Read the full stored bill text
Florida Senate
-
2026
SB 1534
By
Senator Pizzo
37-01625-26 20261534__
1 A bill to be entitled
2 An act relating to patient-directed blood donations;
3 amending s. 381.0601, F.S.; providing a short title;
4 defining terms; requiring blood banks to comply with a
5 licensed physician’s order for an autologous or
6 directed blood donation for a named patient, subject
7 to certain conditions; requiring hospitals that
8 facilitate blood donations or contract with blood
9 banks to allow patients to provide autologous or
10 directed donations under certain circumstances;
11 authorizing blood banks and hospitals to charge a
12 reasonable and necessary fee to cover administrative
13 costs; providing requirements for the fee structure;
14 providing construction; requiring that all autologous
15 and directed donations be collected, tested, stored,
16 and transfused in accordance with certain laws and
17 standards; requiring that a unit of blood or blood
18 component collected for an autologous or directed
19 donation for a specific patient be reserved for that
20 patient; providing exceptions; providing for the
21 reversion of a reserved unit of blood or blood
22 component to general inventory to be used for other
23 patients under certain circumstances; authorizing the
24 use of a reserved unit of blood or blood component in
25 certain emergency circumstances; authorizing the
26 Department of Health to adopt rules; providing an
27 effective date.
28
29 Be It Enacted by the Legislature of the State of Florida:
30
31 Section 1. Section 381.0601, Florida Statutes, is amended
32 to read:
33
(Substantial rewording of section. See
34
s.
381.0601
, F.S., for present text.)
35
381.0601 Patient-directed
blood
donations.—
36
(1)
SHORT TITLE.
—
This
section
may be cited as the “Patient
37
Directed Blood Donation Act.”
38
(2)
DEFINITIONS.
—
As used in this section
,
the term:
39
(a)
“Autologous donation” means the collection and storage
40
of blood or blood component
s
from an individual for transfusion
41
back to the same individual.
42
(
b
)
“Blood bank” means any entity licensed under state or
43
federal law to collect, process, store, or distribute human
44
blood or blood components.
45
(
c
)
“Directed donation” means the collection and storage of
46
blood or blood component
s
from a specific donor for transfusion
47
to a specifically identified patient, ordered by a licensed
48
physician.
49
(d)
“Hospital” has the same meaning as in s. 395.002
.
50
(3)
COMPLIANCE WITH PHYSICIAN ORDERS
; DUTIES OF BLOOD BANKS
51
AND HOSPITALS
.
—
52
(a)
A blood bank shall comply with a licensed physician’s
53
order for an autologous or directed blood donation for a named
54
patient, subject to applicable medical suitability criteria and
55
the availability of services at that facility.
56
(b)
A hospital that facilitates blood donations or
57
contracts with a blood bank shall allow a patient who is
58
scheduled for a medical procedure to provide autologous or
59
directed donations
if
ordered by the patient’s licensed
60
physician, to the extent
that
such donations are medically
61
appropriate and logistically feasible.
62
(4)
ADMINISTRATIVE FEES.
—
63
(a)
A blood bank or hospital may charge a fee that is
64
reasonabl
e and
necessary to cover the administrative costs of
65
facilitating autologous and directed donations, including
66
collection, processing, testing, storage, and distribution.
67
(b)
Fees authorized under this subsection may not be
68
structured in a manner that unreasonably deters medically
69
appropriate autologous or directed donations as ordered by a
70
licensed physician.
71
(5)
SAFETY AND REGULATORY COMPLIANCE.
—This section does not
72
alter or diminish any requirement under federal or state law
73
regarding donor eligibility, screening, testing, labeling,
74
storage, recordkeeping, or compatibility of blood and blood
75
components, including requirements of the United States Food and
76
Drug Administration and applicable accreditation standards.
All
77
autologous and directed donations
must
be collected, tested,
78
stored, and transfused in accordance with such laws and
79
standards.
80
(6)
REVERSION TO GENERAL INVENTORY; EMERGENCY EXCEPTION.
—
81
(a)
A unit of blood or blood component collected as an
82
autologous or directed donation for a specific patient
must
be
83
reserved for that patient, consistent with medical and
84
regulatory requirements, until
one of the following occurs
:
85
1.
The patient no longer requires the unit
;
or
86
2.
The unit is no longer medically appropriate for
87
transfusion to that patient.
88
(b)
When a reserved unit is no longer needed or medically
89
appropriate for the designated patient, and remains suitable for
90
transfusion, the unit may revert to general inventory and be
91
used for other patients in accordance with applicable laws and
92
standards.
93
(c)
In a documented emergency in which an immediate
94
transfusion is necessary to prevent serious harm or death and no
95
suitable alternative unit is available, a reserved unit may be
96
released for emergency use in another patient, consistent with
97
federal and state requirements and hospital policies.
98
(7)
RULEMAKING.
—
The Department of Health may adopt rules to
99
implement this
section
, including
to provide
guidance on
100
reasonable and necessary fees and any reporting or documentation
101
needed to demonstrate compliance with this section.
102 Section 2. This act shall take effect July 1, 2026.