Bill Text: NY A00228 | 2021-2022 | General Assembly | Introduced

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Bill Title: Relates to source plasma donation centers.

Spectrum: Moderate Partisan Bill (Democrat 13-2)

Status: (Passed) 2021-12-21 - approval memo.65 [A00228 Detail]

Download: New_York-2021-A00228-Introduced.html

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                STATE OF NEW YORK
        ________________________________________________________________________

                                           228

                               2021-2022 Regular Sessions

                   IN ASSEMBLY

                                       (Prefiled)

                                     January 6, 2021
                                       ___________

        Introduced  by  M.  of A. GOTTFRIED, ABINANTI, McDONOUGH, THIELE -- 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:

     1    Section 1. Section 571 of the public health law is amended  by  adding
     2  two new subdivisions 2-a and 2-b to read as follows:
     3    2-a.  "Source  plasma  donation  center" means a facility where source
     4  plasma is collected by plasmapheresis. "Source plasma" means  the  fluid
     5  portion  of  human  blood  collected  by  plasmapheresis and intended as
     6  source material for plasma protein therapies.  "Source  plasma  donation
     7  center"  shall  not  include  single  donor plasma products intended for
     8  intravenous use.
     9    2-b. "Plasmapheresis" means a procedure  in  which,  during  a  single
    10  visit  to  the facility, blood is removed from an individual, the source
    11  plasma separated from the formed elements, and at least  the  red  blood
    12  cells are returned to the donor.
    13    § 2. The public health law is amended by adding a new section 575-a to
    14  read as follows:
    15    §  575-a.  Source plasma donation centers. 1. A source plasma donation
    16  center may collect source plasma through plasmapheresis, and may  employ
    17  a person to perform total protein tests using digital refractometers, if
    18  the  source  plasma  donation center and such person comply with all the
    19  requirements of federal law and regulations governing the collection  of
    20  source  plasma,  including,  but  not  limited  to, laws governing staff
    21  supervision, training, and duties, including requirements for performing
    22  total protein tests using digital  refractometers  in  a  source  plasma
    23  donation center.

         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD00571-01-1
        A. 228                              2

     1    2. The commissioner may make reasonable additional regulations govern-
     2  ing source plasma donation centers, including requirements for registra-
     3  tion  as  a  source  plasma  donation center and payment of a reasonable
     4  registration fee. Rules and  regulations  applicable  to  source  plasma
     5  donation centers shall be consistent with this section.
     6    § 3. This act shall take effect on the one hundred eightieth day after
     7  it  shall have become a law. Effective immediately, the addition, amend-
     8  ment and/or repeal of any rule or regulation necessary for the implemen-
     9  tation of this act on its effective date are authorized to be  made  and
    10  completed on or before such effective date.