Senate Bill sb1582e1

    CS for SB 1582                           First Engrossed (ntc)



  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.

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

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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.






    CS for SB 1582                           First Engrossed (ntc)



 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

 4  Regulations, and in a manner that constitutes a danger to the

 5  health or well-being of donors or recipients as evidenced by

 6  the federal Food and Drug Administration's inspection reports

 7  and the revocation of the blood establishment's license or

 8  registration shall be in violation of this part and shall

 9  immediately cease all operations in the state.

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

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

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

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

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

15  Administration's inspection process is declared a nuisance and

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

17  for Health Care Administration or any state attorney may bring

18  an action for an injunction to restrain such operations or

19  enjoin the future operation of the blood establishment.

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

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