HB 1401 2003
1	CHAMBER ACTION
2
3
4
5	The Committee on Health Care recommends the following:
6
7	Committee Substitute
8	Remove the entire bill and insert:
9	A bill to be entitled
10	An act relating to blood establishments; creating part V of
11	chapter 483, F.S., consisting of s. 483.911, F.S.; defining
12	the term "blood establishment"; requiring that a blood
13	establishment be operated in compliance with federal
14	regulations for blood establishments in order to operate in
15	the state; declaring a blood establishment that is
16	operating in a manner that is not consistent with such
17	federal regulations a nuisance; authorizing the Agency for
18	Health Care Administration or any state attorney to bring
19	an action for injunction to cease operations or enjoin
20	future operations of any blood establishment that is
21	operating in a manner not consistent with such federal
22	regulations; providing an effective date.
23
24	Be It Enacted by the Legislature of the State of Florida:
25
26	Section 1. Part V of chapter 483, Florida Statutes,
27	consisting of section 483.911, Florida Statutes, is created to
28	read:
29	PART V
30	BLOOD ESTABLISHMENTS
31	483.911 Blood establishments.--
32	(1) DEFINITION.--For the purposes of this part, a "blood
33	establishment" means any entity, organization, or person
34	operating within the state that examines an individual or
35	individuals for the purpose of blood donation or that collects,
36	processes, stores, tests, or distributes blood or blood
37	components collected from the human body for the purpose of
38	transfusion or any other medical purpose or for the production
39	of any biological product.
40	(2) OPERATION.--Any blood establishment operating in the
41	state shall be prohibited from those activities specified in
42	subsection (1) unless that blood establishment is operated in a
43	manner consistent with the provisions of 21 C.F.R. parts 211 and
44	600-640.
45	(3) CESSATION OF OPERATION.--Any blood establishment
46	determined to be operating in the state in a manner not
47	consistent with the provisions of 21 C.F.R. parts 211 and 600-
48	640 and in a manner that constitutes a danger to the health or
49	well being of donors or recipients as evidenced by the federal
50	Food and Drug Administration's inspection process shall be in
51	violation of this part and shall immediately cease all
52	operations in the state.
53	(4) INJUNCTION.--The operation of a blood establishment in
54	a manner not consistent with the provisions of 21 C.F.R. parts
55	211 and 600-640 and in a manner that constitutes a danger to the
56	health or well being of both donors or recipients as evidenced
57	by the federal Food and Drug Administration's inspection process
58	is declared a nuisance, inimical to the public heath, welfare,
59	and safety. The Agency for Health Care Administration or any
60	state attorney in the name of the people of the state may bring
61	an action for an injunction to restrain such operations or to
62	enjoin the future operation of any blood establishment.
63	Section 2. This act shall take effect October 1, 2003.