Senate Bill sb1582c1

    Florida Senate - 2003                           CS for SB 1582

    By the Committee on Health, Aging, and Long-Term Care; and
    Senator Saunders




    317-2248-03

  1                      A bill to be entitled

  2         An act relating to blood establishments;

  3         defining the term "blood establishment";

  4         providing standards for the operation of a

  5         blood establishment; declaring a blood

  6         establishment that does not meet those

  7         standards to be nuisance; authorizing the

  8         Agency for Health Care Administration or any

  9         state attorney to bring an action for

10         injunction to cease operations or enjoin future

11         operations of any blood establishment that does

12         not meet the standards and that endangers

13         donors or recipients; providing an effective

14         date.

15  

16  Be It Enacted by the Legislature of the State of Florida:

17  

18         Section 1.  Blood establishments.--

19         (1)  As used in this section, the term "blood

20  establishment" means any person, entity, or organization,

21  operating within the state, which examines an individual for

22  the purpose of blood donation or which collects, processes,

23  stores, tests, or distributes blood or blood components

24  collected from the human body for the purpose of transfusion,

25  for any other medical purpose, or for the production of any

26  biological product.

27         (2)  Any blood establishment operating in the state may

28  not conduct any activity defined in subsection (1) unless that

29  blood establishment is operated in a manner consistent with

30  the provisions of parts 211 and 600-640 of Title 21, Code of

31  Federal Regulations.

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CODING: Words stricken are deletions; words underlined are additions.






    Florida Senate - 2003                           CS for SB 1582
    317-2248-03




 1         (3)  Any blood establishment determined to be operating

 2  in the state in a manner not consistent with the provisions of

 3  parts 211 and 600-640 of Title 21, Code of Federal Regulations

 4  and in a manner that constitutes a danger to the health or

 5  well-being of donors or recipients, as evidenced by the

 6  federal Food and Drug Administration's inspection process is

 7  in violation of this section and shall immediately cease all

 8  operations in the state.

 9         (4)  The operation of a blood establishment in a manner

10  not consistent with the provisions of parts 211 and 600-640 of

11  Title 21, Code of Federal Regulations and in a manner that

12  constitutes a danger to the health or well-being of blood

13  donors or recipients as evidenced by the federal Food and Drug

14  Administration's inspection process is declared a nuisance and

15  inimical to the public health, welfare, and safety. The Agency

16  for Health Care Administration or any state attorney may bring

17  an action for an injunction to restrain such operations or

18  enjoin the future operation of the blood establishment.

19         Section 2.  This act shall take effect July 1, 2003.

20  

21          STATEMENT OF SUBSTANTIAL CHANGES CONTAINED IN
                       COMMITTEE SUBSTITUTE FOR
22                         Senate Bill 1582

23                                 

24  The Committee Substitute adds proper references to the code of
    Federal Regulation and specifies that Food and Drug
25  Administration inspections will provide evidence of unsafe
    activity.
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CODING: Words stricken are deletions; words underlined are additions.