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THE BILL ITSELF

SB 1534

Patient-directed Blood Donations

VERSION S 1534 Filed · BACK TO THE SUMMARY · OFFICIAL RECORD

underlined language is being added; struck language is being deleted. Line numbers are the Legislature's own — the same ones amendments cite.

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.
29 Be It Enacted by the Legislature of the State of Florida:
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 components 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 components 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 reasonable 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.