
LBD15433-01-0
A. 9915 2
§ 3. This act shall take effect on the one hundred eightieth day after
it shall have become a law. Effective immediately, the addition, amend-
ment and/or repeal of any rule or regulation necessary for the implemen-
tation of this act on its effective date are authorized to be made and
completed on or before such effective date.