Florida Senate - 2026 SB 1534 By Senator Pizzo 37-01625-26 20261534__ Page 1 of 4 CODING: Words stricken are deletions; words underlined are additions. A bill to be entitled 1

An act relating to patient-directed blood donations; 2 amending s. 381.0601, F.S.; providing a

short title; 3 defining terms; requiring blood banks to comply with a 4 licensed physician’s order for an autologous or 5 directed blood donation for a named patient, subject 6 to certain conditions; requiring hospitals that 7 facilitate blood donations or contract with blood 8 banks to allow patients to provide autologous or 9 directed donations under certain circumstances; 10 authorizing blood banks and hospitals to charge a 11 reasonable and necessary fee to cover administrative 12 costs; providing requirements for the fee structure; 13 providing construction; requiring that all autologous 14 and directed donations be collected, tested, stored, 15 and transfused in accordance with certain laws and 16 standards; requiring that a unit of blood or blood 17 component collected for an autologous or directed 18 donation for a specific patient be reserved for that 19 patient; providing exceptions; providing for the 20 reversion of a reserved unit of blood or blood 21 component to general inventory to be used for other 22 patients under certain circumstances; authorizing the 23 use of a reserved unit of blood or blood component in 24 certain emergency circumstances; authorizing the 25 Department of Health to adopt rules; providing an 26 effective date. 27 28 Be It Enacted by the Legislature of the State of Florida: 29 Florida Senate - 2026 SB 1534 37-01625-26 20261534__ Page 2 of 4 CODING: Words stricken are deletions; words underlined are additions. 30

Section

Section 381.0601, Florida Statutes, is amended 31 to read: 32 (Substantial rewording of section. See 33 s. 381.0601, F.S., for present text.) 34 381.0601 Patient-directed blood donations.— 35

(1) SHORT TITLE.—This

section may be cited as the “Patient-36 Directed Blood Donation Act.” 37

(2) DEFINITIONS.—As used in this section, the term: 38 (a) “Autologous donation” means the collection and storage 39 of blood or blood components from an individual for transfusion 40 back to the same individual. 41 (b) “Blood bank” means any entity licensed under state or 42 federal law to collect, process, store, or distribute human 43 blood or blood components. 44 (c) “Directed donation” means the collection and storage of 45 blood or blood components from a specific donor for transfusion 46 to a specifically identified patient, ordered by a licensed 47 physician. 48 (d) “Hospital” has the same meaning as in s. 395.002. 49

(3) COMPLIANCE WITH PHYSICIAN ORDERS; DUTIES OF BLOOD BANKS 50 AND HOSPITALS.— 51 (

a) A blood bank shall comply with a licensed physician’s 52 order for an autologous or directed blood donation for a named 53 patient, subject to applicable medical suitability criteria and 54 the availability of services at that facility. 55 (

b) A hospital that facilitates blood donations or 56 contracts with a blood bank shall allow a patient who is 57 scheduled for a medical procedure to provide autologous or 58 Florida Senate - 2026 SB 1534 37-01625-26 20261534__ Page 3 of 4 CODING: Words stricken are deletions; words underlined are additions. directed donations if ordered by the patient’s licensed 59 physician, to the extent that such donations are medically 60 appropriate and logistically feasible. 61

(4) ADMINISTRATIVE FEES.— 62 (

a) A blood bank or hospital may charge a fee that is 63 reasonable and necessary to cover the administrative costs of 64 facilitating autologous and directed donations, including 65 collection, processing, testing, storage, and distribution. 66 (

b) Fees authorized under this subsection may not be 67 structured in a manner that unreasonably deters medically 68 appropriate autologous or directed donations as ordered by a 69 licensed physician. 70

(5) SAFETY AND REGULATORY COMPLIANCE.—This

section does not 71 alter or diminish any requirement under federal or state law 72 regarding donor eligibility, screening, testing, labeling, 73 storage, recordkeeping, or compatibility of blood and blood 74 components, including requirements of the United States Food and 75 Drug Administration and applicable accreditation standards. All 76 autologous and directed donations must be collected, tested, 77 stored, and transfused in accordance with such laws and 78 standards. 79

(6) REVERSION TO GENERAL INVENTORY; EMERGENCY EXCEPTION.— 80 (

a) A unit of blood or blood component collected as an 81 autologous or directed donation for a specific patient must be 82 reserved for that patient, consistent with medical and 83 regulatory requirements, until one of the following occurs: 84 1. The patient no longer requires the unit; or 85 2. The unit is no longer medically appropriate for 86 transfusion to that patient. 87 Florida Senate - 2026 SB 1534 37-01625-26 20261534__ Page 4 of 4 CODING: Words stricken are deletions; words underlined are additions. (

b) When a reserved unit is no longer needed or medically 88 appropriate for the designated patient, and remains suitable for 89 transfusion, the unit may revert to general inventory and be 90 used for other patients in accordance with applicable laws and 91 standards. 92 (

c) In a documented emergency in which an immediate 93 transfusion is necessary to prevent serious harm or death and no 94 suitable alternative unit is available, a reserved unit may be 95 released for emergency use in another patient, consistent with 96 federal and state requirements and hospital policies. 97

(7) RULEMAKING.—The Department of Health may adopt rules to 98 implement this section, including to provide guidance on 99 reasonable and necessary fees and any reporting or documentation 100 needed to demonstrate compliance with this section. 101

Section 2. This act shall take effect July 1, 2026. 102